November 2006 Archives

FDA Safety Changes: CNS Stimulants and Roferon A

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roferon aNovember 29, 2006 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise that use of central nervous system stimulants may increase the risk for cardiovascular events and exacerbate psychotic symptoms in certain patients and that chronic use may cause temporary suppression of growth rate in children. Also, interferon-alfa-2a [recombinant] subcutaneous injection may be linked to potential risks for severe infection and pancreatitis.

CNS Drugs May Potentiate Risk for Sudden Death

The FDA approved safety labeling revisions in August for dexmethylphenidate HCl tablets and extended-release capsules (Focalin and Focalin XR, made by Novartis Pharmaceuticals Corp), methylphenidate HCl extended-release capsules (Metadate CD, made by UCB Pharma, Inc), methylphenidate chewable tablets/oral solution (Methylin, made by Mallinckrodt), and methylphenidate tablets, sustained-release tablets, and extended-release capsules (Ritalin, Ritalin SR, and Ritalin LA, made by Novartis Pharmaceuticals Corp).

Private HMOs cost more to Medicare

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medicare card CHICAGO (Reuters) - Private insurers in the Medicare insurance program were paid 12.4 percent more by the government than the health care provided would have cost under traditional Medicare, a report released on Thursday said.

Payments to private insurers were $922 more per enrollee in 2005 than they would have been to the government-run program, the report by the nonprofit research group the Commonwealth Fund said.

Private managed-care companies have taken a bigger role in Medicare, the health insurance program for 43 million elderly, after recent changes pushed by President George W. Bush and the Republican-led U.S. Congress.

Medical reviews often face ethics conflicts

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ethics conflict BOSTON (Reuters) - Scientists assigned to monitor the ethics of medical studies often help decide whether to approve research even when they have financial ties to the company sponsoring the work, a study shows.

Almost one-third of those polled said they "sometimes" or "always" voted on research projects where they had a relationship with the sponsor or the experiment was sponsored by a company competing with one they were financially linked with.

Under federal regulations, researchers who review medical experiments are supposed to avoid conflicts of interest so that patients who volunteer in studies are not subject to reckless research in which scientists might make a profit.

America: 60s are the new middle age

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cosmetic surgeryThirty years ago in America the consensus was a 35-year-old person was middle-aged. Thirty years later that same person can still claim to be middle-aged, according to a new survey released on Monday.

Global research group AC Nielsen surveyed people in 42 countries and found 60 percent of Americans, the world's biggest consumers of cosmetic surgery and anti-aging skincare, believe their sixties are the new middle age.

Cosmetic surgery is altering not just how people look but how they feel by changing perceptions of middle age.

Ob/Gyn Group Urges Pregnant Women to Shun Paxil

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paxilHealthDay News -- A group representing America's obstetricians is recommending that women avoid the antidepressant Paxil if they are pregnant or planning on becoming pregnant, due to a potential heightened risk for birth defects.

The American College of Obstetricians and Gynecologists (ACOG) also cautioned that treatment with other antidepressants should be considered on a case-by-case basis.

ACOG's Committee on Obstetric Practice "recommends that treatment with all SSRIs [selective serotonin reuptake inhibitors] or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible," read the statement, which is in the December issue of Obstetrics & Gynecology.

Dynavax shares rocket on hepatitis B vaccine data

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dynavaxSAN FRANCISCO (MarketWatch) -- Dynavax Technologies Corp. shares soared as much as 44% Wednesday to reach their highest level ever after the company said its experimental hepatitis B vaccine protected all of the patients it tested in a late-stage clinical trial.

Shares of the Berkeley, Calif.-based drugmaker (DVAX) were changing hands for $9.96 in afternoon trading, up $2.56 and off an earlier high of $10.66.

Dynavax said that after three doses, its Heplisav vaccine protected 100% of a "difficult-to-immunize" population of adults aged 40 to 70 years compared with GlaxoSmithKline PLC's (GSK) Engerix-B vaccine, which was found to protect 73.1% of such people. In those ranging from 56 to 70 years of age, Heplisav's rate of protection was similarily 100% vs. a 56.1% rate for Engerix-B.

Health Tip: Who Needs Aspirin?

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aspirinHealthDay News -- Aspirin is often recommended by cardiologists for its blood-thinning properties, but the medication can lead to complications, including stomach problems.

The Cleveland Clinic says you should always check with your doctor before starting a daily aspirin regimen.

In general, the clinic says, people at risk for the following conditions may benefit from aspirin therapy:
  • Heart attack
  • Blood clots or stroke caused by blood clots
  • Unstable angina
  • Transient ischemic attacks (TIAs) or "mini-strokes
source - Healthday

Merck fights each lawsuit but the costs are adding up

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vioxx(Houston Chronicle (KRT) Via Thomson Dialog NewsEdge) Nov. 28--In September 2004, when pharmaceutical giant Merck withdrew its best-selling painkiller Vioxx amid concern over potentially fatal side effects, many of the nation's plaintiff lawyers were wide-eyed with anticipation.

Ominous headlines had circulated for years, prompted by studies that indicated Vioxx increased the risk of a heart attack or stroke. Merck's decision to withdraw the drug from the market, despite annual sales of $2.5 billion, was an invitation for lawsuits.

A trickle grew into a steady stream and eventually a torrent of litigation. The plaintiffs' prospects looked good, especially after the New England Journal of Medicine published an editorial accusing Merck of concealing heart attacks suffered by individuals who were part of a Vioxx study reported in the prestigious magazine in 2000.

FDA Questions Celebrex for Kids' Arthritis

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celebrexPfizer Inc. may fall short in convincing federal regulators that its painkiller Celebrex should receive expanded approval to treat children with a devastating form of arthritis, according to documents released Tuesday.

Pfizer wants Food and Drug Administration approval to sell Celebrex as a treatment for juvenile rheumatoid arthritis, or JRA, which affects as many as 60,000 U.S. children. The disease causes painful joint swelling and can affect growth and development.

However, an FDA review of the New York company's application questions whether the drug works for the pediatric disease. The FDA approved the drug for use in adults with osteoarthritis and rheumatoid arthritis in 1998.

Pfizer to slash U.S. sales force

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pfizerNEW YORK (CNNMoney.com) -- Pfizer said it would cut its U.S. sales force by 20 percent as part of an ongoing effort to reduce costs.

Pfizer (up $0.08 to $27.05, Charts), the world's biggest drug company, announced the impending job cuts in the form of a press release but did not say when the reductions would take place.

The job cuts, which will affect some 2,200 workers, are coming from all levels of Pfizer's sales organization - from senior management to field representatives, Pfizer spokesman Paul Fitzhenry told Reuters.

Painkillers May Threaten Power of Vaccines

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drugsWith flu-shot season in full swing and widespread anticipation of the HPV vaccine to prevent cervical cancer, a new University of Rochester study suggests that using common painkillers around the time of vaccination might not be a good idea.

Researchers showed that certain nonsteroidal anti-inflammatory drugs (NSAIDs), also known as cyclooxygenase inhibitors, react with the immune system in such a way that might reduce the effectiveness of vaccines.

The research has widespread implications: study authors report that an estimated 50 to 70 percent of Americans use NSAIDs for relief from pain and inflammation, even though NSAIDs blunt the body's natural response to infection and may prolong it.

pfizerVANCOUVER, BRITISH COLUMBIA--(CCNMatthews - Nov. 28, 2006) - A major national research project, co-led by Drs. Bruce Carleton and Michael Hayden, to improve drug safety for children, today received a major contribution of $500,000 from Pfizer Canada Inc. The project, named Genotype-Specific Approaches to Therapy in Childhood (GATC), receives major funding from a Genome Canada/Genome BC-sponsored research program and is led from two research centres within the Child & Family Research Institute (CFRI) at BC Children's Hospital.

A failure of modern medicine is the debilitating and lethal consequences of adverse drug reactions (ADRs) which rank as one of the leading causes of death and illness in North America. Children are at a greater risk for severe ADRs, yet there remains a lack of understanding of their causes due in part to an inability to conduct pediatric patient studies of similar rigour and scope as in adult populations. The goal of GATC is to promote the health and well-being of Canadian children and of the global pediatric community by developing cost-effective interventions to reduce life-long disabilities and deaths caused by severe ADRs. The project will identify pediatric patients experiencing ADRs, collect DNA samples, apply genomics-based technologies to identify ADR-associated genetic markers and help predict and prevent drug toxicity.

Cost of California health-care push questioned

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Arnold Schwarzenegger (courtesy Reuters) SAN FRANCISCO (Reuters) - With California facing a $5.5-billion budget gap, Gov. Arnold Schwarzenegger may have to pare his goal of providing health-care coverage to the nearly 7 million uninsured in the state, analysts said on Monday.

The Republican governor crushed his Democratic challenger in an easy re-election victory this month, and aims to use the political momentum to push a plan that on its face should excite California's Democrat-led legislature.

But observers of the state's political scene wonder where money for the plan, which aides are writing, would come from.

"The math doesn't add up," said Larry Gerston, a political scientist at San Jose State University. "I don't understand the means at the moment."

China bans medical ads

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china BEIJING (Reuters) - China, responding to complaints from the public, has banned advertisements for medical treatments and procedures in a bid to halt bogus claims of wonder drugs and clean up an unregulated health industry.

The ban would cover advertising on television, radio and in newspapers and take effect on Jan 1, the Beijing News said on Tuesday.

It would ban guarantees of effectiveness, and the "use of sufferers" and medical personnel to promote treatments and procedures.

Cloning Techniques Produce FDA-approved Antibiotic

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fosfomycinThe successful synthesis of an antibiotic in a non-native host has provided a team of researchers at the University of Illinois at Urbana-Champaign with the potential for developing new treatments for bacterial infections.

The rapid rise of antibiotic resistance poses a serious threat to human health, and demands new treatments effective against resistant pathogens. Fosfomycin is a natural antibiotic approved by the Food and Drug Administration for the treatment of various bacterial infections, and has proven effective for the treatment of infections that have become resistant to the antibiotics penicillin and vancomycin.

Fosfomycin is a member of a class of compounds called phosphonic acids because they contain a carbon-phosphorous bond. Fosfomycin functions by inactivating an essential enzyme involved in the formation of the bacterial cell wall.

Bayer Third-Quarter Profit Beats Analyst Estimates

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bayerBayer AG, Germany's largest drugmaker, said third-quarter profit fell less than analysts estimated and raised the earnings forecast for its pharmaceuticals unit after the 17 billion-euro ($22.3 billion) purchase of Schering AG.

Net income fell 35 percent to 320 million euros, or 42 cents a share, from 493 million euros, or 68 cents, a year earlier, Leverkusen-based Bayer said today. That exceeded the 195 million euro median estimate of nine analysts surveyed by Bloomberg. Sales rose 26 percent to 7.78 billion euros.

Schering's Betaferon multiple sclerosis treatment and Yasmin birth-control pills led the drug unit's gain. Bayer expanded the drug division as governments and health insurers around the world cut health-care spending by trimming prices and using generic medicines. Bayer will close sites in the U.S. in a plan to slash expenses by 700 million euros a year to counter higher raw material costs and the crop-science unit's falling profit.

Cytokinetics says to bear cancer drug development costs

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cytocineticsNov 27 (Reuters) - Cytokinetics Inc. (CYTK.O: Quote, Profile, Research) said it will be responsible for the costs and activities of further development of two cancer drug candidates following an amendment of a collaboration agreement with GlaxoSmithKline plc (GSK.N: Quote, Profile, Research).

The company also lowered its 2006 revenue outlook to $3 million to $4 million, with research and development expense of $52 million to $56 million. Analysts on average were expecting the company to report revenue of $3.8 million, according to Reuters Estimates. (Reporting by Hari Kumar in Bangalore)

© Reuters 2006.

Warning Issued on Dangers of Methadone

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methadonePeople starting treatment with methadone have died and suffered life-threatening side effects, health officials said Monday in warning of the dangers of overdosing on the painkiller.

Overdoses of the increasingly popular narcotic can cause slow or shallow breathing and dangerous changes in heart beat that patients might not feel, the Food and Drug Administration said.

Those side effects, including reports of deaths, have been seen in patients starting methadone treatment for severe pain or who switched to the drug after using other strong narcotic pain relievers, the FDA said in a public health advisory.

The FDA warned that methadone only provides pain relief for four to eight hours, but can linger in the body for eight to 59 hours. That can lead patients to take more of the drug before it has been eliminated by the body, causing the drug to build up in the body to toxic levels, the FDA said.

alba therapeuticsBALTIMORE, Md. - Alba Therapeutics Corporation announced today that it secured a $10 million venture debt commitment from a syndicate consisting of Atel Ventures, Inc., Oxford Finance Corporation and SVB Silicon Valley Bank. This additional source of capital will enable the company to accelerate the clinical development of AT-1001 in celiac disease and other autoimmune indications during 2007.

AT-1001 is an orally administered zonulin receptor antagonist that is currently under investigation in a multicenter, double blind, placebo controlled Phase II dose ranging study to evaluate the safety, tolerability and efficacy of AT-1001 in 79 CD subjects during gluten challenge.

"The promising clinical and preclinical data generated with AT-1001 in celiac disease and other autoimmune conditions warranted that we access this capital in order to expedite activities supporting clinical trials," said Blake Paterson, M.D., Chief Executive Officer of Alba. "We now have the ability to fast track the AT-1001 program to address the enormous unmet needs of celiac patients and others suffering from autoimmune diseases."

AEterna Zentaris: Cancer Drug Tolerated

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aeterna zentarisCanadian biotech drug maker AEterna Zentaris Inc. said Monday that women enrolled in an early stage clinical trial were able to tolerate its experimental cancer treatment.

In the study, 17 women with gynecological and breast cancers were given increasing doses of AN-152, and tolerated the maximum dose of the treatment well, according to the company.

AEterna Zentaris also said that results hinted at effectiveness of the treatment.

Attention woes addressed without use of medication

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play attentionMARYSVILLE, Pa. (AP) — Sierra Lewis was having trouble with her schoolwork. She just couldn't concentrate.

"She's been having problems with staying focused," said her mom, Nancy Lewis of Marysville.

The school, Bible Baptist in Shiremanstown, didn't seem like an issue. It doesn't have a disruptive atmosphere.

So it came back to the 12-year-old and what is often described as Attention-Deficit Hyperactivity Disorder — a persistent pattern of abnormally high levels of activity, impulsiveness or inattention. The answer is usually Ritalin.

Pfizer drug has history of risks

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celebresWASHINGTON -- Despite Celebrex's well-documented link to higher heart risks, Pfizer Inc. wants permission to sell its painkiller to treat children as young as 2 who have arthritis.

Even as critics call for the drug to be removed from the market, Food and Drug Administration advisers will meet Wednesday to consider the company's request to expand Celebrex use.

Celebrex was the first of a class of new-style painkillers, called cox-2 inhibitors , approved in December 1998, and it is the last one to remain on the market. The drugs were designed to relieve pain without causing the stomach distress associated with other treatments, but they have been plagued by safety concerns. Merck & Co. pulled Vioxx from the market in 2004 after its studies showed the painkiller doubled the risk of heart attacks and strokes. Merck now faces more than 20,000 Vioxx lawsuits. Pfizer, under pressure from the FDA, last year halted sales of another cox-2 inhibitor, Bextra , because of heart risks and potentially fatal skin reactions.

Responsible Businesses, Healthy Places To Work?

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businessA study into the relationship between an organisation's understanding and use of corporate social responsibility (CSR) and its health and safety practices has revealed problems within the small- and medium-sized (SME) business sector.

A report by Dr Stavroula Leka and Johanna Churchill from the Institute of Work, Health and Organisations at The University of Nottingham claims there is a lack of knowledge in the areas of both CSR and occupational health and that leadership can be a considerable barrier to the prevention of health and safety problems.
medicaidThe quality of cardiac care for Medicaid patients lags behind the care given to those with HMOs and private insurance according to a new study. The study by Dr. James Calvin, lead study author and director of cardiology at Rush University Medical Center, found Medicaid patients were less likely to receive short term medications and to undergo invasive cardiac procedures. They also had higher in-hospital mortality rates and were less likely to receive recommended discharge care. Differences were fewer and smaller for Medicare patients.

The study is published in the November 21st issue of the Annals of Internal Medicine. In addition to Rush, study participants included Duke University Medical Center, New York University School of Medicine, Northwestern University School of Medicine, University of Cincinnati College of Medicine, and the University of North Carolina at Chapel Hill.
evra patch Health Canada is warning Canadian women that use of a birth control patch may increase their risk of developing blood clots in the legs and lungs.

The department, along with drug maker Janssen-Ortho Inc., issued the statement based on research that showed a U.S. formulation of the company's patch contraceptive may be associated with a higher risk of blood clots than oral birth control pills.

"We're taking the precaution of giving people an additional heads up that there's a risk of blood clots with the product," said Health Canada spokesperson Alastair Sinclair.

China sentences fake Viagra kingpin

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chinaA CHINESE man has been jailed for eight years for making 60 tonnes of fake sex pills, state media reported today as China cracks down on pirates who copy nearly every type of product.

Xi Yongli and his accomplices sold 21.8 million yuan ($3.6 million) worth of America Number One, Male Exclusive, Great Big Brother – the popular Chinese name for Viagra – and other pills and ingredients promising men vibrant sexual lives, a court in central China's Anhui province found, Xinhua news agency said today.

Xi and his gang received sentences spanning from a little over a year to eight years for making and selling medicine without a licence, selling counterfeits, and illegally processing Sildenafil Citrate – the key ingredient in Viagra, Pfizer Inc's top selling male potency pill.

accutaneIsotretinoin is a very effective treatment for severe acne, a condition which can be physically, emotionally, and socially disabling. But the drug can also cause severe birth defects if it is taken by pregnant women. What is the best way to prevent pregnant women from taking the drug, and to prevent women taking it from getting pregnant?

A debate article in PLoS Medicine considers the pros and cons of a new Internet-based system, called iPLEDGE (http://www.ipledgeprogram.com/), which tries to tries to ensure that the drug is dispensed only when there is documentary proof that the patient is not pregnant and is using two forms of birth control.

source - Pharma Lexicon 

mifepristone molecule The New York Times on Tuesday examined the political debates in Australia over the legalization earlier this year of the medical abortion drug mifepristone and whether to pass legislation that would legalize some forms of cloning of human embryos for therapeutic purposes.

According to the Times, Australians often are divided on so-called "values" issues, but political debates on such issues "do not degenerate into personal attacks" as they sometimes do in the U.S. In addition, political candidates in Australia are "not concerned with playing to religious groups," and the political climate has led to Australian politicians having "candid debates on very emotional subjects," the Times reports.

The Australian Parliament in 2002 banned all types of cloning but called for a review of the ban after three years, and in 2005 a government-appointed committee recommended that therapeutic cloning be legalized.

Folic acid can cut heart attack risk

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folic acidLONDON - Can taking folic acid supplements reduce the risk of heart disease and stroke? British researchers believe it can.

After analysing evidence from earlier studies, a team of scientists in Britain said on Friday there is enough research that shows folic acid lowers levels of the amino acid homocysteine and reduces the odds of cardiovacular disease.

"The evidence is very persuasive that lowering homocysteine with folic acid will lower your risk of heart attack and stroke by about 10-20 percent," David Wald, of the Wolfson Institute for Preventive Medicine, Barts and the London, Queen Mary School of Medicine and Dentistry in London, said in an interview.

ADAPT Safety Results Now Published

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PLoSA paper appearing this week in the Public Library of Science journal PLoS Clinical Trials presents findings from a large National Institutes of Health sponsored trial regarding the cardiovascular and cerebrovascular safety of two non-steroidal anti-inflammatory drugs (NSAIDs), celecoxib and naproxen. The trial was initially conducted to test whether these drugs might prevent or delay the onset of Alzheimer's disease.

The paper describes the occurrence of adverse cardiovascular events, particularly heart attacks and strokes, in some 2500 elderly people who took celecoxib, naproxen, or placebo for up to 3.5 years while participating in the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT). The cardiovascular risk of NSAIDs is currently a controversial and hotly debated topic. One such drug, the selective COX-2 inhibitor rofecoxib (Vioxx) has been withdrawn from the market due to concerns about its cardiovascular safety. There is also debate over the safety of other selective COX-2 inhibitors, including celecoxib. Not much data from randomized trials exists on the long-term safety of non-selective, or "traditional", NSAIDs, such as naproxen.

FDA seeks drug safety budget boost from pharma

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FDAThe US Food and Drug Administration (FDA) and the pharmaceutical industry are in strong negotiations to decide how much drug companies will pay the agency to review new drugs from the end of next year, when the current law expires.

Last week, the FDA's deputy commissioner Scott Gottlieb said that pharma companies should contribute additional funds so the agency can study the drugs' safety once they reach the market.

The US drug industry is now negotiating the fourth version of the Prescription Drug User Fee Act (PDUFA) with the regulator – the outcome could change radically the landscape for pharma companies.

Until now, user fees paid by firms have primarily been used to review the safety and efficacy of new drugs before they are approved to be sold on the market.

Judging the Safety of Aprotinin

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trasylolby Dennis T. Mangano, Ph.D., M.D.

I was troubled by the recent, near-unanimous decision of the Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee publicly advocating the safety of aprotinin1 — despite considerable evidence to the contrary,2,3,4 including our recent study2 and the FDA's own initial 1993 warning regarding "kidney toxicity."5 We learned after the Advisory Committee's meeting of newly disclosed records of 67,000 patients, yielding data that were consistent with our warnings (renal failure, stroke, and heart failure)2 and that were inconsistent with the positions of the committee and Bayer.1,6

In defending the committee's decision, Dr. Hiatt makes allegations in this issue of the Journal regarding our "transparency" (FDA access to our data).7 In fact, there is no question that our independent, nonprofit research groups (the Ischemia Research and Education Foundation [IREF] and the Multicenter Study of Perioperative Ischemia [McSPI] reseasrch group) made every effort to have the FDA review in detail all of the source and derivative data from our study2 and all associated documentation and operating procedures.

Covance invests to gain edge in drug safety testing

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covanceCovance has invested in mass spectrometer technology that it hopes will give it the edge over other contract research organisations (CROs) in the safety testing of new drug candidates.

The company said it was the first CRO to acquire the technology, which “is fast becoming a new standard for qualitative mass spectrometry that enables faster, more sensitive and more reliable detection and identification of compounds in complex mixtures than existing hybrid time-of-flight systems.”

The Thermo LTQ OrbitrapT is said to produce accurate mass data on drugs and metabolites in almost half the time of other mass spectrometers as well as facilitating metabolism evaluation of a drug candidate at a much earlier stage of the development process.

Impax Laboratories gets boost from appeals court ruling

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impax

Impax Laboratories Inc. said Wednesday the U.S. Court of Appeals for the Federal Circuit remanded a patent issue back to the lower court, vacating its ruling that was in favor of Sanofi Aventis LLC.

Hayward-based Impax (OTCBB: IPXL) said the patent relates to the use of riluzole in treating amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

In December, U.S. District Court for the District of Delaware granted a preliminary injunction motion brought by Bridgewater, N.J.-based Aventis, which delayed the entry of Impax's generic version into the market.

US judge rejects national class-action lawsuit over Vioxx

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vioxxNEW YORK (AFP) - A US federal judge refused to allow a class-action lawsuit to proceed against Merck for health problems linked to its Vioxx pain medication, in a major victory for the pharmaceutical giant.

Judge Eldon Fallon, asked by an interstate judicial panel to consider how to handle the thousands of lawsuits filed over Vioxx, said the cases did not meet the criteria for a national class action suit, where one court would hear the case for all plaintiffs.

"While the majority of plaintiffs in this case allegedly suffered either a heart attack or stroke as a result of ingesting Vioxx, the extent of each plaintiffs subsequent injuries varies widely," he said in a 25-page decision.

Introgen gets EU patent for cancer drug

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introgenBiotech drug developer Introgen Therapeutics Inc. on Tuesday said the European Patent Office issued a patent covering the company's platform for killing cancer cells.

The patent, which is one of a family of patents issued to University of Texas and licensed to Introgen exclusively, covers one or more of 40 tumor suppressor genes for inducing programmed cell death in cancer cells.

The company seeks to use synthetic nanoparticles to deliver the genes to cancer cells, and shows promise in treating lung cancers that have spread.

Introgen shares rose a penny to $4.74 in afternoon trading on the Nasdaq.

source - BusinessWeek 

Slipped Disc: Surgery Best for Pain?

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slipped discWith time -- and medical help -- slipped disc pain gets better. But disc surgery is faster and works better for bad pain, a large U.S. study finds.

The study shows that patients with a "slipped" or "ruptured" disc -- what doctors call a herniated disc --won't get worse or become paralyzed if they don't have surgery. Instead, they can expect to get better over time.

But when patients don't want to wait, surgery can mean a quick end to excruciating pain, says study researcher William A. Abdu, MD, medical director of the spine center at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H.

Roche Ends PDL BioPharma Pact

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rochePDL BioPharma, the Fremont, Calif.- based biopharmaceutical company, said that Swiss Roche will discontinue its agreement with PDL to jointly develop and commercialize daclizumab for organ transplant patients on longer-term maintenance therapy.

The co-development agreement between PDL and Roche will formally terminate in May 2007.

Roche made this decision subsequent to a periodic internal review of its development programs.

China BiopharmaceuticalsChina Biopharmaceuticals Holdings, Inc., a leading Chinese pharmaceutical company focused on the development, manufacturing and marketing of innovative drugs in China, today announced the completion of all required clinical trials for Desloratadine tablets for seasonal allergic rhinitis, also known as hay fever. The trials were conducted in six hospitals throughout China. The trial results have been sent to the Chinese State Food and Drug Administration (SFDA) for manufacturing and marketing approval. The Company anticipates an approval response from the SFDA in the second half of 2007.

Desloratadine is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis. It is also indicated for the symptomatic relief of pruritus and the reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria. In China, 30% of the population has suffered from an allergy at least once. The $1.5 billion allergy drug market in China continues to grow at a rate of 15% per year.

AstraZeneca trims EPS forecast on generic Toprol

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astrazeneca LONDON (Reuters) - AstraZeneca Plc said on Wednesday it expected 2006 earnings per share to be at the lower end of its $3.85 to $3.95 forecast range following the launch of a copycat version of its heart drug Toprol XL on Tuesday.

The Anglo-Swedish drugmaker also said it had signed an agreement for Par Pharmaceuticals to distribute an authorised generic version of Toprol XL in the United States.

This follows the launch of an unauthorised copycat formulation by Novartis AG's Sandoz on Tuesday.

(c) Reuters 2006

Target Expands $4 Generic Drug Program

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target shop CHICAGO -- Target Corp. expanded its $4 generic drug program to all of its U.S. pharmacies on Monday, moving beyond states where it was matching a plan offered by rival Wal-Mart.

Target said all of its 1,287 pharmacies across the United States would now offer some generic drugs for $4. It was not immediately clear which generic drugs were on Target's list. Previously, the discount retailer had matched the list of drugs being sold for $4 at Wal-Mart. 

Wal-Mart Stores Inc., the world's largest retailer, started selling certain generic drugs for $4 per prescription in Florida in September. Since then, Wal-Mart has brought the $4 drugs to 37 more states and said it plans to extend the plan to additional states as fast as it can.

somaxonSomaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced positive results from the company's Phase 3 clinical trial evaluating SILENOR(TM) (doxepin HCl) in elderly patients with primary sleep maintenance insomnia. SILENOR(TM) demonstrated a statistically significant improvement compared to placebo in the primary endpoint of this trial, subjective Total Sleep Time (sTST) as measured at week one (p<0.0001). Statistical significance was maintained for all timepoints measured throughout the four week treatment period.

This Phase 3 trial was a randomized, double-blind, placebo-controlled, multi-center, parallel group outpatient trial designed to assess the efficacy and safety of 6mg of SILENOR(TM) in elderly patients with primary sleep maintenance insomnia. The trial enrolled 255 elderly subjects with at least a three month history of insomnia. Safety and efficacy were evaluated over a four week period.

Illicit drug users turning to prescription painkillers

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percocetOTTAWA - Forget heroin. Legal prescription drugs readily available in pharmacies are now the major source of illicit opioid drug abuse in several major Canadian cities, which raises questions about drug control in the country, a new study released today reveals. This tendency was also mentioned in U.S. prescription drug crackdown leads to heroin use.

Although heroin addiction has been one of the most significant drug problems in Canada for years, research shows users are turning to opioids, or prescription painkillers such as Oxycontin, Percocet and morphine, at an increasing rate.

"The intensity of the shift surprised me quite a bit,'' said Dr. Benedikt Fischer, study author and addictions researcher at the Centre for Addictions Research of British Columbia. "This study, for the first time, shows that systematically, and I would not have assumed, this is such a dramatic shift.''

Generic drugs may gain from stronger Democrats

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generic drugsNEW YORK (Reuters) - The newly empowered Democrats' vow to cut healthcare costs might spell bad news for the brand-name pharmaceutical industry, but could provide new momentum for generic drug rivals, the Wall Street Journal reported on its Web site on Tuesday.

Boosting the generics industry may prove to be a politically palatable way to follow up on the party's campaign promises, the paper reported.

It quotes Jake Hansen, a vice president at generic drug manufacturer Barr Pharmaceuticals Inc., as saying that because of the shift in Congress, next year could be the most important year to the generics industry since 1984 -- when Congress passed the law that opened the door to the modern generics business.

One pre-surgery antibiotic dose recommended

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antibioticsCHICAGO (Reuters) - One dose of an antibiotic just before surgery is as good as several spread over 24 hours to fight infections at the operation site, saving money and easing fears about bacterial resistance, a study said on Monday.

While guidelines in recent years have promoted the one-dose concept as the most effective, many surgeons have continued to use a broader approach, said the report from Hospital Sao Francisco, in Ribeirao Preto, Brazil.

Doctors there said they examined infection rates for more than 12,000 patients who had surgery in 2002 and 2003, roughly half of them after a one-dose protocol using a narrow-spectrum antibiotic was begun.

Merck looks for ancient Chinese cancer cure

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merck The German drugs giant Merck is seeking help from the world of traditional Chinese medicine to find a cure for cancer. The Chinese medicine company spun out of Hong Kong's Hutchison Whampoa, Chi-Med, will today unveil a potentially lucrative deal to research oncology on behalf of the German group.

Merck will pay Chi-Med to raid centuries of Chinese medical knowhow in search of a natural cancer-fighting product that it can turn into a marketable Western drug.

The financial terms of the deal were not disclosed, but Chi-Med stands to reap tens of millions of pounds from the partnership if it comes up with a drug that is suitable to be put into trial.

Cancer drug trials halted by regulator

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solbecTRIALS of a potential new cancer treatment made from a noxious weed have been halted after concerns were raised by the drug regulator.

Australian manufacturer Solbec Pharmaceuticals has suspended testing of its developmental drug Coramsine, designed to work alongside chemotherapy to treat advanced cancers.

The company was about to enlist up to 120 skin cancer and kidney cancer patients for trials at 16 hospitals nationwide.

However, concerns raised by the Therapeutic Goods Administration (TGA) have put the studies on hold.

allergy, asthmaDUBLIN, Ireland--(BUSINESS WIRE)--Research and Markets has announced the addition of Espicom Business Intelligences New Drug Futures: Respiratory Chapter to their offering.

This chapter of New Drug Futures evaluates, compares and contrasts the prospects for the compounds that will revolutionise the pharmaceutical industry over the next 5 years and beyond in the respiratory sector. The report includes unique sales forecasts by major product.

The Respiratory market is the fourth largest therapeutic category by sales and generated nearly US$32.4 billion (+8% YoY) in 2005. Sales grew steadily in the US, which accounted for around 54% of global respiratory sales, driven by growth in Advair, GlaxoSmithKline's leading combination therapy for the treatment of asthma/COPD and Merck's Singulair for the treatment of asthma and allergic rhinitis. Sales in Europe are now growing steadily; around 5% following the uptake of new treatments such as Symbicort (AstraZeneca) and Alvesco (Altana/sanofi-aventis) which have yet to be approved in the US markets.

Beta Agonists May Alter the Immune System

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beta agonists in inhalers New research at Wake Forest University School of Medicine suggests that certain inhaled asthma medications – as well as similar chemicals our bodies produce during times of high stress – may worsen diseases such as asthma , heart failure and lupus that involve inflammation.

The scientific team led by Raymond Penn, Ph.D., and Matthew Loza, Ph.D, found that beta-agonists, such as those used in the treatment of asthma, increase the accumulation of type 2 T cells, a type of white blood cell that participates in immune system defense mechanisms. In certain diseases such as asthma and lupus, an over-reactive type 2 T cell response occurs and is believed to contribute to the disease.

“Inhaled beta-agonists are very effective in opening up airways and allowing asthmatics to breathe, but their ability to address the underlying inflammation that causes most asthma has been debated for years,” said Penn, an associate professor in the Department of Internal Medicine and the Center for Human Genomics.

AstraZeneca banking on asthma inhaler

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symbicortThe asthma drug AstraZeneca Plc. plans to bring to the United States next year could be just what the doctor ordered for the pharmaceutical giant as it works to rebuild a drug development pipeline hamstrung by the termination of several once-promising prospects.

In mid-2007, AstraZeneca, whose U.S. headquarters is in Fairfax and which employs about 5,000 statewide, plans to roll out Symbicort.

Symbicort is an asthma inhaler that combines two drugs to treat both the swelling of the airways and constriction of the muscles around the airways.

Genentech Gets Another Approval

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genentechThe hardest thing to do for any biopharmaceutical company is obviously just bringing a drug to market. Drug makers though, can make this process easier or harder on themselves by trying to get their drugs approved with a broader label for more indications or to be used sooner in a disease's progression. Because of the conservative nature of the U.S. Food and Drug Administration (FDA) it's usually a smart idea just to bring a drug to market with one label, and then if additional clinical studies suggest it will be useful in other indications, then patient demand and awareness will drive off-label usage of the drug until it receives a broader label.

Drug developer Genentech has pursued this strategy for most of its top drugs, and it has paid off greatly for it. Today, Genentech finally received formal approval to market its breast cancer therapy Herceptin for the early stages of breast cancer before the disease has spread to other parts of the body in the 30% or so of sufferers of the disease that the drug is effective in.

While this formal approval to use Herceptin earlier in the disease's progression will most likely spur higher sales, sales of the drug have been gaining rapidly since the interim results of the trial that brought about this label expansion were announced in April of last year.

FDA OKs Return of Silicone Breast Implants

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silicone breast implantsHealthDay News -- Despite decades of controversy over the dangers of silicone breast implants, the U.S. Food and Drug Administration on Friday lifted a 14-year ban on their commercial use.

The FDA gave approval to two companies, Allergan Inc., of Irvine Calif., and Mentor Corp, of Santa Barbara, Calif., to market the implants to all women aged 22 and older. Until now, women have only been allowed access to the implants as part of research studies.

"In 1992 the FDA required manufacturers to stop selling silicone gel-filled breast implants because of lack of data to support marketing approval," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said during a late afternoon news conference.

Sleep medication at risk

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ambienMethamphetamine, an illicit drug that took hold in the Western states beginning in the early 1990s and spread eastward, began its journey to the top of the priority list of federal drug agents largely because of its manufacture by Mexican criminal organizations.

As the market for meth expanded, bootleggers discovered an easy source of pseudoephedrine, the base ingredient for their controlled substance of choice -- over-the-counter cold remedies such as Sudafed. It was only a matter of time before special interest groups and law enforcement agencies began to lobby federal and state legislatures to dramatically limit and regulate the public's access to these effective and relatively cheap legal cold medicines. These efforts resulted in state and federal legislative crackdowns on the public's access to theretofore easily-accessible cold remedies.

Have these efforts, which have greatly inconvenienced the American consumer and significantly increased government regulation of lawful drugs, helped stem the tide of methamphetamine abuse? Not really.

Democrats reject changes to Medicaid

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DHHSWASHINGTON - States should be given more freedom to enroll the poorest of the poor into managed care programs and adopt changes that have worked elsewhere, a Medicaid reform panel recommended Friday.

However, Democratic lawmakers have contended that the panel, formed nearly 18 months ago by the Bush administration, has lacked independence. Now that the Democrats control Congress, some analysts are predicting the group's recommendations will be "dead on arrival."

"While some in Congress thought this effort would bear fruit, I see no proof of that in this report," said Rep. John Dingell, D-Mich. "It is the job of the Congress to review the Medicaid program and legislate necessary changes, not a hand-picked commission stacked against working families."

Naproxen Painkillers May Pose Heart Danger

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naproxen WASHINGTON -- Researchers looking at the safety of various arthritis and headache remedies said on Thursday they had found some more evidence that the popular analgesic naproxen may cause heart problems.

The researchers themselves cautioned about reading too much into their findings, and outside experts discounted them.

Nonetheless, the researchers said they thought it was important to present their evidence to help experts sort out what the real dangers are.

Challenge to dementia drug ruling

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aricept, exelonThe Government's health watchdog faces court action over its decision to deny tens of thousands of patients access to dementia drugs.

Companies involved in the marketing of one of the drugs said they had no option but to seek a judicial review of how the National Institute for Health and Clinical Excellence (Nice) reached its conclusions.

Nice rejected an appeal last month over its guidance that states that sufferers with early or late-stage Alzheimer's disease should not have access to Aricept (donepezil), Reminyl (galantamine) or Exelon (rivastigmine).

Alcon Sues Apotex to Block Sales of Generic Eye-Allergy Drug

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apotex incBloomberg -- Alcon Inc., the world's largest eye- care company, sued Apotex Inc. to keep it from selling a generic version of the eye-allergy drug Patanol.

Apotex is seeking U.S. Food and Drug Administration approval to sell a copy of the treatment, whose key ingredient is olopatadine hydrochloride. Alcon, a Swiss company, and its Japanese partner Kyowa Hakko Kogyo Co. claim in a suit filed yesterday in Indianapolis the generic version would infringe a patent expiring in 2015. Patanol first got FDA approval in 1996.

Patanol is the top-seller in the U.S. for the treatment of allergic conjunctivitis, a cause of itching, redness and tearing. The U.S. market for eye-allergy treatments was $460 million last year, Alcon said in its annual report, without disclosing how much of that was in Alcon sales.

Helsinn stops cancer drug clinical trial

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exilixisBiotech drug developer Exelixis Inc. said Thursday its licensee, Helsinn Healthcare SA, discontinued a late-stage cancer drug clinical trial when it was found that chemotherapy was more effective.

Helsinn discontinued enrollment of new patients in the becatecarin (XL119) Phase III clinical trial. The anticancer compound targets tumors of the biliary tract, which helps connect the liver to the small intestine.

Helsinn reported that preliminary analysis of the Phase III data by an independent data monitoring committee indicated that patients treated with chemotherapy demonstrated greater-than-expected survival rates by comparison.

Asthma test to get approval for US

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pharmaxisAn asthma diagnostic from Sydney biotech Pharmaxis is expected to gain marketing approval in the US, despite poorer-than-expected results in a trial with an existing product.

Investors pushed Pharmaxis down 45¢, or more than 13 per cent, after it announced that its product, Aridol, was only marginally better than the existing methacholine.

The US Food and Drug Administration-approved test of more than 500 patients with "predominantly very mild symptoms" showed Aridol detected asthma in 58 per cent of the cases, compared with methacholine's 54 per cent. Analysts said the results would not affect chances of FDA approval because the tests showed the product was safe and at least as efficient as the existing diagnostic.

Pharmaxis shares recovered from an earlier plunge to close 4¢ lower at $3.22.

source -  The Age

Cholesterol drug Ranbaxy wins at US appeals court

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ranbaxyUnlike the Lipitor case where Ranbaxy Laboratories Ltd has been facing severe legal hurdles, a US Court of Appeal has upheld a district court's ruling granting Ranbaxy a 180-day exclusivity on the 80 mg strength of the anti-cholesterol drug, Simvastatin (the generic form of Merck's blockbuster drug, Zocor).

"We are pleased with this decision, for both Ranbaxy and the generic pharmaceutical industry, as it preserves the exclusivity of innovative generic pharmaceutical companies who expend significant effort and finances to introduce affordable generic medicines to the US healthcare system,'' said Jay Deshmukh, Senior Vice-President of Global Intellectual Property, Ranbaxy.

U.S. prescription drug crackdown leads to heroin use

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oxycontinWASHINGTON (Reuters) - A crackdown on illegal use of prescription narcotics like the powerful painkiller OxyContin has caused some addicts to switch to heroin, a Justice Department report said on Wednesday.

The report by the department's National Drug Intelligence Center identified the main drug threats in the United States for the coming year.

"In some areas, such substitutions among prescription drug abusers have been widespread, creating new challenges for local law enforcement and public health agencies compelled to address a widening local heroin user population," it said.

Wal-Mart expands generic drug plan

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wal-martBENTONVILLE, Ark. - Wal-Mart Stores Inc., the world's largest retailer, said Thursday it is expanding its $4 generic prescription program to 11 additional states and adding 17 more prescriptions to the program.

The company is adding 502 stores in Idaho, Kentucky, Maine, Massachusetts, Nebraska, Oklahoma, Rhode Island, South Carolina, Utah, Washington and West Virginia, making the plan available in 38 states so far.

Wal-Mart said it intends to continue to push for expansion to other states as quickly as possible.

source - AP 

J&J cancer test lacks long term data

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veridex llcData on Veridex LLC's lab test to quickly detect breast cancer that has spread to lymph nodes lacks long-term information on survival, U.S. regulatory staff said in documents released on Wednesday.

Veridex, a Johnson & Johnson company, is seeking Food and Drug Administration approval of its GeneSearch Breast Lymph Node Assay to find cancerous growths in lymph node tissue that has been removed from breast cancer patients.

An FDA advisory panel is scheduled to review the test on Thursday and make a recommendation on whether it is safe and effective enough to be marketed. The agency usually follows the recommendations of its outside advisers.

Glaxo wins priority review for Tykerb cancer drug

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GSKGlaxoSmithKline Plc's new breast cancer pill Tykerb will receive a priority review from U.S. regulators in a move that should speed its path onto the world's biggest drugs market next year, it said on Thursday.

Priority review designation requires the U.S. Food and Drug Administration to decide on a drug application six months after submission. Tykerb was filed for U.S. approval on Sept. 18.

The oral cancer treatment is a potential rival to the blockbuster Herceptin, which is given by injection, and is a key new medicine for Europe's biggest drugmaker. Glaxo hopes it will confirm its arrival as a major force in oncology.

Pharmion buys cancer drug developer for $59 mln

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pharmion corpPharmion Corp. on Wednesday said it acquired Cabrellis Pharmaceuticals for an initial cash payment of $59 million to expand its portfolio with a cancer drug candidate currently in mid-stage trials.

Pharmion said it will make two additional payments of $12.5 million each if the small cell lung cancer drug, amrubicin, gets U.S. and EU approval.

The deal will result in a $55 million charge in Pharmion's fourth quarter, the biotechnology company said. Cabrellis has $4 million in net cash.

Millions of Americans in Pain

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United StatesEach month, one in four American adults suffers pain for at least 24 hours. That pain lasts for a year in nearly three-fifths of those over 65 and in 37% of those aged 20 to 44.

These numbers are why the CDC has made pain the focus of this year's annual report card on U.S. health.

The painful facts:

  • In a 2004 survey, more than one in four American adults reported low back pain in the last three months.
  • In 2004, 15% of American adults reported migraine or severe headache in the past three months.
  • In 2004, about one-third of adults over 18 and half of adults 65 and older reported joint pain, joint aches, or joint stiffness in the past 30 days. The knee is the most common site of joint pain.

Supplier to settle Medicaid fraud case for $49.5 million

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omnicare One of the nation's leading suppliers of pharmaceutical services to the elderly has agreed to pay $49.5 million to settle large-scale Medicaid fraud claims, federal officials announced Tuesday.

The fraud claims were contained in lawsuits filed in U.S. District Court in Chicago by the federal government and two whistleblowers who formerly were employees of Omnicare Inc., based in Covington, Ky.

The lawsuits charged that Omnicare gave Medicaid patients Ranitidine capsules instead of less expensive tablets of the same drug; Fluoxetine tablets rather than cheaper Fluoxetine capsules; and two 7.5-milligram Buspirone tablets instead of the less costly single 15-milligram tablets.

Switching the form of the drugs increased the amounts Omnicare charged Medicaid by millions of dollars, officials said.

Chocolate helps the heart. Sweet!

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chocolateResearchers from Johns Hopkins University have found that dark chocolate thins blood and protects the heart in the same way as aspirin. The key is a compound in chocolate called flavanol, which slows down platelet clumping that can block off blood vessels and lead to a heart attack or stroke.

You have to eat at least a couple of tablespoons of dark chocolate a day to see some benefit - and it's still not as effective as a single baby aspirin, which is usually prescribed to heart patients.

Matching aspirin would require eating several bars of chocolate a day, which could lead to other problems, such as obesity and diabetes - to say nothing of tooth decay.

Health Care Reform: Tough Choices

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healthcare surveyPolicy makers are expected to spend the next two years cementing their positions on how to fix the out-of-control costs, mediocre quality, and high uninsured rates plaguing the U.S. health care system.

But it doesn't look like the public is going to be much help.

A national survey released Tuesday showed that eight in 10 American adults believe that the health system has problems and needs improvement. But while that may sound like a consensus for big changes, respondents confirmed what researchers noticed long ago: few are willing to sacrifice to get them.

Genentech raises price of cancer drug Tarceva

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tarcevaBOSTON (Reuters) - Biotechnology company Genentech Inc.  has raised the price of its cancer drug Tarceva by 8 percent in the United States, according to a regulatory filing.

Genentech raised the wholesale price of Tarceva -- which is approved to treat lung and pancreatic cancer -- to $2,893.86 from $2,679.50 for a 30-day supply of 150 milligram tablets, according to a document filed on Tuesday by Genentech's partner, OSI Pharmaceuticals Inc. with the U.S. Securities and Exchange Commission.

The increase comes amid growing concern among doctors, governments and insurers about the cost to consumers of the newest generation of cancer drugs, which can cost tens of thousands of dollars a year.

North American gets cancer treatment OK

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north american scientific Cancer diagnostics and treatment products company North American Scientific Inc. said Tuesday the Food and Drug Administration approved a high-dose radiation version of its breast cancer treatment.

The company received approval for the specific design of ClearPath, its breast brachytherapy, or internal radiation, product. The low-dose rate version was approved in April. Brachytherapy uses radioactive seeds placed through the breast using needles or catheters.

Shares of North American Scientific rose 6 cents, or 5.4 percent, to $1.16 on the Nasdaq in morning trading. The stock has traded between 1 cent and $3 over the last 52 weeks, and is off 49 percent since the start of the year.

source - BusinessWeek 

Saliva Painkiller Beats Morphine

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medical researchPARIS  -- Saliva from humans has yielded a natural painkiller up to six times more powerful than morphine, Paris researchers say.

The substance, dubbed opiorphin, may spawn a new generation of natural painkillers that relieves pain as well as morphine but without the addictive and psychological side-effects of the traditional drug.

One gram of opiorphin injected into rats' paws for every 2.2 pounds of body weight achieved the same painkilling effect as 3 grams of morphine, NewScientist News Service reports.

Pfizer seeking to have Celebrex OKd for kids

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celebrexCelebrex - the only Vioxx-like drug still on drugstore shelves - could soon be sold specifically as a treatment for rheumatoid arthritis in children if the Food and Drug Administration approves a Pfizer request to do so.

The FDA has already approved Celebrex (celecoxib) to fight pain and inflammation but not specifically for use in children. Only 20 percent to 30 percent of FDA-approved drugs are specifically labeled for pediatric use.

But now Manhattan-based Pfizer is seeking FDA approval to market Celebrex specifically in children 2 years and older who have rheumatoid arthritis.

Results mixed on Merck's new painkiller

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arcoxiaCHICAGO - The first published studies of Arcoxia, the drug that Merck & Co. hopes will take the place of its withdrawn painkiller Vioxx, are getting mixed reviews from doctors, some of whom say the results do not make a case for the medication's approval.

The critics cite not just Arcoxia's side effects but also that Merck tested it against diclofenac, an older painkiller known to raise heart risks. A fairer comparison would have been to a medicine that does not do that, such as naproxen, sold as Aleve, they say.

"The development program for Arcoxia is fatally flawed," said Dr. Steven Nissen, a Cleveland Clinic cardiologist who formerly headed the Food and Drug Administration's cardiac drug advisory panel. "My advice to the FDA is that they should not approve this drug."

Spectrum Cancer Drug Meets Study Goal

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spectrumSpecialty drug maker Spectrum Pharmaceuticals Inc. said Monday a midstage study of its developing prostate cancer drug met its primary goal of safety and suppressing testosterone levels.

The drug candidate, called Ozarelix, is aimed at treating prostate cancer, which is the second leading cause of cancer-related deaths in men. In a Phase II clinical trial, a 130-milligram dose given every 4 weeks provided continuous testosterone suppression in patients between day 8 and day 85 of the study. The drug also met a secondary goal, the reduction of a prostate specific antigen.

Spectrum received an exclusive license from AEterna Zentaris in 2004 to develop and market Ozarelix in North America and India. The company will receive half of any payments or profits from sales of the drug in Japan.

William P. Fisher, PhDThe technology for calibrating transparent rating scale-based measures of health and functional status is over 50 years old.[1] It is well researched and documented. It has been used to construct scientifically and legally defensible admissions and professional certification tests for over 30 years, in healthcare and other industries.[2,3]

So how is it that this technology is virtually unknown in health services research? I say virtually unknown, because there are a growing number of applications in healthcare of the mathematical models at issue.[4]

What healthcare does not have, however, is an overarching plan for decentralized networks of different brands and configurations of instruments that measure the same things in the same units.

Robert M Centor, MDby Robert M Centor, MD

While thinking about how to answer this question, I have changed my list several times. My first list included malpractice reform, but I have since decided that although malpractice is a major issue, it does not make my top 3.

The best way to address such a question is to consider the biggest problems with our current healthcare system. In addition to malpractice, I have weighed issues such as transitions of care between different sites, medical training, and continuing education. However, I must restrict my list to 3, so here are my top issues in 2006: access to excellent generalists; accurate, complete patient data; and better pharmaceutical data.

My first reform would be to create an agency to perform unbiased research on proposed new drugs. Each pharmaceutical company would have to help fund this agency, but it would need to be kept free of drug company influence. The agency would have the responsibility of determining drug safety and efficacy as well as determining relative efficacy of different drugs.

$120m gift for cancer research

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donationThe estate of a wealthy New York businessman who died in 1992 is donating $120 million of his real estate fortune to six cancer research organizations, including Dana-Farber Cancer Institute and the Massachusetts Institute of Technology. The six recipients will get $20 million each this year and millions more in future years.

The Ludwig Institute for Cancer Research, which was established by shipping tycoon Daniel K. Ludwig, planned to announce the gift today.

Board members of the nonprofit foundation said they have asked the six institutions to abide by several stipulations, including to collaborate on research projects and to study how cancer spreads in the body. Ninety percent of cancer patients die from metastasis, instead of the original tumor. The foundation's board also urged the researchers to choose daring, high-risk projects that might not win government funding.

AHA: Heart Failure Patients Oversold on ICD Survival Benefit

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implantable cardioverter defibrillatorsCHICAGO, Nov. 12 -- Cardiologists may be overselling the life-saving ability of implantable cardioverter defibrillators (ICDs) to the point that many heart failure patients refuse to let the devices be turned off, even if it would be better to do so.

In a survey at Brigham and Women's Hospital in Boston, 36% of patients with ICDs said they would never agree to turn off the defibrillator function under any circumstance, reported Garrick C. Stewart, M.D., at the American Heart Association meeting here today.

More than half would want the device kept on even if they were receiving daily shocks. Most would keep the device on if they were dying of cancer, and every single one would keep it on even if they were struggling to breathe.

Lethal pill deaths spark manhunt

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death from drugsPolice are hunting for a man, whom they believe gives people a lethal blend of two anti-depressant prescription drugs, following the deaths of two men in Sydney.

A third possible victim might have survived.

Authorities are describing the deaths as "suspicious", rather than murder.

The combination of the drugs can bring on a potentially fatal condition referred to as serotonin syndrome, which can cause blood-clots in the brain, kidney failure, hallucinations and comas.

Drugged by cost of sales and PR

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lipitorAUSTRALIA - The most prescribed drug in the country is costing patients and taxpayers almost $200 million a year more than it should because of marketing expenses.

Australians spend $94 million a year at the pharmacist's counter on the cholesterol-lowering drug Lipitor, according to Pharmaceutical Benefits Scheme data.

But more than double that figure is spent on marketing the drug, taking the total cost to the taxpayer — after the PBS subsidy is added — to $581.5 million each year.

Bayer Launches Kogenate FS in Middle East

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kogenate fsBayer HealthCare announced today the official launch of Kogenate FS (Antihemophilic Factor [Recombinant], Formulated with Sucrose) in the Middle East. Kogenate FS is Bayers advanced recombinant factor VIII product for the treatment of hemophilia A, a bleeding disorder characterized by deficient or defective levels of the blood clotting protein known as factor VIII.

The launch was announced at "Hemophilia Care: Past, Present and Future", a medical symposium on the topic of hemophilia and its treatment. The symposium involved more than 100 physicians from across the Middle East who attended to learn more about the latest research and treatment for people living with hemophilia.

Gefitinib shows greater efficacy in Taiwanese patients

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gefitinibA lung cancer drug that has been taken off the shelf in the US market is much more likely to prove effective in some Taiwanese lung cancer patients, according to a local study that was recently published in the journal Lung Cancer.

"We decided to do the study when we realized that Taiwanese patients were doing much better on Gefitinib than studies from abroad would predict," said Huang Hsiu-feng (黃秀芬), the principle investigator of the research into 65 non-small cell lung cancer patients conducted by the National Health Research Institutes.

According to Huang, they found that more than 50 percent of participants responded to the therapy, in contrast to a response rate of around 10 percent found in Western studies.

rockefeller foundationRumours that one of the world's most prestigious private philanthropic organisations - the Rockefeller Foundation - is about to withdraw its commitments to health are untrue, the Foundation's president has told The Lancet in an Editorial published online November 7, 2006.

The Foundation, founded in 1913, has over $3•4 billion in assets and more than 170 employees worldwide. Its funding led to the development of a yellow fever vaccine in 1935 and it has played a central part in establishing American schools of public health. Last year, it donated $8 million to the International Partnership for Microbicides as part of its contribution to prevent HIV transmission; $500 000 to Makerere University, Uganda, for public health education; and $450 000 to the INDEPTH Network in Ghana for epidemiology training. 

Analysis: The politics of health reform

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healthcareWASHINGTON, Nov. 10 (UPI) -- Healthcare reform will emerge as a key political issue over the next two years, says Joel E. Miller, senior vice president for operations at the National Coalition on Health Care.

"Because more and more employers are dropping coverage and more and more workers are deciding that coverage is too expensive even when it's offered, we think that over the next couple of years there will be a full-scale debate on health reform leading up to the presidential elections," he said.

The number of uninsured Americans rose 800,000 between 2003 and 2004 and has increased by 6 million since 2000, according to the NCHC. Approximately 46 million Americans, or 15.7 percent of the population, were without health insurance in 2004, according to the latest government data available.

Scientists build world's first artificial stomach

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artificial stomach (c) APLONDON - British scientists have built what they say is the world's first artificial stomach: a shiny, high-tech box that physically simulates human digestion.

Constructed from sophisticated plastics and metals able to withstand the corrosive acids and enzymes found in the human gut, the device may ultimately help in the development of super-nutrients, such as obesity-fighting foods that could fool the stomach into thinking it is full.

"There have been lots of jam-jar models of digestion before," said Dr. Martin Wickham of Norwich's Institute of Food Research, the artificial gut's chief designer, referring to the beakers of enzymes typically used to approximate the chemical reactions in the stomach.

Generic Zyprexa tentatively approved

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zyprexaBarr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly and Company's ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg. The Company anticipates receiving final approval following the expiration of the 30-month stay in April 2007.

There is currently a disagreement between Barr and Eli Lilly regarding the length of the patent on Zyprexa - and whether Barr is ultimately allowed to sell the generic drug has yet to be decided.

ZYPREXA (olanzapine) is indicated for the treatment of schizophrenia and for the short-term treatment of acute manic episodes associated with Bipolar I disorder.

A tentative approval reflects FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.

Bayer To Bring More Jobs To N.J.

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bayer healthcare(AP) WAYNE, N.J. New Jersey is expected to gain several hundred jobs in its already formidable pharmaceutical sector when Bayer HealthCare moves several units to the state over the next 18 months.

Bayer HealthCare, part of the German chemical and drug maker Bayer AG, said Wayne and Montville would be headquarters for its U.S. pharmaceutical commercial operations, as well as its global oncology and specialized therapeutics units.

The towns will also be home to Bayer HealthCare's U.S.-based global drug development groups and other business support functions, the company announced Thursday.

courtNEW YORK -- Merck & Co. agreed to drop some of its objections to plaintiff lawyers' request for fees in a Vioxx case, but only if it doesn't have to disclose its own legal fees to a judge.

Plaintiff lawyer Ellen Relkin said Merck dropped some of its objections because it fears a N.J. judge may publicly disclose what it spent on a trial that ended earlier this year. Merck lawyer Ted Mayer said the drugmaker's legal fees have no relation to the plaintiff lawyers' request and that companies always want to be careful when asked to reveal such sensitive information.

Any disclosure of what Merck spent on a case would provide a window into how much the drugmaker's strategy of individually trying each of the roughly 24,000 cases it faces will ultimately cost. So far, Merck has set aside about $1.57 billion to cover legal expenses.

Paxil Treats 'Compulsive Hoarding'

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paxilHealthDay News -- The antidepressant Paxil (paroxetine) is effective in treating people with a condition called compulsive hoarding syndrome, researchers report.

This syndrome has three main features: severe anxiety prevents patients from throwing out seemingly worthless items; they're prone to acquiring things, which sometimes leads them into buying sprees; and there's excessive clutter in their homes and work spaces, according to background information in a news release.

Indecisiveness, procrastination and disorganization are other symptoms of the syndrome.

Jury still out on selenium for heart health

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seleniumNEW YORK (Reuters Health) - Despite some evidence that the mineral selenium might protect against heart disease, clinical trials have so far failed to prove the case, according to a new research review.

The findings suggest that people should hold off on taking selenium supplements for the sake of their hearts, say researchers.

A number of studies have found that people with higher body stores of selenium might have a lower risk of heart disease. But such studies, known as observational studies, are not enough to prove cause-and-effect.

For that, researchers have to conduct clinical trials where participants are randomly assigned to take a supplement or a placebo and then have their heart health followed over time.
altanaFRANKFURT (AFX) - Altana AG said sales of its drug Pantoprazole are expected to drop by more than 50 pct in 2011 from the expected 2006 level.

In 2005, Altana posted 1.4 bln eur sales for Pantoprazole.

The company -- which is due to hold an extraordinary general meeting on Tuesday Dec 19 -- said in a detailed statement on the internet that it expects sales for the ulcer drug to fall by another 25 pct by 2016.

Altana is to lose its protection patent for Pantoprazole in Europe in 2009. The statement added that Altana's asthma treatments Ciclesonide and Roflumilast (Daxas) are not in a position to reach their full sales potential, previously put at 1 bln eur each.

Novartis says will not pay more asthma royalties

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NovartisZURICH (Reuters) - Swiss drugmaker Novartis AG  will not pay more royalties for asthma drug Xolair if U.S. biotech firm Genentech Inc. buys Tanox Inc. as planned.

"If Genentech is successful in acquiring Tanox, our rights in this partnership will not change and any royalties paid to Tanox will then be paid to Genentech," Novartis spokesman John Gilardi said. "Our rights under this agreement will not change."

Genentech, which is majority owned by Swiss drugmaker Roche Holding AG, said on Thursday it plans to buy Tanox for about $919 million to boost income from the anti-asthma treatment.

Genentech, Tanox and Novartis have been working together since 1996 to develop and market the drug.

statinsCholesterol lowering 'statin' drugs are cost effective in far more people than current guidelines recommend and should be considered for a wider range of people, say researchers in a study published online by the BMJ today.

Large trials have shown that lowering blood cholesterol levels with statins greatly reduces major vascular events, such as heart attacks and strokes, in people at high risk.

And research published in 2005 from the largest of those trials (the heart protection study) showed that when cheaper generic versions are used, several years of statin treatment is cost effective for a wide range of people with vascular disease or diabetes.

Orencia(r)Bristol-Myers Squibb Company today announced that two-year data from three Phase III pivotal trials demonstrate the long-term efficacy of ORENCIA(R) (abatacept) in adult patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate and TNF antagonists. The data also demonstrate that ORENCIA provided clinically meaningful improvements in multiple aspects of health-related quality of life and physical function, sustained improvements in pain and had a consistent safety and tolerability profile through two years of treatment. These data will be presented at the upcoming 2006 American College of Rheumatology (ACR) Annual Scientific Meeting.

The findings are from analyses of the ongoing open-label, long-term extension component of Phase III pivotal trials investigating ORENCIA, including the AIM (Abatacept in Inadequate responders to Methotrexate), ATTAIN (Abatacept Trial in Treatment of Anti-TNF Inadequate Responders) and ASSURE (Abatacept Study of Safety in Use with other Rheumatoid Arthritis Therapies) trials.

French healthcare reforms spoil appetite for pills

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pharmacy PARIS (Reuters) - The French, among Europe's most avid consumers of prescription drugs, are popping fewer pills and powders -- not because they have become healthier, but because the government is on a mission to cut the country's healthcare bill.

In a major break with previous years, growth in medicine sales has slowed this year, to just 1 percent in the year to August compared with 5 to 7 percent between 1990 and 2005.

Drugmaker Sanofi-Aventis has announced job cuts in France and Germany and French sector body LEEM has warned of more to come, urging the government to see drugs not just as a cost but as products that help the economy and jobs.

Students abusing 'Smart Drugs' to keep grades up

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young studentsFor years, students pulling all-nighters have gulped coffee to stay awake. But now growing numbers are popping pills -- and not to party.

CBS 2's Medical Editor Mary Ann Childers reports it's to help them study. We have hidden the faces, and changed the names and voices of students we talked with about smart drugs.

Adderall, Concerta and Ritalin are widely used to treat children with attention-deficit hyperactivity disorder. They are also being abused by tens of thousands of students who don't have ADHD, but who, like college freshmen Ashley and Jason, want an academic edge.

Both say they began taking Adderall in high school.

Doctors do not discuss drug costs with patients?

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doctor with patientHealthDay News -- U.S. doctors often fail to discuss costs, prescription drug insurance coverage and other related issues when they give new prescriptions to patients, a new study finds.

These are all important issues because they're linked to whether patients will continue taking their medications, the researchers note.

"Though cost discussions are not always necessary, especially if physicians know a patient's financial situation and the best formulary choice for a medication, physicians must have a high level of awareness about medication cost and issues impeding acquisition to medication, because these can be important barriers to patient medication adherence," lead author Dr. Derjung Tarn, assistant professor of family medicine at the University of California, Los Angeles, David Geffen School of Medicine, said in a prepared statement.

Her team's published the findings in the November issue of the American Journal of Managed Care.

painkillers capletsThe FDA today announced a recall of about 11 million bottles of store-brand acetaminophen 500-milligram caplets.

Those caplets are over-the-counter drugs for pain relief and fever reduction. They're sold by about 130 companies, including Wal-Mart, CVS, and other drug stores, grocery stores, and wholesalers.

The recall is due to "small metal fragments found in a small number of these caplets," states an FDA news release.

The fragments range in size from "microdots" to 8-millimeter pieces of wire, according to the FDA.

The FDA and the caplets' maker, Perrigo Company of Allegan, Mich., are investigating how those metal fragments got into the caplets.

So far, no illnesses, injuries, or consumer complaints have been reported to the FDA or Perrigo, according to the FDA.

Biotech drugs for colon cancer face off

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erbituxNEW YORK (Reuters) - Sales of colon cancer drug Erbitux have not been hurt by the launch last month of Amgen Inc.'s rival drug Vectibix, the chief executive of Bristol-Myers Squibb Co. said on Wednesday.

"It is awfully soon, but they launched at a discount, which usually suggests that the product may not be as good as ours or is for a narrower indication," James Cornelius, interim CEO of Bristol-Myers, said at the Reuters Health Summit in New York.

Bristol gets 60 percent of revenue from partner ImClone Systems Inc.'s sales of Erbitux.

Amgen, which priced its drug at $8,000 a month, or a 20 percent discount to the $10,000 a month average cost of Erbitux, is expected a carry out a formidable campaign to dislodge Erbitux as the leading treatment for colon cancer patients who have failed other therapies and said earlier this week the launch of Vectibix is going better than expected.

'Lucentis' prevents old age blindness

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optometrist A new drug that could prevent old age blindness is being developed, according to researchers.

‘Lucentis’, the drug that is being designed to combat the wet type of Age-related Macular Degeneration (AMD), has the potential to prevent blindness in several people, while helping many others to regain their lost vision.

According to a study published in the New England Journal of Medicine, Lucentis has prevented vision loss in 90% of the patients studied. A remarkable improvement in vision was reported in 33% of those experimented on . 716 patients, who formed the subject of the clinical study, received an injection of the drug every month for two years.

This is for the first time that a drug that is used in the treatment of AMD, has been found capable of improving vision. The drug is due to obtain license in Europe by the end of this year.

source IANS 

Once-Weekly Epoetin as Good as Thrice-Weekly Dose

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epoetinNovember 6 (Istanbul) — Cancer patients receiving epoetin to prevent anemia during chemotherapy or radiation treatment fared just as well on once-weekly doses as on the traditional thrice-weekly regimen, but with several advantages. In addition to being far more convenient for patients, the once-weekly regimen had a shorter duration of treatment and less need for dose escalation and probably had a better cost-effectiveness, according to a prize-winning poster presentation at the recent 31st Congress of the European Society of Medical Oncology (ESMO).

These conclusions come from a clinical trial in 409 patients reported by Jose Munoz-Langa, MD, and colleagues, from the Dr Peset University Hospital, in Valencia, Spain. These patients had a variety of solid tumors requiring chemotherapy or radiation and were given epoetin alfa either 40,000 IU once weekly or 10,000 IU 3 times weekly. Two commercial preparations of epoetin alfa are available, Procrit (Johnson & Johnson) and Epogen (Amgen), but the poster did not specify which was used.

Novartis pain drug battles Vioxx stigma

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prexige logoNEW YORK (CNNMoney.com) -- Novartis plans to bring a new arthritis painkiller to the U.S. market, but analysts say its similarity to the disgraced drug Vioxx could kill its chances of becoming a billion-dollar blockbuster.

The Swiss drug giant Novartis AG (up $0.32 to $61.55) said Tuesday that its painkiller Prexige was given a green light in the European Union for the treatment of arthritis. Novartis plans to "resubmit" the drug to the Food and Drug Administration in 2007, following the agency's request for more information in 2003.

Compared to Vioxx from Merck & Co., Inc., (up $0.33 to $46.14, Charts) Prexige has a better profile with regard to heart attack and stroke risks. Nonetheless, the drug is a member of the Cox-2 inhibitor class of drugs -- the same as Vioxx -- and could have a hard time winning the approval of American doctors and patients, not to mention the FDA.

"Doctors will be afraid to use this drug and ultimately that's what limits its potential," said Gbola Amusa, analyst for Sanford C. Bernstein. "Even when it's approved, doctors will see a safety issue with the drug and not use it as much."

 

Researchers Apologize for Disclosure Failure on Drug Study

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athritisHealthDay News -- The failure of researchers to fully disclose pharmaceutical-industry connections in a study of drugs used to treat rheumatoid arthritis has resulted in a letter of apology to the Journal of the American Medical Association.

However, everyone involved is quick to note that both the findings of the study and the methods used were sound. And while the exact meaning of the findings is the subject of debate, there appears to be no question of the validity of the science involved.

The original study appeared in the May 17, 2005, issue of JAMA. In that study, Dr. Eric L. Matteson, a professor of medicine at the Mayo Clinic, and colleagues looked at the risk of cancer among patients taking infliximab (Remicade, Enbrel) and adalimumab (Humira) for rheumatoid arthritis.

These drugs are tumor necrosis factor-alpha blockers (TNFs). TNF blockers bind to tumor necrosis factor-alpha, making it inactive, reducing inflammation and joint damage.

Merck Discloses 4 Tax Disputes

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merckMerck & Co. has disclosed four separate tax disputes in the U.S. and Canada with potential liabilities totaling $5.58 billion, as the drug maker faces tens of thousands of lawsuits over its withdrawn painkiller Vioxx, The Wall Street Journal reported on its Web site Tuesday.

Whitehouse Station, N.J.-based Merck says it is fighting the assessments disclosed in a filing with the Securities and Exchange Commission, the Journal said.

Merck isn't the only drugmaker hit with steep tax bills. In September, GlaxoSmithKline PLC agreed to pay the U.S. government $3.4 billion to settle a dispute over how to tax deals between the London-based company and its American subsidiary.

Preventing Costly Missteps In Drug Development

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computer and drug researchThe script for one of the most dreaded scenarios in new drug development reads like this: Company A sinks several hundred million dollars into putting a new drug onto pharmacy shelves. Only then do serious side effects appear, and force withdrawal of that drug from the market.

Researchers in India now are reporting development of a new and more accurate method for predicting toxicity in the very early stages of drug development.

Nagasuma R. Chandra and colleagues describe the computer technique in the November/December issue of the ACS's bi-monthly Journal of Chemical Information and Modeling. They also report on its use in predicting with high accuracy one form of toxicity - a heart rhythm disorder that forced withdrawal of the popular antihistamine terfenadine (Seldane).

Abbott buys cholesterol drugmaker

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abbott Moving further into the cholesterol management market, Abbott Laboratories said this morning it will buy a New Jersey drugmaker for $3.7 billion in cash, or $78 a share.

Kos Pharmaceuticals, Inc. of Cranbury, N.J. is a pharmaceutical company developing and marketing various drugs to treat 'chronic cardiovascular, metabolic and respiratory diseases,' in a growing $20 billion lipid management market, Abbott said in a statement this morning.

'Kos Pharmaceuticals is an excellent strategic fit for Abbott, both scientifically and commercially,' said Abbott chairman and chief executive Miles White. 'This acquisition expands Abbott's presence in the lipid management market and will provide several on-market and late-stage pipeline products. Kos also complements our existing commercial and research and development expertise, and increases our R&D spending capacity.'

Childhood Trauma Raises CFS Risk

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chronic fatigueJust after the CDC declared a Chronic Fatigue Syndrom (CFS) a "real" disease, there articles contributing to this claim start to appear. Who would expect, right?

"Our observations lend support for the hypothesis that CFS represents a disorder of adaptation that is promoted by early environmental insults, leading to failure to compensate in response to challenge" 

"A key finding was that more severe childhood trauma was linked to a higher risk of CFS. And the type of childhood trauma was important, too." 

The whole article is below. 

 

Xoma wraps up work on $15M biodefense contract

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xoma Xoma Ltd. said Monday it completed its work under a $15 million government biodefense contract.

The Berkeley company (NASDAQ: XOMA) said the National Institute of Allergy and Infectious Diseases (NIAID) gave its final acceptance of the contract, which it awarded to Xoma in March 2005. Xoma developed manufacturing processes for three anti-botulinum neurotoxin monoclonal antibodies.

Xoma won a $16 million follow-on contract in July.

John Castello is Xoma's chairman, president and CEO.

NIAID is part of the National Institutes of Health.

source 

 

erbituxDARMSTADT, Germany: Merck KGaA, a German drug and chemical maker, said Monday that test results of its bowel cancer drug Erbitux did not meet its hopes for patient survival rate.

Results from a trial of 1,300 patient did not show a significant difference in prolonging life when comparing Erbitux taken in combination with standard treatment irinotecan and irinotecan alone.

Merck studied the efficacy of Erbitux in combination with irinotecan, a chemotherapy treatment, and found that patients did not survive without progression of the disease as the company hoped.

Still, Erbitux did show positive results in delaying the progress of the disease, the company said in a statement.

Low grade for Canada in Primary Health care

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According to a global study on effective primary health care for patienhealthcarets that was released by the Commonwealth Fund, Canada ranks much lower than other developed countries, except the U.S.

In the survey conducted on over 6,000 doctors in 7 countries, it was found that Canada lagged in several aspects including wait times for tests, usage of electronic medical records, doctors availability after hours, multi-discipline teams for treatment of chronic illness and financial incentives for care quality improvement.

The survey reveals that Canada is far behind several other countries like New Zealand, Australia, U.K., Netherlands and Germany.

Heart Catheters Do Not Benefit Patients

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heartDoctors should probably stop using pulmonary artery catheters because they do not benefit patients, said doctors from Australia recently in the British Medical Journal.

The pulmonary artery catheter was invented in 1968. It enabled bedside monitoring in critically ill patients by measuring heart output and capillary pressure in the lungs and became widely used in intensive care units.

But reports of serious complications soon appeared and arguments for and against its use have continued ever since.

The most recent evaluation, commissioned by the NHS Health Technology Assessment (HTA) programme, found that pulmonary artery catheters do not benefit patients and concluded that withdrawing them from UK intensive care units would be cost effective.

 

Methadone: One pill that can kill

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methadone pillsby Dan Starks, 6 News

It has proven to be one of the deadliest drugs in the state, and its killing young people across North Carolina.

You may not even know just how strong it is, and that is a warning parents and teens should heed.

It was one phone call. A deadly pill and William Sigmon’s 19-year-old daughter, Linda, was gone.

"My ex-wife called me and told me I needed to go up to the hospital. I said why? She said its Linda. She was lying on the table. They tried to do CPR and shock her back and everything. She was already dead."

Wyeth signs deal for drugs from llamas

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Wyeth LONDON (Reuters) - Ablynx, a Belgian biotech company using llama DNA to develop a new class of drugs, has signed a deal worth up to $212.5 million with U.S. healthcare group Wyeth, the two companies said on Monday.

The agreement will allow Wyeth to develop a new generation of anti-TNF treatments for diseases such as rheumatoid arthritis using ultra-small antibodies.

Ablynx is pioneering medicines called nanobodies, which it believes could treat conditions including arthritis, thrombosis, cancer and Alzheimer's disease. It expects to start testing them on humans early in 2007.

Seniors, shop early for Medicare drug plan

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medicareWASHINGTON - Medicare officials learned an important lesson this year when it came to the new drug benefit, one they hope will lead to fewer headaches for the elderly and disabled come Jan. 1.

Going into the program's first year, officials confidently told beneficiaries to take their time. As long as they enrolled by Dec. 31, they could expect to have insurance coverage for their medicine when they showed up at the pharmacy counter.

But those predictions proved way too optimistic. Many didn't select an insurance plan until just days before the new program took effect. When they showed up at the pharmacy, their application had yet to be processed. Insurers and Medicare operators were swamped with angry phone calls from frustrated pharmacists and patients.

Not enough research for coenzyme Q10

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coenzyme q10ROCHESTER, Minn., Nov. 3 (UPI) -- Scientific evidence doesn't support most of the health claims concerning coenzyme Q10, but some studies do have merit, says a U.S. newsletter.

It's not known if low coenzyme Q10 levels cause disease or if taking supplements can prevent or treat disease, according to the Mayo Clinic Health Letter.

Of the many coenzyme Q10 studies, most have been small. Many have not been "controlled," where some participants take a placebo, but some coenzyme Q10 studies appear to have scientific merit, the newsletter says.

Alzheimer's disease diagnosed 100 years ago

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alzheimer's diseaseATLANTA - One hundred years after the first diagnosis of Alzheimer's disease (AD) November 3, 1906, researchers at the Yerkes National Primate Research Center, Emory University, are focusing on neuroscience, immunology and vaccine research to better understand how AD develops and progresses as well as to advance the treatment and prevention of this progressive brain disorder. AD, which currently affects 20 million Americans, gradually destroys memory and the ability to learn, reason, make judgments and communicate.

"The Yerkes Research Center has developed four major areas of Alzheimer's research critical to identifying preventions and treatments to slow the progression or stop the onset of this devastating disease," said Stuart Zola, director of the center. "Along with investigating potential Alzheimer's disease vaccines, our researchers are developing a transgenic model for the disease, conducting comparative aging studies and detecting early symptoms of the disease."

CDC: Chronic Fatigue Syndrome 'Real'

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a lieSurprising? Not really. It looks like pharma companies are desperately looking for new markets. Now it's chronic fatigue syndrome. What's going to be next?  Being a loser syndrom? Having a bad day syndrom? Being a lazy ass person syndrom? I admirethe creativity of medical industry which leads to more and morenew "diseases" which are "hard to pin". Nevetherless, the drugs production won't be delayed. And there will be people who will be looking for a quick drug fix (instead of working on physical fitness). And there will be news articles and press releases which will advertise new remedies. From everything.

"Still, there is still no lab test, scan, or examination that can reveal chronic fatigue syndrome. It is diagnosed by a patient's history of illness, and after eliminating other conditions.

Also, there is no drug to cure it. Treatment focuses on bringing some relief from symptoms and the return of normal function."

Read more below 

Chronic pain patch delivers direct relief

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biatan ibu patchA Mississauga company has introduced Canada's first dressing for chronic wounds, with a built-in painkiller.

Coloplast Canada is a subsidiary of a Danish company that spent seven years developing the treatment for chronic pain. The product was first introduced in Europe in March.

The dressing, "switches off the pain at the source," said George Baltazar, spokesperson for Coloplast Canada, which has its corporate head offices on Ridgeway Dr. in Erin Mills.

The new dressing, called Biatain-Ibu, delivers ibuprofen directly into the wound.

Drug-benefits manager says 3Q profit 19 percent higher

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medco health solutionsMedco Health Solutions Inc., the biggest U.S. drug-benefits manager, said Friday that third-quarter profit rose 19 percent on sales of biotechnology medicines and cheap generic copies of Zocor cholesterol pills and Zoloft antidepressants.

Net income climbed to $185.8 million, or 62 cents a share, from $156.7 million, or 53 cents, a year earlier, Franklin Lakes-based Medco said. Revenue gained 12 percent to $10.5 billion, helped by a 2005 acquisition. Profit beat analysts' estimates.

Medco, a middleman between drugmakers and health insurance plans, capitalized on patent expirations for Pfizer Inc.'s Zoloft and Merck & Co.'s Zocor, allowing sales of less-expensive pills at higher markups.

Seattle biotech firm halts enrollment in cancer-drug trial

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cell therapeuticsCell Therapeutics said late Friday it has halted enrollment in its most important clinical trial because of premature deaths among patients taking its experimental cancer drug.

James Bianco, chief executive of the Seattle company, said the deaths do not appear related to any safety problems with its drug, Xyotax.

In an interview, Bianco would not say how many patients enrolled have died among the 200 women with lung cancer. But he acknowledged there were more deaths in the group receiving Xyotax than another receiving a standard chemotherapy drug. Further analysis is needed to sort out the reasons, he said.

Science Could Point to MS Treatments

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multiple sclerosisHealthDay News -- New insights into mechanisms controlling the formation of myelin -- the white matter that coats all nerves -- could help lead to treatments for multiple sclerosis (MS) and other myelin-related diseases and injury.

Myelin plays an important role in the overall health and function of the nervous system. MS and other diseases or injuries that damage myelin result in serious problems including uncoordinated movements, neuropathic pain and paralysis.

Researchers at the University of Southern California (USC) and the Institut de Recherches Cliniques de Montreal in Canada found that a protein called Par-3 plays an important role in the formation of myelin during nerve development.

Par-3 acts like a "molecular scaffold" to set up an "organizing center" that brings together proteins essential for the formation of myelin, the researchers said.

 

Analysis: Ancient medicine useful today

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arthritisWASHINGTON, Nov. 2 (UPI) -- Two new studies, one in animals, suggest that ancient medicine may have a lot more to offer than traditional drugs.

A study in the November issue of Arthritis and Rheumatism Journal suggests that turmeric and turmeric dietary supplements may prevent rheumatoid arthritis and osteoporosis in lab animals.

The root turmeric has been used in Asian medicine for centuries for its ability to treat arthritis. Modern anti-inflammatory medications used to treat arthritis have many side effects, so doctors and researchers have been seeking alternative, holistic treatments for the condition.

Today, turmeric dietary supplements are marketed as curcumin, the chemical that gives turmeric its yellow color. It's also thought to act as an anti-inflammatory.

Patch new option for treating ADHD

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skin patchWASHINGTON, Nov. 2 (UPI) -- Medication for children with attention-deficit/hyperactivity disorder, or ADHD, can now be delivered through a patch, researchers reported Friday.

The patch, called DAYTRANA, is meant for children 6 to 12. It gives physicians greater control over the amount of time a child is on medication, as it is easily administered and removed, said Dr. Timothy E. Wilens, a consultant to Shire, the company that produced the patch and funded the research.

The findings were presented recently at a child and adolescent psychiatrists' convention in San Diego.

"I like this because it gives you an off-switch," said Wilens, who is also in the clinical and research program in pediatric psychopharmacology at Massachusetts General Hospital and an associate professor of psychiatry at Harvard Medical School.

Aromatherapy: The Scent of Dispute

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aromatherapyHealthDay News -- Aromatherapy is an affordable, accessible natural path to relief for a variety of health problems, ranging from arthritis pain to nausea to drowsiness, supporters insist.

But skeptics dismiss any claims that the use of essential oils from flowers, herbs and trees can promote health in any way.

And both sides are unlikely to relinquish their positions anytime soon.

Aromatherapy "works for so many different things, it is amazing," said Kelly Holland Azzaro, a registered aromatherapist in Banner Elk, N.C., and vice president of the National Association for Holistic Aromatherapy (NAHA), an industry trade group. "You can experience aromatherapy by inhalation by putting one drop of an essential oil on a tissue and inhaling," she said.

 

a couple(CP) - Health Canada is warning consumers against taking certain unauthorized natural health products promoted for the treatment of erectile dysfunction because they contain pharmaceutical ingredients that should be used only under medical supervision.

The products - Zimaxx, Actra-Rx, 4Everon, Vigor-25 and Nasutra - could pose serious health risks, especially for people with heart disease, those taking heart medications or those at risk for stroke.

Although not authorized for sale in Canada, Zimaxx, Actra-Rx, 4Everon, Vigor-25 and Nasutra are or may have been sold over the Internet or brought into Canada by travellers for personal use, Health Canada said in an advisory Thursday.

For depression relief, try variety of medications.. Really?

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anti depressantsAnother article which is promoting drugs as a remedy for depression. Especially, a full variety.

"Thirteen percent of the 123 study participants who did not get better on the first three drugs they tried were helped by a fourth, researchers found. 

But there is a downside to so many attempts: The more tries people made, the more likely it was that they later would relapse and slide back into depression."

What do I think about it? If you don't care about complications, and are looking for a quick fix (i.e. you are lazy about your health), then go for meds. If one doesn't help, take another. This doesn't help? Try another! Continue until your get seriously sick. Cancer maybe an option as well. It's up to you. Those drugs are not guaranteed to help your depression. Period

What are the alternatives to antidepressants, you may ask? I would recommend to look at photo therapy treatment. There are devices which are helping SAD, depression and even Alzheimer's disease.

Outside In, TrueSun, Alaska Northern Lights, FullSpectrum Solutions - these are only few of companies which produce photo therapy devices that work. Give it a shot. But don't forget to consult a specialist before going for it

Read the article below and decide for yourself.

Women in U.S. sue companies over popular birth control patch

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birth control patchSAN FRANCISCO: More than 40 women sued the makers of a popular birth-control patch, claiming the contraceptive caused serious illnesses and at least one death.

One lawsuit alleges that 43 women suffered from blood clots and other health ailments after taking Ortho Evra, one of the fastest-growing forms of contraception in the U.S.

A second complaint claims that 25-year-old Kelly Bracken of Elk Ridge, Maryland, died of severe blood clots in her lungs and legs after she started wearing the skin patch.

The lawsuits, filed in San Francisco Superior Court on Wednesday, name as defendants the drug's manufacturer, Ortho-McNeil Pharmaceutical Co., a Titusville, New Jersey-based subsidiary of Johnson & Johnson; and San Francisco-based distributor McKesson Corp. The plaintiffs seek unspecified monetary damages.

Gap in Medicare Rx Coverage Is Costly

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medical insuranceThe cost of insurance protection against Medicare's "doughnut hole" coverage gap for prescription drugs is set to increase substantially next year, a report from a consumer watchdog group concluded Wednesday.

The report also found private insurance companies in 13 states do not offer plans with what it deems "meaningful" gap benefits, because plans covering only generic drugs leave out many brand-name medications widely used by seniors. That could leave seniors to go without the price protection or join a managed care plan to obtain the coverage, the report says.

The 13 states include Florida, New York, and Michigan.

Pfizer Drug Dealt Blow in Testing

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Pfizer Pfizer said yesterday that clinical trials of torcetrapib — a heart medication that is the most important drug in the company’s pipeline — confirmed that it raises blood pressure, a potentially serious side effect.

Any problems with torcetrapib would be a serious setback for Pfizer, the world’s largest drug company. Pfizer has been counting on the new medicine to eventually replace the $13 billion in annual sales from the cholesterol-lowering drug Lipitor, which loses patent protection in 2010.

Cardiologists and Wall Street analysts alike have been closely watching the clinical trials of torcetrapib, a medicine intended to raise so-called good cholesterol.

topamaxNewswise — Topiramate (Topamax), a drug commonly prescribed to treat seizures and migraine headaches, can increase the propensity of calcium phosphate kidney stones, researchers at UT Southwestern Medical Center have found.

A study – the largest cross-sectional examination of how the long-term use of topiramate affects kidney-stone formation – appears in the October issue of the American Journal of Kidney Diseases.

Several case reports have described an association between topiramate and the development of kidney stones, but this complication had not been well recognized and physicians have not informed patients about the risk, the UT Southwestern researchers said. More important, the mechanism of stone formation was largely unknown previously.

Safety Concerns About Methadone for Pain Relief

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drug safetyGLENVIEW, Ill. -- A new report from Pain Treatment Topics -- "Methadone Analgesia Safety Overview & Patient Instructions Handout" -- provides essential background information and serves as a gateway to several innovative, evidence-based documents at Pain-Topics.com.

These guide healthcare providers in more safely and effectively prescribing methadone analgesia:

  • Safely Dosing Methadone for Chronic Pain
  • Avoiding Harmful Methadone-Drug Interactions
  • Methadone Cardiac Considerations and Precautions

Additionally, the 12-page "Overview" links to documents discussing the management of opioid-induced constipation, a common side effect, and how to safely discontinue opioid analgesics.

Production problems lead to birth control pills shortage

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WyethTwo popular brands of birth control pills are in short supply across Canada, leaving many women scrambling to fill their prescriptions.

The pills — under the Alesse and Triphasil names — are made by the U.S. company Wyeth Pharmaceuticals. The company temporarily stopped production of the two brands in August, which means some pharmacies have run out, making refills almost impossible to get.

Clue to Sudden Infant Death Syndrome

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deathResearchers have identified a brain defect they think is a major contributor to sudden infant death syndrome (SIDS).

The findings provide the strongest evidence yet of a specific neurological cause for SIDS, a little-understood condition that kills roughly 2,500 infants each year in the United States.

In the study, autopsy tissue taken from babies who had died of SIDS and other causes showed abnormalities in the lower brain stems of the SIDS babies. Among other things, this region of the brain is thought to help regulate breathing and arousal.

Start-up gets funding for anti-cancer drug research

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moneyEsperance Pharmaceuticals Inc., of Baton Rouge, whose nanoparticles target and kill some of the most common types of cancer cells, has secured $9 million in financing from three venture capital firms.

The money will allow Esperance to begin testing its anticancer agent to make sure it is safe and does not have toxic side effects, said Ross P. Barrett, managing partner of Themelios Venture Partners.

Themelios, Louisiana Fund I of Baton Rouge and Research Corporation Technologies Inc. of Tucson, Ariz., put up the $9 million.