ID Admin: December 2006 Archives

chinaSHANGHAI, China-A Chinese court has upheld the validity of drug maker Pfizer Inc.'s patent for Viagra, ordering two companies to stop sales of generic versions of the erectile dysfunction treatment and pay compensation for trademark infringements, a court official said Thursday.

The Beijing No. 1 Intermediate People's Court ordered Beijing Health New Concept Pharmacy Co. to stop sales of blue pills similar to Viagra, according to a court official who gave only his surname, Wang.

More generic rivals approved for Zocor

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zocor U.S. regulators cleared six more companies to begin selling generic copies of Merck & Co.'s cholesterol drug Zocor, signaling steeper price reductions.

The approvals posted on the Food and Drug Administration's Web site Wednesday are in addition to those granted Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. in June when Merck's patents expired. The new versions of the world's second-best-selling cholesterol-lowering pill will drive prices down as much as 70 percent, analysts said. Teva has been selling copies for 8 percent less than Merck.

The price drop may hurt sales of Pfizer Inc.'s Lipitor, the world's top-selling drug, with revenue last year of $12.2 billion, and the source of almost half of the New York-based drugmaker's profits. Lipitor prescriptions declined 6 percent in the fourth quarter as health plans encouraged patients to switch to generic copies of Zocor, Bear Stearns analyst John Boris said in a Dec. 21 research report.

SkyePharma asthma drug costs over-run, gets loan

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skyepharma LONDON (Reuters) - SkyePharma (SKP.L) said on Wednesday that developing its biggest drug hope, Flutiform for asthma, was costing more than it expected and that it had arranged a new 35 million pound loan.

The drug delivery firm also said it was in exclusive talks with a potential buyer of its loss-making injectable drugs business and that it expected to reach a deal shortly.

SkyePharma has been hit by a string of delays in finding partners for its drugs and earlier this year a shareholder rebellion drove out founder and chairman Ian Gowrie-Smith.

InnoMed's Drug Safety Database Goes Live

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IMIResearchers from major pharmaceuticals, Swiss-based computational biology firm Genedata and European Commission (EC) representatives met recently in Dublin for the Second General Assembly of InnoMed PredTox consortium. InnoMed PredTox is a joint Industry, Academic and EC collaboration to improve drug safety testing.

Tasked with exploring the molecular basis of drug-side effects, InnoMed PredTox is an ambitious project involving leading European pharmaceutical companies, academic research institutes and Genedata.

The gathering in Dublin met for an update on general progress over the last nine months and to discuss the consortium’s newly launched central data sharing portal. Biomolecular data from more than 20 laboratories is fed into a joint database, which is based on Genedata’s Expressionist platform.

Medicare's Prescription Drug Plan Enrollment Deadline Looms

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medicare cardHealthDay News  -- The deadline for enrolling in or changing your Medicare prescription drug plan is fast approaching, and experts agree that you need to choose carefully because premiums have increased and drug coverage has changed in many plans.

"In terms of premium increases, 77 percent of drug plan enrollees are in plans where premiums will be increasing," said Larry Levitt, a vice president at the Kaiser Family Foundation. The deadline for picking a plan for 2007 is Dec. 31, and that decision can't be changed again until next November.

However, if a recent survey holds true, many seniors will simply stick with what they've got.

Animal studies 'of limited use'

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lab mouse Tests of drugs on animals are not reliable in all cases, a study warns.

The British Medical Journal research looked at studies in six areas and found animal studies agreed with human trials in just three.

The high-profile London drug trial which left six men ill was carried out after animal studies showed the drug TGN1412 was effective.

This study, led by Professor Ian Roberts, suggests animal studies should be used, but not for all drug research.

Telik cancer drug fails trials; stock plummets

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telik incTelik Inc. said on Tuesday that its experimental cancer drug failed to improve survival in patients with advanced lung cancer or in patients with ovarian cancer, sending its stock plunging nearly 70 percent.

The biotechnology company said a late-stage, or Phase III, trial of its most advanced drug, Telcyta, did not significantly improve survival in patients with advanced lung cancer who had failed other treatments, which was the main goal of the trial.

The Palo Alto, California-based company said a Phase III trial of patients with resistant ovarian cancer also failed the trial's main goal of demonstrating significant improvement in survival.

New Congress to tackle prescriptions, other healthcare issues

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senateBy CHRISTOPHER LEE, The Washington Post

WASHINGTON - Healthcare is to return to the national political stage in 2007, setting up partisan clashes in Congress that could end with rare vetoes from President Bush and help define the 2008 presidential campaigns.

Here is a look at parts of the healthcare agenda in the new Congress:

Medicare prescription drug price negotiations. Proponents, mainly Democrats, say repealing a provision in the 2003 Medicare drug benefit law and forcing the Bush administration to negotiate with drug companies over prices could save billions of dollars a year.

FDA Safety Changes: Keppra, Naropin, Rebetol

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FDADecember 22, 2006 — The US Food and Drug Administration (FDA) has approved safety label revisions to advise of the expected similarity of levetiracetam's safety profile in patients with juvenile myoclonic epilepsy compared with partial-onset seizures; the rare risk for cardiac arrest in patients receiving ropivacaine HCl injection for the purposes of anesthesia or peripheral nerve blockade; and the risk for dental and periodontal disorders associated with use of ribavirin in with concomitant interferon therapy.

Levetiracetam (Keppra) Linked to Somnolence and Behavior Abnormalities in JME Patients

On August 15, the FDA approved safety label changes for levetiracetam tablets and oral solution (Keppra, made by UCB, Inc) to advise of risks associated with their use as adjunctive therapy for myoclonic seizures in patients aged 12 years and older with juvenile myoclonic epilepsy (JME), a new indication.

FDANot all companies are getting what they want for Christmas. Taking on the form of the FDA, Santa has left a lump of coal in some corporate stockings when approvable letters were issued to four companies. Remember that receipt of an approvable letter means that the FDA has some outstanding issues that need to be resolved before an approval can be issued.

These outstanding issues can be quite complex, involving a great deal of time and investment, such as new clinical trials, or relatively simple, such as a label adjustment or a manufacturing process issue. In any case, it means a delay, either slight or lengthy, in getting to market.

New River Pharmaceuticals (NRPH) and Shire (SHPGY)- A second approvable letter was issued to these two companies for a treatment for Attention Deficit Hyperactivity Disorder [ADHD]. The first approvable letter was issued on October 6, 2006 and the company speedily submitted a response on October 24, 2006. According to Yahoo Finance, the FDA is not requesting new studies.

Are Your Painkillers Actually Killing You?

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painkillersBy DAN CHILDS, ABC News Medical Unit

Calls for stronger warning labels for certain over-the-counter (OTC) medications question the safety of products that are a fixture in the medicine cabinets of nearly every American household.

On Tuesday, the Food and Drug Administration proposed stronger warning labels for acetaminophen, widely known by the brand name Tylenol, and the common class of pain relievers known as nonsteroidal anti-inflammatory drugs, or NSAIDs. This group includes ibuprofen and aspirin.

Considering the familiarity of these medicines, many consumers assume they are safe.

Politics turns to the left

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biotechAfter six years of a steady trade wind of Republican influence, the climate on Capitol Hill has suddenly shifted. For an industry like biotech, which always has a finger in the air to see what's blowing their way, there is reason for both comfort and concern. Comfort comes from seeing a majority of voters around the country clearly backing stem cell research, electing federal and state officials who are opting for science over fundamentalism.

Soon enough the Democrats now in control of the House and Senate are going to put President Bush's veto of the recent stem cell bill to the test and see if they now have the votes to push through new federal funds for the field. They might pull it off, but it will be tough. President Bush has made it clear that he isn't budging on this one inch, leaving a dwindling number of Republicans willing to defend a position that has grown clearly out of favor with the electorate. The concern is justified, too. Democrats are making drug costs an issue again, vowing to do everything they can to lower the bill.

Most happy with Medicare Part D

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politics over drugsWASHINGTON, Dec. 22 (UPI) -- U.S. congressional leaders want to push for major changes in Medicare Part D, but most voters favor the new prescription-drug program, a survey finds.

Concern about prescription drugs ranked well down the list of "most important" issues listed by voters in exit polls on Election Day, there are overwhelming majorities of seniors happy with the program, and many say they were likely to support officials who voted to create it, according to Democratic pollster Douglas Schoen of Penn, Schoen & Berland Associates.

Only 2 percent of voters polled for each survey said it was the most important factor in their voting decision.

Group Plans To Re-introduce Drug Bill

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politics over drugsA bipartisan congressional group plans to re-introduce a bill that would allow U.S. residents to import drugs approved by the Food and Drug Administration.

Senators Byron Dorgan, D-N.D., and Olympia Snowe, R-Maine, and Representatives Rahm Emanuel, D-Ill., and Jo Ann Emerson, R-Mo., say passage of the Pharmaceutical Market Access and Drug Safety Act would cut the cost of prescription drugs.

"It is unbelievable that Americans are forced to pay the highest prices in the world for prescription drugs," Dorgan said. "It's time we took some action to put downward pressure on these prescription drug prices, and I think we have a bipartisan group that is going to stand up and move this issue forward."

© 2006 UPI

FDAFDA closes some of its labs. I understand that restructuring is focused on optimizing resources and reducing expenses. Business as usual. However, this article says that "the group believes the closures could slow the response to a bioterrorism attack.."

What bioterrorism attack? This is not the first time media is letting these two words slip into the news. What is the purpose of this sentence - to create a fear amongst americans to use their response as a lever in some politic game, or what?

Do you want to speed up the response to a "bioterrorism attack"? Ban the fast food shops.

Read the article below.. 

FDA Updates Reporting of Adverse Events

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FOIA This week, the FDA updated its quarterly reporting on adverse events. It is a bit of a complicated mess to work your way through. But there are other ways to look at adverse events and given that there have recently been a few drugs experiencing well-publicized adverse events, it seemed like a good subject to explore.

The FDA has a Freedom of Information Act [FOIA] office that processes requests for information. Among the information that can be requested is a printout of the adverse events for a particular drug, or even those related to a particular company. When submitting a FOIA, you can specify any parameters. The only thing you have to do is (1) be patient - it used to take about 6 weeks, but it does vary, and (2) pay for it, but it is not exorbitant and price depends on how lengthy your research is. Depending on what you ask for, you also may need storage - the reports are computer sheet printouts that can go on for pages, so be careful what parameters you choose. If you choose too broadly, you can wind up with a LOT of unwanted information and paper.

GSK To Acquire Praecis Pharmaceuticals For $54.8M

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praecisLONDON & WALTHAM, Mass.--(BUSINESS WIRE) -- GlaxoSmithKline plc (GSK) and PRAECIS PHARMACEUTICALS INCORPORATED (Nasdaq: PRCS) announced today execution of a definitive agreement providing for GSK to acquire all outstanding shares of PRAECIS’ common stock for a cash purchase price of US $5.00 per share or a total of approximately $54.8 million for the entire equity interest of PRAECIS.

“PRAECIS has created novel therapeutic programs and innovative chemical-synthesis and screening technology that will complement our own discovery capabilities,” said Allen Oliff, Senior Vice President, Molecular Discovery Research, GSK.

U.S. Adults Desire Ongoing Review of Pharmaceuticals

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surevyROCHESTER, N.Y., Dec. 21 /PRNewswire/ -- U.S. adults are calling for information on and oversight of the pharmaceutical industry. According to a recent Harris Poll, close to three out of four (71%) adults believe that it is very or highly important that pharmaceutical drugs, even after they are made available to the public, remain under close review by the U.S. Food and Drug Administration (FDA) and drug companies. An additional one in five (20%) says that it is important that the drugs remain under close review. Only nine percent say it is only somewhat or not very important. Of note, the FDA currently has a process in place to conduct post-marketing surveillance of drugs (however, respondents were not asked whether or not they are familiar with this).

Furthermore, many Americans are demonstrating consumerism by proactively seeking out information on drug safety. About four in 10 (41%) indicate that they always or often seek information on drug safety for themselves and/or family members. One-third (35%) say they sometimes seek out information on drug safety and just one-quarter (24%) rarely or never seek out this information.

Altus signs development deal with Genentech

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Altus Pharmaceuticals Altus Pharmaceuticals Inc. will make at least $15 million in a new development deal signed with biotechnology giant Genentech Inc. to create treatments for human growth hormone deficiency.

Cambridge, Mass.-based Altus (Nasdaq: ALTU) announced on Wednesday that it would work with Calfornia-based Genentech (NYSE: DNA) to develop, manufacture and commercialize ALTU-238, Altus' once-per week formulation of human growth hormone.

The alliance focuses on a collaboration and licensing deal in North America, and Genentech will pay Altus $15 million up front; The company gets another $15 million through a Genentech investment in Altus stock. Altus can make up to $140 million more if the collaboration produces milestones in development and commercialization.

New Drugs Declining, Research Costs Increasing, GAO Says

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trendsBy Christopher Lee, Washington Post

Drug companies are becoming less innovative, with the number of new drugs being developed failing to keep pace with the substantial increases in spending on research and development, according to congressional investigators.

A report released yesterday by the Government Accountability Office, the investigative arm of Congress, found that annual research and development spending by the pharmaceutical industry increased 147 percent, to $60 billion, between 1993 and 2004. At the same time, the number of new drug applications to the Food and Drug Administration grew by only 38 percent, and it generally has declined since 1999.

What is more, about two-thirds of the new applications were for drugs that simply represent modifications to existing medicines, while 32 percent were for potentially innovative new drugs.

Drug Danger: Even Proper Use Can Kill

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fentanyl patchA powerful painkiller is raising red flags in western Wisconsin after an increase in the number of overdoses. There have been a string of deaths from Fentanyl overdoses. Some have been intentional, some were not.

In September, Dr. Susan Momont was found dead in her Eau Claire home. Her husband has now been charged with providing the Fentanyl that caused her death.

The St. Croix County medical examiner says three people have died in his county since this spring. Last week, the Chippewa County district attorney said a man there died from an overdose, which may have been a suicide.

Generic Proscar Approved

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proscarHealthDay News -- The U.S. Food and Drug Administration has approved a generic version of Merck & Co.'s Proscar (finasteride). The drug is used to treat symptomatic benign prostatic hyperplasia (BPH), the medical term for an enlarged prostate.

More than half of men in their 60s and as many as 90 percent in their 70s and 80s have some symptoms of BPH, the U.S. National Institutes of Health says.

Approval to produce a 5 mg. generic version of finasteride was granted to Mylan Laboratories Inc., the Pittsburgh-based company said Tuesday.

In the year ending Sept. 30, total U.S. sales of finasteride 5 mg. tablets were $553 million, Mylan said.

genmabDanish biotechnology company Genmab A/S signed a deal Tuesday worth up to US$2.1 billion (€1.6 billion) with pharmaceutical giant GlaxoSmithKline PLC for the global commercialization of a leukemia treatment.

The agreement for the HuMax-CD20 antibody includes an initial license fee of 582 million kroner (€78 million; US$102 million), Glaxo buying a stake of just over 10 percent in Genmab and milestone payments totaling 9 billion kroner (€1.2 billion; US$1.6 billion).

GlaxoSmithKline will invest 2.03 billion kroner (€272 million) for the 4.47 million Genmab shares.

Analysts said the value of the deal was much higher than expected, and could mean that Genmab will be profitable as early as next year.

Freeing the Drug Market

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FDABy David Gratzer

With health-care costs rising year after year — and drug costs rising faster than any other aspect of health spending — Americans wonder how to make drugs cheaper and more accessible. Politicians are listening: During the campaign, for example, Democrats promised seniors a better deal on drugs. But rather than embracing measures that could undermine the innovation of the industry, Congress can quickly and easily reduce the cost of drugs: Return the FDA back to its original mandate.

How much will that medicine cost? It’s a question patients ask me every single day. We love prescription drugs, but bemoan the price of pharmaceuticals. It’s no wonder that Speaker-Designate Nancy Pelosi promises that Washington will “negotiate” drug prices for Medicare, and that she has flirted with reimportation. Not long ago, I might have favored these ideas too — it’s tempting, after all, to think Congress can offer American pharmaceuticals at, say, Canadian prices. But Congressional meddling in the price of drugs would end up destroying the innovation and capital needed to develop new pharmaceuticals, leaving us with Canadian prices and Canadian innovation (or the lack thereof).

Lobbyists focus on safety in debate over generic drugs

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generic drugsWASHINGTON -- Biotechnology lobbyists attempting to slow the development of cheap generic versions of the world's most expensive drugs have been emphasizing questions about their safety in an effort to win support among the new Democratic leaders of Congress.

James C. Greenwood , a former congressman who is president of the Biotechnology Industry Organization , began raising qualms about drug safety with former colleagues on Capitol Hill even as the lawmakers were enlisting cosponsors for legislation to create a speedy mechanism for so-called biogenerics to reach the market.

"We think safety needs to be the primary concern. We think that in order to assure safety, you have to bring a full complement of data with the follow-on product," Greenwood told the Globe in a recent interview.

FDA Proposes New Pain Reliever Warnings

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aspirinFederal health officials on Tuesday proposed sterner warning labels for acetaminophen, aspirin and ibuprofen, again cautioning millions of Americans who take the nonprescription pain relievers regularly of potentially serious side effects.

The over-the-counter drugs remain safe and effective when used as directed, the Food and Drug Administration said. However, overdoses of acetaminophen can cause serious liver damage, even death, the FDA said.

For aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs, there is a risk of gastrointestinal bleeding and kidney injury even when patients take the correct dose. The drug are linked to thousands of deaths a year. The FDA said the risk is rare when compared to the number of patients who take the drugs.

Eli Lilly INDIANAPOLIS, Dec. 16 /PRNewswire-FirstCall/ -- Eli Lilly and Company , in a response to a story about Zyprexa in the December 17, 2006 edition of the New York Times, adds important facts and perspectives that were not evident in the story.

Said Steven Paul, M.D., Lilly's executive vice president of science and technology, "We believe it is critical to physicians and patients that Lilly state some important and relevant facts about our lifesaving medication Zyprexa that are missing from the New York Times article:

Drug Files Show Maker Promoted Unapproved Use

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zyprexa Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials.

The marketing documents, given to The New York Times by a lawyer representing mentally ill patients, detail a multiyear promotional campaign that Lilly began in Orlando, Fla., in late 2000. In the campaign, called Viva Zyprexa, Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.

A Lilly executive said that she could not comment on specific documents but that the company had never promoted Zyprexa for off-label uses and that it always showed the marketing materials used by its sales representatives to the Food and Drug Administration, as required by law.

Chinese factory closed over fake pill

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chinaBEIJING—Chinese authorities have closed down a factory producing fake birth-control pills out of starch and glucose and arrested one person, media reports said today.

Tests by the Food and Drug Administration on the southern island of Hainan found not only that the pills were useless in preventing pregnancy but also contained toxic ingredients, the Beijing News said.

"The fake contraceptive medicines and abortion drugs have greatly harmed women's physical and mental health," it said, citing an expert.

Ortho McNeil The mother of a woman who died in June 2003 after using Johnson & Johnson subsidiary Ortho-McNeil's birth control patch Ortho Evra recently filed a wrongful-death lawsuit in San Francisco Superior Court alleging that the company knowingly misinformed the public about the drug's risk of severe side effects, the AP/San Jose Mercury News reports.

Celena Devault, a 26-year-old woman from Tennessee, began using Ortho Evra in April 2003 and died of a pulmonary embolism in June 2003. Her mother, Mary Devault, filed the lawsuit alleging Ortho McNeil misled the public about the drug's risk of side effects, including pulmonary embolism, stroke, deep vein thrombosis and blood clots (AP/San Jose Mercury News, 12/12).

Undermining drug safety

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drug safetyBy Robert Goldberg, The Washington Times

Recently the Food and Drug Administration updated its warning on the use of oral sodium phosphate products (OSPs) as a cause of kidney failure. What are OSPs? If you had a colonoscopy as I did, you drank an OSP to clear the way for your inspection. In 1998, the FDA limited the OSP bottle size to no more than 90 ml. People were going into toxic shock and dying because they were told to use a bottle of the preparation and used a 240 ml jug instead of the 45 ml or 90 ml container. The FDA just updated warning labels about exceeding recommended doses since OSP-related kidney failure is still a problem.

Drug Industry Oversight

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AHRPThe president of Alliance for Human Research Protection’s explains the importance of informing the public.

Just as Vera Sharav sits down to talk about the lack of government oversight of the drug industry, the phone rings. She jumps up to answer it, and after listening patiently for a few minutes, she starts talking about Prozac, warning the caller that U.S. consumers don’t always get the same detailed health warnings about pharmaceuticals as residents of some other countries. After hanging up, Sharav, president of the advocacy group Alliance for Human Research Protection, gets right to the point.

“We’ve got a major crisis in America now,” Sharav says. “There is carnage going on. There are thousands of preventable deaths every year.” Approval of a drug by the U.S. Food and Drug Administration implies that a drug is safe to market to consumers, but Sharav asserts that the FDA’s assurances are not based on good science.

Ex-VP for J&J files suit for firing

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Ortho EvraTRENTON, N.J. - A former vice president at two Johnson & Johnson subsidiaries claims in a lawsuit he was fired for seeking recalls of numerous faulty products, including the Ortho Evra birth control patch, itself the subject of at least 1,000 product liability suits.

New Brunswick, N.J.-based Johnson & Johnson, one of the world's biggest drug and medical product makers, said yesterday the ex-executive was fired for inappropriate conduct.

In his civil complaint, Dr. Joel S. Lippman alleges he was unlawfully terminated on May 15, after working for Johnson & Johnson for 15 years, because he repeatedly complained about product safety problems and urged several be recalled or not launched. Lippman declined to be interviewed.

FDA needs to watch drugs ads more closely

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FDAThe U.S. Food and Drug Administration needs to more closely regulate direct-to-consumer advertising of prescription drugs, the Government Accountability Office said on Thursday.

It found the agency moved too slowly in reviewing ads on products ranging from impotence remedies to incontinence pills, and too slowly in trying to stop misleading ads.

"We believe that regulatory letters must be issued more quickly," the GAO, the investigatory arm of Congress, said in its report.

The Health and Human Services Department, which oversees the FDA, said the report was unrealistic, and meeting the GAO's recommendations "would require vastly increased staff to essentially review every piece in detail."

Bristol to seek OK for up to 3 cancer drugs in '07

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Bristol Myers SquibbNEW BRUNSWICK, New Jersey (Reuters) - Bristol-Myers Squibb <BMY.N> said on Thursday it could seek approval for as many as three new cancer drugs by next year, including treatments for melanoma and cancers of the breast and bladder.

The company said it plans to seek approval next year for breast cancer drug ixabepilone and to seek approvals by late 2007 or 2008 for bladder cancer treatment vinflunine and melanoma drug ipilimumab.

Aussies develop new anti-cancer drug

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medical researchCANBERRA, Australia (UPI) -- An Australian scientist has developed a drug to treat liver cancer and said the medicine could be available within three years.

Immunologist Professor Christopher Parish, of the Australian National University, told the Australian Broadcasting Corp. that clinical trials showed the drug significantly inhibited the growth of a cancer and its spread to other organs.

'For any primary tumor to grown beyond about a millimeter in diameter, in needs to induce new blood vessels to grow into it,' Parish said. 'Our drug inhibits those new blood vessels growing.'

Analysis: Controversial antibiotic debated

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ketekSILVER SPRING, Md., Dec. 14 (UPI) -- A Food and Drug Administration advisory committee will decide Friday whether to recommend that a widely used but controversial antibiotic be removed from the market.

The drug, known as Ketek, is used to treat respiratory tract infections such as bronchitis, sinusitis, and pneumonia. U.S. Doctors have written an estimated 6 million prescriptions for the drug since it was approved in April, 2004.

But FDA is revisiting that approval in two days of expert hearings Thursday and Friday because of reports suggesting the drug could carry a higher risk of liver failure and other dangerous side effects than similar antibiotics.

Vertex Drug Safety Results Sink Shares

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Vertex Pharmaceuticals CAMBRIDGE, Mass — Vertex Pharmaceuticals Inc. said Wednesday a safety analysis of its developing hepatitis C drug VX-950 showed 9 percent of the patients involved dropped out of the program because of adverse events including gastrointestinal disorders and rash.

The news sent shares of Vertex fell 62 cents to $38.78 in morning trading on the Nasdaq, following a drop in premarket trading.

The midstage study involved 250 patients, with the current interim data involving 74 patients for whom data was available at 12 weeks. Patients were given either the drug, called telaprevir, or placebo in combination with ribavirin. The safety study results showed that 9 percent discontinued treatment because of adverse events, with rash being the most common, compared with 3 percent of the patients taking placebo.

GenVecGAITHERSBURG, Md.--(BUSINESS WIRE)--GenVec, Inc. (Nasdaq: GNVC) announced today that an independent data safety monitoring board (DSMB) has completed a planned interim analysis of safety data from the ongoing Phase II/III clinical trial with TNFerade in locally advanced pancreatic cancer. In addition to its recommendation that the trial continue, the DSMB supported the use of endoscopic ultrasonography (EUS) as an alternative to percutaneous tumor administration. GenVec has provided its interim safety data to the U.S. Food and Drug Administration (FDA) and is waiting for final clearance to move forward with EUS administration.

The Phase II/III clinical trial, known as PACT, is a multi-center, randomized and controlled study of 330 patients, designed to evaluate the safety and efficacy of TNFerade plus standard of care, versus standard of care alone (SOC) in patients with locally advanced pancreatic cancer. This interim evaluation was based on data from 40 patients, 25 of whom received standard of care plus TNFerade.

Pozen stock plunges on FDA request

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pozen incShares of Pozen Inc. sank almost 15 percent Wednesday after the company said federal regulators have raised additional questions about its lead migraine treatment.

Less than two months after Pozen submitted what it called a "full response" to safety questions posed by the U.S. Food and Drug Administration about the migraine treatment Trexima, the federal agency has requested more data and analyses of the drug. Chapel Hill-based Pozen said Wednesday that the FDA has completed its review of the company's response to a June 8, 2006, approvable letter for Trexima and that the agency has "determined the response is not yet complete."

FDA May Expand Antidepressant Warning

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FDAThe FDA said Wednesday it planned to expand warnings on up to a dozen antidepressant medications following studies suggesting the drugs raise the risk of suicidal behavior in a wider range of patients than previously thought.

In 2004, the agency ordered "black box" warnings to be added to antidepressant packaging alerting doctors of evidence that the drugs increase the risk of suicidal thoughts and attempts in children and teens under the age of 18. Officials said Wednesday they would now move to expand the warning to include young adults up to age 25.

The warnings apply to selective serotonin reuptake inhibitors (SSRIs) such as Prozac and Paxil, in addition to related drugs including Effexor and Wellbutrin. Officials said the warnings would also likely be included in medication guides distributed to patients

Healthy Americans Act: health insurance for every citizen

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senator Ron WydenOregon Senator Ron Wyden is introducing a new proposal to provide affordable, high quality, private health coverage for everyone regardless of where they work or live with the Healthy Americans Act.

"The Healthy Americans Act provides a guarantee -- health coverage for every American that is at least as good as Members of Congress receive and can never be taken away," Wyden explained. "The Act provides universal coverage for no more money than our country spends today. Better care, financial health and security, no increase in costs."

Future of nationwide children's study is hazy

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US senateby Lois M. Collins

Plans for the nation's first large-scale, long-term study of children are proceeding along two paths: The first involves getting ready to hit the pavement and start enrolling families by at least 2008; the other would fold up shop.

The future of the highly publicized National Children's Study, created by Congress in 2000, is at a crossroads. The president's 2007 budget proposal not only didn't fund the study but actually directed it to be closed down. Congress responded with strong language from both the House and Senate indicating avid support for the study. But Congress hasn't actually committed a penny yet in future funding.

"They've implied provision (for the study) but didn't say what that will be," said NCS director Dr. Peter Scheidt. "So we've responded by preparing to do both."

Merck Reports Progress on Overhaul

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merckThe drugmaker Merck & Co. is off to a strong start in its year-old program to cut costs, boost revenues and transform company operations, Chief Executive Officer Richard Clark said Tuesday.

The company this year launched five new vaccines and other medicines, all well received, without increasing its sales force, Clark told analysts at Merck's annual business briefing at headquarters in Whitehouse Station, N.J.

Merck is speeding up the time it takes to get experimental drugs through testing and onto the market, launching one of the five new products _ the diabetes drug Januvia _ about four years ahead of when it would have been approved under a traditional development schedule, he noted.

Cancer-trial elation

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progen industriesA LIVER cancer trial of a Brisbane biotechnology company's drug turned out positive results which analysts yesterday described as a "cracker".

The results from the second-round trial were also encouraging enough for Toowong-based Progen Industries to proceed with more advanced research and plans to raise funds.

The sharemarket initially seemed ambivalent, which was linked to investors potentially needing time to absorb the results or an attempt to knock down the share price. But by the afternoon a rush pushed shares up 84¢ to $4.99 – still off all-time highs of $13.18 in February 1997.

Americans Say They're in Good Health

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surveyMost U.S. adults are in good or excellent health. Or, at least, that's what they say, according to a new Gallup poll.

The poll, conducted by telephone from Nov. 9-12, included 1,004 adults. They were asked to rate their physical and mental health.

Of those polled, 79% rated their physical health as "excellent" or "good," while 21% said it was "only fair" or "poor."

FDA: Don't Use Quinine for Leg Cramps

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FDAThe FDA is telling people not to use the malariamalaria drug quinine for leg cramps, citing potentially deadly side effects.

The FDA issued the advice today and ordered all unapproved drugs containing quinine off the market within 60 days.

Qualaquin, the only FDA-approved quinine drug, can be used to treat certain types of malaria; the new order doesn't change that.

But quinine is also often prescribed to treat leg cramps. That unapproved use is too risky, says the FDA.

memory pharmaceuticalsMemory Pharmaceuticals Announces Release of Clinical Hold on MEM 3454

MONTVALE, N.J., Dec. 11 -- Memory Pharmaceuticals Corp. today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug application (IND) for MEM 3454 and has informed the Company that the clinical hold on the development of this drug candidate has been released. The Company now plans to commence its previously-announced Phase 2a clinical trial for MEM 3454 in Alzheimer's disease during the first quarter of 2007.

"Memory has worked diligently with the FDA since this trial was placed on clinical hold in October, and we are pleased that we will now be able to move forward with the proof-of-concept trial for this important drug candidate," stated Jim Sulat, President and Chief Executive Officer of Memory Pharmaceuticals.

Big Pharma's Big Decision: Diversify Or Focus?

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buy, sell or hold?by Centinent Management

The pharma business is a risky undertaking, even for monster companies such as Pfizer (PFE). That was once again clearly demonstrated when Pfizer lost $20 billion in market capitalization last week, after it decided to withdraw its new compound torceptrapib. It is rumored that Pfizer lost an additional $1 billion in development costs on the drug, and the company spent almost 15 years focused on it. Other pharmas the size of Pfizer, the ones that have continued to operate consumer or generic divisions, rarely take hits this size.

The Pfizer case is by no means unique, however. Other big pharmaceutical companies have suffered similar setbacks when one of their key pipeline products failed in trials or showed signs of trouble. The torceptrapib case shows how even a few deaths can cause a company to abandon a promising drug. That is because a tainted drug is unlikely to become a blockbuster.

Nuvelo plunges 79% on drug test failure

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nuveloCHICAGO (Reuters) -- An experimental blood clot dissolver by Nuvelo Inc. and its German partner Bayer failed to meet its main goal in two late-stage studies, sending the U.S. biotechnology company's shares down more than 79 percent Monday.

Nuvelo (down $15.50 to $4.05) shares closed at $4.05, down $15.50.

The companies said they had temporarily suspended enrollment in all trials of the alfimeprase compound pending further analysis and discussions with outside experts and regulatory agencies.

The news rattled investors, who had high hopes for the drug.

"We are very surprised by these results, given the strength of the prior (midstage) results," said CIBC analyst Bret Holley in a note to clients.

avastin BASEL (AFX) - Roche Holding AG said an interim analysis of a Phase III study of Avastin in advanced renal cell cancer has shown that the drug significantly prolongs progression-free survival.

Due to the benefits observed, the independent Drug Safety Monitoring Board has recommended that the study be unblinded and all patients will be offered treatment with Avastin.

In addition, this early analysis indicated a trend towards an improvement in overall survival.

Renal cell cancer is the most common form of kidney cancer accounting for nine out of ten cases and treatment options are limited.

Safety was in line with what has been observed for Avastin in previous studies.

source - AFX 

prozacby Dr. Peter Breggin

On December 13, 2006 the FDA's Psychopharmaceutical Drugs Advisory Committee (PDAC) is meeting in Silver Spring, Maryland to discuss antidepressant-induced suicidal behavior in adults. In 2004 the FDA held similar hearings on children and concluded that antidepressants do in fact cause suicide in humans under age eighteen. A warning has been placed in all antidepressant labels or package inserts.

Now the agency has given advanced notice of its new findings--antidepressants, all of them according to the FDA, cause increased suicidality in young adults. Suicide occurs more than twice as much on antidepressants than on sugar pills in individuals under age 25.

Developing lifesaving drugs is anything but inexpensive

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moneyThose already in Washington, and those newly elected to Congress, who want to artificially control drug prices got an important lesson in economics last week. They also got a tutorial on why new lifesaving drugs are so expensive.

The lesson came as Pfizer, a leading pharmaceutical maker, canceled trials of a new cholesterol-controlling drug — torcetrapib.

As the stock market opened on Monday, Pfizer's announcement over the weekend sent its stock tumbling 14 percent, kicking the stuffing out of the company's estimated worth by more than $20 billion.

Epidural babies can't get grip on what's breast

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breast feedingWOMEN who give birth with the aid of pain-relieving epidurals find it harder to breastfeed than those who give birth naturally, an Australian study has found.

The research suggests some of the drugs used in epidurals make their way into babies' bloodstreams, subtly affecting their brains and development for weeks afterwards -- including making them less willing to breastfeed. The study by University of Sydney epidemiologist Siranda Torvaldsen adds to a growing body of knowledge that makes a link between the use of the pain-killing drug fentanyl in epidurals and problems with breastfeeding. During an epidural a catheter is inserted into the spine to allow the infusion of pain-killing drugs. These deaden the nerves that relay sensations of pain from the lower body.

Axa upgrades PMI to cover all cancer drugs

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healthcareAxa PPP has re-launched its Premier Plus medical insurance plan to cover any drugs used to treat cancer, regardless of whether they are licensed.

Premier Plus now pays for any cancer drug which a patient’s oncologist may wish to use, regardless of whether they are licensed, for as long as the oncologist wishes to give them.

In addition, the plan provides a health check every two years, up to £1,000 for one hearing aid every two years, up to £150 a year for chiropody and up to £15 for an annual eye test and up to £250 for prescription glasses or contact lenses every two years.

Clients can use any hospital in the UK and they can opt for a no claims discount and/or excesses of £100, £200 or £500 to reduce costs if they wish.

source - Ifaonline 

xelodaBASEL (AFX) - Roche Holding AG said that its latest Phase III study of cancer treatment Xeloda with 627 previously treated patients with advanced colorectal cancer met its primary endpoint of progression-free survival.

Study results showed that the chemotherapy combination XELOX -- consisting of oral Xeloda plus oxaliplatin -- was as effective in delaying disease progression as the chemotherapy combination FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin).

The data will be used in worldwide submissions of the drug.

Duff reports on clinical trial safety

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TeGeneroAfter six members of a Phase I trial of TeGenero’s TGN1412 nearly died, an expert scientific group, headed by Professor Gordon Duff, was convened to investigate the incident and recommend new procedures to increase the safety of future ‘first-in-man’ trials.

The drugs, which passed standard pre-clinical trials, were supposed to subtly “retune” the immune system. Instead they sent the immune system into overload and the members of the trial suffered multiple-organ failure. The effects were so severe that fingers and toes had to be amputated.

The report called for increased communication between the drug developer and the regulatory body before application for Phase I trials. Pre-clinical trial safety information should be submitted to a database to speed-up the process. This should allow the regulators to identify potential concerns and discuss these with appropriate independent specialist experts.

GSK invest in miniature antibodies

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GSKThe pharmaceutical giant has agreed to acquire Domantis for £230m (€340m). The UK based company have developed miniature antibodies that can overcome the restrictions in therapeutic applications commonly seen with larger biomolecules.

They achieved this miniaturisation by only producing the small part of the antibody or domain that actually binds to the target, disregarding the extra part of the protein. These domain fragments are up to 13 times smaller than normal antibodies (around 110 amino acids long).

Traditionally, pharmaceutical companies have concentrated on developing small molecule drugs. However, there is a growing trend towards developing so-called biopharmaceuticals: large molecules such as antibodies, vaccines and other therapeutic proteins. However, the increased size means that they have to be administered by injection or infusion, in contrast to orally administered small molecules.

Agonizing dilemma over costly cancer drugs

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healthHow much is one month of life worth?

It's a question that has split governments, bankrupted patients and left hospitals with an agonizing moral dilemma.

Health Canada has approved drugs that prolong the life of cancer patients.

They're expensive. They're not a cure. And usually they only give the patient months more to live.

Patients think they're worth every penny.

Governments can't agree. Some provinces pay. Others say they're not worth the small benefit to a few.

Drugmaker makes chewable contraceptive

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femcon feLooking for a contraceptive that's convenient — and tasty? The first chewable birth-control method, a tiny, spearmint-flavored tablet that also can be swallowed without chewing, has hit pharmacy shelves.

Femcon Fe, which contains the same hormones as standard oral contraceptives, offers a new option for women who don't like swallowing pills and want to take their birth control with them, according to Carl Reichel, president of drugmaker Warner Chilcott of Rockaway.

Warner Chilcott, which makes prescription dermatology and women's health products, officially launched the product Thursday aimed at women who sometimes forget to take their pills.

Now Viagra 'helps the body fight cancer'

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viagraVIAGRA and other impotence drugs help switch on the immune system to attack a range of cancers, a study has found.

The disease usually manages to avoid destruction partly because tumours produce a fog of chemicals that hide it from white blood cells.

But Viagra, a brand name for sildenafil, and other such drugs were found to reduce the amount of these chemicals, enabling the immune system to target the cancer more effectively.

Tests at the Johns Hopkins Kimmel Cancer Centre in the United States found the drug reduced the size of colon and breast tumours in mice threefold.

Senate Approves Permanent FDA Chief

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Andrew von EschenbachDec. 7, 2006 - The U.S. Senate voted 80-11 Thursday to back President' Bush's pick to lead the FDA.

The Senate's approval came after months of protests from Republicans and Democrats that blocked Andrew von Eschenbach, MD, from taking the politically sensitive office.

The agency has been without a permanent chief for nearly four and a half of the last six years. During that time the FDA has faced a range of perceived missteps that have increased lawmakers' appetite to reform the agency next year.

Solvay, Bristol obesity drug advances in trials

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solvayA new anti-obesity drug that works in the same way as Sanofi-Aventis's Acomplia has advanced in clinical trials, triggering a $25 million payment to Belgian drugs, chemicals and plastics maker Solvay.

Solvay said on Friday it had started further Phase II clinical tests of its SLV319 drug following encouraging early results, prompting the payment from its partner Bristol-Myers Squibb Co.

"Clinical and preclinical studies involving this class of drug have shown that blocking the cannabinoid type 1 (CB1) receptor results in reduced food intake," Solvay said in a statement.

The $25 million will be booked into the fourth quarter 2006 figures but Solvay Pharmaceuticals is increasing its R&D and marketing spending by a similar amount.

The Future of FDA

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futureThe Food and Drug Administration celebrated its first century in 2006, but as 2007 begins, it is also stepping into the cross-hairs of a new Democratic Congress. Bolstered by a public that seems increasingly worried about the FDA's ability to protect it, the Congress is eager to leave its mark on the agency. "There is a confluence of legislation in the coming year," says Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs. "There are some big, must-pass bills, and that will create an environment where a lot of people will be proposing a lot of different ideas."

Key among the FDA reform bills will be legislation by Senators Chuck Grassley (R-Iowa) and Chris Dodd (D-Conn.) to give additional resources to the FDA's drug safety office and make it structurally independent of the agency's drug-approval division. This would remove conflicts of interest, a problem identified in several government studies but which the FDA denies exists. The Grassley-Dodd bill (S 930) also would give the agency more teeth to demand that manufacturers conduct postmarketing surveillance and other measures to track safety issues of newly approved drugs.

InnoMed’s Drug Safety Database Goes Live

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researchNewswire Today —  Basel, Switzerland, 2006-12-06 - Joint industry/academic consortium InnoMed PredTox met recently in Dublin for a progress report and to discuss the consortium’s newly launched central biomolecular data sharing platform, developed by Swiss-based computational biology firm Genedata.

Researchers from major pharmaceuticals, Swiss-based computational biology firm Genedata and European Commission (EC) representatives met recently in Dublin for the Second General Assembly of InnoMed PredTox consortium. InnoMed PredTox is a joint Industry, Academic and EC collaboration to improve drug safety testing.

Tasked with exploring the molecular basis of drug-side effects, InnoMed PredTox is an ambitious project involving leading European pharmaceutical companies, academic research institutes and Genedata.

Halozyme Shares Leap on Roche Agreement

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haolzyme therapeutics NEW YORK — Shares of biopharmaceutical company Halozyme Therapeutics Inc. jumped Wednesday after the company said it signed a deal with Roche worth up to a potential $581 million.

Shares of Halozyme soared $1.71, or 60 percent, to $4.56 on the American Stock Exchange in morning trading, following a flurry of premarket activity. The stock hit a new 52-week high of $4.93, eclipsing a previous high of $3.72.

The agreement calls for San Diego-based Halozyme's drug delivery technology, called Enhanze, to be used in Roche compounds. Roche will pay Halozyme $20 million upfront for the application of the technology to three predefined Roche biologic targets. Roche will have the option to exclusively develop and commercialize the technology with an additional 10 targets over the next 10 years.

5 Years Later, Gleevec Fights Cancer

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gleevecDec. 6, 2006 -- When first introduced in 2001, Gleevec was hailed as a miracle drug poised to usher in a new age in cancer treatment. Now, five years later, it appears that promise is being fulfilled.

The longest follow-up yet of chronic myeloid leukemia (CML) patients treated with Gleevec shows a survival rate of 95% after five years. (The survival rate does not count people who died from causes unrelated to CML or stem-cell transplantation). Before the drug’s introduction, about half of patients died within five years of diagnosis.

And there is more good news. Relapse rates seem to be trending down the longer patients stay on the drug. After three years of treatment, 15% of patients in the study experienced relapses. Two years later, that figure had risen by just 2%.

Gleevec was the first treatment to specifically target cancer cells, leaving healthy cells unharmed. It is marketed by Swiss drug maker Novartis. 

India's Dabur Pharma gets FDA nod for cancer drug

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paclitaxel MUMBAI, Dec 7 (Reuters) - Indian drug maker Dabur Pharma Ltd. (DABR.BO) has received approval from the U.S. Food and Drug Administration for oncology drug paclitaxel injections, the regulatory agency's Web site showed.

Paclitaxel is the generic equivalent of Bristol-Myers Squibb Co.'s (BMY.N) Taxol, used in treating ovarian and breast cancer.

 © Reuters 2006.

New FDA drug safety projects rely on IT

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FDAThe Food and Drug Administration plans to improve the Web portal so that anyone can report adverse drug effects and will try data mining to learn more about any problems with regulated medicines.

The agency, which has been criticized for paying too little attention to prescription drugs after they are approved for sale, also will offer a downloadable software module that doctors and other practitioners can use to report on drugs. The module will work with existing electronic medical records, making reporting easier for those with EMR systems.

Dr. Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs, disclosed those and other information technology tactics in a November speech. Gottlieb did not give a timetable for completing the projects, and FDA spokeswoman Crystal Rice said such questions were premature.

baybioSAN FRANCISCO, Dec. 5 -- BayBio released today the flagship industry study, BayBio:IMPACT 2007, providing an in-depth look at the impact of the billions of doses that the 393 innovative life-saving drugs and technologies from Northern California have on individual lives around the world. To ensure continued growth and address current barriers, the study calls for partnership and collaboration with public officials, healthcare practitioners and the investment community.

Northern California is home to the world's largest life sciences cluster, housing one-third of the U.S. industry. The region continues to deliver novel approaches to virtually all diseases, especially epidemics such as diabetes, obesity and infectious disease and cancer. Additionally, Northern California's life sciences industry has pioneered the path for other hubs, providing key insight based on its own unique 30 years of experience and lately leading the way to personalized medicine becoming a reality.

TennCare focuses on preventative measures

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tenncareTennCare officials say they want to spend $6.2 million on preventive measures that will help enrollees take better care of themselves and avoid serious illnesses.

The request is part of $99.3 million needed from the state to make improvements to the expanded Medicaid program, officials told Gov. Phil Bredesen during state budget hearings today.

"Some of our enrollees need extra help in how they should take care of themselves," said Dr. Wendy Long, TennCare's chief medical officer.

NIH scientist charged with conflict

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briefcase with moneyWASHINGTON — Federal prosecutors on Monday charged a senior scientist at the National Institutes of Health with conflict of interest for taking $285,000 in fees from a drug company that was involved with his government research.

Dr. P. Trey Sunderland III is the first official in 14 years to be prosecuted for conflict of interest at the NIH, an agency rocked in recent years by revelations of widespread financial ties to the drug industry. Sunderland accepted the fees from 1998 to 2003 from Pfizer Inc.

Sunderland, who has headed the NIH's geriatric psychiatry branch, is scheduled to appear Friday in a federal courtroom in Baltimore, according to the office of U.S. Atty. Rod J. Rosenstein.

Nastech stands by its drug

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nastech BOTHELL - Shares of Nastech Pharmaceutical Co. tumbled Tuesday after it revealed delays in developing a nasal spray for osteoporosis, resulting in the postponement of a $15 million payment from its drug partner.

Nastech's stock price fell $2.99, or nearly 16 percent, to close at $16.20.

In a conference call with investors, Nastech's chairman and chief executive said the hurdle doesn't quell the enthusiasm about the parathyroid hormone spray.

"We continue to be excited about the potential for PTH spray to be a safe and effective noninjectable treatment for osteoporosis," Steven Quay said.

Danish allergy giant in the melting pot

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alk abello A new Danish drug giant is flourishing in Hørsholm after ALK-Abelló has launched its allergy tablets, Grazax, on its first market. It is predicted that the company will develop the sale to surpass Lundbeck’s present turnover. Consequently, the shares are up by 37.5 per cent in two days and it has made the shareholders wealthier by approximately DKK 3.2 billion.

“I estimate that the sale in Europe may reach DKK 4.5 billion within a number of years and that sale in the USA may yield just as much,” says share analyst Henrik Simonsen at the investment bank SEB Enskilda, which does not wish to guess the what the shares will end at.

Evolutec plunges on hay fever drug failure

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evolutec group LONDON (SHARECAST) - Drug group Evolutec collapsed Monday after it said its rEV131 hay fever treatment performed no better than a placebo.

“No significant differences were observed between rEV131 and placebo in the phase IIb trial in allergic rhinitis and the primary endpoint was therefore not met,” it said in a statement.

“This is tremendously disappointing for Evolutec and its shareholders,” said chief executive Mark Carnegie Brown.

U.N. health agency launches pharmaceutical review

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UN GENEVA (Reuters) - The World Health Organization launched on Monday its first intergovernmental review of the pharmaceutical sector to try to find ways of making medicine more easily available to the world's poorest people.

In their five-day talks, the World Health Organization's 193 member countries are expected to look at how international patents limit access by keeping drug prices high, and to highlight areas now lacking investment, such as tropical and parasitic diseases.

A WHO commissioned report earlier this year drawn up by former Swiss President Ruth Dreifuss slammed the existing drug development, marketing and pricing system.

Elderly perplexed over Medicare choices

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medicare CHICAGO (Reuters) - When it comes to finding the best deal on prescriptions under the Medicare health insurance program, 68-year-old Carol Paremske of Miami says she knows all the tricks.

The Internet-savvy senior knows about step therapy, which requires a patient to try a less expensive drug favored by the insurer before using the one prescribed by a doctor. She knows about the so-called doughnut hole, where coverage is limited after spending tops about $2,300. She's called the private companies that run the plans and the government help lines.

Still, a week before the Medicare agency suggests seniors decide which Medicare prescription drug plan to choose for 2007, she is perplexed.

"The thing is so complicated and convoluted. You don't really know if you are saving money or if it is just going to the drug companies," Paremske said.

niaspanPfizer Inc.'s new experimental heart drug is dead, but the dual approach the company was testing -- boosting good cholesterol while lowering the bad -- is very much alive, specialists said Monday.

A drug already on the market, Niaspan, raises good cholesterol without serious risks, and a large federal study is testing it with statin medications -- the very thing Pfizer was trying to do before being forced to abandon research on its drug, torcetrapib, over the weekend because of safety problems.

For consumers, the main fallout may be a delay in getting a new medicine that avoids Niaspan's chief side effect, a hot prickly sensation called flushing that patients hate but that can be minimized, doctors said.

FDA/CMS summitWASHINGTON--(BUSINESS WIRE)--Dr. Stephen Galson, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration, led a slate of keynote speakers and panelists from industry, regulatory agencies and academia at Windhover’s 2nd Annual FDA/CMS Summit today. Across the presentations was a common resonating theme of imminent drug safety reform. However, rather than being seen as an obstacle to business, industry executives and regulators suggest the coming discussion presents an opportunity to define a new model of drug development and evaluation for the 21st century.

Executives from MedImmune, Merck and Roche posited that developments in personalized medicine and a focus on value-based healthcare offer a business opportunity on which companies may capitalize. To understand the implications of potential changes to drug safety evaluation, as well as other hot topics, the audience of more than 200 heard from:

Crucell to Break Even with $200M Vaccine Contracts

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crucell Shares of Dutch biotech Crucell N.V. (CRXL) rose more than 2% in European trading as the company announced it had been awarded $200 million in contracts over the next 3 years by supranational organizations for its pediatric vaccines.

Quinvaxem and Hepavax-Gene vaccines will be made available to children in developing nations by the supranational organizations.

Quinvaxem is the first liquid vaccine to harbor antigens against some of the world's leading pediatric diseases including, diphtheria, tetanus, pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b. The vaccine was co-developed with Novartis (NVS) in Crucell's South African laboratories.

Doctors question safety of drug-coated stents

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drug-coated stentsBEIJING, Dec. 4 (Xinhuanet) -- More than 6 million people worldwide -- a modern record for any medical device -- were relieved of chest pain or heart attack risk by the insertion of drug-coated stents in their arteries the last few years, but now doctors say their long-term safety is in question.

Unless their patients remain on Plavix, a 4-U.S.-dollar-a-day anti-clotting drug whose long-term safety has not been proven, doctors are worried these stents may raise the risk of life-threatening blood clots months and even years later.

And thousands of others each day who develop new blockages are being treated by doctors no longer sure of what to do. Many are returning to the old metal stents, and some are fundamentally rethinking when to use stents at all and are considering alternatives like bypass surgery or medications.

UHSSEIU, the nation's largest health care union, issued a report today entitled "Failure to Care: A National Report on Universal Health Services' Behavioral Health Operations." The report alleges poor case management and understaffing at behavioral health facilities owned by the corporate health care giant, Universal Health Services (UHS).

The report documents cases of understaffed facilities and poor case management leading to sexual abuse, runaway patients, physical assaults on patients, violations of patients' rights, and patient dumping in several states. The report documents incidents from 13 different facilities in six states, including Massachusetts, Connecticut, Delaware, Georgia, Texas, and Nevada.

LONDON (AFX) - ValiRx PLC said it is investing 193,000 stg in emerging US biotechnology company Morphogenesis Inc in addition to subscribing for 250,000 share warrants, exercisable at 1 usd within the next three years.

The cancer therapeutics company said its investment is funding Morphogenesis' ImmuneFx, a cancer vaccine that targets tumours in both humans and pets and said it is due to go into phase II pre-clinical trials in 2007.

The company said it now holds 1.806 mln shares and 250,000 warrants in Morphogenesis.

source - AFX 

bayer LEVERKUSEN, Germany (AFX) - Bayer (nyse: BAY ) AG and Onyx Pharmaceuticals Inc said Phase III skin cancer tests of their Nexavar (sorafenib) tablets failed to meet their primary endpoint of improving progression-free survival (PFS).

'We are disappointed, first and foremost, for the patients with refractory metastatic melanoma for whom treatment options are so limited,' Onyx chief executive Hollings Renton said in a statement.

'However, this trial does not change our commitment to, and belief in, Nexavar. We hope to demonstrate utility in a wide variety of tumours and we will continue to broaden our clinical program, including increasing our attention to the more common malignancies in which anti-angiogenics have demonstrated activity.'

source - AFX 

pfizerPfizer Inc. said Saturday it has cut off all clinical trials and development for a cholesterol drug that was supposed to be the star of its pipeline because of an unexpected number of deaths and cardiovascular problems in patients who used it.

The world's largest drugmaker said it was told Saturday that an independent board monitoring a study for torcetrapib, a drug that raises levels of HDL, or what's commonly known as good cholesterol, recommended that the work end because of "an imbalance of mortality and cardiovascular events."

The news is devastating to Pfizer, which had been counting on the drug to revitalize stagnant sales that have been hurt by numerous patent expirations on key products. It has said it was spending around $800 million to develop Torcetrapib.

satireby Mike Adams

In a surprising move, the FDA has now banned the manufacture and use of vitamin D, citing studies that show vitamin D to be a powerful physiological substance that needs to undergo FDA approval before individuals are allowed to use it. Since sunlight exposure causes vitamin D production in the human body, individuals who intentionally expose themselves to sunlight will now be arrested and have their blood confiscated by federal health authorities. All citizens are advised to coat themselves with sunscreen every time they go out in the sun and avoid sun exposure until further notice.

Individuals caught seeking sunlight may be charged with not only possession, but trafficking of the vitamin D drug. DEA agents have been alerted and will be called in to arrest sunbathers. Sunscreen checkpoints will also be set up in public places where sunlight may occur, and any citizen who fails to test positive for the presence of sunscreen on their skin will be immediately arrested and charged with trafficking vitamin D.

Hat companies and sunscreen manufacturers hailed the FDA's decision.

Herpes study put pregnant women at risk

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pregnant womanWASHINGTON (AP) - Dozens of poor and minority pregnant women were put at risk when they were given dummy pills instead of a drug believed to prevent outbreaks of genital herpes, consumer watchdogs charged Friday.

The researchers defended their work, saying in part the study was to assess the uncertain risks of the drug to the women's fetuses.

In the study, researchers at Parkland Hospital in Dallas gave 170 pregnant women the drug valacyclovir to see if the drug would reduce herpes outbreaks at birth. The virus can be fatal to newborns if infected during delivery.

New schizophrenia drugs no better than generic

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perphenazine.jpgby Shankar Vedantam

Treating schizophrenia with an older, cheaper drug, rather than with heavily promoted newer medications, reduces the cost by as much as 30 percent with no apparent difference in safety and effectiveness, according to the first study to examine the economic implications of antipsychotic drug prescribing practices in the United States.

The newer drugs, such as Zyprexa, Seroquel and Risperdal, have cornered the lucrative U.S. market for antipsychotic drugs at a cost of $10 billion a year -- or around $100 for every family.

The findings have roiled the field of psychiatry in a fierce debate over the study's implications and have triggered concerns it could lead public and private insurers to limit drastically which drugs they will pay for.

Pfizer Seeks to Cure Its Ills

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pfizerWhile hopes remain high for Pfizer's new cholesterol drug, the pharma giant is ready to run a leaner operation and look beyond its own labs

At the start of Pfizer's (PFE) Nov. 30 meeting for Wall Street analysts, a crowd gathered around a poster about torcetrapib, the drug giant's experimental product to treat high cholesterol. Torcetrapib could be the crown jewel in Pfizer's pipeline—a newfangled treatment that simultaneously raises "good" cholesterol while lowering the "bad."

But recent trial results suggest it raises blood pressure in some patients, a side effect that could stifle the market potential of what was to be a blockbuster replacement for Pfizer's Lipitor, the world's top-selling drug, which is facing generic competition. "Have you identified what causes the increase in blood pressure?" asked an analyst of a Pfizer scientist. "No," came the simple reply.

Prescription Labels Often Misunderstood

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drugsHealthDay News -- Many Americans, including those with college degrees, have trouble interpreting the instructions on prescription drug labels, a new study finds.

Indeed, only 34.7 percent of the people with lower literacy, grade level or below, interviewed for the study could determine the number of pills to take daily when faced with "take two tablets by mouth twice daily," according to the study report in Annals of Internal Medicine.

And 9 percent of all those interviewed had trouble with the instruction, "take one tablet by mouth once each day."

Pfizer raises 2006 estimate, adds drug candidates

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pfizer Pfizer Inc. raised its 2006 earnings estimate and said the number of experimental products it has under development, including drugs for AIDS, obesity and cancer, jumped 60 percent since early this year.

Pfizer, the world's biggest drugmaker, increased its adjusted earnings estimate to at least $2.05 a share from a previous forecast of $2 a share, the New York-based company said today in a statement. There are 242 drugs in the pipeline, the statement said, an increase of 90 since February 2006.

Pfizer needs new products to replace revenue it will lose as patent protection runs out by 2011 on drugs that generated almost half of the company's $51 billion in sales last year. The best-selling Lipitor cholesterol drug, which accounts for $13 billion a year, will face generic competition in four years. New Chief Executive Officer Jeffrey Kindler is also expanding a plan to cut $4 billion in costs by 2008.
sanofi-aventisSanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for Ambien® (zolpidem tartrate) and Ambien® CR (zolpidem tartrate extended-release).

The decision was based on pediatric data submitted to the FDA, including results of a study in the pediatric population conducted following a written request from the FDA in December 2005.

Two plead guilty in case over imported Lipitor

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lipitorTwo pharmaceutical drug distributors pleaded guilty Thursday to taking part in a $42 million conspiracy to illegally import and sell the cholesterol reduction drug Lipitor and other medicines.

Richard K. Rounsborg, 48, of Kearney, Neb., and Albert David Nassar, 51, of New York, each pleaded guilty to conspiracy.

U.S. Attorney Bradley Schlozman said they bought Lipitor intended for distribution in South America, then illegally imported it into the U.S. to sell at a lower cost than Lipitor made for the U.S.

The Lipitor bought and sold by the conspirators was not manufactured by Pfizer, which makes Lipitor for distribution in the U.S.

source - STL Today 

EU backs Glaxo combination drug for cervical cancer

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GSKLONDON, Dec 1 (Reuters) - GlaxoSmithKline Plc (GSK.L) said on Friday it had won European regulatory approval to sell its Hycamtin medicine as a treatment for cervical cancer in combination with another cancer drug, cisplatin.

The decision was expected after European regulators signalled last month that they intended to approve the new combination treatment.

U.S. regulators approved the combination drug in June.

© Reuters 2006