SHANGHAI, 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.
U.S. regulators cleared six more companies to begin selling generic copies of Merck & Co.'s cholesterol drug Zocor, signaling steeper price reductions.
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.
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.
HealthDay 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.
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 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.
By CHRISTOPHER LEE, The Washington PostWASHINGTON - 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.
December 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.
Not 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.
By 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.
After 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.
WASHINGTON, 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.
A 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
FDA 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..
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.
LONDON & 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.
ROCHESTER, 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 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.
By 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.
A 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.
HealthDay 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.
Danish 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.
By David Gratzer
WASHINGTON -- 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.
Federal 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.
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:
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.
BEIJING—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.
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).
By 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.
The 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.
TRENTON, 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.
The 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."
NEW 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.
CANBERRA, 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.'
SILVER 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.
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.
GAITHERSBURG, 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.
Shares 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."
The 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
Oregon 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.by 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."
The 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.
A LIVER cancer trial of a Brisbane biotechnology company's drug turned out positive results which analysts yesterday described as a "cracker".
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.
Most 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."
The 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 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.
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.
CHICAGO (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.
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
by 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.
Those 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.
WOMEN 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 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
BASEL (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.
After 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.
The 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.
How 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.