Government Agencies FDA

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    A judge on Tuesday sentenced former Food and Drug Administration chief Lester Crawford to three years' supervised probation with fines of roughly $90,000 for lying about stocks he owned in companies regulated by his agency.

  • Federal health advisers recommended Tuesday that the government approve the first bird flu vaccine as a stopgap measure, despite evidence it wouldn't protect most people.

  • Genentech shares traded lower after data from a clinical trial indicated that a lower dosage of the blockbuster cancer drug Avastin was as effective as the standard dose for lung cancer patients.

  • Genentech's asthma drug Xolair should carry the strongest warning possible about the drug's risk of a serious reaction known as anaphylaxis, U.S. health regulators said today.

  • GlaxoSmithKline has won FDA approval to sell the formerly prescription-only diet drug Xenical over-the-counter.  The drug can help people lose, on average, about six pounds.  It'll be called "Alli" (pronounced like "ally"). GSK will split the profits with Roche, which owns prescription Xenical. ... An analyst says Alli could have peak sales of $100 million to $300 million, which would be a blockbuster by OTC-drug standards.

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    A protest in Washington may underscore public concerns about cloning, but the food industry is in no rush to bring cloned food to market.  The FDA says cloning produces no health hazards and doesn't plan to require special  labels for food derived from cloned animals.

  • Big Pharma is facing a dose of big reforms proposed by Congress. Some heavy-hitters are pushing for more oversight of the drug industry by strengthening the authority of the FDA. Do we need increased regulations and should the FDA be given more authority?  Those were the issues at the heart of a heated debate today on CNBC’s “Morning Call.”

  • The government is considering setting higher standards for birth control drugs used by millions, saying that newer pills appear to be less effective at preventing pregnancy than those approved decades ago.

  • While on Capitol Hill the new Congress begins to take on the pharmaceuticals industry, the healthcare investment community is holding its annual confab in the hills of San Francisco--House Speaker Nancy Pelosi's home district. I'm at the 25th Annual JPMorgan Healthcare Conference at the Westin St. Francis on Union Square. The four-day event is just getting started, but the halls are...

  • The same rare, but fatal viral infection that forced Biogen Idec and Elan to recall, and recently relaunch, the multiple sclerosis drug, Tysabri, may also be a side effect of Rituxan, also from Biogen Idec and Genentech. In an SEC filing -- not a press release -- and on the FDA website, the companies and the agency disclosed yesterday evening that two people with lupus died after taking Rituxan.

  • Two lupus patients died from a rare brain infection after taking the Genentech and Biogen drug Rituxan, U.S. health officials said in an advisory issued Monday.

  • The drug, designed to treat hot flashes associated with menopause, will be marketed in the U.S. by Bradley Pharmaceuticals .

  • Treatment with antidepressants increases the risk of suicidal thoughts and behavior in patients up to age 24, according to proposed changes to the drugs' labels unveiled by health officials.

  • At the Merck annual analyst day here in company headquarters in central New Jersey, the company revealed for the first time what many on the Street had suspected: it has a so-called CETP inhibitor in the drug development pipeline.  That's the same type of drug that Pfizer pulled the plug on last week because of an increased risk of death.

  • From the Pfizer shocker about Torcetrapib, to new guidance from Merck and Lilly, to the FDA Advisory Committee meeting on the safety of drug-coated stents -- it was an incredibly busy week. Some final thoughts on the stent meeting...

  • Greetings from the Gaithersburg, Maryland Hilton! That's where the FDA is holding the advisory committee meeting on the safety of drug-coated stents. For less high-profile FDA meetings this hotel and the Holiday Inn across the street (the FDA alternates between them) are just fine. But for a big meeting like this one the venue is way too small.

  • While I'm in the car--not driving--on my way to the airport to go to the FDA Advisory Committee meeting on drug-coated stents I wanted to pass along some news from the Eli Lilly analyst meeting this morning in New York that I just left.

  • So, it took the torpedoeing of torcetrapib to get new Pfizer CEO Jeff Kindler to finally talk to us. He came on "Power Lunch" today for his first TV interview since taking the helm more than four months ago. A former litigator, he is media savvy, telegenic and a smooth-talker. I don't know why he didn't come on before he was put in the position of serious crisis management with a major hole to fill in the company's drug pipeline and about a ten percent decline in the stock price.

  • Saturday night Pfizer dropped a bombshell.  Two days after the company announced it planned--if all went well--to file for FDA approval of its developmental cholesterol pill Torcetrapib in the second half of next year, Pfizer suddenly pulled the plug on the drug.  Tests had shown this pill raises good cholesterol and lowers bad.  But the FDA says early Saturday morning Pfizer's Independent Data Safety Monitoring Board told the company about people who died in a clinical trial.