The FDA said the recall was classified as the most serious Class 1 type, where there is a probability of serious health problems or death.» Read More
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.