Pharmalot… Pharmalittle… A Quick Round-Up
Make a commentBy Ed Silverman // December 14th, 2007 // 11:17 am
A few stray items are worth noting, and we do not wish to keep you waiting until later to pass these along…
Wyeth was sent a warning letter by the FDA over a “misleading” magazine ad for its Effexor XR depression pill. The agency charges the drugmaker minimized the risks associated with the drug, used inappropriate studies to suggest the pill is more effective than other therapies and falsely inflated the number of Effexor patients to suggest the drug is better and more widely accepted than other meds. This is the warning letter and this is the magazine ad.
Amgen hopes osteoporosis meds will relieve its worsening financial pain. At a big cancer meeting in San Antonio, Texas, scientists will introduce the first of a series of pivotal studies of its experimental denosumab drug, and a lot is riding on the new data. “This molecule represents the great majority of value investors ascribe to Amgen’s pipeline,” Eric Schmidt, a biotech analyst with Cowen, tells The Wall Street Journal. “The market has put a lot of hope” into it. He says denosumab could achieve sales topping $2 billion a year if and when approved for both osteoporosis and cancer patients.
The FDA has approved the first drug to treat a rare genetic disorder called phenylketonuria, or PKU, which can lead to mental retardation, possibly allowing some people to relax a regimented diet now used to control the disease, The New York Times writes. All babies born in the United States are screened for the disease, called phenylketonuria, or PKU. The new drug, called Kuvan, “will be life-changing for some patients,†says Stephen Cederbaum, a professor at the University of California, Los Angeles, who is an adviser to BioMarin Pharmaceutical, which developed the drug. He claims that one of his patients, a 25-year-old man who began taking Kuvan as part of a clinical trial, was able to get his first taste of cheese and pizza and to eat enough other foods that “for the first time in his life, he’s not hungry.â€