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The FDA acknowledged the need for greater transparency and an increased focus on safety in its drug review process through a series of recommendations it issued last week.
While the climate for drug safety reforms was thought to have improved with Democrats’ takeover of both chambers of Congress, the obstacles remain the same for drug safety legislation recently
introduced by Sens. Chris Dodd (D-Conn.) and Chuck Grassley
(R-Iowa), sources say.
Eli Lilly’s profits took a hit in the fourth quarter of 2006, dropping 81 percent due to a nearly $500 million product liability settlement involving its antipsychotic Zyprexa.
Amgen’s anemia drug Aranesp should not be used to treat fatigue or to reduce the need for red blood cell transfusions in cancer patients because it is ineffective and potentially dangerous for these uses, the company said.
Strong pharmaceutical sales helped Johnson & Johnson (J&J) reach a 3.5 percent increase in fourth quarter earnings, even after the major cost of acquiring Pfizer Consumer Healthcare, the company announced.
Pfizer is making major changes in the way the company is run in an effort to drive down costs, increase revenue and enhance innovation, Pfizer announced at a meeting of its senior staff.
GlaxoSmithKline (GSK) will undertake a head-to-head study of its candidate to prevent cervical cancer against Merck’s drug Gardasil in an effort to sway the market, GSK said.
The FDA needs to change the way it studies and labels contraceptives to ensure more accurate findings and more effective use of these products, an agency advisory committee found.
Leading Senate Democrats believe that they are only a few votes away from having the support necessary to overcome a promised presidential veto of stem cell legislation and say that increasing public and political pressure will be enough to give them the necessary support.
The FDA needs to change its labeling requirements for contraceptives to incorporate data about the drugs’ effectiveness and its noncontraceptive benefits, as well as to ensure that the labels are more readable and concise, an agency advisory committee recommended.