Livial helps women’s bones, but raises chances for stroke
NEW YORK While it can prevent breast cancer and broken bones in elderly women, Schering-Plough’s menopause drug Livial can also double the risk of stroke, a study has found.
The study, published in Thursday’s issue of the New England Journal of Medicine, shows that Livial reduced the risk of spinal fractures by 45 percent and the risk of breast cancer by 68 percent in women aged 60 to 85. The study, however, had to be stopped before completion in part because some participants began having strokes.
Schering-Plough bought the drug through it’s acquisition of Akzo Nobel’s Organon unit in 2007, but the Food and Drug Administration refused to approve it the previous year.
Bloomberg quoted the study’s author as saying the drug was useful in women aged 50 to 60, but should not be given to women after the age of 60 or 65.
FDA new response procedure could confuse investors
WASHINGTON The Food and Drug Administration’s decision to change how it responds to drug companies’ submissions for drug applications is not only affecting the companies, but investors as well, according to Reuters.
The approach could cloud a drug review process already growing less predictable as global pharmaceutical companies find less success winning U.S. approval for new products. The policy “may not give as much visibility to the direction the FDA is going,” Morningstar analyst Damien Conover said.
In the past, an approvable letter told companies their applications could be cleared if certain conditions were met. A not-approvable letter was seen as a sign of more serious problems.
The complete response letters will spell out what drugmakers could do to win approval, the FDA said.
But the agency by law must keep the letters confidential. Investors must rely on the companies, which often disclose only the type of letter received and give little detail about the FDA’s complaints. Manufacturers typically do not release a letter’s actual text.
Based on those facts, investors will now be guided by the companies as to what happens to a drug that could be a potential blockbuster on the market.
Insmed ceo lobbies for follow-on biologics rule
WASHINGTON The chief executive of a biotech company in Richmond, Va., wants to make it possible to get generic biologic drugs approved, the Washington Post reported Wednesday.
Geoffrey Allan, chief executive officer of Insmed, has been lobbying members of Congress in an effort to teach them the differences between chemical and biotech drugs. Allan hopes his company will become the first United States company to develop generic biologic drugs, also called “biosimilars.”
While the market for generic chemical drugs is expanding, there is no way to get generic biologic drugs approved. Allan hopes that Congress will change the laws to make generic biologic drug competition possible.