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There are lessons pharma companies can take from the state of the US automobile industry. Here are a few of them.
Medicare is considering national coverage restrictions for Amgen’s newly approved Nplate (romiplostim). But Amgen says there is no need for CMS to get involved: FDA has the situation well in-hand thanks to its new drug safety tools.
Pfizer is no longer marketing inhaled insulin, but the regulatory work continues. FDA makes clear that any future inhaled insulin products will need a risk management plan and mandatory post-marketing studies.
FDA is looking at a February advisory committee for the Lilly/Daiichi anti-clotting drug. That would put the review of the “priority” application at 14 months and counting. What does prasugrel mean for the priority review process?
GSK suffered a major commercial loss after news of Avandia’s cardiovascular safety exploded onto the market in 2007. But there is a sliver of a silver lining for GSK: FDA’s post-Avandia safety rules are making it tougher for new competing products to reach the market, maybe stretching out the commercial life for Avandia.
It’s a buyer’s market for type 2 diabetes drugs, and you can thank FDA for that. At least, that is the sentiment of business development executives from Big Pharma. Transaction data in 2008 back up that view.
Revisions to PhRMA’s 2002 voluntary marketing code that go into effect in January delve into the specifics of what pharma sales reps can and cannot do regarding interactions with health professionals. A lot of it comes down to food.
A year ago, Congress sent FDA two very clear, but contradictory, messages: Hold more advisory committee meetings, but with tougher conflict-of-interest rules that preclude participation by many of the expert panelists the agency relied on in the past. The result is a system that is stretched to the limits.
The clinical trials used to develop drugs and biologics over the last 50 years need to be re-tooled and improved. Drug development certainly isn’t getting any easier; adaptive clinical trials may be one way to make the system more efficient.
FDA’s inaugural quarterly web posting of early safety signals with marketed drugs and biologics has left investors bewildered over how to interpret the listings. But the presence of rigorous risk management programs may be a comforting factor for Wall Street and Big Pharma.
