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An FDA advisory committee just recommended big changes for diabetes drug development—required cardiovascular outcomes trials. That shouldn’t come as much of a surprise. This should: the recommendations include products with no evidence of a CV signal. Welcome to the new world of drug development.
There is no question that the outlook for innovation is bleak. But by defining the R&D enterprise more broadly—especially by engaging external stakeholders—industry can turn the picture around.
FDA will not necessarily require a formal Risk Evaluation & Mitigation Strategy for drugs that already have mandatory consumer medication guides. That means Lilly has a freer hand to compete against Lyrica in an important new market--and now the question becomes what FDA might do to impose tighter controls on the Pfizer brand.
FDA wants industry to endorse a pilot program that would make sponsors responsible for testing proposed brand names for medication errors. Industry is concerned the process will make reviews less predictable, instead of more. This looks like a classic dilemma for regulated industry: everyone will benefit if the pilot works, but will anyone take the risk with their own product?
FDA is in the midst rebuilding a severely understaffed agency. The center for drugs is about halfway through the process, with the Office of New Drugs receiving the bulk of new hires. But when it comes to the reviewer level, not all divisions are created equal.
Health care reform is coming, whether a Republican or Democrat is elected president in November. So who’s going to do it?
Two years after shaking up the vaccine field with its big acquisition of Chiron, Novartis has identified a make-or-break pair of projects in the meningitis area. The meningitis vaccines will determine whether Novartis’ bet will turn into a smart long-term diversification or a low-return move into an unfamiliar and unfriendly segment of health care.
Between big-name statins going generic and high-profile blow-ups, cholesterol drug development has been tough going. Some drug companies think the next big thing in lipid management is something different altogether: prescription-grade supplements. It may be just the thing for a risk-averse FDA.
United and Humana remain by far the biggest players in the stand-alone drug insurance market for Medicare, but the field is gaining on them. They don’t seem to mind. Is that a sign that the market is “mature”? Or a warning of rocky times ahead for a critical program for pharma?
A new active surveillance system is taking shape under the guidance of the Food & Drug Administration. What will it look like?
There are a number of policy advisors and former government officials who will shape health care reform in 2009 following the November presidential election between Democratic nominee Senator Barack Obama and his Republican counterpart Senator John McCain. Here are just a few names biopharma stakeholders should become familiar with as the country gets closer to a change at the White House.
The FDA Science Board report highlighted areas in which the agency's scientific and regulatory processes need improvement. Frank Torti, FDA’s recently named chief scientist and second-in-command at the agency, proposes an agenda on how FDA will respond.
"Just the $8 billion of research invested in this country—$70,000 per employee—somebody in Congress had better wake up and realize that's an asset worth preserving, not attacking."
Billy Tauzin
CEO, Pharmaceutical Research & Manufacturers of America
US Chamber of Commerce Life Sciences Awards, June 9
"Pharmacovigilance trumps approval. Pharmacovigilance is the name of the [regulatory] game."
Steven Burrill
CEO, Burrill & Company
Biotechnology Industry Organization annual meeting, June 18
