By Rachel Sachs Yesterday, the FDA approved a steroid, deflazacort, for the treatment of Duchenne Muscular Dystrophy (DMD). DMD is a rare, heartbreaking, and ultimately fatal genetic disease with few if any real treatments, and the steroid may be helpful to patients. Deflazacort’s sponsor, Marathon, has offered the drug at a list price of $89,000…
Looking Forward: The Next Generation of Bio similars February 7, 2017 12:00 PM Description Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an…
By Christopher Robertson As many readers of this blog know, the FDA requires that, prior to entering the market, companies prove safety and efficacy for each intended use of their products, but physicians are then free to prescribe the products for any other uses. (Companies are not allowed to promote off-label uses however.) A recent national survey by…
By Beau H. Miller This article was originally published as part of research issued by the Jefferies Biotechnology Equity Research group. Since the Amgen v. Regeneron ruling that resulted in Judge Robinson of the District Court of Delaware granting a permanent injunction removing Regeneron’s Praluent from the market (pending appeal), there have been a number…
Looking Forward: The Next Generation of Bio similars February 7, 2017 12:00 PM Description Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an…
Health Law Year in P/Review Featured Panel: The End of ObamaCare? Health Care Reform Under A New Administration January 23, 2017 Wasserstein Hall, Milstein West AB Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA Register for this event The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during…
By Kevin Outterson Nick Bagley and I have an op-ed in today’s New York Times calling for serious economic incentives for antibiotics, delinking revenues from sales volumes with a $4 billion prize system. From the piece: On Friday, the Centers for Disease Control and Prevention released a disturbing report about the death of an elderly…
By Zack Buck With little fanfare, last month, the Centers for Medicare and Medicaid Services (CMS) abandoned its proposal to begin a payment pilot in which Medicare Part B would change the way it pays for pharmaceutical drugs. As I blogged about last March, under the proposed pilot, providers’ payments would be changed from the…
Health Law Year in P/Review Featured Panel: The End of ObamaCare? Health Care Reform Under A New Administration January 23, 2017 Wasserstein Hall, Milstein West AB Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA Register for this event The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during…
By I. Glenn Cohen This new post by Petrie-Flom’s Faculty Director I. Glenn Cohen appears on the Health Affairs Blog as the first entry in a series that will stem from our Fifth Annual Health Law Year in P/Review event to be held at Harvard Law School on Monday, January 23, 2017. “The best-laid plans of mice and men often go awry.”…
