What's New
Is Merck Less Bullish on Biosimilars? / Of all the Big Pharma manufacturers, none seemed more optimistic about the commercial potential of biosimilars than Merck. But over the last several months, Merck shut down its BioVentures Group and skipped an FDA public meeting on the abbreviated approval pathway. / The RPM Report May 2012
Feature Articles
The Inevitable Outcome: Diabetes Safety Model Expands to Weight Loss…and Beyond? / The cardiovascular outcomes standard used for diabetes drugs since 2008 is moving to weight loss. That is important in itself, but also for what it says about the lessons FDA has taken from the diabetes experience—and what it might mean about regulatory expectations for other chronic drug classes in the future. / The RPM Report May 2012
Weighty Issues: GW Obesity Drug Outcomes Project Tests a Model for Patient Input in Drug Development / A stakeholder project on obesity treatment outcomes will complete its work this summer, setting the stage for FDA to rethink efficacy endpoints for weight loss drug development. The closed-door project is happening in parallel with public advisory committee discussions on pending applications and safety standards. / The RPM Report May 2012
Patient Advocacy 3.0: Outreach Stretches to First Stages of Regulatory Development / FDA is ready to bring patient voices and perspectives into the drug approval framework. Practically, that means that drug sponsors will have to develop new skills and structures for working with a familiar stakeholder group at an unfamiliar point in the drug development process. / The RPM Report April 2012
The Supreme Court and Biosimilars: What if it All Goes Away? / After the bruising health care reform debate in Congress, biopharmaceutical companies were comfortably on the periphery of the legal arguments playing out in the Supreme Court. But being peripheral has its disadvantages: if the Court sides with the challengers, it is possible that one of the “peripheral” provisions tossed aside will be the new biosimilars pathway. / The RPM Report April 2012
FDA Beat
Musical Tables in Generic Drug Litigation / Generic drug litigation remains a prominent part of food and drug law practices. But with the growing complexity of the case law—and the blurring lines within industry—it is very hard to predict which client and which attorney will be on what side. / The RPM Report May 2012
The Limitations of Antibiotic Incentives / Congress is on the verge of enacting important new incentives for antibiotic development. At the same time, a federal court ruling on Vancocin generic approvals underscores the importance of doing things the right way. / The RPM Report May 2012
CMS Beat
Reimbursement of Biosimilar and Biosimilar-similar ESAs / Affymax received FDA approval for the first new ESA in years. Now the company is trying to secure favorable reimbursement for its product, Omontys. / The RPM Report April 2012
Street Smarts
Prometheus Rebound: Where Weak Patents Can Benefit Pharma / Biotech and pharma companies were disappointed when the Supreme Court limited patent rights surrounding personalized medicine. But the ruling may end up simplifying the path to adoption of targeted therapies by reaffirming a much more critical point: the therapeutic—not the diagnostic—is the dominant partner. / The RPM Report April 2012
Pointed View
The Impact of REMS on Generic Drug Approvals and Drug Competition / From the conception of the REMS in the FDAAA Act of 2007, Congress was concerned that giving FDA authority to impose new post-marketing controls could raise competitive issues about market access for generics. Congress was right to be concerned. / The RPM Report May 2012