PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More

HHS stands by its final rule expanding the discounts for orphan drugs that hospitals and healthcare providers can apply when used to treat non-rare diseases, the agency said in a court filing opposing PhRMA’s attempts to invalidate the rule. Read More

The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing last week that outlines how it intends to approach one contentious issue involving compounders. Read More

Looking to add to its growing skin care product portfolio, Valeant Pharmaceuticals said Monday it will acquire medical devicemaker Solta Medical for $250 million. Read More

Drugmakers should review the marketing contracts they have in place with pharmacies or other third parties to ensure the information they send to patients complies with new HHS limitations. Read More

U.S. lawmakers Wednesday introduced a bill that would prohibit patent litigation settlements in which a brand drugmaker compensates a generic drugmaker to delay sales of a competing generic drug, commonly referred to as “pay-for-delay” deals. Read More

The House late Thursday passed a comprehensive budget deal that, in easing some of the pain of sequestration, puts the FDA’s fiscal 2014 outlook in the hands of congressional appropriators typically friendly to the agency. Read More

The FDA is not backing down on its stance that Novartis abused the citizen petition process to stall approval of generic versions of Reclast, and the agency has rejected a company request that it retract its statements from the public record. Read More

Lawmakers want the FDA to explain how hackers broke in to the CBER online submission system to steal personal user information and what the FDA has done to prevent a recurrence. Read More

A bipartisan federal budget deal reached Dec. 10 removes the threat of sequestration hanging over fiscal 2014 and 2015 FDA user fees, and would ensure they aren’t locked away along with some of last year’s payments. Read More