The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) unanimously voted against recommending approval for Novartis AG’s serelaxin based on the strength of a single pivotal trial in acute heart failure (AHF).

Balancing the realities of budget constraints with the tantalizing promise of biomedical research, a House appropriations subcommittee Wednesday looked for ways to deliver on the promise at the National Institutes of Health (NIH) while living within the means of fiscal 2015 spending caps.

If the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) follows the lead of FDA reviewers Thursday, it will send Novartis AG’s serelaxin back for more testing.

Caught in the crossfire of an innovator drug company and the sponsor of a 505(b)(2) drug, the FDA is now facing a lawsuit for not assigning a therapeutic equivalence (TE) rating to Perrigo Israel Pharmaceuticals Ltd.’s testosterone gel 1 percent, which was approved more than a year ago based on its bioequivalence to Abbvie Inc.’s Androgel.

Someone has got to be on the hook for every prescription drug, be it brand or generic. That’s the policy behind the FDA’s proposed rule that would enable generic drugmakers to change their labels independently of the brand drug.

Whether the needs of the many outweigh the needs of the few is the debate swirling around the FDA’s proposed rule that would allow generic drugmakers to change their labeling independent of the brand drug.

Biosimilar makers have their work cut out for them if they hope to increase the use of their follow-on biologics in Europe. Much of that work is in helping doctors over the learning curve.

Through blogs, Facebook posts, message boards, tweets and other social media avenues, patients share millions of health care-related data each day in the virtual world, creating a real-world goldmine of information for drugmakers willing to listen and engage.

Senators found much to praise at the FDA, but the pace of progress and recent controversial drug approval decisions raised more than a few eyebrows at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Thursday.

Putting children over politics, senators set aside their differences to unanimously pass a bill that creates a new fund for pediatric research at the National Institutes of Health (NIH). The Gabriella Miller Kids First Research Act now heads to the president for his signature.