Every challenge is also an opportunity. And these challenges offer biopharma companies an opportunity to improve communications in a way that also helps improve overall health.

With supply and labor constraints creating backlogged custom-manufacturing schedules, developers have felt the pain in cost and speed to market.

Over the last 2 years, a greater spotlight has shone on inequalities in health care, and the greater need to improve health equity.

Concerns over blood clotting risk had derailed testing of the hemophilia treatment last year, leading the companies to adjust their trial protocol.

The British drugmaker decided the medicine, which works similarly to Novartis’s Leqvio, wasn’t potent enough to justify further testing. 

A “practically clean” version of the bill will allow the FDA to continue its review and testing programs, while leaving more ambitious goals to be dealt with in a funding bill later this year.

Committee members voted in support of Rebiotix’s treatment for recurrent C. diff infections of the intestines, a condition with no regulated options after antibiotics fail.

The approval is another example of so-called tissue-agnostic indications, which are based on a cancer’s genetic signature rather than where it is in the body.

The French drugmaker terminated a nearly decade-old deal that helped Allogene emerge as the sector's largest "off-the-shelf" cell therapy developer.

The British drugmaker is investing in Spero Therapeutics and acquiring most of the rights to an oral antibiotic the FDA previously rejected, but could approve if it succeeds in a new Phase 3 trial.

The deal results from a strategic review Sesen, formerly known as Eleven Biotherapeutics, undertook after the FDA rejected its top drug last year. 

The drug, Pedmark, has been in development for more than two decades and was previously rejected twice by U.S. regulators.