Author name: Leonardo Arias

The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.

The FDA is undergoing a major transformation in its drug approval processes, regulatory oversight and transparency initiatives. This webinar explores the implications of these reforms and what they mean for innovation, compliance and strategy in the biopharma industry.

The Medicare giant likes what it’s seen in the first two weeks of open enrollment. But there are steps it can take if membership growth starts getting out of hand, executives said.

The general manager for the business says building a market is something the medtech giant knows how to do.

According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.

Pfizer and Novo Nordisk seem to want Metsera bad. Analysts are wondering, though: is the obesity biotech really worth this much effort?

CEO Ivan Tornos said multiple factors emerged late in the quarter that caused the shortfall. Zimmer’s shares plunged more than 15%.

Prospect Medical Holdings is seeking approval from a bankruptcy court to close its hospitals in Rhode Island. Regulators and the new buyer say Prospect needs to follow through with a deal to sell them.

The company is considering selling assets that could be more easily separated from the rest of the business without creating challenges for customers, executives said on a third quarter earnings call. 

Qiagen has identified Parse Biosciences’ technology as complementary to its sample technology and bioinformatic businesses.