BioMarin Pharmaceutical is shaking up its leadership team, raiding Amgen for an R&D chief to replace a departing company veteran and pulling off the coup of signing a high-profile former Roche dealmaker.

The FDA has thrown a wrench in Regeneron’s plans to challenge Johnson & Johnson and Pfizer in a blood cancer market, hitting the Big Biotech with a complete response letter over issues at a third-party manufacturer.

Windtree Therapeutics’ roots may have received some urgently needed financial watering last month thanks to a private placement of its stock, but the biotech still doesn’t have enough money to keep its pipeline of cardiovascular meds in health for more than a year.

Pain-medicine-focused Latigo Biotherapeutics is welcoming CRO founder Neil Singla, M.D., aboard as chief medical officer.

Johnson & Johnson said Tuesday it will buy heart failure implant company V-Wave in a deal worth a potential $1.7 billion.

Pfizer and BioNTech may have a strong pedigree in the mRNA vaccine game, but, when it comes to flu, they’ve run up against the same problem as their peers—neutralizing influenza strain B.

As Eli Lilly continues to capitalize on its trove of Mounjaro and Zepbound cash with major outside deals, the company’s early external innovation and collaboration arm, Lilly Catalyze360, is welcoming all comers into the fold.

The FDA granted a green light to its first at-home, over-the-counter test to detect a person’s exposure to syphilis, offering a private option to help detect the sexually transmitted infection.

The FDA has given a green light to a hydrogel applicator that can be quickly deployed to help stem severe, life-threatening bleeding within seconds.

At Bayer, a groupwide restructuring is being rolled out as a top priority. But, to Juergen Eckhardt, M.D., who leads both the investment arm Leaps by Bayer and the pharma business development team, the ongoing overhaul won’t disrupt the German company’s dealmaking appetite.