Fierce Biotech

• Bayer’s oral FXIa inhibitor asundexian has significantly reduced the risk of stroke in a phase 3 trial, giving a boost to a potentially blockbuster mechanism that has suffered setbacks over the past two years.

• No matter who Fierce could pull aside for a quick coffee at the conference, the general view was of a renewed sense of cautious optimism.

• Hundreds of industry leaders have signed a letter to FDA Director Marty Makary, M.D., about the importance of having a predictable regulatory agency, citing a survey in which 82% of biopharma respondents said they were concerned about the FDA’s ability to function.

• The FDA is hiring more than 1,000 new employees and rolling out a pilot communication program in an effort to speed up the review of new drugs.

• Gilead’s general counsel and EVP of corporate affairs Deborah Telman will hang up the gloves by Dec. 5, the company announced in a brief filing Nov. 15. Gilead didn’t offer any explanation for Telman’s departure, plainly stating that the executive’s employment will “terminate later in the month.”