Here are the latest stories being discussed in biopharma today:
1. Despite being sought after in the biopharma sector, neuroscience companies have attracted only a few bidders in recent multibillion-dollar deals. SEC filings show that only one other bidder participated in Bristol Myers Squibb’s $14 billion acquisition of Karuna Therapeutics, while AbbVie was the sole serious buyer for Cerevel Therapeutics, which it will purchase for $8.7 billion.
2. Research indicates that there’s no direct link between price increases of physician-administered drugs and rises in out-of-pocket costs. The study, conducted by authors at Harvard Medical School, found no association between cost increases for individual drugs and the corresponding price changes.
3. Autolus Therapeutics anticipates a potential US approval for obe-cabtagene autoleucel (obe-cel), its CAR-T candidate for adult acute lymphoblastic leukemia, by November 16. The company has been promoting its CD19-directed CAR-T as a safer alternative to competitors, referencing studies that show low levels of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
4. The FDA sent a letter to Novartis claiming “false or misleading” information in a TV commercial for the metastatic breast cancer drug Kisqali. The ad, which ran between 2022 and September 2023, could lead metastatic breast cancer (MBC) patients to believe that Kisqali is more effective than demonstrated across various parameters like overall survival rates and quality of life.
5. The FDA published a surplus of Federal Register notices outlining instances when priority review vouchers (PRVs) have been redeemed under the rare pediatric and material threat medical countermeasure (MCM) PRV programs. The notices have come as Congress procrastinates on reinsuring the MCM PRV program, which sunsetted on Oct. 1, 2023.
6. Apnimed has announced the appointment of Graham Goodrich, a seasoned biopharma marketing executive, as its new chief commercial officer. Goodrich will build a team to commercialize Apnimed’s oral sleep apnea candidate, currently in Phase III studies.
