Stocks tumbled on Aug. 5, with the Dow Jones Industrial Average falling more than 1,000 points amid a disappointing jobs report released by the U.S. Labor Department on Aug. 2. The BioWorld Stock Index, which tracks approximately 510 U.S. biopharma stocks, was up 17.27% for the year on July 26 before closing Aug. 5 up only 3.47%, representing a significant drop. Likewise, the Nasdaq Biotechnology Index fell as much as 200 points that day. Despite the downturn, the biopharma industry remains well-positioned to outshine other sectors during challenging economic times.
The possibility of a 2025 approval looks to be off the table for Actinium Pharmaceuticals Inc.’s Iomab-B, at least in the U.S. In a move that H.C. Wainwright analyst Joseph Pantginis dubbed “a major surprise,” the FDA has requested a head-to-head study demonstrating overall survival before it will consider approving the radiotherapy candidate for use in patients with active relapsed or refractory acute myeloid leukemia.
Cellular immunotherapy is the Lamine Yamal of cancer therapy. It is easy to forget how young the field is – and that as stunning as it is to watch in action already, it is still reaching its full potential. One aspect of doing so is working in a broader range of tumor types. The field made a giant step toward that goal with last week’s approval of Tecelra (afamitresgene autoleucel, Adaptimmune Therapeutics plc), the first CAR T cell to be approved for treatment of a solid tumor.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Celltrion, Corvus, Healx, Immuneering, PDS, Prestige.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Biogen, Cerevel, Hillevax, Limmatech, Merck KGaA, Milliporesigma, Mirus, Paratek, Valneva, Xbrane.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, ALX, Eli Lilly, Kiromic, Neurosense, Otsuka, Regenxbio, Sound.