The U.S. FDA’s Oncology Drugs Advisory Committee, in two separate sessions, took up the matters of Carvykti (ciltacabtagene autoleucel) from Johnson & Johnson and the Bristol Myers Squibb Co. product Abecma (idecabtagene vicleucel) – specifically, whether the benefits of each CAR T therapy outweigh the risks in relapsed or refractory multiple myeloma (MM). Read More
As widely expected, Madrigal Pharmaceuticals Inc.’s resmetirom picked up the first U.S. FDA approval for treating nonalcoholic steatohepatitis (NASH), an advanced form of nonalcoholic fatty liver disease that has been steadily increasing in global prevalence. Branded Rezdiffra, the liver-directed THR-beta agonist gained accelerated approval for use in conjunction with diet and exercise to treat adults with noncirrhotic NASH with moderate to advanced liver fibrosis, specifically stages F2 and F3. Read More
Two sNDAs, one from Bristol Myers Squibb Co. (BMS) and the other from Mirum Pharmaceuticals Inc., have received U.S. FDA approval to further expand their treatment indications. Read More
In 2023, the BioWorld Neurological Diseases Index (BNDI) closed with a 4.36% increase, outperforming the Nasdaq Biotechnology Index (up 3.74%) but falling short of the surge seen in the Dow Jones Industrial Average (up 13.7%). The rebound marked a significant turnaround from November, when BNDI recorded an 18.37% year-to-date decline. Read More
The U.S. FDA has approved Beigene Co. Ltd.’s Tevimbra (tislelizumab-jsgr) as a monotherapy for treating adults with unresectable or metastatic esophageal squamous cell carcinoma following prior chemotherapy that did not include a PD-1 inhibitor. A humanized IgG4 anti-PD-1 monoclonal antibody, tislelizumab is designed to minimize binding to Fc-gamma receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. Read More
Aquestive Therapeutics Inc.’s oral epinephrine prodrug to treat life-threatening allergic reactions, Anaphylm, produced a faster time to maximum concentration than currently available autoinjectors in healthy adults, early pivotal phase III data show, meeting both pharmacokinetic (PK) primary and secondary endpoints. Read More
In February, deals formed by biopharma firms reached $7.76 billion, down from January, which marked the sixth-highest month in BioWorld’s records going back to 2016. Meanwhile, biopharma M&As amounted to $18.22 billion for the month, positioning it among the top 10 highest-value months in the past four years. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atrogi, Immuneering, Navitor, Nuvectis, Ocuterra, Scisparc, Spruce, Supernus. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: First Wave, Immunogenx, Mapp, Ono, Partex, Probiogen, Sanofi, Sibylla. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 60 Degrees, Cybin, Gynica, Keros, Mirum, Poseida, Xcovery. Read More
