Becoming the first treatment for rare genetic disorder Prader-Willi syndrome, breakthrough therapy drug DCCR (diazoxide choline) gained U.S. FDA approval as Vykat XR the evening before its March 27 PDUFA date, sending shares of developer Soleno Therapeutics Inc. up 38%. Read More
A survey of members of the Bioindustry Innovation Organization (BIO) has exposed what is at stake for the sector, on both sides of the Atlantic, if proposed tariffs are imposed on pharmaceutical imports to the U.S. "A staggering 94% of biotech firms anticipate surging manufacturing costs if tariffs are placed on imports from the EU,” according to BIO. Read More
The U.S. Department of Health and Human Services HHS reported a plan to reduce staffing by 10,000 in an immediate reduction, which when paired with retirement initiatives will drop staffing by as many as 20,000. Read More
Equillium Inc. is forging ahead with regulatory plans for itolizumab in first-line treatment of patients with acute graft-vs.-host disease (GVHD), despite a phase III disappointment. Shares of the La Jolla, Calif.-based firm (NASDAQ:EQ) closed March 27 at 46 cents, down 29 cents, or 39%, on top-line data from the Equator study testing itolizumab, which is designed to target the CD6-ALCAM signaling pathway. Read More
Bispecific antibodies have gotten plenty of press in recent years, but less prominent in headlines are bifunctional ones – i.e., those that boast one binding site for an antigen and another site for a non-antibody molecule such as a toxin or drug, taking aim at a single target and bringing a secondary function for extra oomph. Read More
New hires and promotions in the biopharma industry, including: Areteia, Asgard, Atyr, Auregen, Avalo, Biomea Fusion, Photocure, Psyence, Rezolute, Tevogen, Verrica. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aligos, Calidi, IGC, Leap, Merakris , Merakris, Vaximm, Wave Life Sciences. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aadi, GV20, Ionis, Kaken, Mitsubishi, Sobi, Turn, Vesigen, Whitehawk. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Exelixis, GSK, Intellia, Kashiv, Kelun, Merck, Neurim, Plus, Sanofi, Theratechnologies, Vast. Read More
