A higher rate than expected of serious bleeding, including five deaths, in ovarian cancer patients receiving upifitamab rilsodotin (UpRi) led the U.S. FDA to place a partial clinical hold on two trials, possibly delaying Mersana Therapeutics Inc.’s BLA filing targeted for later this year. Read More
With the drug already under review by the U.S. FDA for dry eye disease (DED), Aldeyra Therapeutics Inc.’s reproxalap hit statistical significance in the second phase III study for allergic conjunctivitis (AC), and the firm is mulling what CEO Todd Brady called the “high-class problem” of how to best commercialize the product. A partner may help puzzle that out. Read More
Eli Lilly and Co.’s phase II data with LY-3462817 (peresolimab), a monoclonal antibody (MAb) that functions as a PD-1 agonist for rheumatoid arthritis (RA), juiced hopes for the approach being tried by a handful of firms. Read More
Sino Biopharmaceutical Ltd. formed a partnership with Gmax Biopharm International Ltd. to develop obesity candidate GMA-106. As part of the $57 million deal, Sino Biopharm acquired greater China rights to develop and commercialize the drug, in exchange for up-front and milestone payments to Gmax. Read More
In their continuing battle against high prescription drug prices, U.S. lawmakers are firing yet another volley at the middlemen – this time to delink their administrative fees from drug prices. Several members of the Senate Finance Committee, including the leadership, introduced the bipartisan Patients Before Middlemen Act June 14 with the intent of wrapping it into a larger drug pricing legislative package the committee plans to complete over the next few months. Read More
Biopharmas raising money in public or private financings, including: Auxilius, Awakn, Biora, Editas, Invirsa, Metagen, Neuvivo, Theradaptive, Zentalis. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 2seventy, Enterome, Eyebiotech, Hoth, Inventiva, IO Biotech, Kymera, Mindbio, Mindrank, Mirum, Nurix, PDS, Recursion, Theranexus, Ventyx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Abcellera, Beigene, Coherus, Confo, Eli Lilly, Erytech, Fortress, Helocyte, Mercury, Pharmacyclics, Pherecydes. Scilex, Sorrento, Tracon and Verve. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Alentis, Eagle, Ipsen, Paxmedica, Pepgen. Read More
