Astrazeneca plc’s good news with its oral selective estrogen receptor degrader (SERD) and estrogen receptor antagonist, camizestrant, when used as part of a combo in breast cancer raised optimism for the approach, which has caught on in various biopharma quarters.
The BioWorld Biopharmaceutical Index (BBI) ended 2024 down 2.24%, despite hitting a peak of 25.19% in late August. While it remained in positive territory through November, up 3.58%, the steady decline through the later months of the year pushed the index into the red by December’s close.
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
The prospects of an oral obesity candidate used as a monotherapy or combination therapy is in question after Kallyope Inc. posted disappointing phase II data on a government website, indicating that its lead candidate, K-757, failed to meet all endpoints.
The map of cystic fibrosis (CF) research is being redrawn in the U.K. as improvements in treatment, and in particular the introduction of CF modulator drugs, mean people with the rare inherited disease are living much longer.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcutis, Ardelyx, Auron, BMS, Celltrion, Gilead, Glaukos, Indivior, Innovent, Insmed, Invivyd, Opus, Porosome, Pyxis, Regeneron, Takeda, Telix, Teva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allogene, Enodia, Eli Lilly, Foresight, Idorsia, Nxera, Pfizer, Viatris.
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