Merus NV gained accelerated U.S. FDA approval of Bizengri (zenocutuzumab) as the first and only targeted therapy indicated for NRG1-positive pancreatic adenocarcinoma and non-small-cell lung cancer patients with advanced unresectable or metastatic disease. The approval came about seven months after the FDA accepted the BLA for filing under priority review, and two months ahead of the PDUFA goal date of Feb. 4, 2025, which had been extended by three months in November as the agency reviewed CMC information submitted in response to its request. Read More

China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke. Read More

Among the drug developers with clinical results featured at the annual meeting of the Society for Urologic Oncology (SUO) in Dallas were Protara Therapeutics Inc. with phase II numbers and CG Oncology Inc. with a phase III update. Protara’s shares (NASDAQ:TARA) closed Dec. 5 at $6.02, up $2.48, or 70%, having traded as high as $10.48 during the day. Less reactive was stock in CG (NASDAQ:CGON), which ended at $33.56, down $2.35. Read More

Seeking accelerated approval as a fallback when clinical evidence is not quite strong enough for traditional approval appears destined for the dustbins of history. Read More

In breast cancer, neoadjuvant chemotherapy reduces the tumor before surgery. However, the response to this treatment does not depend solely on the subtype of malignancies. Other factors could play a key role in its effectiveness, as shown in a study that described how the estrous cycle phases contribute to this variation. The researchers propose adjusting the approach to the most suitable moment for patients. Read More

New hires and promotions in the biopharma industry, including: Astrazeneca, Biogene, Cartography, Preveceutical, Servatus. Read More

Biopharmas raising money in public or private financings, including: Antag, Foresee, Hemostemix, Refoxy, Revolution Medicines. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Atea, Can-Fite, Eli Lilly, Everest Medicines, Evommune, Impact Biotech, Neurosense Therapeutics, Relmada Therapeutics, Scitech Development, TC Biopharm, Teva Pharmaceutical. Thermosome, Trevi, Vivavision. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Dewpoint, Eli Lilly, GSK, Ionis, Martin, Mitsubishi, Rgenta, Rgenta, Theratechnologies, Vincerx. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allay, Biocardia, Biopharmaceutical Research, Leo, Outlook, Simcere, Stoke. Read More