Investor hopes rose sharply for Merus NV’s phase III trials – data should roll out next year – with bispecific antibody petosemtamab after mid-stage results impressed Wall Street in head and neck squamous cell carcinoma. Shares of Utrecht, the Netherlands-based Merus (NASDAQ:MRUS) jumped, too, closing May 23 at $55.14, up $13.54, or 33%, on interim data as of the Feb. 27 cutoff date. Read More
Imunon Inc. soared by 179% on the heels of phase II Ovation 2 data showing that its IMNN-001 immunotherapy led to a 13-month increase in overall survival among women with ovarian cancer. Patients in the intent-to-treat population, receiving the drug plus standard-of-care neoadjuvant and adjuvant chemotherapy (N/ACT), achieved median overall survival (OS) at 46 months vs. 33 months with N/ACT alone. Increased activity was seen among patients treated with poly ADP-ribose polymerase inhibitors, with the median OS not yet reached after more than five years vs. 37 months in the control arm. Read More
GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate in combination therapy for the treatment of adults with relapsed or refractory multiple myeloma. Read More
Adalta Ltd. is outlicensing all of its internal products and focusing instead on inlicensing early stage T-cell assets from Asia, mostly from China, Adalta CEO Tim Oldham told BioWorld. Dubbed its “East to West” strategy, Adalta is integrating Asia's prowess in T-cell therapy development with the efficiency and quality of Australia's clinical and manufacturing ecosystem to create a pathway connecting Eastern innovation in cellular immunotherapies with Western regulated markets and patients. Read More
News from Tectonic Therapeutic Inc. in January took away some of Wall Street’s jitters about the relaxin pathway brought about by Eli Lilly and Co.’s recent moves, but another big pharma player – Astrazeneca plc – is still providing suspense in pulmonary hypertension in heart failure with preserved ejection fraction. Read More
Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc. Read More
Cinclus Pharma Holding AB has chosen Zentiva k.s. to handle manufacturing and commercialization duties in Europe for linaprazan glurate, which is being developed to treat severe erosive gastroesophageal reflux disease. Read More
It’s been nearly five years since the U.S. FDA, under the first Trump administration, issued a final rule and guidance on state importation plans (SIP) for importing less expensive prescription drugs from Canada. Yet only one state, Florida, has an approved SIP. In hopes of adding to that number, the FDA is enhancing its drug importation program to ease the way for states and tribes to bring prescription medicines in from Canada, at Canadian prices. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annji, Aurinia,Insmed, Revalesio, Satellos. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AFT, Biodexa, Eikon, Eli Lilly, Emtora, Hyloris, Inside, OSE, Senti. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Bioarctic, Celltrion, Eli Lilly, Kelun-Biotech, Relief, Urogen. Read More
