Deals involving antibody-drug conjugate (ADC) therapies continue to gain momentum with Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. the latest firms to team up on global development and commercialization activities, as Daiichi offers up rights to three of its potentially first-in-class ADC candidates for $22 billion, making it the largest ADC agreement to date. Read More
The U.S. FDA cleared Pfizer Inc.’s Penbraya (meningococcal groups A, B, C, W and Y vaccine), the first pentavalent shot designed to provide coverage against the most common serogroups causing meningococcal disease in adolescents and young adults through age 25. Read More
This summer’s phase III news from Qilu Pharmaceutical Co. Ltd. with iruplinalkib – an oral inhibitor of ALK and ROS1 tyrosine kinase – reinforced an ongoing interest in the pair of oncology targets, where a handful of developers remain busy. Most notably of late is Nuvalent Inc., which rolled out stock-boosting data Oct. 4. Read More
Abivax SA’s debut on the U.S. market received a somewhat chilly reception Oct. 20, as the firm priced on the low end of its proposed range and ended the first day of trading in the red. But the company managed to pull in about $235.8 million in gross proceeds, the majority of which will support late-stage efforts for obefazimod, an oral candidate with a novel mechanism of action it hopes to advance in the lucrative inflammatory bowel disease space. Read More
The World Health Organization recently endorsed an economical malaria vaccine with a 75% effectiveness rate, which costs less than half of the initial vaccine (RTS,S/AS01) created two years ago. The new vaccine, R21/Matrix-M, developed by the University of Oxford and the Serum Institute of India, marks a significant milestone after decades of scientific research. Read More
The first three quarters of 2023 delivered a mix of approval news, with an uptick in U.S. FDA clearances over the previous year, but still tracking lower than 2017-2021. Global approvals are on a different trajectory, down year over year. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4moving, Akeso, Biontech, Bristol Myers Squibb, Candel, Flare, Genentech, Kura, Neurona, Numab, Regulus, Sabin Vaccine Institute, Telix. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Alaya.bio, Apotex, Biomarin, Calico, GSK, Hansoh, Laronde, Novartis, Sail, Senda, Teva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aspen Neuroscience, Pfizer Canada, SAB, Senhwa, Skyline, Spago, Sumitomo, Takeda, Vaxcyte. Read More
