For the first time this year, BioWorld’s Biopharmaceutical Index is showing signs of life with an increase of 5.6%, boosted primarily by Alzheimer’s disease efforts from Biogen Inc. and Eli Lilly and Co. Biogen’s stock (NASDAQ:BIIB) is up about 36.4% this year and has been front and center due to its controversial FDA approval for Aduhelm (aducanumab) in June. Lilly’s stock (NYSE:LLY) has climbed by more than 44%, and it was granted breakthrough therapy designation a month ago for its Alzheimer’s candidate donanemab. Read More
Amgen Inc. will pay $900 million in cash to acquire privately held Teneobio Inc. In exchange for the cash, Amgen gets all of Teneobio’s outstanding shares, which could end up paying out quite a bit as contingent milestone payments to Teneobio’s equity holders could be worth up to $1.6 billion. Read More
Gene therapy’s one-and-done mindset proved “a boon and a bane,” said Avak Kahvejian, general partner at Flagship Pioneering. “You have one shot to get it right, is what that really means,” and his firm founded Ring Therapeutics Inc. to design redosable drugs in the space. Read More
Another shoe dropped on Oncopeptides AB when the U.S. FDA issued an alert July 28 citing trial data showing an increased risk of death with the company’s only marketed drug, Pepaxto, used in combination with dexamethasone to treat multiple myeloma. The agency said it’s continuing to evaluate the Ocean trial results and may hold a public meeting to discuss the safety findings and explore the continued marketing of Pepaxto (melphalan flufenamide), which was granted accelerated approval in February as a fifth-line treatment for relapsed or refractory multiple myeloma. Read More
Interim data for Soberana-02, a Cuban COVID-19 conjugate vaccine, surpassed the threshold set by the WHO, according to the Finlay Institute of Vaccines (IFV) in Havana that developed it, although the results have not been peer reviewed. Read More
New hires and promotions in the biopharma industry, including: Alkahest, Attralus, Biocryst, Immix, Immunoscape, Neonmind, Saliogen, Scancell. Read More
Biopharmas raising money in public or private financings, including: Angelini, Aristea, Azurrx, Caribou, Cybin, DA32, Deep Genomics, Idorsia, Intelgenx, Mink. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axon, Biogen, Cerecor, Effector, Eisai, Entasis, Grunenthal, Infinity, Merck, Redx, Relmada, Xylocor. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bayon, Courier, Dyadic, ERS Genomics, Eyegate, GC Pharma, I-Mab, Ingeneron, Insilico, Kiromic, Mirum, Mymd, Oragenics, Plus, Pulmosim, Therapeutic Solutions, Tonix, Valo Health. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Betterlife, Day One, Hope, Kineta, Kronos, Lyndra, Merck, Petros, Sol-Gel, Ultragenyx. Read More
