Abpro Corp. and Celltrion Healthcare Inc. entered a global partnership valued at up to $1.75 billion involving ABP-102, a bispecific antibody targeting HER2-positive cancers, a move Abpro CEO Ian Chan said would help “accelerate this type of therapy for patients in need.” With ABP-102 in preclinical development, Abpro decided to start looking for a partner. HER2 is “one of the biggest targets in biotech, mostly relevant for breast, colorectal and gastric cancers,” Chan told BioWorld. “Celltrion happened to have a lot of experience in the space.” Read More
About four months after starting its search for strategic alternatives, Sesen Bio Inc. disclosed an all-stock merger with privately held cell-therapy specialist Carisma Therapeutics Inc., a move that sent shares (NASDAQ:SESN) down 22 cents, or 32.7%, to close at 45 cents. Sesen stockholders are expected to own about 41.7% of the combined firm, and Carisma the remainder. Read More
It took resolving issues from two complete response letters for Fennec Pharmaceuticals Inc. to finally land U.S. FDA approval of Pedmark. The injectable formulation of sodium thiosulfate is for reducing the risk of platinum-induced ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors. Approval of the NDA arrived Sept. 20, three days before its Sept. 23 PDUFA date. Read More
Merck KGaA has struck a collaboration and option-to-license deal with Nerviano Medical Sciences Srl centered around NMS-293, a next-generation PARP-1 inhibitor already in early clinical development for brain tumors. Merck is making a play for the poly (ADP-ribose) polymerase (PARP) inhibitor market, first opened up in December 2014 by Astrazeneca plc, when Lynparza (olaparib) was first approved in advanced ovarian cancer, going on to become a blockbuster through a partnership with Merck & Co Inc. Read More
It failed to meet the primary endpoint at six months, but the European chief investigator for Biogen Inc.’s phase III trial of tofersen in treating amyotrophic lateral sclerosis (ALS) now describes the study as “trailblazing,” following a six-month open label extension. Read More
President Joseph Biden’s recent statement that the COVID-19 pandemic is over may or may not reflect popular fatigue with the associated public health emergency (PHE), but the statement struck a different tone in some quarters on Capitol Hill. Sen. Richard Burr (R-N.C.) was one of several who argued that the need for the PHE had thus necessarily run its course, with Burr specifically calling into question the need for additional funding for COVID-related federal health efforts. Read More
An analyst recently observed that mental health treatments are stuck where cancer was 50 years ago. However, there have been major advancements in developing psychedelic medicines to address that problem. BioWorld staff writer Lee Landenberger talked with James Lanthier, the CEO of Mindset Pharma, which is developing what it calls “next-generation” psychedelic medicines to treat neurological and psychiatric disorders. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acerus, Adapsyn, Algernon, Coeptis, Day One, Evotec, Foundation, Gilead, Hemoshear, Horizon, J&J, Novocure, Persephone, Poolbeg, Puma, Takeda and Vaxxas. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alligator, Alnylam, Antengene, Aptevo, Artiva, Astrazeneca, Beigene, Bluebird, Bristol Myers Squibb, Cyxone, First Wave, Genentech, Heron, Leo, Medexus, Psyence, Roche, Seagen, Xortx. Read More
