Inhibrx Inc. and Sanofi SA have agreed to a deal worth up to $2.2 billion, whereby the latter’s Aventis Inc. subsidiary will acquire INBRX-101, an optimized, recombinant alpha-1 antitrypsin (AAT) augmentation therapy undergoing a registrational trial for AAT deficiency (AATD), an inherited genetic disorder caused by single nucleotide variants in the SERPINA1 gene. Read More
Getting revolutionary genetic medicines to the right place is the reason Genedit Inc. was created, and CEO Kunwoo Lee pared down the mission in one word. “Delivery, delivery, delivery,” Lee told BioWorld in describing the goal of Genedit’s Nanogalaxy platform that is focused on delivering genetic medicines into select tissue. Privately held Genedit will work with Genentech to find and develop hydrophilic nanoparticles for creating nucleic acid-based drugs to treat autoimmune diseases. Genedit is getting $15 million up front in a new deal that could bring in up to $629 million in near-term, preclinical and clinical development, commercial and net sales milestones. Read More
Jilin, China-based Huisheng Biopharmaceutical Co. Ltd. gained China NMPA approval for Huiyoujing (proline janagliflozin tablets), its independently developed sodium glucose transporter 2 (SGLT2) inhibitor for type 2 diabetes. The regulatory clearance, announced on Jan. 23, makes janagliflozin the second China-made SGLT2 inhibitor after Jiangsu Hengrui Medicine Co. Ltd.’s henagliflozin (SHR-3824), which was launched domestically in May 2022. Read More
A tire company is the latest to test out the waters of the biopharmaceutical industry with Tirebank Co. Ltd. and 13 affiliated individuals becoming the largest shareholders in flailing Korean antibody biotech Pharmabcine Inc. with a 13.31% stake. Read More
The U.S. FDA is undergoing a significant overhaul of operations which is designed in part to make the agency’s Office of Regulatory Affairs (ORA) more efficient and less obtrusive to product centers, such as the Center for Devices and Radiological Health. Read More
Biontech SE and Duality Biologics Co. Ltd. have progressed BNT-323/DB-1303 to pivotal phase III trials, beginning in China in patients with hormone receptor-positive and HER2-low metastatic breast cancer. Read More
Using interactions between viral peptides and human proteins as a starting point, researchers from Enyo Pharma Inc., the University of Lyon and other institutions were able to bootstrap themselves to a mitochondria-targeting small molecule that showed activity in a mouse model of nonalcoholic steatohepatitis (NASH) with chronic kidney disease. Read More
Biopharmas raising money in public or private financings, including: Accent, Adicet, Arxx, Calcimedica, Calluna, CG, Hephaistos-Pharma, Outlook, Oxitope, and Transcode. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Aim, Ascletis, Astrazeneca, Biontech, BMS, Bold, Duality, Gannex, Gilead, Ionis, Janssen, Novartis, Spruce. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altis, Bayer, Bluerock, BMS, Centogene, CN Bio, Fujifilm, Genmab, Janssen, J&J, Mirati, Opsis, Roche. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 60 Degrees, Alvotech, Amgen, Galderma, Innocare, Janssen, NS, Pharvaris, Strand, Unibio. Read More
