Astellas Pharma Inc. and Vir Biotechnology Inc. have signed a global co-development pact to advance VIR-5500, Vir’s PRO-XTEN dual-masked CD3 T-cell engager targeting prostate-specific membrane antigen for treating prostate cancer. Under the deal terms, San Francisco-based Vir will receive $335 million in up-front and near-term payments, including $240 million in cash, $75 million in equity investment and a $20 million near-term milestone. Vir is also eligible to receive up to $1.37 billion in development, regulatory and sales-based milestones plus royalties on ex-U.S. sales. Read More
Targeting an ultrarare disease affecting about 250 U.S. residents, Immedica Pharma AB’s Loargys (pegzilarginase) won accelerated FDA approval to treat hyperargininemia in those ages 2 and older with arginase 1 deficiency (ARG1-D). Read More
Almost three months to the day after Protara Therapeutics Inc. made known positive interim data from the phase II trial testing cell-based therapy TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs), Palvella Therapeutics Inc. scored positive top-line results from the phase III Selva study evaluating Qtorin 3.9% rapamycin anhydrous gel for microcystic LMs. Read More
In handing a win to Regenxbio Inc., the U.S. Court of Appeals for the Federal Circuit also cleared some leaves from the 101 patent eligibility threshold after years of Supreme Court decisions cluttering the passageway. Read More
Minimed Group Inc., Medtronic plc’s diabetes business, is looking to raise up to $784 million in its IPO. Medronic last May revealed plans to spin off the unit as an independent public company and expected to complete the separation within 18 months. Read More
Innovacell Inc. launched a ¥14.16 billion (US$91.2 million) stock sale on the Tokyo Stock Exchange Feb. 24, ending a near two-year lull of biotech listings in Japan while signaling a dynamic year ahead for cell-based therapeutics. Read More
In yet another upheaval in an agency already racked by upheaval, the U.S. CDC announced Feb. 23 that Ralph Abraham, its principal deputy director, chose to step down, effective immediately, so he could “address unforeseen family obligations.” Read More
New hires and promotions in the biopharma and med-tech industries, including: Akari, Foghorn, Ideaya, Merck, Neutrolis, Pelage, Smsbiotech, Synthekine, Zura. Read More
Biopharma and med-tech companies raising money in public or private financings, including: ADC, Eupraxia, Generate, Hemogenyx, Rakovina, Syndex. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Abivax, Aim Immunotech, BMS, Gossamer, J&J, Moonlake, Novo Nordisk , Virion. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Allurion, Armata, Beren, Allurion, Bracco, Cstone, Dr. Reddy’s, Eli Lilly, Guerbet, J&J, Reunion, Sandoz, Savara, Tessera, Teva, Vanda. Read More
