Blackstone Life Sciences made an investment of up to $750 million in Moderna Inc.’s influenza program created with its mRNA technology. The new funding is designed to help propel the program forward and may help bolster a stock that has struggled in the past 12 months. Read More
Merck & Co. Inc. is looking to a fast launch for sotatercept, its newly U.S. FDA-approved pulmonary arterial hypertension (PAH) drug. The agency cleared the drug, branded Winrevair, under priority review on its March 26 PDUFA date, marking the first in a new class of therapies the company has touted for its potential for disease modification. Read More
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide. Read More
An increasingly popular target across varied cancer types is the immune system regulator V-domain Ig suppressor of T-cell activation (VISTA), where a number of developers have taken early stage aim – among them Sensei Biotherapeutics Inc., with SNS-101, which Wainwright analyst Edward White believes could be the first anti-VISTA monoclonal antibody approved as a therapeutic agent. But there’s plenty of work ahead. Read More
Scientists from the Australian National University have discovered the gene mutation responsible for causing psoriasis, and the findings could lead to improved diagnosis and treatment for patients with psoriasis and psoriatic arthritis, a chronic inflammatory skin disease. “We were able to identify the gene that could be important in enabling this progression from a skin-only condition to a skin-and-joint condition,” lead study author Chelisa Cardinez told BioWorld. Read More
Thanks to technological advances, the U.S. FDA is reducing the quantity of reserve drug samples that must be retained from bioavailability and bioequivalence studies. Read More
New hires and promotions in the biopharma industry, including: Galapagos, Idrx, Keiferx, Mannkind, Noetik, One Biosciences, Rocket, Synthego, Xortx. Read More
Biopharmas raising money in public or private financings, including: Biotech Group Acquisition, Galderma, Ibio, IGC, Stoke, Tevogen, Vaccinex. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Corteria, Eledon, Intravacc, Mei, Moderna, Nanoscope, Nkgen, Opus, Osivax, Praxis, Protagonist, Sellas, Stoke, Tectonic, Valneva, Viking. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allarity, Alterity, Astellas, Astralbio, Gamida Cell, Ibio, Hoth, Johnson & Johnson, Juvisé, Marinus, Novartis, Ovid, Pieris, Pyxis, Scilex, Sorrento. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aptamer, Argenx, Astellas, Atamyo, Beam, Cinfina, Esperion, Entera, Intrabio, Janssen, J&J, Medexus, Mesoblast, Synthekine, Takeda, Tiumbio, Verrica. Read More
