The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory Committee (ODAC) appraised the possibility that the antibody-drug conjugate could return to market for relapsed/refractory multiple myeloma (r/r MM).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Shorla.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 23andMe, 365mc, Acumen, Atara, Cantargia, JCR, Mink, Otsuka, Pierre Fabre, Polypid, Raziel, Sanofi.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4Teen4, Ascendis, Gilead, Hengrui, Kailera, Kairos, Sellas, Viiv.
A total of 33 states, plus the District of Columbia and Puerto Rico, agreed to participate in the U.S. CMS’ voluntary, outcomes-based program aimed at helping state Medicaid programs cover high-priced cell and gene therapies, starting with therapies for sickle cell disease.
The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.
Biopharma dealmaking gained momentum in the second quarter (Q2) of 2025, surpassing the previous quarter and staying well above the 2024 quarterly average of $57.63 billion. Total deal value reached $71.45 billion across 278 transactions in Q2, rising from $66.86 billion and 333 deals in Q1. The quarter also marked a notable jump from Q2 of 2024, when $55.3 billion was raised through 360 agreements.
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