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). Read More
Carving out $400 million in annual cost savings is going over well with Sarepta Therapeutics Inc.’s investors, as the company’s stock got a 19.6% boost on July 17. Its big seller, the gene therapy Elevidys (delandistrogene moxeparvovec), continued its revenue numbers decline, so Sarepta chopped operating expenses by letting about 500 employees go in a 36% cutback and pared its development path. Read More
Scientists at Newcastle University U.K., have reported the births of eight healthy babies following mitochondrial transfer, in which the fertilized egg of a woman carrying mutations in their mitochondrial DNA was placed in the enucleated egg of a non-carrier. Read More
Thirty-six biotechnology, pharmaceutical and medical device companies sought a capital raise on the Hong Kong Stock Exchange in the first half (H1) of 2025, a review by BioWorld found. Of those, 34 companies were from mainland China. Read More
The Australian government has awarded nearly AU$100 million (US$64.65 million) in grant funding to three biopharma/med-tech incubators to support emerging Australian biopharma and med-tech startups. Read More
Johnson & Johnson beat analysts’ expectations for its second quarter results, led by medical device sales of $8.54 billion. All med-tech segments performed better than anticipated, with cardiology reporting exceptionally strong 22.3% growth. In addition, the innovative medicines division shocked the Street with 4.9% growth, despite the loss of patent protection for the blockbuster drug, Stelara. Read More
Expanding on guidance issued a dozen years ago, the U.S. FDA released a draft guidance to help sponsors developing cancer drugs for use in novel combinations determine the contribution of the individual drugs’ effect. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Cantargia, Cognition, Cue, Okyo, Zevra. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Chemspace, Debiopharm, Ikena, Inmagene, Ioncologi, Ocuvex, Onconetix, Orogen, Repare, Sandboxaq. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amphix, Biocon, Bio-Thera, Endeavor, Genascence, Kalvista, Kezar, Sanofi. Read More
