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.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Chemspace, Debiopharm, Ikena, Inmagene, Ioncologi, Ocuvex, Onconetix, Orogen, Repare, Sandboxaq.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Cantargia, Cognition, Cue, Okyo, Zevra.
Expanding on guidance issued a dozen years ago, the U.S. FDA released a draft guidance to help sponsors developing cancer drugs for use in novel combinations determine the contribution of the individual drugs’ effect.
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.
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.
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.
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.
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