The U.S. FDA’s Oncologic Drugs Advisory Committee took up the matter of GSK plc’s relapsed/refractory multiple myeloma drug, Blenrep (belantamab mafodotin). A B-cell maturation antigen-directed antibody-drug conjugate, Blenrep was taken off the market by GSK in November 2022 after a phase III confirmatory study failed. Corneal toxicity is one of the issues to be discussed.
Sarepta cutbacks propel the stock forward
Carving out $400 million in annual cost savings is going over well with Sarepta Therapeutics Inc.’s investors as the company’s stock (NASDAQ:SRPT) was getting a 19% boost at midday. As its big seller, the gene therapy Elevidys (delandistrogene moxeparvovec), continues to see its revenue numbers decline, Sarepta bolstered its business by chopping its operating expenses by about $400 million and letting about 500 employees in a 36% workplace cutback. The U.S. FDA also asked Sarepta to include a black box warning on Elevidys label in Duchenne muscular dystrophy, warning of possible acute liver injury and acute liver failure in ambulant patients. Sarepta has paused Elevidys shipments to non-ambulant patients as it looks to add more prophylactic immunosuppression.
Eight babies born after successful mitochondrial transfer
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 babies, four girls and four boys, including a pair of identical twins, now range in age from a few weeks to just over 2 years old. All have met their normal developmental milestones to date.
34 mainland China biotechs file for Hong Kong IPO in H1 2025
Thirty-six biotechnology, pharmaceutical and medical device companies sought a capital raise on the Hong Kong Stock Exchange (HKEX) in the first half (H1) of 2025, a review by BioWorld found. Of those, 34 companies were from mainland China.
Australia awards AU$100M in grants to biopharma/med-tech incubators
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. The three companies will act as incubators to uplift SMEs with promising medical innovations to be commercialized in Australia. The funding is provided under the Medical Research Future Fund’s Medical Research Commercialization Initiative. Over the next 10 years, the initiative will provide $450 million to assist commercial development of Australian medical research.
Med tech helps boost J&J to strong 2Q beat
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 posting 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.
Also in the news
Aegle, Alzecure, Amphix, Apimeds, Aptose, Astrazeneca, Biocon, Bio-Thera, Briacell, Cantargia, Chemspace, Citius Oncology, Cognition, Cue, Debiopharm, Endeavor, Evox, Gain, Genascence, Hanmi, Ikena, Inmagene, Ioncologi, Kalvista, Kezar, Ocuvex, Okyo, Onconetix, Orogen, Polyactiva, Puretech, Repare, Sandboxaq, Sanofi, Satellos, Windtree, Zevra