Tempest Therapeutics Inc. has begun the hunt for a phase III partner to help reach the market with TPST-1120, the oral selective peroxisome-proliferator activated receptor-alpha (PPAR-alpha) antagonist that showed clinical superiority on multiple study endpoints in phase Ib/II as an add-on in first-line unresectable or metastatic hepatocellular carcinoma (HCC). Read More
Novo Nordisk A/S’ semaglutide is making headlines again this week, with a phase IIIb testing the ubiquitous GLP-1 agonist on kidney outcomes halted early for efficacy. The independent data monitoring committee for the trial, dubbed Flow, concluded results from an interim analysis met prespecified efficacy criteria. Final data will read out in the first half of 2024. Read More
Insanity has often been defined as doing the same thing and expecting different results, and Japan seems to be trapped in that rut largely because it can’t seem to do innovation differently, said speakers at the BioJapan 2023 meeting held Oct. 11 in Yokohama, Japan. Read More
Sanofi SA will pay $10 million up front and potentially $1 billion down the road to build artificial intelligence (AI) drug discovery modules with Biomap – the Silicon Valley-based biotech led by Chinese billionaire, software engineer and serial entrepreneur Robin Li known for founding China’s largest internet search engine and AI platform, Baidu, in 2000. Read More
As it continues its crackdown on accelerated approval, the FDA continues to stress that successfully completing confirmatory trials should be the top priority for sponsors of drugs that enter the U.S. market via accelerated approval. Read More
Scientists at Egenesis Inc. have transplanted kidneys from genome-edited pigs into cynomolgus monkeys that remained functional for long periods after transplantation. The monkeys, whose own kidneys were removed during the surgery, survived for a median of 176 days after receiving one pig kidney. Maximal survival was just over 2 years. The data were published today in Nature. Egenesis CEO Mike Curtis told reporters that the study has achieved the longest survival to date “using clinically translatable immunosuppression … longer survival has been achieved using really aggressive immunosuppression that really isn’t clinically translatable.” Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annexon, Immpact, Inovio, Supernus. Read More
