Citing clinical trial data backed by real-world data, members of the U.S. FDA’s Antimicrobial Drugs Advisory Committee voted overwhelmingly, 16-1, March 16 that the overall benefit-risk assessment is favorable for the use of Pfizer Inc.’s Paxlovid to treat mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Read More
Health Guard Biotechnology Inc. raised ¥294 million (US$43 million) in an IPO on the SME-focused Beijing Stock Exchange, with the funds going to push the development of its HPV vaccines. Read More
The U.K. Medicines and Healthcare products Agency (MHRA) is to stop carrying out its own appraisals of drugs that are being reviewed by the U.S. FDA, the EMA or Japan’s PDMA, and will instead set up “global recognition routes,” through which companies can apply to place products on the U.K. market that have passed regulatory scrutiny elsewhere. Read More
Seamless Therapeutics GmbH raised $12.5 million in seed financing to take forward a novel gene editing technology based on reprogramming recombinase enzymes. Read More
An investor has seen promise in First Wave Biopharma Inc.’s targeted, systemic gastrointestinal disease biotherapeutics, offering $4 million in a private placement as enrollment picks up pace in a phase II trial for the company’s lead candidate, adrulipase. Read More
It is approved as a food additive. But it now appears that sucralose can dampen T-cell-mediated immune responses, suggesting it could be a means of treating T-cell-dependent autoimmune disorders. While stressing (repeatedly) that they were studying intakes well above normal, at high but achievable doses sucralose has an unexpected effect on T-cell responses and functions in autoimmune, infection and tumor models, researchers at The Francis Crick Institute, London, reported in Nature March 15, 2023. Read More
Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK-021), is advancing from phase I trials to pivotal phase III trials in patients with tenosynovial giant cell tumors (TGCT) in the U.S. and China following clearance from both regulators.Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bellicum, Cantargia, Dermavant, Direct, Epicentrx, Evecxia, Horizon, Index, Inhibikase, Mabwell, Oryzon, Oxurion, Protagonist, Recode, Stoke. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Artisan, Beigene, Bicycle, Celyad, Concentra, Delsitech, Eton, Gensight, Immunoprecise, Jounce, Libera, Owlstone, Prelude, Summit, Takeda, Talem, TTC Tulex, Yishengbio and YS. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Argenx, Biontech, Bioprojet, Cognition, Deciphera, Edesa, Pfizer, Skye. Read More
