Pointing to his company’s work on “the next frontier in small molecules,” Ribometrix Inc. CEO Mike Solomon said the potential $1 billion-plus deal with Roche Holding AG offers evidence of big pharma’s mounting interest. Expertise in RNA folds helped Ribometrix nail down an agreement with Basel, Switzerland-based Roche’s Genentech arm that brings $25 million up front and potential milestone payments beyond $1 billion, as the pair discovers and develops RNA-targeted small-molecule therapeutics. Genentech gains exclusive rights to several predefined targets, including an exclusive global license for the development and commercialization of molecules. Read More
Mycovia Pharmaceuticals Inc. said new phase III data on its oral antifungal, oteseconazole, showed that 37 weeks after women with a history of recurrent vulvovaginal candidiasis received a dose of the medicine for an episode of acute yeast infection, just 5.1% saw a recurrence of infection vs. 42.2% of those treated with fluconazole. Furthermore, oteseconazole proved noninferior to fluconazole in the resolution of symptoms at day 14 of the study. Read More
Imara Inc. reported a mixed bag of phase IIa study data for its lead candidate, IMR-687, for treating sickle cell disease in adults, bringing an end to a study that the company found cumbersome and that eventually stung its stock. Read More
LONDON – The EMA has recommended approval of Moderna Inc.’s COVID-19 vaccine, becoming the fourth western regulator to do so, after Israel approved the product on Jan. 5 and the FDA and Health Canada in December. Read More
Using an adenine base editor, researchers at the U.S. NIH, Vanderbilt University Medical Center and Harvard University have succeeded in treating the premature aging syndrome Hutchinson-Guilford progeria syndrome (progeria) in mice, extending the animals’ lifespan and preventing much of the vascular damage that is typically the cause of death in children with progeria. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Fed Circuit: Nonsensical claims indefinite; USPTO seeks more uniformity between PTAB, courts; EC investing in startups. Read More
Biopharmas raising money in public or private financings, including: Aileron, Clearside, Eleva, Eyegate, Histogen, Myeloid, NGM, Revelation, Senti. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Creative Medical, Erasca, Imara, Infinity, Inovio, Millendo, Mycovia, Ocuphire, Regenxbio, Seres, Vir, Windtree, Zentalis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amolyt, Astellas, Astrazeneca, Everest, Inventiva, Moderna, RDIF, Redhill, Stealth. Read More
