Irked by what state officials described as "bureaucratic roadblocks" to Florida's proposal for importing cheaper prescription drugs from Canada, Florida Gov. Ron DeSantis on Aug. 31 announced a state lawsuit against the U.S. FDA.
In pursuit of "an opportunity to accelerate the establishment of clinical development and commercial capabilities in the U.K.," Neurocrine Biosciences Inc. said it will buy Diurnal Group plc for about £48.3 million (US$56.5 million). Cardiff, U.K.-based Diurnal is a specialty pharma developing hormone therapies for rare and chronic endocrine conditions. The all-cash transaction represented a 144% premium of the Aug. 26 closing price of Diurnal shares (LSE:DNL). Shares closed 134.7% higher Aug. 30 at £26.40.
Interim analysis of a phase III trial testing a single dose of Pfizer Inc.'s bivalent respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in older adults has revealed efficacy good enough to support a planned BLA submission for the vaccine to the U.S. FDA in fall 2022, the company said. Preparation for further submissions to other regulatory agencies are underway.
Additional deaths believed to be associated with one of Foghorn Therapeutics Inc.'s lead candidates led the U.S. FDA to put a full clinical hold on its phase I study in relapsed and/or refractory acute myelogenous leukemia and myelodysplastic syndrome.
Carmot Therapeutics Inc. has raised $160 million in series D financing to support a trio of early to midstage clinical programs focused on treating diabetes and obesity with peptide-based small-molecule incretin receptor modulators.
As a growing roster of nations moves to protect individual genomic and other health data in the name of privacy under the General Data Protection Regulation in the EU and similar laws elsewhere, chief aggregators of such data, drug developers, are struggling.
As a growing roster of nations moves to protect individual genomic and other health data in the name of privacy under the General Data Protection Regulation in the EU and similar laws elsewhere, chief aggregators of such data, drug developers, are struggling.
Ionis Pharmaceuticals Inc. and Astrazeneca plc, partners on the antisense oligonucleotide inhibitor eplontersen, said interim phase III data showed the candidate had a positive impact on disease progression in patients with hereditary transthyretin-mediated amyloid polyneuropathy, giving them confidence to plan for a U.S. FDA NDA filing in the indication before the end of 2022.
With just 10% of therapeutic programs successfully moving from first toxicity dose to market, drug developers are on a constant hunt for new tricks to put the odds in their favor. Strategies abound, from biomarker-guided patient selection to deeper regulatory engagement. But big pharma executives and an academic expert weighing the challenge at the BIO International Convention said June 14 they see another tool slowly gaining traction with the potential to decrease timelines and boost chances for approval: in-silico modeling.
Just days after U.S. FDA advisors unanimously backed use of both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines in children 6 months and older, the FDA has expanded emergency use authorizations for the products. Availability could follow as soon as June 21, after a meeting of the CDC’s ongoing Advisory Committee on Immunization Practices, wraps up June 18.
