A complete response letter (CRL) from the U.S. FDA for GC-4419 (avasopasem) is causing Galera Therapeutics Inc. to dramatically change course to survive, with the company laying off about 70% of its workforce. That layoff, which will reach across several company departments, is designed to extend the cash runway into the second quarter of 2024. The adjustment comes after Galera expanded its commercial leadership in May to prep for a potential launch of avasopasem before the end of 2023.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Futura, Georgiamune, Lemonex, Precigen, Virios.
The accelerated clearance won by Johnson & Johnson (J&J) from the U.S. FDA for Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma (r/r MM) in adults brings to the market the bispecific antibody that takes aim at G protein-coupled receptor class C group 5 member D, a target of interest to other developers as well.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aleta, Aspen, Biophytis, Lisata, Novartis, NS, Puma.
Building on capabilities developed during the COVID-19 pandemic, the U.K. Health Security Agency’s Vaccine Development and Evaluation Centre hit the ground running.
Calling it a “landmark judgment,” the U.K.’s Competition and Markets Authority welcomed the Competition Appeal Tribunal’s Aug. 8 unanimous decision upholding an £84 million (US$107 million) fine levied against London-based Advanz Pharma Corp. for excessive drug pricing.
A logjam of clinical trial applications that has bult up at the U.K. Medicines and Healthcare products Agency (MHRA) is deterring companies from conducting studies in the U.K., according to the Bioindustry Association.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Ascentage, Biocity, Biogen, Huidagene, Impact, Iveric, Jacobio, MBX, NS, Rhythm, Viatris.
Even as biopharma challenges to the constitutionality of the “excise tax” included in the Inflation Reduction Act await action in the U.S. federal court system, the Treasury Department and the Internal Revenue Service (IRS) said they intend to issue proposed regulations to implement the tax.
Despite the U.S. FDA’s approval of Sage Therapeutics Inc.’s priority NDA for postpartum depression, the accompanying complete response letter (CRL) for major depressive disorder has undercut the company’s plans. Withholding the approval for MDD slices away a huge amount of the potential market for Sage and its collaborator, Biogen Inc.
RSS
