While Spruce Biosciences Inc.’s tildacerfont missed its phase II primary endpoint in classic congenital adrenal hyperplasia (CAH) last March, the U.S. FDA approved Crenessity (crinecerfont) from Neurocrine Biosciences Inc. for treating pediatric and adult CAH patients. The nod could lead the drug to become a blockbuster, analysts said. Read More
A year after manufacturing issues resulted in a complete response letter for cosibelimab, the U.S. FDA approved Checkpoint Therapeutics Inc.’s drug, branded Unloxcyt, as the first anti-PD-L1 antibody for use in metastatic or locally advanced cutaneous squamous cell carcinoma patients who are not candidates for curative surgery or curative radiation. Read More
Newron Pharmaceuticals SpA scored €44 million (US$46.26 million) up front in a potential €117 million licensing deal with EA Pharma Co. Ltd. to pad the clinical runway of its late-stage oral schizophrenia asset, evenamide (NW-3509), sending company stock prices up near 20%. Read More
Puretech Health plc has announced phase IIb data showing its reformulation of pirfenidone has improved the tolerability and increased the efficacy of the marketed antifibrotic in the treatment of idiopathic pulmonary fibrosis. The tweak on the original molecule involved substituting three hydrogen atoms with three of the heavier counterpart, deuterium, improving stability, whilst retaining the antifibrotic effect. Read More
Recce Pharmaceuticals Ltd. is progressing synthetic antibiotic Recce-327 to pivotal phase III trials in Indonesia for the treatment of diabetic foot infections. The trial, which is assessing Recce-327 as a topical gel (R327G), is expected to begin in the first quarter of 2025, Recce CEO James Graham told BioWorld. Read More
Biopharma deal activity in November reached $29.18 billion, up from $22.29 billion in October. Year-to-date deal values have increased 3.6%, from $194.13 billion in the first 11 months of 2023 to $201.19 billion through November this year, overtaking 2023 to be the highest year on record through the month. Read More
New hires and promotions in the biopharma industry, including: Akari, Fairjourney, Crinetics, Fibrogen, Kalvista, Neophore, Neural, Vectory, Xilio. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actimed, Assertio, Bicycle, Corcept, Incyclix, Iteos, Jaguar, Repare. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boundless, EA Pharma, Editas, Elevation Oncology, Lakeshore, Newron. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS, Ascendis, Bridgebio, Eli Lilly, Galderma, Geron, Gilead, Merck, Roche, Sanofi. Read More
