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BioWorld - Monday, March 16, 2026
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
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Synthetic antibiotic Recce-327

Recce moves to pivotal trials in Indonesia for diabetic foot ulcers

Dec. 16, 2024
By Tamra Sami
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.
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Puretech’s modified pirfenidone impresses in phase IIb IPF trial

Dec. 16, 2024
By Nuala Moran
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.
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Checkpoint cleared: FDA approves Unloxcyt in skin cancer

Dec. 16, 2024
By Jennifer Boggs
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.
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FDA Approved stamp

Blockbuster bound? Neurocrine’s hyperplasia drug approved

Dec. 16, 2024
By Lee Landenberger
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.
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Brain illustrated with pills

Newron stock soars on €117M EA Pharma deal for schizophrenia drug

Dec. 16, 2024
By Marian (YoonJee) Chu
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%.
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Other news to note for Dec. 16, 2024

Dec. 16, 2024
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boundless, EA Pharma, Editas, Elevation Oncology, Lakeshore, Newron.
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In the clinic for Dec. 16, 2024

Dec. 16, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actimed, Assertio, Bicycle, Corcept, Incyclix, Iteos, Jaguar, Repare.
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Financings for Dec. 16, 2024

Dec. 16, 2024
Biopharmas raising money in public or private financings, including: Aptevo, Candel, Esperion, Inovio, Next Innovative.
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Appointments and advancements for Dec. 16, 2024

Dec. 16, 2024
New hires and promotions in the biopharma industry, including: Akari, Fairjourney, Crinetics, Fibrogen, Kalvista, Neophore, Neural, Vectory, Xilio.
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Regulatory actions for Dec. 16, 2024

Dec. 16, 2024
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.
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