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.
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.
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.
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%.
Heartbeam Inc. received U.S. FDA 510(K) clearance for its portable, non-invasive electrocardiogram system that enables on-the-go recording of heart signals. The cable-free, credit card-sized device uses five electrodes to capture signals from three directions and can be used whenever a patient feels symptoms, overcoming the challenge of identifying intermittent arrhythmias, which are often not experienced during scheduled appointments, without requiring patients to wear a device continuously.
GC Biopharma Corp. will buy plasma collector Abo Holdings Inc. in a ₩138 billion (US$96.28 million) cash acquisition as the vaccine and plasma-derived medicinal products developer works to accelerate entry of Alyglo (IVIG-SN 10%) in the U.S., where it was approved last year.
The U.S. FDA’s emphasis on alternatives to ethylene oxide is gaining momentum with the help of internationally recognized standards — such as ISO 11737 — in a move that will enable a less cumbersome approach to non-EtO device sterilization.
The first patenting to emerge from Filtro Medical Inc. describes the development of blood filtration devices designed to reduce systemic exposure to chemotherapy or other therapeutic agents that have been delivered into a target treatment location.
Capstan Medical Inc. closed an oversubscribed series C fundraising round that brought in $110 million for the structural heart-focused company. Capstan aims to combine valve implants, advanced catheter technology and a robotic platform to facilitate expanded minimally invasive treatment options for patients with heart valve disease.
The fact that both the U.S. Federal Trade Commission and the Department of Justice have oversight of mergers and acquisitions is something of a regulatory oddity. But David Balto, an attorney specializing on antitrust matters, told BioWorld that this may change in 2025 thanks to support for such a move from both Congress and the White House.
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