Smith & Nephew plc received U.S. FDA 510(k) clearance for Aetos Stemless, its stemless anatomic total shoulder implant. The greenlight for the device is a boon for the company’s orthopedics portfolio, which faces increasing pressure from U.S. competitors.
Released from a clinical hold by the U.S. FDA in late September, Biomea Fusion Inc.’s menin inhibitor, icovamenib, has charged ahead to produce positive top-line data from a phase II study in type 2 diabetes (T2D). The data, however, didn’t stop the stock from dropping to near its lowest level of the past 12 months.
Kura Oncology, Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor ziftomenib showed encouraging data across multiple studies, the most encouraging of which were in combination with other standard of care therapies in patients with NPM1-mutant and KMT2A-rearranged acute myeloid leukemia.
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%.
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.
Kyorin Pharmaceutical Co. Ltd. has acquired Bayer AG’s phase II obstructive sleep apnea candidate, BAY-2925976, in a deal worth €85M (US$89.3 million) plus sales-based royalties and commercial milestones.
The potential for TL1A-targeting duvakitug to impact unmet needs of patients with ulcerative colitis (UC) and Crohn’s disease (CD), and to provide antifibrotic effects for a host of other diseases, boosted shares of Teva Pharmaceutical Industries Ltd. and Sanofi SA by 26.5% and 6.7%, respectively, as the partners released what analysts called “best-in-class” results from the phase IIb Relieve UCCD study and prepare for a phase III trial in 2025.
Becton, Dickinson and Co. reached an agreement with the U.S. Securities and Exchange Commission (SEC) to resolve an investigation related to allegations that the company misled investors regarding the Alaris infusion system, which BD added to its portfolio with the $12.2 billion acquisition of Carefusion in 2015. BD will pay a $175 million civil penalty and agreed to a cease and desist order for the device.
Labcorp Holdings Inc. launched its new H5N1 bird flu molecular test for humans in the U.S. as an international outbreak of the disease continues to spread in cows and poultry – and people. As BioWorld reported recently, just one mutation would make the flu variant highly transmissible in humans.
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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