The U.S. FDA granted Signum Surgical Ltd. de novo marketing clearance for its Biohealx technology as a treatment for anal fistula. Biohealx is a single use, bioabsorbable implant, designed to not only to treat the condition in a minimally invasive procedure but also promote healing, prevent fistula recurrence and protect patient continence.
Tracon Pharmaceuticals Inc. is shuttering all development of its subcutaneous PD-L1 antibody, envafolimab, after the pivotal trial failed to meet the primary endpoint in soft tissue sarcoma.
At a time when much of the biopharma space can’t seem to get enough of antibody-drug conjugates (ADC), Bristol Myers Squibb Co. is backing away from a potential $3 billion-plus collaboration with Eisai Co. Ltd., handing back full rights to the latter’s folate receptor alpha-targeting ADC, farletuzumab ecteribulin (FZEC), citing a portfolio reprioritization.
Cartesian Therapeutics Inc.’s phase IIb study of its lead candidate, Descartes-08, in treating generalized myasthenia gravis (gMG) hit its primary endpoint while the company also notched a $130 million private placement equity financing.
Following a data-cleaning delay and mixed results in Alzheimer’s disease, Annovis Bio Inc. reported phase III Parkinson’s disease data showing treatment with buntanetap stops cognitive decline and improves motor and other functions, including postural instability and gait difficulty, meeting all primary and secondary endpoints.
Radiopharm Theranostics Ltd. announced a AU$70 million (US$46.69 million) institutional placement, and as part of that capital raise, radiopharma company Lantheus Holdings, Inc., has agreed to make an initial equity investment of AU$7.5 million.
The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28.
The U.S. FDA posted notice of a recall of the system monitor for the Heartmate left ventricular assist device by Abbott Laboratories, an action necessitated by reports of a series of malfunctions that may lead to inadvertent operator error.
After snaring the U.S. FDA’s approval for the Evoque tricuspid valve device, Edwards Lifesciences Corp. petitioned the Centers for Medicare & Medicaid Services for a national coverage determination for transcatheter tricuspid valve replacement devices.
Partners Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. received a complete response letter (CRL) from the U.S. FDA for their first-in-class HER3-directed antibody-drug conjugate HER3-DXd (patritumab deruxtecan) to treat patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer.
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