Aug 20, 12:00 PM

FDA Rejects enVVeno VenoValve; Novocure Files Pancreatic Cancer PMA

The U.S. Food and Drug Administration issued a not-approvable letter to enVVeno Medical for its VenoValve, a surgical replacement venous valve intended to treat severe chronic venous insufficiency. Regulators said the company’s pivotal data lacked objective hemodynamic measurements to confirm the reported improvements in pain, quality of life and revised Venous Clinical Severity Score, and flagged safety concerns tied to the open surgical procedure that led to re-hospitalisations. enVVeno said it is weighing options, including an appeal or resubmission, while continuing development of a less-invasive version of the device. The decision sent enVVeno shares plunging roughly 70 percent in pre-market trading. In a separate filing, Novocure submitted a premarket approval application for its Tumor Treating Fields therapy in patients with locally advanced pancreatic cancer who are not candidates for surgery. The submission seeks to expand use of the company’s alternating-electric-field technology beyond approved indications in glioblastoma and pleural mesothelioma. Tivic Health reported it has received two investigational new drug applications covering Entolimod, a Toll-like receptor-5 agonist being developed for acute radiation syndrome and for oncology settings. The transfer of the INDs from Statera Biopharma allows Tivic to start discussions with the FDA on late-stage trials.

#enVVeno Medical #VenoValve #Venous Clinical Severity Score #enVVeno #Novocure #Tumor Treating Fields #Tivic Health #Entolimod #Statera Biopharma #Tivic #FDA

Written with ChatGPT .

FDA Rejects enVVeno VenoValve; Novocure Files Pancreatic Cancer PMA

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