The FDA granted an investigational device exemption (IDE) to Hancock Jaffe Laboratories Inc. for Venovalve, clearing the way for the company to begin a pivotal trial of the implantable valve in patients with chronic venous insufficiency (CVI) of the deep veins of the leg. The company’s first patent covering the device was issued by the U.S. Patent and Trademark Office on April 7.
Better Therapeutics Inc. has commenced a real-world evidence study with Steward Health Care to assess the long-term impact of its BT-001 digital therapeutic in the treatment of type 2 diabetes. The investigational prescription solution delivers cognitive behavioral therapy to patients with uncontrolled type 2 diabetes.
“There is a big need for a drug in outpatients. If you could treat them and keep them out of hospitals, that would be important and play a big role in getting us through this pandemic,” Romark Laboratories LC’s CEO, Marc Ayers, told BioWorld.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve Life Sciences, Agenus, Aligos, Ardelyx, Ascletis, Astrazeneca, Auris, Endo, Galectin, Gannex, Innocoll, Kyowa Kirin, Moderna, Nervgen, Orphomed, Proqr, Rocket, Romark, Synthetic Biologics and Veracyte.
HONG KONG – Covig-19, an anti-SARS-CoV-2 hyperimmune immunoglobulin therapy that Takeda Pharmaceutical Co. Ltd. developed alongside the Covig-19 Plasma Alliance, has failed to meet its endpoints in a global phase III trial.
Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen.
HONG KONG – In a surprisingly candid statement, the director of China’s Centers for Disease Control conceded that the efficacy of Chinese coronavirus vaccines is "not high" and may require improvements.
LONDON – The U.K. is moving on to the next phase of testing mixed dosing schedules for COVID-19 vaccines, launching a study in which it will assess the effect of using Moderna Inc. or Novavax Inc.’s products as the second dose in a heterologous prime boost trial.
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