With phase III data due from Phathom Pharmaceuticals Inc. in the near term, investor eyes are turning to the ways that lead compound vonoprazan, a potassium-competitive acid blocker, might distinguish itself from proton pump inhibitors (PPIs) in gastroesophageal reflux disease (GERD).
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biogen, EMD, Horizon, Implicit, Kintor, Merck KGaA, Quantum Leap, Roche, Takeda, TG.
Phase I data on immune responses induced by Inovio Inc.'s COVID-19 DNA vaccine candidate, INO-4800, showed it induced neutralizing antibodies and T-cell responses against all spike protein variants tested in a phase I study, including those first detected in the U.K., South Africa and Brazil. A preliminary report on the analysis, published on bioRxiv, preceded the reporting of phase II data on the candidate expected later this quarter as well as a potential move to phase III testing, pending resolution of a partial clinical hold on the study first announced in September 2020.
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.
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