The results of Reducer 1, an international, three-arm observational study of an initial 241 patients with refractory angina were remarkable, Neovasc COO Bill Little told BioWorld.
HONG KONG – Tokyo-based Daiichi Sankyo Co. Ltd. has hit its goals in a phase III study testing the use of prasugrel hydrochloride in thrombotic stroke patients.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Amgen, Chi-Med, Cytomx, Northwest, Noxxon, Polarityte, Theratechnologies, UCB.
Since the stock-jolting phase III blowup in March of Milestone Pharmaceuticals Inc.’s etripamil for paroxysmal supraventricular tachycardia (PSVT), questions have lingered regarding the short-acting channel blocker’s regulatory path forward – but no longer. Shares of Montreal-based Milestone (NASDAQ:MIST), which in the spring plummeted to an all-time low of $1.70, made up for the loss and then some, closing at $8.91, up $5.57, or 167%, on word that the FDA has agreed to terms whereby an NDA for the nasal spray may be submitted without launching another phase III study.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Ampio, Aravive, Clarity, Corcept, Genfit, Incyte, Pipeline, Quadriga.
Testing Nuplazid (pimavanserin) against major depressive disorder (MDD), Acadia Pharmaceuticals Inc. became the latest to fail in the indication as the company unveiled top-line results from the 298-patient phase III effort called Clarity.
Exero Medical Ltd. aims to improve monitoring the gastrointestinal system after surgery with a wireless, biodegradable anastomotic leak sensor implant. It has started a tiny five-patient, first-in-human study as a proof of concept for its technology.
HONG KONG – Osaka, Japan-based Shionogi & Co Ltd. continues to make global inroads with its influenza treatment, Xofluza (baloxavir marboxil), submitting supplemental new drug applications in Japan and Taiwan for a post-exposure prophylaxis indication on the back of positive results from its phase III trials.
HONG KONG – Shanghai-based I-Mab Biopharma Co. Ltd. expects to begin clinical trials for the world’s first and only claudin18.2 and 4-1BB bispecific program in a year.
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