To help better utilize real-world data in drug development, the EMA published its final guideline Oct. 26 on the use of registry-based studies to support regulatory decision-making.
Shares of Angion Biomedica Corp. tumbled more than 50% Oct. 27 on disappointing top-line data from its phase III study testing ANG-3777’s ability to improve organ function in patients receiving deceased donor kidney transplants. The company’s management, however, remained cautiously optimistic that the safety results and signals of biological activity could bode well for an exploratory phase II study testing the drug in acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass, which is expected to read out later this quarter.
What Cortexyme Inc.’s chief operating officer Christopher Lowe called “a giant step forward” in Alzheimer’s disease (AD) research with atuzaginstat (COR-388) was viewed differently by Wall Street, which walloped shares (NASDAQ:CRTX) by 76%, or $44.17, causing the stock to close at $13.51.
The race for a Japan-made COVID-19 vaccine is heating up as players make progress with their trials. Daiichi Sankyo Co. Ltd. recently shared the results from its phase I/II trial for DS-5670, its mRNA vaccine. The mRNA vaccine candidate initiated studies in March 2021. The findings showed that in terms of immunogenicity, both neutralizing activity and IgG titer increased after the vaccination.
Innovent Biologics Co. Ltd.’s phase III Orient-31 trial for sintilimab in EGFR-mutated nonsquamous non-small-cell lung cancer (nsqNSCLC) met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar injection) and chemotherapy, the treatment improved progression-free survival vs. chemotherapy alone. “The detailed results of Orient-31 will be released in 2021, and Innovent will file for the new drug application for that indication around early 2022,” Ronnie Ede, chief financial officer and executive director at Innovent, told BioWorld.
Apollo Endosurgery Inc. presented strong results from its endoscopic sleeve gastroplasty study with patients achieving an excess body weight loss of 49.2% at 12 months and the great majority maintaining that loss for two years. Serious adverse events occurred in 2% of patients and all resolved without intensive care or surgical intervention.
Smart Medical Systems Ltd. has released positive data showing its FDA-cleared G-eye balloon endoscope has a higher adenoma detection rate (ADR) compared to Olympus’ Endocuff Vision (ECV) technology in patients undergoing screening or surveillance colonoscopy.
LONDON – A U.K. study following up 32.5 million people for 28 days after their first dose of a COVID-19 vaccine has shown an increased risk of hemorrhagic stroke after receiving the Pfizer Inc./Biontech SE product, and confirmed case reports of an increased risk of developing Guillain-Barré syndrome after the Astrazeneca plc vaccine.
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