The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Task force gives CAS screening another thumbs down; USPTO expands program with Japan’s, South Korea’s patent offices; Boston Sci recalls electrode for ICD due to risk of fracture; CDSCO posts lists of approved tests.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ardent Health Services, Ams, Axim Biotech, Bendcare, Botanisol Analytics, Casenet, Centene, Color, Colossal Contracting, Congenica, Decipher, Epredia, Extra Horizon, Fujifilm, Gabriel Precision Oncology, Gpm, Histosonics, Inspiremd, McGinley Orthopedics, Medline, Meridian Bioscience, Mobile Heartbeat, Netsmart, New England Biolabs, Ocean Insight, Quantumdx, Veeva, Veracyte, Vizient, Zyter.
While the Biden administration’s America Rescue Plan began its journey through Congress Feb. 3 as the next U.S. effort to address the COVID-19 pandemic, lawmakers came together to identify steps to improve vaccine distribution and curb ongoing supply shortages.
Vaxart Inc. investors who stuck by company shares Feb. 3 had to swallow a bitter pill – watching shares of the oral vaccine developer (NASDAQ:VXRT) fall 57.8% to $9.85. Driving the trade in part was news that, during a phase I trial, neutralizing antibodies to SARS-CoV-2 were not detected in most of the five subjects given two doses of VXA-CoV2-1, its oral recombinant protein vaccine for the potential prevention of SARS-CoV-2 infection. Furthermore, the company concluded it was "unable to evaluate" a study of the candidate organized by Operation Warp Speed.
Pfizer Inc. reported solid earnings for 2020 and said it expects even bigger things this year as the company projects approximately $15 billion in earnings from the COVID-19 vaccine it co-developed with Biontech SE.
CAJICA, Colombia - Colombia approved two different phase II/III trials for COVID-19 vaccine candidates over the last week, advancing one candidate developed by Germany’s Curevac AG and another by China’s Clover Biopharmaceuticals Inc.
LONDON – Two new U.K. studies point to long-term persistence of COVID-19 antibodies after both natural infection and vaccination, conferring protection against subsequent infection for at least three months.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aruvant, Asana, Biocryst, Innovent, Prothena, RDIF.
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