The latest global regulatory news, changes and updates affecting biopharma, including: FDA weighing Xeljanz safety results; EMA initiates OPEN collaboration; NICE evaluating guidance processes; TGA seeking comments; USPTO extends program with Japan’s, Korea’s patent offices; NICE recommends Keytruda in NSCLC; Florida researcher indicted.
The U.S. FDA is still struggling to keep up with the volume of diagnostic emergency use authorizations (EUAs), but it is not for want of effort. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said on the Feb. 3 testing town hall that the agency is processing nine such applications per day, a big jump over the rate of one per day in the early weeks of the COVID-19 pandemic.
HONG KONG – Seegene Inc. has developed a COVID-19 test kit that is able to both detect and identify multiple mutant variations of the virus. “Getting test results from the Allplex SARS-CoV-2 Variants Ⅰ Assay takes two hours, which is normally how long getting results from a PCR test takes,” a Seegene spokesperson told BioWorld.
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.
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