The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA slaps two companies for illicit COVID offerings; FDA approves new PET imaging agent for prostate cancer.
Nearly a year after the SARS-CoV-2 virus first appeared in Wuhan, China, a ray of hope is shining on the world with high efficacy reported for four vaccines and U.S. emergency use authorizations granted to three more therapeutics.
LONDON – The first 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine are due to arrive in the U.K. over the next few days, after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration now expected to start on Monday, Dec. 7.
The latest global regulatory news, changes and updates affecting biopharma, including: Canada moves to make some COVID-19 flexibilities permanent; Industry group forms to advance subcutaneous technology.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Biontech, Catalyst, Elusys, Kempharm, LG Chem, Mesoblast, Oyster Point, Pfizer, Protagonist, Regent, Telix, Vanda, Wanbang.
Salient Bio launched a robotics-driven PCR test for COVID-19 with 99% for use in mass testing for the virus. The company says the "fastest ever" test notifies users of test results in less than a day and is priced to be cost effective for businesses. Salient plans to expand the number of tests utilizing the modular diagnostics platform in 2021 to include a range of pathogens. Even with vaccines on the horizon in the coming months, the London-based company expects brisk demand for its product.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adapthealth, Aerocare Holdings, Ams, Bayer, Biotricity, Biovo Technologies, Blackford Analysis, Boston Scientific, Change Healthcare, Decision Diagnostics, Eir Healthcare, Electrocore, Ers Genomics, GE Healthcare, Health Decisions, Healthstream, Illumina, Irhythm Technologies, .lumen, Meso Scale Diagnostics, Nanostring, New England Home Medical Equipment, Nuance, Nvidia, Oncobay Clinical, Pieriandx, Premier Medical Laboratory Services, Serb, Stark International Lux, TCA/Genetworx Labs, The iQ Group Global, Vesper Medical, Vivlion.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Baylis Medical, Biocardia, Biodesix, Bioskryb, Caredx, Hancock Jaffe Laboratories, Ihealthscreen, Multi Radiance Medical, Quotient, Sensus Healthcare.
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