The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Bedfont Scientific, Philosys, Rutgers Clinical Genomics Laboratory, Spectrum Solutions, University of Kentucky.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha Software, Aptar, Atrion, Beroni, Bioreference Laboratories, Cryolife, Fullerton Health, Guardant Health, Helius Medical Technologies, Livinguard, Opko Health, Orthofix, Twist Bioscience, United Health Products.
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
In the rush to develop a COVID-19 vaccine, integral parts of the equation are being overlooked in the U.S., according to a whistleblower complaint filed this week by Rick Bright over his removal as director of the Biomedical Advanced Research and Development Authority (BARDA). Even if millions of doses of vaccine are ready to go by January, as the NIH’s Anthony Fauci a few weeks ago said could happen, there may not be enough needles and syringes to deliver those doses.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Arch, Bridge, Cynata, Cytokinetics, Junshi, Pluristem, Redhill, Sesen, Takeda.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acadia, Arcturus, Beroni, Fortress, Oncogenuity, Sorrento, Zyus.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Cytodyn, Daewoong, Five Prime, Flexion, Kadmon, Lundbeck, Millendo, Protagonist, Revance, Savara, Scholar Rock.
Just days after Foster City, Calif.-based Gilead Sciences Inc. gained emergency use authorization (EUA) from the FDA for antiviral Veklury (remdesivir) for the treatment of patients with SARS-CoV-2 infection, the virus that causes COVID-19, Japan invoked its own exceptional approval pathway to give the drug the green light to treat patients with severe COVID-19.
Several companies have reported quarterly results over the past couple of days, and those offering testing for COVID-19 have seen impressive numbers. Standing out was San Diego-based Quidel Corp., whose numbers caught the attention of William Blair’s Brian Weinstein. Indeed, its $174.7 million in revenue far exceeded his organization’s estimate of $160 million, driven by influenza.
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