HONG KONG – South Korea’s Hanmi Pharmaceutical Co. Ltd. has filed a new drug approval application for Rolontis (eflapegrastim) with the country’s Ministry of Food and Drug Safety (MDFS).
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.
The latest global regulatory news, changes and updates affecting biopharma, including: Biomedical Advanced Research and Development Authority, CHMP, EMA, FDA, Gilead Sciences, National Institute for Health and Care Excellence, Nichi-Iko Pharmaceutical, Office of Special Counsel, Sagent Pharmaceuticals, SEC, Shriram Institute for Industrial Research, Therapeutic Goods Administration, U.S. Senate.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Applied Medical Resources, Cook Medical, GT Medical Technologies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caption Health, Cardiofocus, Cytosorbents, Helius Medical Technologies, Optiscan Biomedical, Ortho Clinical Diagnostics, Thermo Fisher Scientific, Transit Scientific.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpha Cognition, Histogen, Moderna, Seattle Genetics.
The U.S. FDA has issued an emergency use authorization (EUA) for an antigen test for the SARS-CoV-2 virus from Quidel Corp., of San Diego, that is more readily deployed than other diagnostic tests for the pathogen. Quidel’s offering can be used at the point of care (POC) and as a lab test.
The FDA granted Setpoint Medical Corp. an investigational device exemption (IDE) approval to study its bioelectronic platform in rheumatoid arthritis (RA) patients. The Valencia, Calif.-based company expects to begin enrollment in a multicenter, double-blind, randomized, sham-controlled pivotal trial in patients with RA in the third quarter of 2020, Setpoint President and CEO Murthy Simhambhatla told BioWorld.
The U.S. FDA has expanded the emergency use authorization (EUA) for Rutgers University’s saliva-based COVID-19 test to include at-home use of Spectrum Solutions LLC’s SDNA-1000 whole saliva collection device, a development that underscores the need for wider testing as localities across the country emerge from lockdown and restart their economies. This is the first at-home option for saliva collection; the action comes just two weeks after the FDA authorized Laboratory Corp. of America’s polymerase chain reaction test for SARS-CoV-2, the virus that causes COVID-19, to include the company’s Pixel self-collection kit for nasal samples.
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