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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Aspenstate, Elemaster, Myriad, Visioncare.
Three biopharma drugs are up for FDA approval this week, including one new chemical entity, dasotraline, from Sunovion Pharmaceuticals Inc. to treat binge eating disorder, and two other candidates that are part of supplemental filings for expanded indications.
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).
About 15 months after closing its multibillion-dollar acquisition of Loxo Oncology Inc., Eli Lilly and Co. has secured an accelerated FDA approval for the first of the deal's headline assets, the RET kinase inhibitor selpercatinib, now branded as Retevmo.
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