The latest global regulatory news, changes and updates affecting biopharma, including: Drug Enforcement Administration, Department of Health and Human Services, FDA, International Coalition of Medicines Regulatory Authorities, EMA, European Commission, National Institute for Health and Care Excellence, NIH, Office for Human Research Protections, Pharmaceuticals and Medical Devices Agency, Therapeutic Goods Administration.
Wayne, Pa.-based Intact Vascular Inc. has secured U.S. FDA approval for the first peripheral vascular implant to repair below-the-knee (BTK) post-angioplasty dissections. The company expects to begin shipping units of the Tack endovascular system (4F) in about two weeks.
The age of molecular testing for the COVID-19 pandemic is still with us, but the emphasis in the months ahead will be on serological testing as a quicker, more useful mass testing alternative. However, test developers have a number of hurdles to overcome in devising these serological tests, including that antibodies for the virus’s antigens emerge at different times in the disease cycle, just one of several challenges that have to be met in the effort to bring the SARS-CoV-2 virus to heel.
Since April 10, 2020, the FDA has issued emergency use authorizations (EUAs) to several companies that make blood purification devices that can clear excess cytokines in the blood of patients with COVID-19. Monmouth Junction, N.J.-based Cytosorbents Corp.; Lakewood, Colo.-based Terumo BCT Inc.; and Marker Therapeutics AG, a subsidiary of Marker AG, of Zug, Switzerland, have all recently received EUAs for use of their products in adults with confirmed COVID-19 infections who are admitted to intensive care.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Sterilization Products, Axonics, Becton Dickinson, Intact Vascular, The Learning Corp, Mobidiag, Spectral.
When it comes to guidance on interchangeables, the Pharmaceutical Research and Manufacturers of America (PhRMA) has some guidance for the FDA: Be more definite.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7 Hills, Alnylam, AVM, Epirium, Grid, Kadmon, KD Pharma, Lifemax.
The U.S. FDA’s routine guidance agenda may be badly disrupted by the COVID-19 outbreak, but the agency continues to pump out guidances and emergency use authorizations (EUAs) directed to the pandemic. While the FDA has included only one serological test under the diagnostic EUA paradigm, Rep. Diana DeGette penned a letter inquiring into when the agency intends to move more decisively on serological tests, arguing that the absence of action on this front endangers the nation’s economic health as well as the public’s health.
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