TORONTO – Whether it’s President Trump obtaining the drug Regeneron or COVID-19 test kits fast tracked in the U.S. and Canada, this has been the year of temporary emergency approvals for drugs and medical devices. What is sometimes overlooked are permanent programs like Canada’s Special Access Program and the U.S.’s Expanded Access Program, designed to provide therapeutics to patients who have exhausted every avenue for a cure or relief from a devastating disease.
If a new federal rule withstands politics and potential court challenges, U.S. health care prices may finally be freed from their historic black box. The Centers for Medicare & Medicaid Services, along with the Departments of Labor and the Treasury, issued the Transparency in Coverage final rule Oct. 29 requiring most private health plans to disclose pricing and cost-sharing information so Americans will know in advance how much they will have to pay for prescription drugs, medical devices and other health care products and services.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chf Solutions, Dia Imaging Analysis, Illuminoss Medical, Medtronic.
Keeping you up to date on recent developments in diagnostics, including: A case for pooled testing of SARS-CoV-2; FIT as effective as colonoscopy in ruling out suspected colorectal cancer; Looking to comparative genomics analysis to explain COVID-19 susceptibility.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apstem, Asieris, Avrobio, Genprex, Insignis, Mesoblast, Oncosec, Pepromene, Rafael, Regeneron, Tricida.
Developers of tests for the COVID-19 pandemic are deploying an increasingly wider range of test systems for molecular testing, but the FDA’s Toby Lowe said that despite the seeming interchangeability of real-time PCR (rt-PCR) systems, performance of a reference panel for a tweaked test must reflect the use of the rt-PCR system that is listed in the existing emergency use authorization (EUA).
With the world heading straight into a "very tough" stretch of the COVID-19 pandemic in which "too many countries are seeing an exponential increase in cases," according to World Health Organization Director-General Tedros Adhanom Ghebreyesus, two lucrative deals announced Oct. 28 showed little slack in efforts to confront the virus, even as evidence is still developing.
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