The diagnostic industry in the U.S. and elsewhere has scrambled to keep up with the COVID-19 pandemic, and one of the key developments will be a test that can be used at home without medical supervision. However, Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the Sept. 16 diagnostic town hall that the agency is keen on authorizing such a test, but has yet to receive any emergency use authorization filings. “We want to see a home test submission, and we’re willing to be very flexible here,” Stenzel said.
Researchers at the University of California at San Diego have used RNA-targeted CRISPR to reverse symptoms in an animal model of myotonic dystrophy type 1 (DM1). They reported their findings in the Sept. 14, 2020, issue of Nature Biomedical Engineering.
Spurred by reports of biopharma executives exercising stock options in conjunction with announcements about COVID-19 vaccine developments and government contracts, U.S. lawmakers want to close the loopholes that make such actions legal.
A Sept. 16 Senate hearing revisited the Trump administration’s response to the COVID-19 pandemic, and the CDC took the opportunity to post a vaccine distribution plan. CDC director Robert Redfield advised the committee, however, that sufficient quantities of vaccine to cover everyone in the U.S. might not be available until the third quarter of 2021, adding that now is the time to stand up a distribution network for a vaccine that will require cold-chain storage.
Given the minimal accountability written into the 340B prescription drug discount program, a few biopharma companies recently began taking oversight into their own hands by demanding data claims or refusing to extend the mandated discounts to contract pharmacies.
The U.S. FDA has been easing gently down the road of real-world evidence (RWE) in regulatory decision-making, and the case of the Watchman left atrial appendage device is instructive in this regard. Robert Shipley, of Boston Scientific Corp. (BSX), said on webinar hosted by the Advanced Medical Technology Association that the FDA changed gears and agreed to a registry for a post-approval study for the first generation Watchman, but added that the use of registry data and other RWE for approval of a next-generation device is as yet more aspirational than practicable.
Siemens Healthineers AG snagged a key role in the mystery playing out across the world's pandemic stage – what do antibody test results mean in terms of immunity to SARS-CoV-2 and how do different tests assessing different proteins compare? The U.S. CDC and the Joint Research Centre (JRC) of the European Commission tapped the Erlanger, Germany-based company to take the lead in developing a process to standardize antibody assays.
What’s the plan? The U.S. CDC is being asked that question a lot these days – not just about COVID-19, but also about preparing for what could be a tough influenza season as flu bugs circulate with the coronavirus.
Ignoring industry’s threat of a lawsuit, U.S. President Donald Trump is moving forward with his plan for “most-favored nation” pricing of certain prescription drugs. The president, on Sept. 13, signed the executive order he threatened in July if industry didn’t come up with a better offer by Aug. 24. Industry did make a counter offer last month, but apparently it wasn’t enough.
Don May, Advamed’s executive vice president for payment and health care policy, said on a Sept. 11 press briefing that any device that misses its first year of new technology add-on payment (NTAP) eligibility may not be able to recover that year unless CMS makes an exception for the pandemic, seemingly leaving the Boston Scientific Eluvia device with only two years of eligibility for its NTAP application.
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