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.
Visible Genomics has launched a set of noninvasive genetic tests aimed at assessing the overall risk of developing age-related macular degeneration (AMD) or progressing with the disease. AMD is a common condition that affects the part of the eye called the macula. It typically blurs the central vision used in tasks like reading and driving and develops around age 50.
RapidAI, which focuses on imaging for stroke, has launched the Rapid Web App to help stroke teams stay updated on imaging results and communicate securely. Using the app, team members can receive real-time browser notifications of new cases, preview Rapid results and source files and engage in workflow communications via a desktop or laptop computer.
A new type of SARS-CoV-2 antigen test that relies on single molecule array technology may be able to help clinicians identify which patients are most likely to experience severe disease.
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