BD recently announced that it has partnered with Southeaster Grocers and Everly Health to distribute its at-home COVID-19 tests in grocery stores. Through the partnerships, Everly Health will distribute the BD Veritor at-home COVID-19 tests to Southeastern Grocers’ Fresco y Más, Harveys Supermarket and Winn-Dixie stores in the southeastern U.S. Veritor at-home COVID-19 tests are […]
COVID-19
FDA issues draft guidance for transitioning medical devices granted EUAs during pandemic
The FDA is proposing that it give medical device makers about half a year’s notice before terminating emergency use authorizations post-pandemic. That was one of the major takeaways from the draft guidance that the FDA released today. It considers ways to transition medical device regulation once COVID-19 moves from a pandemic to an endemic phase. […]
The pandemic tested Medtronic’s mettle: Its CFO explains how
CFO Karen Parkhill discusses leadership, innovation and restructuring Medtronic — the largest organization in medtech. Karen Parkhill drew on her experience in the banking industry to offer Medtronic a prognosis as the COVID-19 pandemic started rippling across the globe. Parkhill, Medtronic’s CFO and EVP, was CFO of JPMorgan Chase’s commercial banking business during and after the […]
Biden announces plans to buy, distribute 500M at-home, rapid COVID-19 tests
The White House today announced a COVID-19 response plan that includes a major effort to increase at-home rapid testing. President Joe Biden’s plan includes opening new federal testing sites to increase capacity and the distribution of 500 million at-home, rapid tests to Americans. The Biden administration plans to purchase a half-billion rapid tests this winter […]
BD acquires digital at-home test maker Scanwell Health
BD (NYSE:BDX) announced today that it completed the acquisition of smartphone-enabled, at-home medical test developer Scanwell Health. Financial terms for the transaction were not disclosed. BD expects the acquisition to be immaterial to its fiscal 2022 results, with Scanwell’s financial results reported under BD’s integrated diagnostic solutions business within the life sciences segment. Franklin Lakes, […]
PharmaJet partner announces COVID-19 vaccine trial with needle-free injection tech
PharmaJet announced today that one of its pharmaceutical partners, Nykode Therapeutics, has begun a trial for a COVID-19 vaccine with PharmaJet’s needle-free injection technology. Nykode’s Phase 1/2 clinical trial will specifically address the emerging SARS-CoV-2 variants, with the DNA-based vaccines delivered intramuscularly with PharmaJet’s Stratis needle-free injection system. Get the full story at our sister site, […]
Aerogen inks partnership to deliver COVID-19 vaccine with its mesh aerosol delivery tech
Aerogen and CanSinoBio announced today that they entered a partnership to deliver the latter’s COVID-19 vaccine with Aerogen’s technology. Galway, Ireland-based Aerogen’s proprietary vibrating mesh aerosol drug delivery technology will be used to deliver CanSinoBio’s recombinant novel coronavirus vaccine — Convidecia — under the development and commercial supply partnership. Commercial terms for the partnership were not disclosed. Get […]
Fujifilm to expand vaccine production plant in England
Fujifilm (TSE:4901) is spending big to double the size of its United Kingdom-based vaccine manufacturing facility. According to a news release, Fujifilm is spending about $532.8 million (£400 million) to expand its Teesside (north-east England) plant making the Novavax COVID-19 vaccine. The expansion includes facilities specializing in antibody treatments and viral gene therapies. Fujifilm said […]
FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron
Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy. In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests, […]
Why Public Citizen is skeptical about the COVID-19 antiviral molnupiravir
Dr. Michael Carome, director of Public Citizen’s health research group, is concerned about Merck’s SARS-CoV-2 antiviral molnupiravir. If it wins emergency use authorization (EUA), molnupiravir would be the first oral treatment for COVID-19. But Carome brought up several potential problems with molnupiravir during today’s public comment period of the FDA’s Antimicrobial Drugs Advisory Committee meeting. […]
COVID-19 test makers say their products also detect Omicron
Abbott, BD, Hologic, PerkinElmer and Thermo Fisher are reassuring the public that their COVID-19 tests detect the Omicron variant. Discovered last week in South Africa, the new variant has enough mutations that it has raised concerns worldwide — even though it is still unknown for sure whether the mutations cause greater transmissibility or vaccine evasion. […]