Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11. The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA. The companies last week announced that the […]
coronavirus
Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.
BD says glass prefillable syringes still perform after deep cold storage
BD (NYSE:BDX) today shared the results from a preliminary study investigating the impact of deep cold storage on glass prefillable syringes. Franklin Lakes, N.J.-based BD’s study evaluated deep cold storage (-20°C and -40°C) as traditional vaccine formulations are commonly stored up to about 2°C to 8°C, while mRNA vaccine formulations (the type of COVID-19 vaccine made […]
Abbott is reopening Illinois facility to make more COVID-19 tests
Abbott (NYSE:ABT) is reopening an Illinois facility that makes its rapid, at-home COVID-19 tests as demand for the diagnostics rises again. The Chicago Tribune first reported that production of the BinaxNow rapid COVID-19 tests will begin at the Gurnee, Illinois-based facility within the coming weeks as an Abbott spokesperson confirmed to the outlet that the company […]
FDA advisory panel recommends boosters only for older and high-risk individuals
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals […]
Medtronic, Johnson & Johnson warn of hospital worker burnout headwind
Medical device manufacturers are worried that the COVID-19 pandemic’s latest wave will make for a tougher recovery in elective procedures after Delta variant cases subside. Top officials from Medtronic (NYSE:MDT), Johnson & Johnson (NYSE:JNJ), NuVasive (NASDAQ: NUVA) and Zimmer Biomet Holdings (NYSE:ZBH) recently warned investors of the problem. The concern is that the highly contagious […]
Report: U.S. set to buy hundreds of millions of Pfizer’s COVID-19 vaccine to share
The Biden administration reportedly plans to purchase and share with the world hundreds of millions of doses of Pfizer’s COVID-19 vaccine. The Washington Post reported today that the U.S. has plans to make another large purchase of COVID-19 vaccines, although details of the deal have not been made clear. Neither the White House nor Pfizer have […]
Prenetics is going public through a SPAC deal
Genomic and diagnostic testing company Prenetics announced that it will merge with Artisan Acquisition Corp. and go public. Artisan, a special purpose acquisition company (SPAC), will provide a business portfolio across retail, hospitality, healthcare, property and other strategic businesses for Prenetics to substantially expand its platform through the merger, according to a news release. The […]
Cepheid wins EUA for new version of COVID-19, flu, RSV combination diagnostic
Cepheid announced today that it received FDA emergency use authorization (EUA) for its Xpert Xpress CoV-2/Flu/RSV Plus diagnostic. Sunnyvale, California-based Cepheid designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV). Nearly one year ago, the […]
Scancell picks PharmaJet’s needle-free injection systems to deliver COVID-19 vaccine candidates
PharmaJet announced today that its partner, Scancell, chose its needle-free injection platform to administer its COVID-19 vaccine candidates. Scancell selected Golden, Colorado-based PharmaJet’s devices to administer two SARS-CoV-2 DNA-based vaccine candidates, SCOV1 and SCOV2. The vaccines will be exclusively administered using the PharmaJet Tropis and PharmaJet Stratis needle-free injection systems. Get the full story at our sister […]
FDA outlines plan to ‘follow the science’ as it mulls over COVID-19 vaccines for children
FDA leaders have issued a statement regarding the agency’s plan moving forward with regards to authorizing COVID-19 vaccines for children. The FDA plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country, the agency said in a news release […]
Moderna submits initial data to FDA for COVID-19 vaccine booster
Moderna (NSDQ:MRNA) announced that it initiated its submission to the FDA for a booster dose of its COVID-19 vaccine. Cambridge, Massachusetts-based Moderna expects to submit data to the European Medicines Agency and other regulatory authorities around the world in addition to the FDA in the coming days for the booster shot at a 50 µg dose […]