President Joe Biden has struck a deal with Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) to provide 500 million COVID-19 vaccine doses to roughly 100 countries over two years. The two companies today confirmed the news, saying that the U.S. government will purchase at a not-for-profit price 200 million doses in 2021 and 300 million in early 2022. Doses […]
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.
Amazon wins EUA to sell its COVID-19 test directly to consumers
Amazon subsidiary STS Lab Holdco received FDA emergency use authorization (EUA) for the direct-to-consumer sale of its COVID-19 test. The FDA authorized the test with indications as a direct-to-consumer product for testing individual anterior nasal swab specimens self-collected at home with the Amazon COVID-19 test collection kit DTC by any individual 18 years or older, […]
U.S. to buy nearly 2 million courses of Merck’s COVID-19 antiviral treatment
Merck (NYSE:MRK) announced today that it agreed to supply the U.S. government with its molnupiravir (MK-4482) for treating COVID-19. Molnupiravir, developed through a collaboration between Merck and Ridgeback Biotherapeutics, is currently under evaluation in a Phase 3 clinical trial for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 infection and at least one risk factor […]
Pfizer expands COVID-19 vaccine trial involving children under 12
Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years […]
Biden administration wants to boost funding for new pharma manufacturing processes
The Biden administration today released findings from 100-day supply chain assessments, determining the need to boost pharmaceutical manufacturing. According to a fact sheet, the administration plans to take immediate action to “address vulnerabilities and strengthen resilience” with its effort to take on near-term supply chain disruptions for four products: semiconductor manufacturing and advanced packaging; large […]
Abbott, Walgreens partner on boosting COVID-19 testing in Philadelphia
Abbott (NYSE:ABT) and Walgreens announced a pilot program designed to increase access to rapid COVID-19 testing in Philadelphia. Under the newly formed partnership, Pennsylvania Electronic Benefit Transfer (EBT) cardholders in Philadelphia will be able to receive Abbott’s BinaxNOW COVID-19 antigen self-tests weekly at no cost, according to a news release. Customers can visit any of […]
BD surpasses 2 billion orders for COVID-19 injection devices
BD (NYSE:BDX) announced today that orders for its needles and syringes hit 2 billion amid global COVID-19 vaccination efforts. Franklin Lakes, N.J.-based BD’s latest milestone comes less than six months after the company surpassed 1 million orders for vaccine delivery devices in December 2020. The order total encompasses commitments to governments all over the globe, including the […]
HHS wants investors to help prevent next pandemic
The U.S. Department of Health and Human Services (HHS) is turning to venture capital to speed the development of medical devices to stave off or fight public health emergencies. HHS’s Biomedical Advanced Research and Development Authority (BARDA) plans to provide the nonprofit Global Health Investment Corporation (GHIC) with a minimum of $50 million over five years, with […]
Moderna seeks full FDA approval for its COVID-19 vaccine
Moderna (NSDQ:MRNA) announced today that it submitted for full FDA approval of its mRNA COVID-19 vaccine for individuals 18 years of age and older. Cambridge, Mass.-based Moderna initiated the rolling submission process with the FDA for a Biologics License Application (BLA) to license its mRNA COVID-19 vaccine, according to a news release. The move mirrors […]
Abbott stock down on reduced 2021 earnings outlook
Abbott (NYSE:ABT) announced today that it is cutting its earnings outlook for the year amid reduced demand for COVID-19 diagnostics. The news sent ABT shares down more than 8% to $106.91 apiece by midday trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly. Abbott had […]
U.K. authorizes J&J COVID-19 vaccine
The United Kingdom announced that it approved the single-dose COVID-19 vaccine developed by Johnson & Johnson’s Janssen Pharmaceutical business. The Medicines and Healthcare products Regulatory Agency (MHRA) granted the regulatory approval, making Janssen’s the fourth COVID-19 vaccine authorized by the independent regulator and the first to be approved as a single-dose option, according to a […]