Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. bought 50 million more doses of its COVID-19 vaccine. The U.S. purchased the additional doses of the vaccine in its effort to support preparedness for pediatric vaccinations as it seeks authorization for use in younger adolescents and children. Get the full story at our sister site, Drug Discovery […]
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.
HHS, DOD invest more than $562M to increase COVID-19 test manufacturing
The U.S. Department of Health & Human Services (HHS) and Department of Defense (DOD) have awarded more than $562 million for COVID-19 test manufacturing. The funding — part of the American Rescue Plan to boost manufacturing of key products that increase domestic testing supply — went to a dozen U.S. companies to support the production […]
Abbott rises on Street-beating Q3, increased EPS guidance
Abbott (NYSE:ABT) shares ticked up this morning on third-quarter results that easily topped the consensus forecast. The Abbott Park, Illinois-based company posted profits of $2.1 billion, or $1.17 per share, on sales of $10.9 billion for the three months ended Sept. 30, 2021, for a 70.5% bottom-line gain on sales growth of 23.4%. Adjusted to […]
Johnson & Johnson rises on Q3 earnings beat
Johnson & Johnson (NYSE:JNJ) shares ticked up today on third-quarter results that topped the consensus earnings forecast. The New Brunswick, N.J.-based company posted profits of $3.7 billion, or $1.37 per share, on sales of $23.3 billion for the three months ended Sept. 30, 2021, for a 3.2% bottom-line gain on sales growth of 10.7%. Adjusted […]
FDA hits pause on reviewing Moderna COVID-19 vaccine for adolescents
The FDA has decided to postpone deciding whether to extend emergency use authorization of Moderna’s (NSDQ:MRNA) COVID-19 vaccine. Some regulators have concluded that the risk of myocarditis is higher in recipients of the Moderna vaccine than the Pfizer-BioNTech vaccine. Japan recently authorized men 30 and under who received an initial dose of the Moderna vaccine […]
Pfizer officially asks FDA to expand COVID-19 vaccine access to younger kids
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that they submitted a request to the FDA to expand the authorization of their COVID-19 vaccine to younger children. Expanded FDA emergency use authorization would allow for the use of the COVID-19 vaccine candidate, which has full FDA approval for people 16 years of age and older, in children aged […]
New BD syringe manufacturing lines are up and running in Nebraska
BD (NYSE:BDX) announced today that it increased its manufacturing capacity and domestic supply for syringes and needles. Franklin Lakes, N.J.-based BD’s new syringe and needle manufacturing lines, which were completed on an accelerated timeline, represent BD’s partnership with Department of Health and Human Services’ (HHS) Assistant Secretary for Preparedness and Response (ASPR). Get the full story […]
FDA grants EUA for PerkinElmer’s combination COVID-19, flu, RSV diagnostic
PerkinElmer (NYSE:PKI) announced today that it received FDA emergency use authorization (EUA) for its PKamp respiratory panel 1 assay. Qualified laboratories can now use Waltham, Massachusetts–based PerkinElmer’s PKamp respiratory SARS-CoV-2 RT-PCR panel 1 assay to simultaneously test for several serious respiratory ailments. The assay can detect SARS-CoV-2 (the virus causing COVID-19), influenza A, influenza B […]
Antivirals could be a vital weapon in the COVID-19 pandemic endgame
Antivirals have several advantages over vaccines. They tend to be broadly effective against viral variants and offer faster-acting protection than vaccines. In addition, antivirals are usually simple to transport and don’t require ultra-cold storage. And oral antivirals would have an advantage in terms of the speed of protection they offer. For SARS-CoV-2, antivirals also could […]
Masimo officials think their tech could reduce healthcare worker burnout
Masimo (NSDQ:MASI) announced today that University Hospitals (UH) of Cleveland is using its Masimo Patient SafetyNet system. Irvine, California–based Masimo’s Patient SafetyNet remote monitoring and supplemental alarm system could combat nurse burnout by improving workflows and reducing workloads, according to a news release. Such burnout has been a topic of interest amid the latest surge […]
Early safety concerns accompanied Merck’s molnupiravir, the first potential oral COVID-19 therapy
The antiviral molnupiravir appears to be destined to become the first oral treatment for COVID-19. Merck and its partner Ridgeback Biotherapeutics intend to file for emergency use authorization after announcing that the drug appears to reduce the risk of hospitalization or death by about 50%. One potential hurdle for the drug is whether unvaccinated individuals […]