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 […]
COVID-19
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 […]
Pfizer and BioNTech submit initial data to FDA on its COVID-19 vaccine and younger children
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 […]
Gottlieb: Delta wave could burn out by Thanksgiving
Pfizer board member Dr. Scott Gottlieb has predicted that the COVID-19 Delta surge could mark a high-water mark of the pandemic. “This may be the last major wave of infection,” said Gottlieb, who served as the FDA commissioner from 2017 to 2019. In an interview with CNN, Gottlieb predicted that the pandemic in the U.S. […]
SeaSpine warns of COVID-19 hit to surgical revenue
SeaSpine Holdings (NSDQ:SPNE) is the latest medical device maker warning that the SARS-CoV-2 Delta variant wave is hurting its business. Carlsbad, California–based SeaSpine filed an update for investors with the Securities and Exchange Commission on Sept. 24, citing “ongoing uncertainty regarding the duration and severity of COVID-19 and/or staffing shortages on spine surgery procedure volumes […]