In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears. In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer. No placebo recipients developed the condition. Get the full story from Drug […]
COVID-19
FDA analysis finds J&J’s single-done COVID-19 vaccine is safe, effective
An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA […]
Medtronic rises on Street-beating Q3
Medtronic (NYSE:MDT) shares ticked up when the market opened today on third-quarter results that topped the consensus forecast. The Fridley, Minn.-based medtech giant posted profits of $1.3 billion, or 94¢ per share, on sales of $7.8 billion for the three months ended Jan. 29, 2021, for a -33.4% bottom-line slide on sales growth of 0.8%. Adjusted […]
FDA issues guidelines to address COVID-19 variants
The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19. Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing […]
BD, Scanwell Health collaborating on smartphone-enabled, home COVID-19 rapid test
Becton Dickinson (NYSE:BDX) announced today that it is collaborating with Scanwell Health to create an at-home rapid COVID-19 test. Scanwell Health, a developer of smartphone-enabled at-home medical tests, will offer its mobile app to pair with a BD antigen test for SARS-CoV-2, the virus causing COVID-19, according to a news release. As part of the collaboration, […]
MedTech 100 roundup: Slight dip after all-time best for industry
The medtech industry’s stocks rose higher than they ever had to begin last week before eventually dropping to a slightly more normal level. MassDevice‘s MedTech 100 index ended the week (Feb. 19) at 108.72 points, marking a -1.7% dip from the 110.63-point mark set at the end of the previous week (Feb. 12). On Monday (Feb. […]
Pfizer vaccine stable at standard freezer temps, effective with single dose
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80° C and –60° C, according to current CDC guidelines. Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would […]
Biden announces $4B to support global vaccinations worldwide
President Joe Biden announced that the U.S. is set to provide $4 billion to the COVAX Facility to support access to safe and effective COVID-19 vaccines. Money appropriated by a December 2020 Congressional vote will comprise an initial $2 billion contribution to Gavi, the Vaccine Alliance for the COVAX advance market commitment (AMC) covering 92 […]
J&J submits EUL application to WHO for single-shot COVID-19 vaccine
Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which […]
EU and US take steps to battle coronavirus mutations
The EU recently added clauses to COVID-19 vaccine contracts to prioritize vaccines that are effective against emerging SARS-CoV-2 variants. Meanwhile, a U.S. House bill that would provide $1.75 billion for genomic sequencing of coronavirus samples is scheduled for floor debate and the Senate is considering similar legislation. The UK variant (B.1.1.7) that is spreading across […]
This vocal biomarker software can screen for COVID-19
Startup Vocalis Health today announced that its artificial intelligence-aided screening tool, VocalisCheck, screening tool, VocalisCheck, has obtained a CE mark for screening for COVID-19. VocalisCheck is designed as a screening tool that can deliver a reliable risk score to guide people who may need diagnostic testing for the coronavirus. A smartphone or other device using […]
