Abbott (NYSE:ABT) announced that it received FDA emergency use authorization (EUA) for over-the-counter use of its BinaxNOW COVID-19 test. The new indication for the diagnostic allows individuals with or without symptoms to access the BinaxNOW COVID-19 Ag self-test over the counter, without a prescription. The company plans to begin shipping to major food, drug and […]
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FDA approves inhaled pulmonary hypertension treatment from United Therapeutics
United Therapeutics (NSDQ:UTHR) announced today that it received FDA approval for its Tyvaso inhalation solution for pulmonary hypertension. Research Triangle Park, N.C.–based United Therapeutics’ Tyvaso (treprostinil) inhalation solution is designed to treat patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability, according to a news release. Get the full story […]
Factory error ruins 15M J&J COVID-19 vaccine doses
Employees at an Emergent BioSolutions facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded. A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did not meet quality standards,” […]
Merit Medical must face shareholder lawsuit
A federal judge in California quashed a bid by Merit Medical to dismiss a lawsuit alleging misrepresentation of success to stockholders. The consolidated class action complaint states two claims for securities fraud, alleging that Merit CEO Fred P. Lampropoulos and CFO Raul Parra, plus the company itself, made multiple misrepresentations to investors that resulted in […]
Pfizer, BioNTech report COVID-19 vaccine works well among adolescents
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that their COVID-19 vaccine produced 100% efficacy among adolescents. In adolescents aged 12 to 15 years old with or without prior evidence of SARS-CoV-2 infection, the BNT162b2 vaccine demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants between 16 and 25. The vaccine […]
Trump advisor urged PPE push, drug scale-up early in pandemic
A top advisor to former President Donald Trump urged his pandemic response team in February 2020 to respond swiftly to the spread of COVID-19, but told Trump that his recommendations had been largely ignored. Then-assistant to the president Peter Navarro wrote an impassioned memo to Trump on March 1, 2020, recommending that the federal government boost […]
Zimmer Biomet launches new suite of digital and robotic technologies
Zimmer Biomet (NYSE:ZBH) announced today that it launched the ZBEdge connected intelligence suite of digital and robotic technologies. Warsaw, Ind.–based Zimmer Biomet’s ZBEdge technologies, both currently available and soon to be launched, include the Rosa robotic surgery platform, anatomical visualization and guidance systems such as the Signature One, the iAssist knee alignment system, and optical […]
3M, others may have unmasked a solution to future N95 shortages
A handful of companies including 3M are working to ensure that a scramble for disposable masks never happens again. The face of the next pandemic could be very different than that of COVID-19, thanks to a handful of companies that have redesigned reusable industrial face masks to better protect healthcare workers and help prevent mask […]
4 innovative devices delivered through catheters
Physicians use catheters to deploy numerous life-saving devices across the healthcare realm, from cardiovascular to neurovascular. They typically insert the thin, flexible tubes in a process called catheterization to deploy devices such as left ventricular assist devices (LVADs), transcatheter aortic valve replacements (TAVRs) and occluders to stop bleeding. The catheter industry is regularly innovating to […]
FDA clears point-of-care STI test
The FDA announced today that it authorized the Binx Health IO CT/NG assay at point-of-care settings to diagnose STIs. Point-of-care settings include physician offices, community-based clinics, urgent care settings, outpatient healthcare facilities and other patient care settings operating under a CLIA certificate of waiver, certificate of compliance or certificate of accreditation, according to a news […]
Medtronic veteran Brooke Story to lead BD’s Integrated Diagnostic Solutions
Another Medtronic veteran is leaving the company to take on new challenges elsewhere, and this time it involves BD. Brooke Story will become worldwide president of BD Integrated Diagnostic Solutions, effective April 5. Story has been at Medtronic for 15 years, most recently serving as president of Pelvic Health and Gastric Therapies at the medtech […]