Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Alpha Healthcare, Anatomage, Baylis, Bioaesthetics, Biosyent, Boston Scientific, Elekta, Healthcare Services Group, Helius Medical Technologies, Humacyte, ID Genomics, Iotron Medical Meadowlands Diagnostics, Osteoid, Photocure, Provista Diagnostics.
Johnson & Johnson has announced new data supporting use of its COVID-19 vaccine as a booster shot, after separate trial data from the U.K. showed effects of several vaccines waned after six months.
As many lower and middle-income countries continue to scramble for COVID-19 vaccine doses, which are largely being manufactured in Europe and the U.S., their own regulatory rules may be getting in the way in some instances.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beeline, Cynergi Health Partners, Lightpoint Medical, Neupath Health, Opum, Provista Diagnostics, Thuasne Group, Todos Medical, Veon.
Cadila Healthcare Ltd. (also known as Zydus Cadila) has received emergency use authorization (EUA) in India for Zycov-D, making it the world’s first plasmid DNA vaccine for COVID-19. Besides the adult population, the Drug Controller General of India’s nod has also given the South Asian country its first COVID-19 vaccine for adolescents ages 12 to 18.
The FDA has granted full approval to Pfizer Inc.’s COVID-19 vaccine in a move that is hoped will convince unvaccinated citizens that the shot is safe and effective. The mRNA vaccine, which will be branded as Comirnaty and was first developed by Germany’s Biontech SE, has been available since Dec. 11 last year under an emergency use authorization (EUA) and is the first to receive the FDA’s full endorsement.
The FDA’s pre-IND response to Virpax Pharmaceuticals Inc.’s MMS-019, a molecular masking spray being developed as an over-the-counter product to limit transmission of SARS and influenza, has the company breathing easier and ready to chase an NDA. Virpax is in a crowded field of 43 COVID-19 intranasal therapeutics and vaccine programs.
The FDA’s emergency use authorization (EUA) program is still active in the area of tests and test kits, which is due in part by the emergence of the Delta variant of the SARS-CoV-2 virus and the associated warnings that the effectiveness of vaccines may be declining. One example of the sustained emphasis on testing is the EUA granted to Thermo Fisher Scientific Inc. for two PCR test kits that can detect the latest variants of the virus, a demonstration that the demand for these updated tests seems unlikely to ebb anytime soon.
Plans for offering COVID-19 vaccine booster shots in the U.S. took a big step forward Aug. 18, as Health and Human Services (HHS) public health and medical experts laid out their intention to offer booster shots across the country for people 18 and older beginning the week of Sept. 20 and starting eight months after an individual's second dose.
LONDON – Researchers at Birmingham University are looking for commercialization partners after finding a happy medium between the speed but limited accuracy of COVID-19 lateral flow antigen tests, and the use of slower but more accurate PCR and other RNA amplification diagnostics.
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