LONDON – The COVAX initiative, set up in a bid to ensure equitable distribution of COVID-19 vaccines, is poised for a global rollout starting in Q1 2021, after sealing agreements to access 2 billion doses of a number of different products. That puts the world on a clear pathway to ending the acute phase of the pandemic, by protecting the most vulnerable people around the world, according to GAVI, the vaccines alliance, which is spearheading COVAX.
PERTH, Australia – Researchers at the QIMR Berghofer Medical Research Institute in Queensland have developed a way of testing whether COVID-19 patients’ immune systems are gearing up to fight the virus that causes the disease.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cerenion, Ecolab, Integrum, Occlutech.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M Littmann Stethoscopes, Assure Tech, Aurora Spine, Bc Platforms, Beckman Coulter, Biosig Technologies, Bruker, Cerus Endovascular, Emurmur, Fulgent Genetics, Htg Molecular Diagnostics, Ingenion Medical, Inivata, Johnson & Johnson, Medsential, Misonix, Natera, Oncimmune, Paxman Coolers, Physiomics, Pra Health Sciences, Pwnhealth, Research Instruments, Roche, Tabula Rasa Healthcare.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: EPA posts ethylene oxide rule on OMB agenda; HHS announces sustained support for testing; FTC gives nod to Stryker/Wright deal.
Keeping you up to date on recent developments in neurology, including: Research suggests SARS-CoV-2 enters the brain; Technique developed to predict seizures; Machine intelligence improves brain mapping research; Hearing, blood sugar linked to cognitive function among older Latinos.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Antegene, Astrazeneca, Canbridge, Karyopharm, Novaremed, Novo Nordisk, Oyster Point, Polaryx, Synairgen.
As expected, the FDA's Vaccines and Related Biological Products Advisory Committee voted near-unanimously on Dec. 17, with one abstention, that available evidence shows the benefits of Moderna Inc.'s COVID-19 vaccine, mRNA-1273, outweigh its risks for people 18 and older. The vote bolsters the likelihood that the regulator will grant the vaccine an emergency use authorization (EUA), which could come as soon as Friday. Not the same as an approval, the authorization would allow for the vaccine's use for the prevention of COVID-19 in the U.S. even as further trials and regulatory evaluation remains underway ahead of a company BLA submission.
RSS
