The latest global regulatory news, changes and updates affecting medical devices and technologies, including: General Motors, Inbios International, Philips, Ventec Life Systems.
Novavax Inc., one of the first biopharma companies to reveal its efforts to develop a SARS-CoV-2 vaccine in January, has identified a prefusion protein for testing in an Australian phase I trial, slated to start in mid-May.
Keeping you up to date on recent developments in orthopedics, including: Excess weight during pre-school linked to higher bone fracture risk; Cells must age for muscles to regenerate in muscle-degenerating diseases; COVID-19 pandemic may exacerbate childhood obesity.
LONDON – An unseemly row has broken out at the heart of EU science, with Mauro Ferrari, head of the European Research Council (ERC), accusing the European Commission of failing to coordinate and fund R&D needed to combat COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, Aeglea, Aeterna Zentaris, Algernon, Bellerophon, BMS, Nicox, Polaryx and Roche.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Addex, Aivita, Catalyst, Neuclone, Novotech, Obi, Trillium, Viriom.
The U.S. FDA has granted several emergency use authorizations (EUAs) to address the COVID-19 pandemic, a series of actions designed to lower regulatory hurdles. Despite these developments, the agency is keeping a close eye on issues, such as product claims, and both federal and state agencies are in a position to prosecute for hoarding and price gouging.
To better tap into the potential of transcranial magnetic stimulation (TMS), Stanford University researchers developed a high-dose, precision-targeted protocol known as Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT).
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