The latest global regulatory news, changes and updates affecting biopharma, including: Australia eases substitution requirements; Guidance details fast-tracking modified vaccines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kronos, Nervgen, Nicox, Novadip, Ocumension, Pfizer, RDIF, Regeneron, Sanofi.
LONDON – The SARS-CoV-2 variant of concern that caused a wave of infection in Manaus, Brazil, in December and January has been found to be both more transmissible and to evade immunity conferred by prior natural infection with the virus. A combined Brazil/U.K. genome sequencing and epidemiological study found the variant, called P.1., is between 1.4 and 2.2 times more transmissible than earlier lineages, and can evade 25% to 61% of the protective immunity elicited by previous infection.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO reviews FEMA's pandemic supply chain management efforts; Testing lab owner sentenced to three years; Health Canada renews interim order for importation of devices; FDA: claims of registration certificates may be misleading; MDCG issues gap guidance pending Eudamed completion; FDA seeking nominations for advisory committee.
As the World Trade Organization (WTO) debate intensified this week over a demand to waive patent protections for COVID-19 vaccines and therapies, the group’s new director-general, Ngozi Okonjo-Iweala, urged members to “walk and chew gum” at the same time by working with “companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know-how and technology transfer now.”
According to an analysis conducted by BioWorld of the 2020 financial reports filed by public biopharmaceutical companies with market caps greater than $1 billion, and excluding big pharma companies, the amount that was invested in research and development (R&D) during the year increased by 23% compared to the same period last year.
LONDON – A further U.K. real-world study of COVID-19 vaccines has found a single dose dramatically reduces the chances of the most elderly and frail being admitted to the hospital as a result of serious infection.
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