Moderna Inc. has received conditional authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency for its bivalent COVID-19 booster vaccine mRNA-1273.214 (Spikevax bivalent original/omicron). The conditional approval, which covers adults aged 18 years and older, marks a new phase in the ongoing global effort to curb the COVID-19 pandemic, as the new vaccine represents the first commercial product to incorporate omicron-specific epitopes. It contains 25 micrograms each of the spike proteins of the omicron BA.1 variant and the original Wuhan strain of SARS-CoV-2.
Regulatory harmonization of artificial intelligence (AI) and machine learning (ML) is high on the checklist for companies that want to develop these products, but legislatures and regulatory agencies across the globe seem less interested. Koen Cobbaert, senior manager for quality standards and regulation with Royal Philips NV, told BioWorld that there is a race on to be the first market with a full-fledged set of regulations, a fact of life that does little to advance the cause of harmonization.
With drug shortages becoming a fact of life during the pandemic, the U.K.’s Medicines & Healthcare Products Regulatory Agency (MHRA) is issuing two guidances to help ensure access to essential medicines in Great Britain and Northern Ireland, especially during shortages and public health emergencies.
The U.K.’s drugs regulator has approved the COVID-19 vaccine from Valneva SE – although the shot is likely only to be offered to health workers in Scotland after the Westminster government rejected it because rivals beat it to market.
A sense of normalcy is returning to the U.K., at least from a regulatory perspective. The U.K.’s Medicines and Healthcare Products Regulatory Agency will continue to support COVID-19 clinical trials with ongoing regulatory and scientific input, but all further applications and meeting requests for COVID-19 products will be considered according to usual timelines rather than on an emergency basis, the agency said Feb. 23.
The U.S. FDA appears to be on a roll when it comes to rolling out new guidance pertaining to prescription drugs. In recent days, the agency has released draft guidances on antibody-drug conjugates and immunogenicity information in labeling, revised a draft guidance on assessing pressor effects of drugs and finalized a guidance on population pharmacokinetics.
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) unveiled a proposal to overhaul its requirements for clinical trials for drugs and devices, just one of several significant regulatory proposals in recent months. One of the proposed changes would be to require more patient engagement in the design of trials, while another feature would allow sponsors to go through the MHRA process and an ethics review in a single application, thus potentially streamlining the up-front work required for these studies.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled two guidances for the use of real-world evidence (RWE) in regulatory decision-making. The policy seems limited to pharmaceutical clinical trials, with no indication when it will be expanded to include medical technology.
The U.K. is stepping up its response to the Omicron COVID-19 variant after the country’s regulatory agency approved Xevudy (sotrovimab), the antibody therapy from Glaxosmithkline plc and Vir Biotechnology Inc. At the same time the country placed orders for 114 million more doses of COVID-19 vaccines from Pfizer Inc. and Moderna Inc., for use in 2022 and 2023.
Given the negative response to a proposed amendment allowing the price of NHS-dispensed drugs to be listed on labeling, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has decided not to go forward with the policy, it announced Nov. 11.
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