It was a busy week for the U.K.’s drugs regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA), which fast tracked decisions on novel drugs for cancer and eczema and made a ruling on booster COVID-19 jabs from Astrazeneca plc and Pfizer Inc. But even as Prime Minister Boris Johnson tweeted his support over the approval of Amgen Inc.’s cancer drug Lumykras, there are questions over the future of the regulator as it faces a round of job cuts because of a lack of funding following Brexit.
Astrazeneca plc, en route to potentially delivering a new protection against COVID-19 for people inadequately protected by or unable to be vaccinated, has cleared a crucial hurdle with its long-acting combination therapy, AZD-7442, which met the goals of a phase III pre-exposure prophylaxis trial. The U.K.-based pharma’s readout arrived just as Regeneron Pharmaceuticals Inc. announced the MHRA’s conditional marketing authorization for its Roche Holding AG-partnered COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), also known as REGEN-COV.
PERTH, Australia – Starpharma Holdings Ltd. is pausing sales of its antiviral nasal spray, Viraleze (SPL-7013), in the U.K. after its retail partner, Lloydspharmacy, received a letter from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) related to promotional claims made about the antiviral with respect to SARS-CoV-2 and COVID-19.
Building on existing guidance and nearly eight years’ experience with biosimilar monoclonal antibodies and fusion proteins, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a final guidance detailing a streamlined approach to licensing biosimilars.
LONDON – The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) stood by its view that the benefits of Astrazeneca plc’s COVID-19 vaccine “continue to outweigh the risks,” as it published the latest summary of reported adverse events.
In a Feb. 17 update to its guidance on managing clinical trials during the COVID-19 pandemic, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) said all sponsors of ongoing clinical trials for indications other than treatment or prevention of COVID-19 are required to evaluate the impact a COVID-19 vaccine may have on the trial.
LONDON – The COVID-19 vaccine developed by Astrazeneca plc and Oxford University has been approved by the U.K regulator, with the first doses being shipped on Dec. 30 and a mass vaccination program due to begin on Jan. 4. AZD-1222, now named COVID-19 Vaccine Astrazeneca, is authorized for emergency use and will require two doses for durable effect.
LONDON – The first 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine are due to arrive in the U.K. over the next few days, after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration now expected to start on Monday, Dec. 7.
LONDON – An independent U.K. inquiry has found that failure to take seriously concerns raised by patients has resulted in life-threatening problems caused by medical devices and drugs being ignored for decades.
The industry is again preparing for a no-deal Brexit, as political shifts indicate that the U.K. crashing out of the EU on Oct. 31 is an increasingly likely outcome.
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