UK medicines regulator gives approval for first UK COVID-19 vaccine

UK medicines regulator gives approval for first UK COVID-19 vaccine. The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. A dedicated team of MHRA scientists and clinicians carried out a rigorous, scientific and detailed [...]

Regulator formally asked to assess Oxford University and AstraZeneca vaccine

Regulator formally asked to assess Oxford University and AstraZeneca vaccine. A coronavirus vaccine rollout in the UK could be a step closer after the regulator was formally asked by the Government to assess the Oxford University and AstraZeneca jab. The move “marks a significant first step in getting the vaccine approved for deployment” if it meets safety, efficacy and quality standards, the Department of Health and Social Care (DHSC) said. It comes a week after the Medicines and Healthcare products Regulatory Agency [...]

Medical technology gives healthcare a shot in the arm

Medical technology gives healthcare a shot in the arm Doctors have been spurred by Covid-19 to experiment with tech but it is not a cure-all Tony Young: ‘technology is empowering our patients and our professionals’ Please use the sharing tools found via the share button at the top or side of articles. Copying articles to share with others is a breach of FT.comT&Cs and Copyright Policy. Email licensing@ft.comto buy additional rights. Subscribers may share up to 10 or 20 articles per month [...]

WHO advises against Gilead’s remdesivir for all hospitalised COVID-19 patients

WHO advises against Gilead's remdesivir for all hospitalised COVID-19 patients     LONDON (Reuters) - Gilead's drug remdesivir is not recommended for patients hospitalised with COVID-19, regardless of how ill they are, as there is no evidence it improves survival or reduces the need for ventilation, a World Health Organization panel said on Friday. "The ... panel found a lack of evidence that remdesivir improved outcomes that matter to patients such as reduced mortality, need for mechanical ventilation, time to clinical improvement, and [...]

COVID-19: Pfizer-BioNTech vaccine now 95% effective and will be submitted for authorisation ‘within days’

COVID-19: Pfizer-BioNTech vaccine now 95% effective and will be submitted for authorisation 'within days'   The Pfizer-BioNTech vaccine has now proved 95% effective in preventing coronavirus and has met the safety criteria needed for emergency authorisation, the firms have said. Pfizer and BioNTech say they plan to submit the COVID-19 vaccine to the US regulator for emergency use approval "within days" after "no serious safety concerns" were reported. The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is also poised to fast-track authorisation [...]