Tag: MHRA

MHRA approves Moderna COVID-19 shot for 12 to 17-year-olds

Frank

UK – The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Moderna’s COVID-19 vaccine for use in children aged 12 to 17 years, weeks after the Pfizer shot was given a greenlight for deployment in this age set. The UK’s health regulator has confirmed the vaccine, known as Spikevax, is safe and effective in this age group, the statement read.  While most children develop mild or no symptoms with COVID-19, they are still able to spread the virus and some remain at risk of becoming seriously ill. Moderna’s vaccine…

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UK medicines and healthcare products regulatory agency approves over-the-counter contraceptive pill

Frank

UK – The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a reclassification of HRA Pharma’s contraceptive pill, making it available to buy in the UK without a prescription. Following the reclassification authorization, the progestogen only pill containing 75 micrograms desogestrel will be available for women in the UK to purchase over the counter after a pharmacy consultation. HRA Pharma said it is also working with the US Food and Drug Administration (FDA) for a similar switch and would become the first non-prescriptive contraceptive drug to be used…

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USD 3.6 million worth of illegally sold medicines and devices seized in UK as part of global crackdown

Frank

UK – Over 3 million medicines and medical devices valued at over £9 million have been seized by UK officers as part of a global operation tackling the illegal online sale of medicines and medical devices. In the UK, 113,000 illegally operating websites were also removed or had their URLs blocked. Eight search warrants were executed, with 7 criminals arrested. Under Operation Pangea, over 100 countries joined forces to seize non-compliant medical products and also to identify and remove thousands of illegally operating websites and URLs offering medicines and devices.…

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Biosphere tenant Iksuda Therapeutics raises $47m to reinforce Antibody Drug Conjugate pipeline

Frank

UK – UK-headquartered Iksuda Therapeutics has announced the closing of a $47m (£34m) financing round, with the funds to be used to support the advancement of its lead antibody drug conjugate (ADC) assets. This includes the company’s lead pre-clinical ADC candidate IKS03, a potentially ‘best-in-class’ CD19-targeted asset for B-cell cancers. Iksuda will use the funds to support the progression of IKS03 into first-in-human Phase clinical trials, and will also be used to fast-track its earlier-stage programs. Currently, the company’s drug development pipeline is focused on the improved safety and efficacy…

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