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UK agency pilots biobank to study links between genetics and drug side effects

Pharmaceutical Technology

The Medicines and Healthcare products Regulatory Agency (MHRA) aims to launch a pilot genetic biobank that will gather patient data to associate drug-related adverse events to their genetic makeup. According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank.

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UK approves Moderna’s bivalent COVID-19 vaccine

European Pharmaceutical Review

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s COVID-19 vaccine, Spikevax, that targets two coronavirus variants as a booster. The regulator confirmed that the vaccine meets its standards of safety, quality and effectiveness.

Safety 105
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First CRISPR-based gene-editing therapy authorised

European Pharmaceutical Review

It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia. Side effects from treatment were similar to those associated with autologous stem cell transplants.

Safety 114
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MHRA approves first gene therapy for infusion into the brain

European Pharmaceutical Review

It has been granted marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. The most common side effects observed were initial insomnia, irritability and dyskinesia. The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over.

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How Artificial Intelligence Could Be the Ultimate Weapon Against Cancer

MedCity News

Artificial intelligence (AI) is rapidly transforming the healthcare industry, with its ability to process and analyze vast amounts of data. However, not all patients respond well to immunotherapy and it can have significant side effects. Even just a year ago, we couldn’t fathom a cure for cancer. Now, we can.

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Pfizer bivalent COVID-19 vaccine starts rollout

pharmaphorum

The decision follows approval by the Medicines and Healthcare products Regulatory Agency (MHRA) last Saturday, which gave the green light for use of the new vaccine in those aged 12 years and above. Data from a clinical trial found side effects to typically be mild and self-resolving and to be no worse than the original booster dose.

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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. In addition, no serious safety concerns linked to the vaccine were observed.