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

Pharmaceutical Technology

The biobank will work in parallel with the MHRA’s Yellow Card website, which is used for reporting adverse events and side effects caused by medicines and medical devices, per the 25 May announcement. 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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How can evidence-based medicine (EBM) methodology support drug withdrawals?

European Pharmaceutical Review

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Supporting regulators. It focused on data from France, Germany and the UK.

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First FDA pregnancy-approved Pertussis vaccine to protect newborns

European Pharmaceutical Review

Since 2012, the CDC has recommended the vaccine series during the third trimester of each pregnancy. Side effect data related to those given the non-US variation during pregnancy was consistent with data for individuals who were given the non-US formulation post labour.

FDA 105
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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

Medicine 116
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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies. 2012; 18 (6): 21-27. percent for MBK-01 and 4.26 Intern Med J.

Safety 111
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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

Additionally, EURneffy could alleviate the risk of accidental needle-related side effects (such as injection into the blood vessel and hand) 3 and it has the attributes of being smaller in size, has better temperature sensitivity, and is less complex to use compared to needle-based injectors. Hand (N Y). 2007; 2(1):5-11.

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Tributes as former NICE, MHRA chair Sir Mike Rawlins dies

pharmaphorum

” Rawlins was knighted in the 1999 Queen’s New Year Honours for services to the improvement of patient protection from the side effects of medicines, and in 2017 was appointed Knight Grand Cross of the Order of the British Empire (GBE) for services to the safety of medicines, healthcare, and innovation.