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Eli Lilly secures MHRA authorisation for Alzheimer’s treatment
Authorisation in Great Britain means eligible Alzheimer's patients can access the treatment, which is part of a new class of amyloid targeting therapies.
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Medicines and Healthcare products Regulatory Agency
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Botanical drugs – what is the best way forward for regulatory and market approval?
Botanical drugs, also known as traditional herbal therapies, have long been used, but obtaining regulatory approval for these medicines, or therapies, is convoluted. Often manufacturers will market their botanical drugs as dietary supplements or traditional therapies, designations that require far less regulatory approval than marketisation as a drug. In this…
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The imperative of fridge-free vaccines
Bruce Roser of Stablepharma gives an overview of efforts to develop thermostable vaccines. Could ‘fridge-free’ formulations improve the cost-effectiveness and accessibility of vaccination?
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Guidance recommending BMS cardiac myosin inhibitor published
NICE’s final guidance recommending Bristol Myers Squibb’s first-in-class obstructive hypertrophic cardiomyopathy (oHCM) drug on the NHS, is now published.
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New preventative medicine for COVID-19 authorised in UK
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reported that Evusheld, developed by AstraZeneca, has been granted approval to help protect against the effects of COVID-19.
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Licence of Esmya (ulipristal acetate) suspended
Esmya (ulipristal acetate)'s licence has been suspended due to the risk of serious liver injury, says the UK government.
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MHRA issues Medicine Defect Information about Aripiprazole
The regulatory body has issued guidance based on a complaint that stated a precipitate formed in Aripiprazole 1mg/ml oral solution.
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Medreich ranitidine tablets recalled due to possible NDMA contamination
Medreich Plc is recalling a number of ranitidine products due to possible contamination with an impurity N-nitrosodimethylamine (NDMA).
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Specific batches of levothyroxine recalled as precautionary measure
Due to a notification of the impurity, liothyronine, exceeding the specification limit, certain batches of levothyroxine 100micrograms/5ml oral solution are being recalled.
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MHRA issues recall of paracetamol tablets
A drug alert has been issued for two batches of paracetamol tablets found to have discolourations due to fungi.
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Three further Losartan batches recalled
The MHRA has recalled three batches of Losartan tablets due to contamination with the nitrosamine N-nitroso-N-methylamino butyric acid...
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Licences for manufacturers and wholesalers of medicines and ingredients
Updated public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended...
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US perspective on the impact of Brexit on the pharmaceutical sector
As the UK prepares to withdraw from the EU on 29th March 2019 at 23:00, this article delivers a US perspective on what Brexit is likely to mean for pharmaceutical companies.
