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MHRA approves first oral advanced therapy for Crohn’s disease
The MHRA has approved the first marketing authorisation globally for the use of RINVOQ®▼ (upadacitinib) in Crohn's disease.
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Medicine and Healthcare products Regulatory Agency (MHRA)
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New UK point of care manufacturing regulatory framework
A first-of-its-kind regulatory framework for point of care manufacturing of innovative medicines is set to be introduced in the UK, ensuring these products are as safe as conventional medicines.
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UK medical cannabis manufacturer granted GMP registration
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a UK manufacturing facility good manufacturing practice (GMP) registration for its cannabis API.
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MHRA approves biosimilar for vision disorders in Great Britain
A marketing authorization for Ximluci® biosimilar referencing Lucentis® (ranibizumab) in Great Britain has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
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MHRA granted almost £1m to advance digital and data regulation
Almost £1m awarded to MHRA will advance projects to innovate AI and microbiome regulation and develop synthetic clinical trial data.
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Global Blood Therapeutics: driving innovation in sickle cell disease
Sebastian Stachowiak, Head of Europe & GCC at Global Blood Therapeutics (GBT), explains how, while the company establishes its presence in Europe, it continues its commitment to advance the care of people living with sickle cell disease by collaborating with the sickle cell community to develop breakthrough therapies, raise awareness…
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MHRA approves Xevudy (sotrovimab) to treat COVID-19
The Medicines and Healthcare products Regulatory Agency (MHRA) approve sotrovimab for people with mild to moderate COVID-19 infection and at least one risk factor for developing severe illness.
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Metformin oral solution recalled due to nitrosamine impurity
A Class 2 recall notice for one batch of Rosemont Pharmaceuticals metformin hydrochloride 500mg/5ml oral solution has been issued by the MHRA.
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MHRA approve first monoclonal antibody treatment for COVID-19
The MHRA have approved Ronapreve as the first monoclonal antibody combination product for the treatment of COVID-19 infection in the UK.
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MHRA approves COVID-19 Vaccine Moderna in 12-17-year olds
The MHRA has approved the use of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) in children aged 12-17 years old.
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Class 4 Medicines Defect: missing safety information in some Perindopril products
The MHRA reports that certain packs of Perindopril products are missing important safety information, the products are not being recalled.
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UK to establish human challenge studies for COVID-19 vaccines
The UK government hopes to expedite the development of a COVID-19 vaccine by investing £33.6 million in the first phase of establishing human challenge trials.
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Paracetamol tablets recalled due to potential fungal contamination
Specific batches of paracetamol tablets are being recalled as some pots have been found to contain discoloured tablets due to fungal contamination.
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MHRA updates biologic quality guidance document
The UK Medicine and Healthcare products Regulatory Agency has released a revision to its standards for ensuring high quality of biologic products.
