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Nirsevimab gets Promising Innovative Medicine Designation from MHRA
expresspharma
January 19, 2021
Nirsevimab is an innovative monoclonal antibody in Phase 2 and Phase 3 trials for the prevention of respiratory syncytial virus (RSV) infections in healthy late preterm, term and high-risk infants.
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Diurnal seeks marketing authorisation for Chronocort in the UK
pharmatimes
January 14, 2021
UK speciality pharma Diurnal has submitted a marketing authorisation application for Chronocort (modified-release hydrocortisone) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for patients with the rare condition congenital ...
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MHRA review recommends discussion around epilepsy medication and pregnancy
pharmatimes
January 11, 2021
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has urged women receiving epilepsy medication to discuss their treatment options if they may be pregnant or are planning to become pregnant in the future.
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NICE collaboration creates new route for medicines approval
pharmatimes
January 06, 2021
A collaboration between the UK's National Institute for Health and Care Excellence (NICE), drug regulators, the NHS and equivalent organisation in Scotland has opened a new route for medicine approval in the UK.
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UK approves AstraZeneca’s Covid-19 vaccine for emergency use
pharmaceutical-technology
January 04, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorisation for emergency supply to AstraZeneca’s Covid-19 vaccine in the country.
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UK MHRA approves Oxford/AstraZeneca COVID-19 vaccine
expresspharma
December 31, 2020
Britain has ordered 100 million doses of the jab, with 40 million expected to be available by the end of March.
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MHRA approves Polyphor’s phase 1 trial of novel inhaled antibiotic
pharmatimes
December 23, 2020
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Swiss biotech Polyphor’s first-in-human phase I study of its novel inhaled antibiotic murepavadin.
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Oxford/AstraZeneca vaccine likely to get approval by year-end in UK
expresspharma
December 21, 2020
AstraZeneca has said a further 15 million doses of active ingredients are ready and can be filled into vials in a matter of days.
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Class 4 Medicines Defect: missing safety information in some Perindopril products
europeanpharmaceuticalreview
December 17, 2020
The MHRA reports that certain packs of Perindopril products are missing important safety information, the products are not being recalled.
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MHRA issues anaphylaxis warning for Pfizer BioNTech vaccine
expresspharma
December 10, 2020
The Medicines and Healthcare Products Regulatory Agency (MHRA), Britain’s drug regulator said anyone with a history of anaphylaxis to medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving fuller guidance on an earlier allergy ...