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Contraceptive mini pill to be made available over the counter in the UK
pharmaceutical-technology
July 12, 2021
The contraceptive pill will be available to buy over the counter at UK pharmacies for the first time after a landmark ruling from the Medicines and Healthcare products Regulatory Agency (MHRA).
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MHRA and Health Canada release new clinical safety reporting guidance
europeanpharmaceuticalreview
July 08, 2021
Under the new guidance, Development Safety Update Reports must include a description of the process used to review the worldwide safety data of the investigational drug.
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MHRA authorises Diurnal’s CAH therapy Efmody
pharmatimes
July 02, 2021
Speciality pharma company Diurnal announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Efmody a marketing authorisation in Great Britain.
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bluebird bio’s sickle cell gene therapy granted MHRA ‘innovation passport’
pharmatimes
July 01, 2021
bluebird bio’s gene therapy for sickle cell disease LentiGlobin has been granted an ‘innovation passport’ from the UK Medicines and Healthcare products Regulatory Agency (MHRA).
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MHRA approves Paion’s ‘ultra-short-acting’ anaesthetic Byfavo
pharmatimes
July 01, 2021
Paion’s ‘ultra-short-acting’ anaesthetic Byfavo has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for use in procedural sedation.
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Ontozry scores MHRA authorisation for focal-onset seizures
pharmatimes
June 18, 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Arvelle Therapeutics’ Ontozry a marketing authorisation (MA) for the adjunctive treatment of focal-onset seizures, with or without secondary generalisation.
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Amicus' Pompe disease therapy joins early access scheme
pharmatimes
June 10, 2021
Patients with late-stage Pompe disease who are failing to respond to enzyme replacement therapy will now have early access to an alternative treatment option, after Amicus Therapeutics' cipaglucosidase alfa with miglustat was approved for the UK's ...
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£3m worth of illegally sold meds and devices seized in UK
pharmatimes
June 10, 2021
UK officers have seized more than 3 million medicines and medical devices valued at over £9 million as part of a global operation tackling the illegal online sale of medicines and medical devices.
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MHRA authorises Pfizer/BioNTech’s COVID-19 vaccine for 12- to 15-year-olds
pharmatimes
June 08, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has extended the authorisation of Pfizer/BioNTech’s COVID-19 vaccine for use in children aged 12 to 15 years old.
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Onyx Scientific Receives Commercial API License for UK Facility
contractpharma
June 04, 2021
Onyx Scientific, a small molecule API contract development and manufacturing organization (CDMO) has received a commercial API license for its UK facility.