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Benefits of AZ vaccine outweigh risks, says MHRA pharmatimes
April 08, 2021
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that there is a possible link between AstraZeneca's COVID-19 vaccine and “extremely rare, unlikely to occur blood clots”.
MHRA authorises Lilly’s RET inhibitor Retsevmo pharmatimes
March 11, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Eli Lilly’s Retsevmo a conditional marketing authorisation for the treatment of RET fusion-positive advanced lung cancer and thyroid cancer.
MHRA green light for DemeRx’s opioid use disorder trial pharmatimes
March 11, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the launch of a Phase I/IIa trial of DemeRx and atai Life Sciences’ ibogaine HCl (DMX-1002) for the treatment of opioid use disorder (OUD).
Modified COVID-19 vaccines can avoid ‘lengthy’ clinical studies, says MHRA pharmatimes
March 05, 2021
Updated COVID-19 vaccines that are modified in response to new variants will not require a brand new approval or ‘lengthy’ clinical studies to receive authorisation, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
Will fast-track vaccines for coronavirus variants: UK MHRA expresspharma
March 05, 2021
The accelerated process is based on that used for seasonal flu vaccines each year, said MHRA.
UK grants marketing authorisation to “landmark” breast cancer therapy europeanpharmaceuticalreview
February 23, 2021
Seagen’s Tukysa® (tucatinib) was approved in the UK as part of a combination regimen for the treatment of adults with locally advanced or metastatic HER2-positive breast cancer.
Novel chemotherapeutic pro-drug approved for FIH trial in the UK europeanpharmaceuticalreview
February 20, 2021
If the proof-of concept trial of AVA6000 Pro-doxorubicin is successful, it could lead to a pipeline of pro-drug chemotherapies with limited toxicity, say the drug’s developers.
MHRA launches public consultation on reclassification of two contraceptive pills pharmatimes
February 19, 2021
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on the potential reclassification of two progestogen-only contraceptive pills containing desogestrel.
Patients gain early access to Pfizer's atopic dermatitis drug pharmatimes
February 04, 2021
People living in the UK with severe atopic dermatitis are to be given early access to Pfizer's abrocitinib following a green light by the Medicines and Healthcare products Regulatory Agency (MHRA).
Sanofi’s RSV treatment nirsevimab awarded PIM pharmatimes
January 22, 2021
Sanofi’s nirsevimab has been awarded a Promising Innovative Medicine (PIM) designation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for the prevention of respiratory syncytial virus (RSV) associated lower respiratory ...

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