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Several countries have temporarily stopped the use of the vaccine while reports of blood clots are investigated by the EMA’s pharmacovigilance committee and other authorities.
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.
As the UK enters new territory following its departure from the EU, legal experts Marie Manley and Chris Boyle from Sidley Austin explore the resultant consequences for biopharma companies and the regulatory opportunities that lie ahead.
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.
The UK has conditionally approved Enhertu® (trastuzumab deruxtecan) as a monotherapy for the treatment of unresectable or metastatic HER2 positive breast cancer based on Phase II trial results.
The approval makes Ogluo™ Europe’s first ready-to-use liquid glucagon for rescuing diabetic patients from severe hypoglycaemic events.
In this article, we investigate three of the latest developments in COVID-19 therapeutics that are delivered intranasally.
Sarah Ellson from Fieldfisher spoke with European Pharmaceutical Review to discuss the position of medicinal cannabis in the UK and the impacts of Brexit.
The MHRA has given the green light to the Moderna COVID-19 vaccine for use in the UK, making it the third to be approved in the country.
Brian Pinker was the first person to receive AZD1222, the COVID-19 vaccine developed by the University of Oxford and AstraZeneca, this morning.
Following reports of the Pfizer/BioNTech COVID-19 vaccine causing anaphylaxis, the MHRA has said those prone to allergic reaction should not receive the jab.
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
The UK's MHRA has given temporary emergency authorisation to Pfizer and BioNTech's COVID-19 vaccine, making it the first in the world to receive approval.
Both the UK and US have said that, if approved, the Pfizer and BioNTech COVID-19 vaccine could be administered to people as early as December.
By joining the Access Consortium, the MHRA will work together with agencies from Australia, Canada, Singapore and Switzerland to expedite therapeutic product approvals.
