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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UK Medicines and Healthcare products Regulatory Agency (MHRA)
New guidance on the licensing of biosimilar products that reduces unnecessary clinical trials is expected to put the UK ahead of Europe and facilitate a boom in these essential life-saving medicines, creating greater patient access and saving the National Health Service (NHS) hundreds of millions of pounds. It could also…
In this article, Aman Khera, the Global Head of Regulatory Strategy for Worldwide Clinical Trials, makes a case for regulatory involvement in drug development from start to finish and explains how the role of the regulator is changing, as well as what this means for pharma.
EU and UK regulators have approved Adtralza (tralokinumab), a monoclonal antibody, for treating moderate-to-severe atopic dermatitis in adult patients.
In this article, EPR summarises the list of 10 recommendations for the UK Government, published by experts in the medicinal cannabis industry, to ensure the UK capitalises on the opportunities afforded by the market.
The importance of analytical balances in laboratory operations demands that they be fit for purpose over the operating range and acceptance criteria specified in the laboratory user requirements specification. In this article, Bob McDowall, Director of R D McDowall Limited, discusses the regulatory requirements for analytical balances operating in GMP…
Novavax has agreed to participate in the University of Oxford’s Com-COV2 study evaluating the safety and efficacy of regimens consisting of doses of COVID-19 vaccines from different manufacturers.
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.