NICE nod for Takeda’s Adcetris in advanced stage CTCL

UK – NICE nod for Takeda’s Adcetris in advanced stage CTCL

The indication is for treating adult patients with CD-30 positive advanced versions of the disease, after at least one prior systemic therapy. The approval...
EMA Management Board: highlights of March 2019 meeting

Europe – EMA Management Board: highlights of March 2019 meeting

EMA’s Management Board has re-elected Christa Wirthumer-Hoche as its chair for a three-year mandate. Dr Wirthumer-Hoche is Head of the Austrian Medicines and Medical Devices Agency,...
New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

With a little more than a week left before the UK could depart from the EU without a deal, the UK’s Medicines and Healthcare...
A Right Royal Deadlock: Can "Crown" use unlock patented drug?

UK – A Right Royal Deadlock: Can « Crown » use unlock patented drug?

Following a two year deadlock between the NHS and Vertex Pharmaceuticals, the NHS, in July 2018, offered to make the 'largest ever' financial commitment...
EMA Management Board: highlights of March 2019 meeting

Europe – ICH M10 on bioanalytical method validation

This guideline is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the...
New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

UK – Completed Paediatric Studies – submission, processing and assessment in the event of...

The UK is leaving the EU on 29 March 2019. Securing a deal remains the Government’s top priority. This has not changed. However, the government must...
MHRA Guidance on a No-Deal Brexit

UK – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master...

Leaving the EU with a deal remains the government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no...
NICE u-turn backs use of Darzalex combo for myeloma relapse

UK – NICE u-turn backs use of Darzalex combo for myeloma relapse

The National Institute for Health and Care Excellence is now backing NHS use of Janssen’s Darzalex plus Velcade and dexamethasone (DVd) after first relapse...
UK’s MHRA Offers 6 New No-Deal Brexit Guidances on Importing, Exporting Medicines

UK – UK’s MHRA Offers 6 New No-Deal Brexit Guidances on Importing, Exporting Medicines

With the possibility of a no-deal Brexit still looming, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday released six new guidance...
EMA Management Board: highlights of March 2019 meeting

Europe – EMA now operating from Amsterdam

As of today, EMA is operating from Amsterdam. EMA left its London premises on 1 March, and following a transitional week of teleworking, its...

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