Pharma deals at 41st JP Morgan Healthcare conference
Against a backdrop of challenging circumstances around the globe in 2022, what do the pharma deals announced during the recent [...]
MHRA ramps up assessment capacity for in-vitro diagnostic devices
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended the designation of UL International UK Ltd as an [...]
JP Morgan Healthcare conference research trends in 2023
PMC reviews insights from the 41st JP Morgan Healthcare conference, focusing on some of the new treatments and technologies to [...]
EC adopts proposal to allow more time to certify medical devices
Fears of a shortage of medical devices have led the European Commission (EC) to adopt a proposal to extend the [...]
ICH webinar to update on M11 clinical trial guideline
A free webinar on the M11 Guideline has been organised by the International Council for Harmonisation (ICH) M11 Expert Working [...]
BIA reassured by Chancellor on life science support
The UK BioIndustry Association (BIA) appears to have won a reprieve on proposed cuts to SME R&D tax credits, via [...]
EMA reminder that clinical trials must use CTIS
The European Medicines Agency (EMA) has issued a reminder that from 31 January 2023 clinical trial sponsors must use the [...]
OHE Innovation Policy Prize
The Office of Health Economics (OHE) launched a biennial competition in early 2022 to answer the question ‘How can policymakers [...]
EMA and ECDC collaborate on vaccine safety and effectiveness monitoring studies
The European Medicines Agency (EMA) and European Centre for Disease Prevention and Control (ECDC) held the first meeting of the [...]
UK government commits over £175 million to genomics research
On 13 December 2022 the UK government announced a programme of funding for genomic research, including £105 million for diagnosis [...]
Amgen strengthens rare disease drug portfolio with purchase of Horizon
A deal valued at $27.8 billion has been struck between Amgen and Horizon Therapeutics, wherein Amgen will buy the orphan [...]
ABPI asks UK government to review VPAS as clawback will hit 26.5% of sales revenue in 2023
In 2023 manufacturers of branded medicines will be required to return almost £3.3bn in sales revenue to the government under [...]
Medical affairs outsourcing trends and benefits
What is the outlook for medical affairs up to 2030, and what are the advantages for pharma and biotechs from [...]
UK MHRA updates how to report medical device vigilance
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated the way to report adverse incidents involving medical devices. [...]
European Council backs delay to Medical Devices Regulation (MDR) deadlines
The Regulatory Affairs Professionals Society (RAPS) reports that the European Council supports a proposal made by the European Commission to [...]