news
mRNA COVID-19 vaccines safe for pregnant women, finds EMA review
A review of studies involving 65,000 pregnancies suggests mRNA COVID-19 vaccines do not increase the risk of pregnancy complications.
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Regulation & Legislation
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SAHPRA and USP to increase availability of safe health products in South Africa
SAHPRA and US Pharmacopeia have signed a Memorandum of Understanding to expand access to quality-assured health products in South Africa.
news
Have your say on future UK clinical trial legislation
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on far-reaching proposals to revise the clinical trial legislation in the UK.
![Gilead sign at their headquarters in Silicon Valley, California USA[Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Gilead-2-300x278.jpg)
![Gilead sign at their headquarters in Silicon Valley, California USA[Credit: Michael Vi/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Gilead-2-e1642427117214.jpg)
news
Gilead joins the Association of the British Pharmaceutical Industry
With the Association of the British Pharmaceutical Industry (ABPI), Gilead Sciences will work to tackle health crises and shape international trade and regulation.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, January 2022
The EMA’s pharmacovigilance committee (PRAC) began reviewing terlipressin containing medicines and recommended updates to COVID-19 vaccine safety information.
news
Accelerating Clinical Trials in the EU (ACT EU) initiative launch
The new ACT EU initiative seeks to transform how clinical trials are initiated, designed and run in the European Union.
news
NICE recommends Rinvoq® for adults with active psoriatic arthritis
AbbVie’s Rinvoq® (upadacitinib) will be available on the NHS in England and Wales for adults with active psoriatic arthritis, following NICE approval.
news
Kaftrio® with ivacaftor approved by EC to treat children with cystic fibrosis
Children with cystic fibrosis aged six to11 years could benefit from Kaftrio® in combination with ivacaftor, as a treatment targeting the underlying cause of the disease.
webinar
The path forward — Altasciences’ approach to project management
11 January 2022 | By Altasciences
Discover the opportunities Altasciences' hybrid approach to project management can offer your drug development programme.
news
European Commission approves Lumykras® for lung cancer treatment
Amgen’s Lumykras® (sotorasib) has been approved for adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation.
news
New strategy could improve generic drug quality assessments
Population pharmaceutical quality assessment could be used to improve the quality consistency of generic drugs, suggests study.
whitepaper
Infographic: Solutions for your cleanroom facility
Our customised microbial solutions ensure your cleanroom is compliant and free of contamination to manufacture safe and effective products.
article
Nearly two years on, how are European pharma supply chains coping with COVID-19?
When the pandemic broke out in 2020, pharmaceutical supply chains showed signs of potential failure across the continent. Now, with COVID-19 cases rising once more, and an end to the problem not yet in sight, we discuss with Medicines for Europe how these supply chains are faring, almost two years…
whitepaper
Technical note: System precision in HPLC analysis of APIs and impurities
HPLC users expect robust, reliable systems with equivalent performance and reproducibility between systems that greatly facilitates method transfer.
article
Event review: The Future of QA/QC for Complex Biologics
On 30 November and 1 December 2021, European Pharmaceutical Review hosted its first ever event – The Future of QA/QC for Complex Biologics Online Summit. Bringing together more than 600 attendees, 15 expert speakers and Thermo Fisher Scientific and Merck as sponsors, the summit gave industry experts the chance to…
