news
US pauses administration of Janssen COVID-19 Vaccine
The FDA and CDC have decided to temporarily suspend use of Janssen’s single dose vaccine while reports of rare and severe blood clots are investigated.
List view / Grid view
Regs & Legs
Filter the results
webinar
Quality Risk Management tools to improve data integrity in Micro QC
12 April 2021 | By Charles River Laboratories
Join us on 1 June at 15:00 BST, as Jordi Iglesias visually summarise the ICH Q9 Quality risk management GMP document and explain how you can use the approach and tools described to proactively improve your microbiological QC assays in terms of data integrity.
news
Global Pharmacovigilance Observatory to aid pharma’s understanding of regulatory decisions
The observatory will collate drug safety data, analyses and decisions into a single source to help pharma identify regional differences in decision-making.
article
The big debate. Beyond the data and document distinction: how to transform life sciences experiences via improved information flow
The life sciences industry may have been slower than other markets to appreciate the benefits of holistic data and document management, but that is changing rapidly now. Here, life sciences data and content management visionaries Steve Gens of Gens & Associates, Remco Munnik of Iperion and James Kelleher of Generis…
news
EC approves Cabometyx® and Opdivo® combination for advanced renal cell carcinoma
The combination was approved on Phase III trial results which show it doubled progression-free survival and reduced risk of death by 40 percent, compared to standard of care.
news
Evrysdi™ approved for treatment of spinal muscular atrophy in Europe
The European Commission has granted marketing authorisation to Roche’s Evrysdi™ (risdiplam) as a treatment for spinal muscular atrophy in infants, children and adults.
news
What strains should be in this year’s seasonal influenza vaccines?
The European Medicines Agency has published its recommendations for 2021-2022 seasonal influenza vaccine composition.
article
Introducing NICE’s new board members
European Pharmaceutical Review explores who will be joining the National Institute of Health and Care Excellence (NICE)’s board as a new non-executive director on 1 April 2021.
news
WHO issues alert for falsified COVID-19 vaccine
The World Health Organization (WHO) has warned that a falsified COVID-19 vaccine, identified as Pfizer’s BNT162b2, could still be in circulation in the Americas.
![sign of the European Medicines Agency building in Amsterdam [Credit: martinbertrand.fr/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/EMA-1-300x278.jpg)
![sign of the European Medicines Agency building in Amsterdam [Credit: martinbertrand.fr/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/EMA-1-e1617017465349.jpg)
news
European Medicines Agency’s CHMP meeting highlights March 2021
In its March meeting the EMA’s human medicines committee recommended five medicines for approval and concluded its review of regdanvimab as a treatment for COVID-19.
news
FDA approves Abecma, the first cell-based gene therapy for adults with multiple myeloma
Abecma (idecabtagene vicleucel) was approved for adults with relapsed or refractory myeloma based on its 72 percent overall response rate in a trial.
news
EMA approves increased manufacturing capacity for COVID-19 vaccines
The approval of at least one new manufacturing site based in Europe for each of the approved COVID-19 vaccines should increase supply for the EU.
news
EMA accepts regulatory submission for Takeda’s dengue vaccine candidate
The submission is the first in a series that will include dengue-endemic countries, it includes long-term Phase III safety and efficacy data for the TAK-003 vaccine candidate.
news
FDA sends warning to companies selling unapproved CBD products
The warning letters were issued to two companies illegally selling over-the-counter cannabidiol (CBD) products for pain relief.
news
NICE approves olaparib and bevacizumab for use on the Cancer Drugs Fund
The recommendation will allow more data to be collected about the combination treatment while allowing patients with high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer to access the medication.