news
Evrenzo™ approved for CKD-related anaemia treatment in EU
The European Commission (EC) has approved Astellas’ Evrenzo™ for adult patients with symptomatic anaemia of chronic kidney disease (CKD).
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European Medicines Agency (EMA)
news
Abecma is the first treatment approved by EC for multiple myeloma
The European Commission (EC) has approved Abecma, the first anti-BCMA CAR T-cell therapy for patients with multiple myeloma.
news
MHRA approves COVID-19 Vaccine Moderna in 12-17-year olds
The MHRA has approved the use of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) in children aged 12-17 years old.
news
ICMRA set out recommendations for AI regulation in medicine
The ICRMA has set out recommendations to help regulators tackle the challenges posed by artificial intelligence (AI) in medicine.
news
EMA endorses global facilitation of track and trace systems
The European Medicines Agency has endorsed ICMRA recommendations to facilitate the use of track and trace systems for medicinal products at a global level.
news
EMA’s human medicine committee (CHMP) meeting highlights, July 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.
podcasts
EPR Podcast Episode 1 – Richard Daniell, Teva Pharmaceuticals
Learn about current and future European pharmaceutical supply chains from Richard Daniell at Teva Pharmaceuticals in European Pharmaceutical Review’s first podcast.
article
EMA’s transformative treatments of 2020
In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.
news
Marketing of Zynteglo suspended as precaution due to potential cancer risk
bluebird bio has chosen to suspend sales of Zynteglo while they investigate whether safety concerns identified with a related investigational gene therapy may apply to the licenced medicine.
article
New regulatory landscape for biosimilars in the UK and EU post Brexit transition period
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.
article
Manufacturing of CAR T-cell therapies: an overview
The emergence of CAR T-cell therapies has ignited a revolution in the field of cancer treatments. While existing products show outstanding curative capability, they are hampered by significant clinical and commercial challenges, many of which stem from their manufacturing process. Maciej Nakoniecznik discusses how a combination of biological and technological advances…
news
EMA initiates rolling review of CureVac’s CVnCoV COVID-19 vaccine
The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
article
Carving out a slice of the European medical cannabis market
The European medical cannabis market lacks a common regulatory framework; Peter Kohut charts a route through the complexity and highlights opportunities for the taking.
![Jazz Pharmaceuticals Sign with Logo [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Jazz-pharmaceuticals-300x278.jpg)
![Jazz Pharmaceuticals Sign with Logo [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Jazz-pharmaceuticals-e1612534960797.jpg)
news
Jazz to acquire GW Pharmaceuticals for $7.2 billion
According to Jazz Pharmaceuticals, the combined company will be a leader in neuroscience, well positioned to maximise the value of its diversified portfolio.
news
J&J submits COVID-19 vaccine data to FDA for emergency authorisation
J&J have submitted Phase III trial data in their application to the FDA for emergency authorisation of their COVID-19 vaccine candidate.
