news
Collaboration working to promote health research, development and innovation
A strategic European health research and innovation agenda is being compiled by five industry associations and the European Commission.
List view / Grid view
Regulation & Legislation
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EMA human medicines committee meeting highlights, June 2021
Drugs recommended for approval by the European Medicines Agency’s human medicines committee included a gene therapy and two generics, among five others.
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Supply of biosimilars and generics with Adrian van den Hoven, Medicines for Europe
In this interview, Adrian van den Hoven, Director General of Medicines for Europe, discusses all things supply of generic and biosimilar medicines for the continent. Also, in a bonus video, Adrian discusses challenges disrupting access to biosimilars and generics in Europe.
whitepaper
Infographic: Simplified bacterial endotoxin testing
Endotoxin automation using microfluidics enables simpler, compliant processes for pharma QC, QA, validation and IT. BET assay setup is simplified and less LAL is required.
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European Pharmaceutical Review Issue 3 2021
In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…
news
UK and Europe approve Adtralza for treating atopic dermatitis
EU and UK regulators have approved Adtralza (tralokinumab), a monoclonal antibody, for treating moderate-to-severe atopic dermatitis in adult patients.
news
UK releases implementation plan for developing clinical research delivery
The new implementation plan lays out the steps the UK Government and clinical research community will take to improve research and tackle health inequalities.
news
EU approves Koselugo for treatment of neurofibromatosis and plexiform neurofibromas
The European approval of Koselugo was based on its ability to reduce inoperable plexiform neurofibromas in paediatric patients with neurofibromatosis type 1.
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France’s temporary authorisation (ATU) programme: reform implications
The new ATU programme may support more efficient use of healthcare spending but could it mean fewer patients receive early access to treatments? Here, experts from Charles River Associates discuss the new ATU programme reforms and how they could impact pharma.
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Video: BET automation is easy and simple with microfluidics
Endotoxin automation doesn’t mean complex instrumentation and setup. See how microfluidics enables easy BET assay setup so QC labs achieve high throughput with less hands-on time.
news
Chinese patent reforms to bolster pharma innovation
Market research suggests the new drug patent reforms in China, in addition to other regulatory changes, will incentivise innovative pharma research.
![MBE Medals [Credit: HCSA (Health Care Supply Association)].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/MBE-300x278.png)
![MBE Medals [Credit: HCSA (Health Care Supply Association)].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/MBE.png)
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MBE awarded to NICE’s Interventional Procedures Advisory Committee chairman
Professor Tom Clutton-Brock was awarded an MBE for his work in approving novel ventilators for the UK’s National Health Service during the COVID-19 pandemic.
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Navigating pharmacovigilance complexity in the US and EU: notes for biotechs
Pharmacovigilance obligations present significant challenges for biotechs. Small companies face the same rigor as large pharma - and it does not help that there is divergence between the requirements of the FDA, the EU and its member states. Here, seasoned pharmacovigilance experts and non-executive advisors to Arriello, Eric Caugant in…
news
Health Canada to modernise its clinical trial regulations
Health Canada has proposed a single regulatory framework for clinical trials for all health products that will support innovation and streamline drug and medical device development.
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On-demand webinar: Celsis® for sterility – product spotlight
A rapid sterility test method that can be validated as quickly and confidently as it provides test results.
