Drug linked to 33 deaths in Northern Ireland is reclassified
4 April 2019 | By European Pharmaceutical Review
The prescription drug pregabalin is now being treated as a class C drug...
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Regs & Legs
Whitepaper: Cubis® II Pharma Compliant by Design
2 April 2019 | By Sartorius
Sartorius' Cubis® II balance series offers customisable modularity to ensure compliance with FDA directive 21 CFR Part II and EU Annex 11. This whitepaper outlines details of the technical solutions that will enable companies to achieve full compliance.
Pharma to benefit from FDA digital health regulations
29 March 2019 | By European Pharmaceutical Review
Companies that invest heavily now stand to steal a lasting lead over rivals that hesitate...
Whitepaper: Emerging trends in regulatory expectations
25 March 2019 | By PQE Group
Regulatory expectations nowadays focus on harmonisation of global regulations. This whitepaper by PQE looks at current and emerging trends in regulatory expectations.
Acting FDA Commissioner named
19 March 2019 | By Iqra Farooq
As Dr Scott Gottlieb steps down from his role next month, Dr Ned Sharpless has been announced as his short-term replacement...
Prometic Bioseparations introduces GMP-ready columns
15 March 2019 | By Prometic Bioseparations
An introduction to Prometic Bioseparations based in Cambridge. For over 30 years the company has provided innovative purification solutions to the Biopharmaceutical industry.
New generic valsartan approved to address shortages
14 March 2019 | By Nikki Withers (European Pharmaceutical Review)
The FDA has prioritised the review of this drug application after multiple recalls of generic valsartan products from several manufacturers...
European firms fuel growth in patent applications
13 March 2019 | By Nikki Withers (European Pharmaceutical Review)
Pharmaceutical and biotechnology patent applications increased by 13 percent last year, with over 6,000 applications coming from European companies...
Watson-Marlow expert Dr. Sade Mokuolu to present Biomanufacturing Masterclass at INTERPHEX 2019
11 March 2019 | By Watson-Marlow Fluid Technology Group
Watson-Marlow Fluid Technology Group has partnered with Interphex to promote safer, more reliable bioprocessing....
Compulsory licenses in Germany: a tool for licensing negotiations?
8 March 2019 | By Christof Hohne
The Merck v. Shionogi case of 2017 laid the groundwork for further establishing compulsory licensing as a strategic tool in Germany, particularly in pharma patent litigation. A recent decision in a proceeding brought by Sanofi now provides more guidance on the threshold for obtaining such a compulsory license. This article…
Indian government plans to colour code generics
7 March 2019 | By European Pharmaceutical Review
Colour-coded generics might help consumers differentiate between generics and branded medicines...
FDA commissioner Scott Gottlieb resigns
6 March 2019 | By Nikki Withers (European Pharmaceutical Review)
Scott Gottlieb has announced that he will resign from the position of commissioner of the US Food and Drug Administration (FDA) at the end of the month...
Preparing for a no-deal Brexit
6 March 2019 | By Nikki Withers (European Pharmaceutical Review)
The pharmaceutical industry has increasingly voiced its concerns about the possibility of a no-deal Brexit and its impact on supplies and access to medicines. Here, the European Medicines Agency (EMA) gives some last-minute advice to pharma companies ahead of March 2019.
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