List view / Grid view

Regs & Legs


EC grants marketing authorisation to Entresto

25 November 2015 | By Victoria White

The European Commission has granted marketing authorisation to Novartis’ Entresto (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).

Foreword: Importation testing: an unnecessary burden on industry?

22 October 2015 | By ,

One of the principle objectives of the Internal Conference on Harmonisation (ICH) initiatives was to introduce harmonised approaches, prevent duplication and eliminate wasteful and unnecessary testing. Although good progress was made initially, there was evidence that certain countries, regions and trans-national organisations were unhappy with some of the proposed harmonised…

New third-party audit scheme for excipient suppliers

22 October 2015 | By Iain Moore, President, EXCiPACT asbl

There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits…

Counterfeit medicines and the need for a global approach

16 October 2015 | By David Shore, Pfizer

Counterfeit medicines pose a serious risk to public health around the world. The trade in fake drugs is considerable; according to Pfizer’s own company records, more than 200 million counterfeit doses of Pfizer product have been intercepted since 2004. Meanwhile, the issue of counterfeits has no single or simple solution…

CHMP recommends heart failure drug Entresto

25 September 2015 | By Victoria White

The CHMP has adopted a positive opinion for Novartis’ Entresto (sacubitril/valsartan), marking an important milestone towards the drug becoming available in the EU.

Rapid methods update: revisions to a United States Pharmacopeia chapter

3 September 2015 | By Michael J. Miller, PhD Microbiology Consultants, LLC

From 2010 to 2013, European Pharmaceutical Review published a very successful series on rapid microbiological methods (RMM) that included hot topics such as the European Medicines Agency’s and US Food and Drug Administration’s expectations, implementation strategies, scientific principles behind the technologies and validation.

An evaluation of pharmaceutical copayment reforms in Spain

3 September 2015 | By Jaume Puig-JunoyPompeu, Fabra University / Beatriz G. Lopez-Valcarcel and Santiago Rodríguez-Feijoó, University of Las Palmas de Gran Canaria

The sudden fall of public revenues after the long-lasting economic crisis that began in 2008 has led many public health systems in European countries to cut public health financing through high copayments or coinsurance rates on drug prescriptions dispensed in pharmacies.

DKSH signs agreement with Actelion to drive growth in Asia

11 August 2015 | By Katie Sadler, Digital Content Producer, European Pharmaceutical Review

DKSH, the Market Expansion Services provider with a focus on Asia, and Actelion Pharmaceuticals Singapore PTE Ltd, an affiliate of Actelion Ltd, a global biopharmaceutical company, have started a collaboration to support the business growth in Asia.

HerpV and GEN-003 will drive genital herpes treatment market growth to 2023

21 July 2015 | By Victoria White

The global market value for genital herpes therapeutics will increase from approximately $490 million in 2013 to just under $668 million by 2023, largely driven by the introduction of therapeutic vaccines, HerpV and GEN-003, towards the end of the forecast period, says research and consulting firm GlobalData.

Send this to a friend