PharmTech Europe News

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.

Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.

The European Medicines Agency reviews the safety of human papillomavirus vaccines.

The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.

The Latvian government and Pharma have signed a letter of intent on June 29, 2015, agreeing on measures and a mutual cooperation in projects that will help improve medicines access and health outcomes in Latvia.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

The agency creates initiative to stimulate pediatric drug development.

The pharmaceutical industry wants to speed up the variations process by eliminating redundant assessment by different national agencies in the European Union.

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.

EMA confirms its recommendation to suspend medicines approved based on GVK Biosciences studies.

Novartis announces that its lung cancer drug, Zykadia, gained European Union approval.

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.

The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed?

Drug developers understand the importance of early communication with regulators, but is EMA providing enough flexibility and support to companies?

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the manufacturing process following a change in the manufacturer.

As the prevalence of falsified medicines continues to increase, Switzerland is taking measures to secure its supply chain such as the implementation of serialization.

A review of some of the latest packaging and drug-delivery innovation presented at Pharmapack Europe.

Proposals to make the decentralized procedure more efficient were discussed at the January 2015 EGA conference.

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”

The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

A global framework of standards enabling collaboration among industry stakeholders is needed to battle the increasing threat of counterfeit medicines.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Generic medicines Association (EGA) have announced the reiteration of their joint Europe 2020 Strategy submission ahead of the adoption of the European Commission Work Programme.

The agency emphasizes the need for robust scientific assessment and more information on safety and efficacy profiles of Ebola therapies in development.

BioCity has announced a new investment fund, created following a significant contribution by AstraZeneca. The £5 million fund will be managed by BioCity and will make equity investments, typically between £50,000 and £250,000, in life-science companies based at Alderley Park, Cheshire, United Kingdom.

A review of how mergers and acquisitions have shaped the pharmaceutical industry landscape.

To gain insights into the current trends of the biotechnology sector in the United Kingdom, Pharmaceutical Technology Europe spoke with Steve Bates, chief executive officer of the BioIndustry Association (BIA), the trade association for biotech companies in the UK.

Last year, the Turkish Government unveiled plans to position the country in the top 10 most-preferred locations for R&D investment in the pharmaceutical sector by 2023. This article provides an overview of the incentives introduced under the Technopolis Law and the R&D Act.

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.