24.02.2012 - The European Medicines Agency (EMA) will publish information about all drugs under review, beginning on March 1. On a monthly basis the company will issue a list disclosing the international non-proprietary name and therapeutic areas of each product under review as well as information on the type of salt, ester or derivative of the active ingredient.
Until now, EMA has published information just about orphan drugs under review. Information on other products will not be released until the Committee for Medicinal Products for Human Use (CHMP) has issued an opinion. The plan is part of the agency ’s new policy on transparency and access to documents. The agency will also assume more responsibility in the field of pharmacovigilance. Up to now, the EMA focused its post-marketing drug safety monitoring on the 568 centrally authorised medicines for human use. But as of mid-July, the EU drug watchdog will stepwise include pharmacovigilance data from nationally authorised medicines. The newly formed Pharmacovigilance Risk Assessment Committee (PRAC) will be responsible for the implementation of the new European drug safety rules.
20.01.2015 Ebola research projects are set to receive €215m in funding from the European Commission’s IMI2 Ebola+ programme. Among the project partners are vaccine developers Glaxosmithkline, Johnson&Johnson and Merck.
13.01.2015 Shire beefs up its rare disease portfolio after acquiring NPS Pharma with the aim of becoming a leading biotech in a US$5.2bn deal. Part of the deal is the US biotech's lead portfolio of gastrointestinal and hormone replacement therapies.
09.01.2015 The excitement surrounding CRISPR genome editing shows no sign of abating. This month, Novartis and US biotech Intellia Therapeutics became the first ever biotech-pharma collaboration to use the groundbreaking technology.
06.01.2015 With the aim to utilise Ireland’s many natural resources and keep abreast of the latest EU developments in bioeconomy, a multi-disciplinary team has been funded to maximise national income, exports and job creation related to Ireland’s bioeconomy.