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.
01.12.2015 Almirall is strengthening its dermatology focus with the takeover of Poli Group. Part of the deal are the group’s two pharma companies, German Taurus Pharma GmbH and Swiss Polichem S.A., and Italian Polichem S.r.l., which produces plastics additives.
26.11.2015 Bioeconomy movers and shakers from every corner of the globe met this week at the world’s first Global Bioeconomy Summit in Berlin to discuss, debate and define better ways to ensure the bioeconomy succeeds on an international level.
24.11.2015 After weeks of speculation it is official: US pharma major Pfizer and Irish Botox maker Allergan will merge. With the deal, Pfizer is planning to dodge the high US taxes, causing indignation among US politicians.
23.11.2015 Amidst talk of the IPO window closing and cancelled flotations, diagnostics firms are still striking a chord with investors. Swedish Immunovia and German Curetis are successfully raising public money.
17.11.2015 The first Italian accelerator specifically for biotech projects has been launched with help from Sofinnova Partners. The plan of BiovelocITA: to help Italy grow into one of Europe’s strongest biotech markets.
13.11.2015 Scientists in Bath, UK, have developed a medical dressing that turns fluorescent green when it detects infection. The researchers hope that the smart burns dressing will help fight antibiotic resistance.
13.11.2015 Out with the old: Roche is discarding four sites with 1,200 staff in an effort to restructure its manufacturing network for small molecules. Instead, a new manufacturing site will be built in Switzerland.
10.11.2015 Algae have many skills, but cancer fighting was not one of them – until now. Researchers from Australia and Germany have genetically engineered diatom algae to accurately deliver chemotherapeutic drugs.