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.
24.07.2015 Biotech companies across Europe continue to raise cash on the public markets, generating €3bn in total financing proceedings in the first half of 2015. Compared to 2014, this is almost twice as much.
23.07.2015 US money keeps flowing into Europe's biotechs. As the race for the peanut allergy market heats up, NASDAQ listed French biotech DBV has announced the successful closing of US$281m (€256m) share offering for its allergy products.
16.07.2015 Sanofi has announced plans to restructure its business in five standalone global business units starting in January 2016. The goal is to promote growth and help the company launch a catalogue of new drugs over the next five years.
15.07.2015 GlaxoSmithKline (GSK) has become the first drugmaker to join the Francis Crick Institute. It is a consortium made up of six scientific and academic institutes to conduct research and drug development in the UK. The new institute is set to become a world-leading centre of biomedical research and innovation.
10.07.2015 Karolinska Development has slashed the reported value of its portfolio by almost half by revising its valuation model for early stage companies and divesting its shares in pain med maker Pharmanest.
08.07.2015 Horizon Pharma plc. has set its sights on US-American speciality pharma company Depomed Inc. After getting nowhere with the rival’s board, Horizon has now launched a US$3bn hostile bid for the pain and CNS specialist.
07.07.2015 Irish pharma play Allergan plc. is boosting its eye care business by acquiring US-American medtech company Oculeve. Included in the deal are Oculeve’s dry eye disease development programmes.
03.07.2015 Biotech giant Biogen is investing CHF1bn in a new pharmaceutical production plant in the Swiss town of Luterbach. Noted as one of the world’s oldest biotech firms, Biogen will create up to 400 jobs at the new plant.