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.
19.11.2014 It’s not every day that a company is pushed into the top ten of its sector, but that day has come for Actavis. Christmas came early for the new pharma giant after completing a US$66bn (€53bn) takeover battle for the Botox manufacturer Allergan.
18.11.2014 Merck KGaA and US rival Pfizer have signed a immuno-oncology alliance worth billions: Merck will share the development and commercialisation of its cancer antibody with its US partner – for €2.3bn.
14.11.2014 Cosily coinciding with World Diabetes Day on 14th November, French biopharma Les Laboratories Servier has struck a US$1bn deal with US pharma Intarcia Therapeutics for the exclusive rights to Intarcia’s unprecedented therapy for type 2 diabetes.
12.11.2014 Glitz and glamour are not words often used to describe science and mathematics. But once a year, celebrities from the science and showbiz world come together at the Breakthough Prizes, a glitzy television bash that honours scientists for their achievements. French life scientist Emmanuelle Charpentier was among this year’s winners.
04.11.2014 Galecto Biotech has entered an agreement with Bristol-Myers Squibb for the acquisition of the company and its lead drug, providing the Swedish company with the potential of reaching over US$400m.