Politics

EMAUKEU

EMA pushes its transparency initiative forward

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.

http://www.european-biotechnology-news.com/news/news/2012-01/ema-pushes-its-transparency-initiative-forward.html

ResearchUKSwitzerlandItaly

29.08.2014 Just a week ago, Glaxosmithkline defused the WHO’s claim that an Ebola vaccine could be ready by 2015. Now, the British company’s own candidate vaccine is to be rushed to human trials with the help of funding from an international consortium.

BusinessGermany

24.08.2014 Germany's Morphosys is licensing a preclinical bi-specific antibody for the treatment of prostate cancer from Emergent Biosolutions. The US developer will rake in up to €138m for the commercialisation rights to the compound.

BusinessUK

20.08.2014 Biopharmaceutical contract manufacturer Fujifilm Diosynth Biotechnologies is expanding its cell culture manufacturing capacity further with a new 2,000l single-use bioreactor at the company’s site in Billingham, UK.

BusinessEUGermanyUK

15.08.2014 Some of Europe’s biggest pharma companies are competing in a bidding war for US biotech Intermune Inc., Bloomberg reports, citing insider reports as the source.

ResearchEUGermanyUK

13.08.2014 The Ebola epidemic is still raging on in West Africa and thus far there is

neither vaccine nor cure for the viral disease. The only flickers of hope:

an experimental antibody serum and an early-stage vaccine.

BusinessFrance

11.08.2014 Will Sanofi succeed where Pfizer failed? The French pharmaceutical company has taken on the commercialisation of Mannkind Corporation’s inhaled insulin product Afrezza.

ResearchSwedenGermany

08.08.2014 Boehringer Ingelheim is walking away from Swedish Orexo's prostaglandin inhibition project OX-MPI. Germany's largest researching pharmaceutical company had been responsible for the project's research and development since 2005.

ResearchSwitzerlandDenmark

06.08.2014 Roche is re-expanding its involvement in RNAi technologies. The Swiss pharmaceutical company will pay up to €335m for the acquisition of the Danish company Santaris Pharma A/S.

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No liability assumed, Date: 28.08.2014