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

Swiss Biotech DaySwitzerland

16.04.2015 The Swiss biotech industry can look back on 2014 as a good year, but political uncertainties do remain. This was one of the topics discussed during the Swiss Biotech Day in Basel, which attracted more than 400 participants.

EventEUFrance

16.04.2015 The changing landscape in healthcare was just one of the hotly discussed topics of the 27th Annual EuroMeeting of the international association DIA.

R&DBelgium

14.04.2015 Belgian Thrombogenics NV has launched a new oncology company with Gent-based life sciences institute VIB. The new venture will develop an antibody for the treatment of a fast-growing brain tumour that affects children and adolescents.

Stock MarketsEUFranceUKNorwaySweden

09.04.2015 The European public markets remain highly attractive for biotech companies. Twice as many companies went public in the first quarter of 2015 than during the same period last year.

FinancingAustriaUKSwitzerlandGermany

08.04.2015 To bring its lead product of a new class of antimicrobials to phase 3 trials, Nabriva Therapeutics has completed a US$120m Series B financing.

Research & DevelopmentNetherlands

07.04.2015 Gene therapy is attracting more and more big pharma companies. Now, Bristol-Myers Squibb has forged a US$1bn collaboration with Dutch uniQure, also picking up a 4.9% share in the company.

Stock MarketsFrance

02.04.2015 Sensorion is the latest French biotech to go public, following a spate of IPOs on Paris Euronext. The biopharma plans for a €12m IPO to finance its pipeline of inner ear disease drugs.

M&AIreland

31.03.2015 In its aim to expand its drug portfolio in orphan disease products, Horizon Pharma has acquired US company Hyperion Therapeutics for US$1.1bn in cash. The takeover entitles the UK biopharma to all of Hyperion’s common stock.

BusinessGermany

31.03.2015 Merck Serono has forged a US$941m (€876m) deal with US Intrexon for the development and commercialisation of CAR-T therapies. The new CAR-T projects are set to strengthen their R&D technology portfolio in immuno-oncology.

Stock MarketsFranceEU

27.03.2015 Europe is once more proving that it can be a good bet for biotech companies going public. A newly established EU-wide lobbying initiative could help the IPO boom on its way.

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