News

Evotec reports first annual profit in 18 years

Country
Germany

Evotec AG reported both operating and net profits for 2010, the first time in the company’s 18-year history, as it started to reap the rewards of a strategic shift towards drug discovery alliances with other companies instead of solo development.

GSK withdraws regulatory applications for dutasteride

Country
United Kingdom

GlaxoSmithKline Plc said it is withdrawing its regulatory applications for dutasteride (Avodart) which was being investigated to reduce the risk of prostate cancer in men at an increased risk of the disease.

Sanofi raises $7 billion to finance Genzyme acquisition

Country
France

Sanofi-Aventis SA has fixed the terms of its offering of $7 billion of US dollar-denominated notes which will finance its acquisition of Genzyme Corp. The French multinational is acquiring the US company for about $20.1 billion.

EMA launches clinical trial registry

Country
United Kingdom

The European Medicines Agency has launched an online registry which, for the first time, gives the public access to information on interventional clinical trials in the European Union that heretofore has only been available to the regulatory authorities in the member states.

Merck, Sanofi end their animal health venture

Country
France

Merck & Co Inc and Sanofi-Aventis SA have abruptly ended their agreement to create a joint animal health venture citing difficulties in getting approval from antitrust authorities in different jurisdictions in the world.

Novartis acquires Chinese vaccine producer

Country
Switzerland

Novartis has announced the acquisition of 85% of a privately-held vaccine company in China, Zhejiang Tianyuan Bio-Pharmaceutical Co Ltd. Financial details were not disclosed. The company has an R&D and manufacturing site near Shanghai.

EMA reminds former executive director of restrictions

Country
United Kingdom

The European Medicines Agency’s management board has taken the unusual step of reminding its former executive director, Thomas Lönngren, of restrictions that apply to his professional activities for two years following his departure.

Roche reports on hedgehog pathway inhibitor

Country
Switzerland

The Roche group said that its investigational hedgehog pathway inhibitor, vismodegib, which is being developed to treat advanced basal cell carcinoma, met its primary endpoint of overall response in a pivotal Phase 2 clinical study.

CHMP starts safety reviews of three medicines

Country
United Kingdom

The European Medicine Agency’s main scientific committee has started safety reviews of three marketed medicines following reports of adverse events. The medicines are Revlimid, Vivaglobin and pioglitazone-containing drugs.

CHMP gives positive opinions to four medicines

Country
United Kingdom

The European Medicine Agency’s main scientific committee has issued positive opinions for three new medicines, including a new oral contraceptive. In addition, it has given a positive assessment to a C1 inhibitor that is similar to a marketed product.