European Commission news from FierceBiotech

It hasn't had a lot to show for it so far, but Pfizer became the world's number one spender on research and development last year, grabbing the top spot from Ford. The list, assembled by the Read more...

Pfizer shelled out more on R&D last year than any other company in the world, and drugmakers in general have stepped up their research budgets, the European Commission says. Pfizer spent $8.18 Read more...

It's always interesting to come to Europe and hear the latest about the Innovative Medicines Initiative, an attempt by the Europeans to develop a Read more...

Despite being relatively new to the biotech field, Sweden's biotech industry is doing brisk business. The country has already attracted $46 million in venture capital this year and Swedish biotechs Read more...

European drug regulators granted orphan drug status to Chelsea Therapeutics' remedy for hypotension, Droxidopa, and recommended the same for Progen's experimental liver drug, known as PI-88. Designed Read more...

A new report from the European Commission examines 27 EU countries (as well as non-members Switzerland, Norway, Iceland, Croatia and Turkey) to determine what factors foster a successful biotech Read more...

The EMEA has recommended the European Commission approve Zeltia's drug Yondelis for the treatment of soft tissue sarcomas. The company's shares surged on the news. The recommendation comes almost Read more...

Press Release: Positive Opinion For Type 2 Diabetes Treatment, JANUVIA

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The European Medicines Agency has given GlaxoSmithKline a thumb's up for Daronrix, its pandemic flu vaccine. The European Commission will now take up the issue. Glaxo's victory at the EMEA followed an extraordinarily swift development process, with clinical trials beginning in April. The drug developer filed what's called a mock-up dossier on the vaccine, asking for approval against one strain of the H5N1 virus. In the event of a potential pandemic, Glaxo would adapt the vaccine to work …

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The European Commission has approved Encysive's Thelin for pulmonary arterial hypertension, or high blood pressure in the pulmonary artery. The move came after the FDA decided it would need to see additional data on the drug before it could be approved. The FDA issued a second approvable letter for Thelin in late July, which Encysive officials say contained one outstanding issue. That raised analysts' concerns that Thelin would not be approved prior to the arrival of Myogen's ambrisentan. …

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