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EU Medicines Agency plans to appeal interim rulings on release of clinical trial data

Shook Hardy & Bacon LLP
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European Union
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May 16 2013

According to a news source, European Medicines Agency (EMA) Director Guido Rasi intends to appeal interim rulings recently issued by the European

Universities abroad experiment with no-fee licensing to drive biotech partnerships

Shook Hardy & Bacon LLP
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Australia, Canada, European Union, United Kingdom, USA
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May 16 2013

Universities in Australia, Canada, Europe, and the United Kingdom have reportedly embraced a 2010 Glasgow University initiative under which companies

EU medical device manufacturers address plan to change regulatory directives

Shook Hardy & Bacon LLP
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European Union
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February 8 2013

Eucomed, an organization that represents the interests of the European medical device industry, has issued a position paper that assesses a number of

EC approves first gene therapy medicine in western world

Shook Hardy & Bacon LLP
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European Union
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November 15 2012

The European Commission has given final approval to uniQure’s gene therapy Glybera for the treatment of lipoprotein lipase deficiency patients with recurring acute pancreatitis

European Commission proposes regulation on access to genetic resources

Shook Hardy & Bacon LLP
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European Union
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October 18 2012

To carry out European Union (EU) obligations under the Nagoya Protocol on Access to Genetic Resources and Benefit-Sharing, the European Commission (EC) has proposed a regulation that would ensure that only legally acquired genetic resources and associated traditional knowledge are used in the EU and that such resources are fairly and equitably shared

EU regulators charge pharma companies with antitrust violations in pay-for-delay deals

Shook Hardy & Bacon LLP
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European Union
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August 2 2012

The European Commission (EC) has reportedly charged nine pharmaceutical companies with breaches of European Union (EU) antitrust rules for entering pay-for-delay deals with generic competitors

European Commission study recommends changes to medical device and drug laws

Shook Hardy & Bacon LLP
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European Union
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May 17 2012

The European Commission has issued a report that analyzes the European Union’s (EU’s) REACH regulation, which addresses the registration, evaluation, authorization and restriction of chemical substances, and identifies overlap with other EU laws

Wellcome Trust creates £200-million fund for UK, EU biotech startups

Shook Hardy & Bacon LLP
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European Union, United Kingdom
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March 29 2012

The U.K.-based Wellcome Trust has announced the creation of a £200-million fund to make long-term investments in British and European biotechnology startups

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Workarea - Healthcare
Jurisdiction - European Union
Author - Thomas T. Moga
Author - John D. Garretson
Author - Patrick Henderson
Author - Madeleine McDonough

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