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EU Medicines Agency plans to appeal interim rulings on release of clinical trial data
- Shook Hardy & Bacon LLP
- -
- European Union
- -
- 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
- -
- Australia, Canada, European Union, United Kingdom, USA
- -
- 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
- -
- European Union
- -
- 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
- -
- 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
- -
- European Union
- -
- 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
- -
- European Union
- -
- 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
- -
- European Union
- -
- 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
- -
- European Union, United Kingdom
- -
- 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
EU Court of Justice interprets law extending patent protection for medicinal products
- Shook Hardy & Bacon LLP
- -
- European Union
- -
- December 15 2011
The Court of Justice of the European Union (ECJ) has issued two rulings interpreting EU law at the request of British courts addressing whether drug makers can obtain a supplementary protection certificate (SPC), which extends patent protection, for products with active ingredients additional to those specified in the original patent
European Medicines Agency seeks feedback on biosimilars guideline
- Shook Hardy & Bacon LLP
- -
- European Union
- -
- December 15 2011
The European Medicines Agency has issued for public comment a “Concept paper on the revision of the guideline on similar biological medicinal product.”
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