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EMA office in Amsterdam opened – Wooden shoes, orphan drugs and drug pricing in the context of Brexit

On 9 January 2019, the European Medicines Agency (EMA) opened its office in Amsterdam, the Netherlands. As the UK will leave the EU 29 March 2019 due to Brexit, the EMA is relocating from...

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Hogan Lovells Publications

Pharma companies may benefit from proposed patent law changes in China; public comment invited

On 4 January, China's National People's Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to...

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China takes significant steps to consolidate generic drug industry and lower prices

On 7 December, China announced its newly implemented pilot centralized drug procurement program will cut prices for certain off-patent generic drugs by up to 96%. Under the program, China...

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FDA introduces new standardized inspection protocols for sterile drug manufacturers to modernize and strengthen oversight

On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators...

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Trump touts “historic” plan to overhaul Medicare payments, create International Pricing Index

President Trump today touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing...

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Boost for digital health in Germany – restrictions on remote treatment could be overturned in May 2018

At the next Annual General Meeting of the German Medical Association (Deutscher Ärztetag), the current restrictions on remote treatment by German physicians will most likely be...

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FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited...

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FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative...

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EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation....

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Personalised Medicines at the top of the European Agenda

In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published.

The workshop discussed the views of ...

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Excessive pricing in pharmaceutical products attracts the European Commission’s attention

In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last...

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