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Blog Post

Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers

On 28 January 2019, the European Commission published its Report to the Council and Parliament regarding "Competition enforcement in the pharmaceutical sector (2009-2017)" ("Report")....

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Blog Post

South Africa's green rush- "weeding" out the confusion

Following the recent landmark decision of the South African Constitutional Court, in which the private and personal use of cannabis was decriminalised, together with the publication of...

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Blog Post

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases

On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines...

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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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Blog Post

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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Blog Post

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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Blog Post

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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