P4A experts regularly share their unique perspectives that inform and challenge the norm through articles and white papers.

Rare Diseases: A New Purpose

How drug repurposing could help drive orphan drug access if pharma can accept the risks By Nader Murad, Senior Analyst Email: nmurad@partners4access.com The US National Institutes of Health describes drug repurposing as “studying drugs that are already approved to treat one disease or condition to see if they are safe and effective for treating other…

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Partners4Access Briefing: November 2018 update on the European Commission regulation proposal on health technology assessment

By Christina Poschen, Consultant Email: cposchen@partners4access.com Background Since 2004, the European Union’s centralised drug approval is in place, allowing manufacturers to submit just one application to gain marketing authorisation in all European Union Member States. Although there were voluntary agreements and working groups to further harmonize health technology assessment, so far, there are 28 different systems…

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Sanofi to buy Bioverativ in $11.6 billion deal

French pharmaceutical giant Sanofi have agreed to acquire Bioverativ, a U.S. hemophilia specialist for $11.6 billion. This deal is the biggest for Sanofi in seven years, with the aim of achieving a stronger position in the rare disease space. After initially falling due to investor speculation that Bioverativ was overvalued, shares in Sanofi have since…

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UK regulator attempts to ease fears of impending access abyss

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced that there would be no sudden changes to the UK regulatory framework in the event of a no-deal following Brexit negotiations. It went on to confirm that it would provide “adequate notice to industry and ensure that companies had sufficient time to implement any changed…

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