Major Public Health Interest? Scholar, Insmed & Soleno Ask EMA To Fast-Track Their Products

The European Medicines Agency is considering whether apitegromab, brensocatib and diazoxide choline, from Scholar, Insmed and Soleno respectively, are drugs that are of potential major public health interest, particularly from the point of view of therapeutic innovation.

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Drug marketing applications are reviewed faster under the EMA's accelerated assessment pathway (Shutterstock)

The European Medicines Agency was this week deciding whether the planned EU marketing authorization applications (MAAs) for three investigational products deserved accelerated assessments – apitegromab, brensocatib and diazoxide choline.

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Vertex’s Alyftrek For CF Among Six Orphans On Track For Pan-EU Approval

 

The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.

Semaglutide For MASH Among Raft Of New EU Filings

 

Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.

SpringWorks To Make Its Case For Nirogacestat At High-Stakes EMA Meeting

 

Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.

EMA To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 

The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

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Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

 

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

Vertex’s Alyftrek For CF Among Six Orphans On Track For Pan-EU Approval

 

The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.