Eight New Filings At EMA: Three Granted Fast Track Status

New EU marketing applications from Novimmune, Theratechnologies/TaiMed Biologics and Loxo Oncology have all been granted accelerated assessment by the European Medicines Agency.

Samples of medicines, tablets, capsules, vitamins, and placebo
Marketing applications for new drugs are under review by the EMA

The European Medicines Agency has accepted for review marketing authorization applications (MAAs) for eight new drugs and has agreed to fast track its assessment for three of them.

The MAAs granted accelerated assessment are for Novimmune’s emapalumab*, for treating children with primary hemophagocytic lymphohistiocytosis (HLH), Theratechnologies/TaiMed Biologics’ multidrug resistant HIV treatment, Trogarzo (ibalizumab), and Loxo Oncology’s larotrectinib, for...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Product Reviews

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By 

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

More from Pink Sheet

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By 

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By 

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.