Coming Attractions: Novel Agents In Line For US FDA Decisions By Year-End

Interactive table from the Pink Sheet breaks down the 40 novel drugs and biologics have user fee goal dates before the new year.

Coming Attractions clapper board
The second half of the year could see an exciting slate of NME releases. • Source: Shutterstock

The US FDA has a hefty slate of new molecular entities and novel biologics with Prescription Drug User Fee Act goal dates in the second half of 2024, setting the agency up for another strong year of novel approvals.

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New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.

New EU Filings

 

Levodopa/carbidopa (ND0612), Mitsubishi Tanabe Pharma’s investigational drug-device combination therapy for the treatment of motor fluctuations in people with Parkinson’s disease, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Japan Recommends Beyonttra, Raises Enhertu Price

 
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Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.

Generic Approvals Maintained Pace In December And January, But Is A Slow-Down Coming?

 

Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.

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EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.

Sponsors Of Two Orphans And An Acne Treatment To Defend Marketing Authorization Applications At EMA

 

Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.

EU Marketing Approval Gap Between Lilly’s Donamemab and Eisai’s Leqembi Could Narrow

 

The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.