A Rundown Of Real-Time Oncology Review Approvals And Pending Applications

Seattle Genetics holds the award for fastest supplemental approval (11 days) and fastest new molecular entity approval (119 days) under the US FDA's RTOR program, according to the Pink Sheet's Performance Tracker.

The US FDA has approved supplements for 17 drugs, as well as four new molecular entities and novel biologics, under the Real-Time Oncology Review pilot since the program launched in February 2018.

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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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