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AB Science & Daiichi Try Their Luck Again With EU Filings

 
• By Neena Brizmohun

The sponsors of Alsitek and quizartinib are hoping that new data generated for the drugs will resolve the concerns raised by the European Medicines Agency when it previously rejected the products for marketing in the EU.

Astrocyte and blood vessel
Alsitek is an investigative treatment for the fatal motor neuron disorder, ALS • Source: Shutterstock

The European Medicines Agency has begun reviewing new EU marketing authorization applications (MAAs) for two drugs it had previously rejected – Alsitek (masitinib) and quizartinib – and a product that was approved but then withdrawn for commercial reasons – catumaxomab.

Alsitek, from AB Science, and quizartinib, from Daiichi Sankyo, are for treating amyotrophic lateral sclerosis (ALS) and acute...

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US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

US FDA’s July AdComms: Pediatric Vaccine Safety, Blenrep’s Return, (Maybe) Capricor’s Cell Therapy

 
• By Sue Sutter

The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.