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14 Approvals To Look Out For In Q3

 
• By Alexandra Shimmings

As many as 14 new products are up for US approval in the third quarter, research by Informa Pharma's Biomedtracker shows. Scrip takes a look at the candidates and their chances of reaching the market.

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PDUFA date: Aug. 21

Agios Pharmaceuticals Inc. is hoping its small-molecule inhibitor of isocitrate dehydrogenase 1 (IDH1) will become the first targeted treatment to relapsed or refractory acute myeloid leukemia (AML) patients who have an IDH1 mutation

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Pipeline Watch: Thirteen Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 
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The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

Pipeline Watch: Five Approvals And One Phase III Readout

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Merck KGaA Seals SpringWorks Buy

 
• By Kevin Grogan

The German group is paying $3.9bn to get hold of the US firm and its two approved products.

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Deal Watch: Lilly Looks To Creyon For Oligonucleotides

 
• By Joseph Haas

Plus deals involving J&J/Addex/Sinntaxis, Concentra/Kronos, Granata/Oviva, Coeptis/Z Squared, Ligand/Channel and more.

BioNTech Aims To Diversify BNT323 Manufacturing As Filing Nears

 
• By Alaric DeArment

The company plans to expand manufacturing of the HER2-targeting ADC beyond China and plans to file for US FDA approval in 2025.

Accelerated Approval May Be Out Of Reach For PTC’s Huntington’s Drug

 
• By Joseph Haas

PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.