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Keeping Track Of Breakthroughs: AZ Farxiga, ImmunoGen ADC For Hematologic Cancer, Inventiva NASH Candidate Earn Designation

 
• By Bridget Silverman

The latest breakthrough therapy designation news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Person running; breakthrough concept
The DAPA-CKD study on Farxiga’s was stopped early in March 2020 because of “overwhelming efficacy.” • Source: Shutterstock

The US Food and Drug Administration’s recent grants of breakthrough therapy designations stand in very different therapeutic spaces. AstraZeneca PLC’s established antidiabetic Farxiga (dapagliflozin) won its first BTD for treatment of patients with chronic kidney disease, a common condition with more than 4 million diagnosed cases in the US. Inventiva S.A.'s lanifibranor was tapped for treatment of non-alcoholic steatohepatitis, which affects 3% to 12% of US adults, according to the US National Institutes of Health

ImmunoGen, Inc.’s antibody-drug conjugate candidate IMGN632, on the other hand, earned a BTD for treatment of relapsed or refractory...

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More from Review Pathways

England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway

 
• By Eliza Slawther

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Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By Xu Hu

The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.

More from Pathways & Standards

Faster HTA Reviews & Pricing Reform Could Help Fix Canada’s Drug Access Woes

 
• By Eliza Slawther

Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.

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