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CymaBay Builds Seladelpar Case In PBC, But Door Not Closed On NASH

 
• By Joseph Haas

The company pointed to cirrhosis benefit and less pruritis in a pooled analysis presented at EASL, which will help it will take on Intercept in primary biliary cholangitis on tolerability, cirrhosis benefit.

Biliary tract
CymaBay hopes to take on Intercept in second-line PBC

For the past year, CymaBay Therapeutics, Inc. has focused on developing its PPAR delta agonist seladapar in primary biliary cholangitis, as it looks to get past the roadblocks it faced in non-alcoholic steatohepatitis. The company is confident that it can take on Intercept Pharmaceuticals, Inc.’s lead in PBC with Ocaliva with seladepar’s better tolerability and benefit in cirrhotic patients – and a pooled analysis presented at the European Association for the Study of Liver meeting suggests it will have the data to do so.

CymaBay’s PBC and NASH programs suffered a major setback in November 2019 when the US Food and Drug Administration placed...

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Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie

 
• By Anju Ghangurde

Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.

Four Chinese Firms Snag Global First-In-Class Approvals In China

 
• By Dexter Jie Yan

Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.

Ultragenyx and Mereo Still Confident Despite Setrusumab Slip Up

 
• By Kevin Grogan

The osteogenesis imperfecta drug stumbled in a second interim analysis.

Taiho’s Oral, Mutation-Agnostic DMD Candidate Misses Phase III Endpoint

 
• By Lisa Takagi

The oral, twice-daily candidate was expected to control decline in motor function in DMD patients regardless of their gene mutations.

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Lupin’s Cimzia Biosimilar Candidate Reflects Strategy To Separate Wheat From Chaff

 
• By Vibha Ravi

Lupin's choice of a Cimzia biosimilar candidate and partnering with Zentiva reflect a strategy to sort the wheat from the chaff. Of 118 biologics to lose patent protection between 2025 and 2034 as per IQVIA, it’s going for a biosimilar with a single competitor though there could be other spoilers

Taiho’s Oral, Mutation-Agnostic DMD Candidate Misses Phase III Endpoint

 
• By Lisa Takagi

The oral, twice-daily candidate was expected to control decline in motor function in DMD patients regardless of their gene mutations.

ProKidney Pins Hopes On Accelerated Approval For Rilparencel

 
• By Alaric DeArment

After posting encouraging Phase II results, the company plans to meet with the US FDA about using data from an ongoing Phase III study for an accelerated approval.