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Exelixis’ Cabometyx R&D On Track Despite Pivotal Kidney Cancer Setback

 
• By Ayisha Sharma

The US firm’s Cabometyx has missed the mark in combination with Roche’s Tecentriq in a challenging kidney cancer setting, but analysts argue the setback is minimal as they highlight two major readouts coming this year.    

Blue and purple graphic image of pair of kidneys
There Could Be 15,000 Deaths Due To Kidney Cancer This Year • Source: Shutterstock

A regimen of Exelixis, Inc.’ Cabometyx and Roche Holding AG’s Tecentriq has missed the mark in the Phase III CONTACT-03 trial in advanced renal cancer patients, but is shrugging off the failure in light of more commercially important pivotal cancer readouts for the product expected later this year.

CONTACT-03 enrolled 522 people with locally advanced or metastatic clear cell or non-clear cell renal cell carcinoma (RCC) whose disease...

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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.