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Regulus HCV Candidate Is Out, But New CEO Has BD Pedigree

 
• By Joseph Haas

The micro-RNA-focused biotech believes the jaundice seen with HCV candidate RG-101 was specific to the drug, not the target or delivery system, but is switching focus to other promising programs, such RG-012 for Alport syndrome.

Liver infection

The promise of Regulus Therapeutics Inc.'s microRNA add-on therapy RG-101 for hepatitis C to reduce duration of treatment to four weeks was diminished by an FDA clinical hold, but the biotech revealed it has ended the program in a June 12 pipeline update. A nascent program for cholestatic disease was also discontinued.

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Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
• By Kevin Grogan

The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

In Brief: BriaCell’s Breast Cancer Cell Therapy Boosts Survival In Phase II

 
• By Sushmita Panda

BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.

Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC

 
• By Dexter Jie Yan

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.

Camzyos nHCM Failure Could Open Door To Threat From Cytokinetics’ Aficamten

 
• By Alaric DeArment

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.

More from R&D

Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC

 
• By Dexter Jie Yan

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.

AstraZeneca Logs Japan Growth Despite Price Cuts

 
• By Lisa Takagi

AstraZeneca logs growth in Japan despite a big reimbursement price cut for one of its top sellers and expects 40 approvals in the country over the next six years.

Camzyos nHCM Failure Could Open Door To Threat From Cytokinetics’ Aficamten

 
• By Alaric DeArment

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.