Zydus Reports Topline P-IIb/III (EPICS-III) Trial Data of Saroglitazar for Primary Biliary Cholangitis (PBC)

Shots:Zydus has reported topline P-IIb/III (EPICS-III) trial results in PBC pts resistant or intolerant to ursodeoxycholic acid (UDCA), where pts were randomized to Saroglitazar (1mg) or PBO, following optimal dose selectionTrial met its composite 1EP, showing a 48.5% treatment difference in biochemical response, & also achieved its key 2EP with a higher proportion…

ByRidhi RastogiSeptember 1, 2025

VIEWPOINTS

Awareness Campaign: Catherine Frenette from Gilead in Conversation with PharmaShots

Shots: At this year’s European Association for the Study of the Liver (EASL) Congress in Amsterdam, Gilead shared new data and 29 abstracts, including three oral presentations. But the data wasn’t the only thing that got people talking about Gilead’s commitment to transforming the lives of people living with liver conditions EASL saw the launch…

BySaurabh ChaubeyAugust 18, 2025

NEWS

GSK Reports the US FDA’s NDA Acceptance of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots:The US FDA has accepted NDA of linerixibat for the treatment of cholestatic pruritus in PBC pts (PDUFA: Mar 24, 2026)NDA is supported by P-III (GLISTEN) trial assessing linerixibat (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus; pts could switch to linerixibat in Part B of the trialTrial…

ByRidhi RastogiJune 2, 2025

NEWS

GSK Reports the P-III (GLISTEN) Study Results of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots:GSK has reported P-III (GLISTEN) trial data assessing linerixibat (n=119) vs PBO (n=119) to treat PBC pts (N=238) with cholestatic pruritus; pts could switch to linerixibat in Part B of the trialTrial met its 1EP, showing significantly reduced itch per WI-NRS scale in PBC pts, as assessed by monthly itch score, over 24wks.…

ByRidhi RastogiMay 8, 2025

NEWS

Gilead Receives CHMP’s Positive Opinion of Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Shots: The CHMP has recommended Seladelpar + ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or as monotx. in those intolerants to UDCA. The EC’s decision is expected in Q1’25 Opinion was based on a P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs PBO in PBC patients (n=193). It showed…

ByDipanshu DixitDecember 13, 2024

NEWS

US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC)

Shots: Gilead’s Livdelzi (Seladelpar) as monotx. or in combination with ursodeoxycholic acid (UDCA) has received accelerated approval for adults unable to tolerate UDCA or with inadequate response to UDCA, respectively. Not recommended for individuals with decompensated cirrhosis The approval was based on a P-III (RESPONSE) study showing 62% vs 20% (Livdelzi vs PBO) composite biochemical…

ByDipanshu DixitAugust 14, 2024

NEWS

Ipsen’s Iqirvo (Elafibranor) Gains the CHMP’s Positive Opinion for Treating Primary Biliary Cholangitis (PBC)

Shots: The CHMP’s positive opinion of Iqirvo (PPAR agonist) + ursodeoxycholic acid (UDCA) for PBC adults having inadequate UDCA response or Iqirvo alone for UDCA intolerant patients was based on P-III (ELATIVE) study. EC’s decision is anticipated in Q3’24. The company has submitted Iqirvo for PBC to the MHRA The P-III (ELATIVE) study assessed Iqirvo…

ByDipanshu DixitJuly 26, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in June 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2024 The US FDA approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Ipsen’s Iqirvo for the treatment…

ByDipanshu DixitJuly 16, 2024

NEWS

Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis

Shots: The US FDA has granted accelerated approval to Iqirvo (80mg tablets) in addition to ursodeoxycholic acid (UDCA) to treat PBC adults having inadequate response to UDCA or as monotx. in UDCA intolerant patients. Full approval depends on (ELFIDENCE) confirmatory trial The approval was based on a P-III (ELATIVE) study assessing the safety & efficacy…

ByDipanshu DixitJune 10, 2024

Zydus Reports Topline P-IIb/III (EPICS-III) Trial Data of Saroglitazar for Primary Biliary Cholangitis (PBC)

Awareness Campaign: Catherine Frenette from Gilead in Conversation with PharmaShots

GSK Reports the US FDA’s NDA Acceptance of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

GSK Reports the P-III (GLISTEN) Study Results of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Gilead Receives CHMP’s Positive Opinion of Seladelpar to Treat Primary Biliary Cholangitis (PBC)

US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC)

Ipsen’s Iqirvo (Elafibranor) Gains the CHMP’s Positive Opinion for Treating Primary Biliary Cholangitis (PBC)

Insights+: The US FDA New Drug Approvals in June 2024

Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis

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