Intercept’s CRL Just Continues Upheaval In NASH

Jun 29 2020

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With approval timeline for OCA now thoroughly unclear and Genfit on the ropes, might the top spot in NASH end up with Galmed, AbbVie, Madrigal, Inventiva or Gilead instead?

Drugs question mark — The NASH competition may be wide-open again

A year of overturned expectations in the non-alcoholic steatohepatitis space continued on 29 June with Intercept Pharmaceuticals Inc.announcing the receipt of a complete response letter from the US Food and Drug Administration for obeticholic acid (OCA), which has had potential to be the first approved NASH drug. One year ago, the general expectation was that Intercept might be headed to market with OCA by now, with Genfit SA on its tail with elafibranor as a strong second-to-market candidate.

Genfit’s aspirations took a possibly mortal blow in May as elafibranor failed its Phase III trial. (Also see "RESOLVE-IT...

Scrip-NewProducts (Premium-2): Top 12 Pharma Companies: Pfizer Tops The Leaderboard Again

Jun 14 2025

• By Nabil

The world’s biggest pharmaceutical companies mostly saw growth in 2024 but 2025 promises to be more of a mixed bag with headwinds including losses of exclusivity, Medicare Part D redesign and challenges in the Chinese market.

Innovent/GenFleet Score China’s First KRAS G12C Inhibitor Approval

Mar 10 2025

• By Dexter Jie Yan

The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.

Cagrisema Leads The Charge For 2025

Mar 10 2025

• By Elizabeth Cairns

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.

Small But Mitey: Tarsus To Amp Up Strong Xdemvy Launch

Mar 10 2025

• By Alexandra Shimmings

Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.

EHA: Lilly’s Jaypirca Posts First Phase III Triplet Win In CLL While BTK Degraders Advance - Clone

Jun 18 2026

Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.