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Latest From Intercept Pharmaceuticals, Inc.

Gilead Offers Up $4.3bn For CymaBay And Phase III PBC Candidate

Adding to its liver disease portfolio, Gilead agreed to pay a 27% premium for CymaBay and seladelpar, which has a 14 August FDA action date to compete in second-line primary biliary cholangitis.

M & A Business Strategies

As 2024 Begins, US FDA’s Novel Agent Prospects Look A Lot Like 2023

Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.

US FDA Performance Tracker Drug Review

Accelerated Approval Withdrawals: Will Non-Oncology Indications Stop ‘Dangling’ In 2024?

While at least 25 accelerated approval cancer indications or drugs have been pulled or requested withdrawn since 2020, there has not yet been a similar concerted regulatory effort in the non-oncology space despite a large number of products with overdue postmarketing requirements.

Pink Sheet Perspectives Review Pathway

Ipsen In Pole Position For Rare Liver Disease

The FDA is set to make a decision on elafibranor for primary biliary cholangitis by June next year, which could give Ipsen a head start over CymaBay's seladelpar.

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