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Home » primary biliary cholangitis

Articles Tagged with ''primary biliary cholangitis''

Welireg, Emcitate among drugs EMA recommends for approval

Dec. 13, 2024
By Nuala Moran
The EMA’s Committee for Medicinal Products for Human Use recommended 17 drugs for approval at its December meeting, bringing the total for 2024 to 114. That is up from the 77 drugs recommended for approval in 2023, of which 39 were novel.
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Digital handshake

Tolerogenic assets at heart of Cour-Genentech $940M autoimmune deal

Dec. 3, 2024
By Karen Carey
During a busy day of dealmaking, Cour Pharmaceutical Development Co. Inc. entered a pact with Roche Holding AG’s Genentech unit to advance tolerogenic nanoparticle treatments for an autoimmune disease indication, garnering up to $940 million in up-front and milestone payments. Cour’s partnership with Genentech is its biggest to date, and the largest deal announced by a biopharma company on Dec. 3. A total of seven deals amounted to a combined single-day deal value of $3.67 billion.
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Ocaliva

PBC therapy Ocaliva gets conditional nod revoked in Europe

Nov. 27, 2024
By Nuala Moran
The conditional marketing approval for Ocaliva (obeticholic acid) has been revoked with immediate effect, following a standoff between the EMA and Advanz Pharma Ltd., the company that markets the primary biliary cholangitis (PBC) therapy in Europe. On Sept. 5, London-based Advanz won a short reprieve after challenging the EMA’s June 28 ruling that the marketing authorization for Ocaliva should be revoked, when the General Court of the EU granted a temporary suspension of EMA’s decision. However, on Nov. 27, Advanz announced the court had said it would not be extending the suspension.
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Tharimmune surges on phase II plans in liver disease pruritus

Oct. 30, 2024
By Jennifer Boggs
Shares of Tharimmune Inc. shot up more than 100% in early trading Oct. 30 as the firm disclosed regulatory backing to launch a phase II trial this quarter testing TH-104, a transdermal buccal film version of nalmefene, to treat pruritus that is associated with primary biliary cholangitis.
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Intercept faces a skeptical FDA in rare liver disease adcom

Sep. 13, 2024
By Lee Landenberger
Intercept Pharmaceuticals Inc. lost its uphill battle to convince the U.S. FDA’s Gastrointestinal Drugs Advisory Committee that the risks of its second-line primary biliary cholangitis drug outweigh the benefits. The committee overwhelmingly said the data in the follow-up studies of treating the rare disease with Ocaliva (obeticholic acid), which has accelerated approval from the FDA, was insufficient.
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Intercept‘s Ocaliva facing challenging adcom

Sep. 11, 2024
By Mari Serebrov
Friday the 13th could be a make-or-break day in the U.S. for Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid). That’s the day the company will make its case before the FDA’s Gastrointestinal Drugs Advisory Committee for turning an 8-year-old accelerated approval into traditional approval.
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European Union flag with wooden gavel

Advanz wins stay, keeps PBC drug Ocaliva on Europe market for now

Sep. 5, 2024
By Nuala Moran
Advanz Pharma Ltd. has won a stay on the withdrawal of its primary biliary cholangitis (PBC) drug, Ocaliva (obeticholic acid), after the European Commission (EC) said on Sept. 3 that the conditional marketing approval should be revoked. Following that, London-based Advanz launched a legal challenge, announcing on Sept 5 that the General Court of the EU has temporarily suspended the EC’s decision. As a result, the conditional marketing authorization for Ocaliva remains in place until further notice from the court, and the 7,000 existing patients – and new ones – will still have access to the farnesoid X receptor agonist.
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Livdelzi

Bile files: PPARs weighed as Gilead’s Livdelzi joins in PBC

Aug. 16, 2024
By Randy Osborne
Label comparisons began promptly with the accelerated U.S. FDA clearance of Gilead Sciences Inc.’s oral peroxisome proliferator-activated receptor (PPAR)-delta drug, Livdelzi (seladelpar), for primary biliary cholangitis (PBC). The space includes Ipsen Pharma SA’s dual PPAR alpha/delta agonist, Iqirvo (elafibranor), licensed from Genfit SA and cleared in June 2024, as well as Ocaliva (obeticholic acid), the first-in-class farnesoid X receptor agonist from Intercept Pharmaceuticals Inc., greenlighted for PBC in May 2016.
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Leqembi

EMA’s CHMP issues thumbs-down on Alzheimer’s drug Leqembi

July 30, 2024
By Nuala Moran
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 14 drugs and the extension of the label of 11 others at its July meeting, but, inevitably, it was the decision to turn down the Alzheimer’s disease therapy Leqembi (lecanemab) that stirred the greatest reaction.
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Liver
Immune

PVT-201 gets US orphan status, cleared for Aussie trial

July 30, 2024
Parvus Therapeutics Inc.'s PVT-201 has received orphan drug status from the U.S. FDA for the treatment of primary biliary cholangitis (PBC), an autoimmune disease of the liver.
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