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.
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.
The European Court of Justice declared that the European Commission was out of bounds in attempting to thwart Illumina Inc.’s proposed reacquisition of Grail Inc., which Illumina said relieves it of a fine of roughly €430 million (US$474.92 million).
The European Commission has approved Cstone Pharmaceuticals Ltd.’s PD-L1 monoclonal antibody, sugemalimab, in combination with platinum-based chemotherapy for first-line treatment of adults with metastatic non-small-cell lung cancer with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
The industry is again raising concerns that new EU health technology assessment rules coming into force on Jan. 12, 2025, will have the opposite of the desired effect and slow down access to innovative therapies.
The European Council formally approved another delay for the In Vitro Diagnostic Regulation
implementation, which now gives developers of existing high-risk in vitro diagnostics until December 2027 to obtain a renewed CE mark.
The EU has given the go ahead for a large-scale transnational project that will invest €6.9 billion (US$7.45 billion) to address unmet medical need and fill gaps across the pharmaceutical value chain.
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
