The EGFR inhibitor cetuximab in combination with Lilly's Gemzar (gemcitabine) does not improve survival in patients with locally advanced unresectable or metastatic pancreatic cancer, ImClone and Bristol-Myers Squibb announce April 10. A 700-patient Phase III trial examining the combination therapy for first-line treatment failed to demonstrate overall survival, but development will continue for nine Phase I and Phase II trials in the indication. Positive results of a 400-patient Phase III trial in recurrent and/or metastatic head and neck cancer were announced April 4. First-line use of Erbitux with chemotherapy met the study's primary endpoint of overall survival, the companies say. Erbitux is currently approved for head and neck and colorectal cancer...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
