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 US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.
Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.
At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.
