Telik initiates a Phase III registration trial comparing its apoptosis-inducing oncologic Telcyta to AstraZeneca's Iressa for single-agent, third-line treatment of non-small cell lung cancer. ASSIST-2 (Assessment of Survival In Solid Tumors-2) will randomize 520 patients to either Telcyta (TLK286) or Iressa (gefitinib); endpoints include survival, time to tumor progression and objective response rate. Another registration trial, in women with resistant ovarian cancer (ASSIST-1), is underway. Other ongoing studies include combination regimens in NSCLC and ovarian cancer, and a single-agent study in previously untreated metastatic breast cancer. ASSIST-1 and -2 are both under special protocol assessments with FDA, Telik notes. Telcyta has fast-track designation for both indications...
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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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While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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