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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A new pilot aims to take Brazil closer to ‘digital transformation.’
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.
