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The PAREXEL Clinical Development Optimization process uses advanced technology to help expedite drug development through all four critical stages of clinical development – design, start-up, trial execution, and

Kalydeco has also been approved to use in CF patients at least 18 years old and more who have an R117H mutation. Vertex had earlier secured approval to

Helsinn Healthcare together with Roche Palo Alto filed an infringement lawsuit against Teva Pharmaceuticals USA and Teva Pharmaceutical Industries (collectively Teva) in the US. The US District Court

The Phase I/IIa trial, which is anticipated to start in the first half of 2016, will be funded and carried out by the NCI on about 55 patients.

The extension will run until November 2019 with an option to add another year. Summit will retain the exclusive rights to any intellectual property resulting from the alliance.

Roche’s option stems from a pre-existing deal with Novartis. Ophthotech’s agreement with Novartis, which was signed in May last year, remains in effect. Ophthotech retains exclusive rights to

Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used in combination with

Turing head of research and development Eliseo Salinas said: "I’m happy to report that TUR-004 was well tolerated and assessments continue as planned. "This is certainly a small

The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS) in patients receiving