Specialty Pharma Journal

Sanofi's JAK2 Inhibitor Meets Primary Endpoint in Late-Stage Trial for Treatment of Myelofibrosis

Today, Sanofi announced that its JAK2 inhibitor met the primary endpoint in both dose groups during a Phase III study evaluating the drug for treatment of myelofibrosis.

The pivotal study, JAKARTA, evaluated once-daily, oral SAR302503 compared to placebo. The study consisted of 289 patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis, which were randomly assigned a 400mg dose of SAR302503, 500mg dose...

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Unraveling Accreditation, Certification, and Certificate Programs

When it comes to the approval or designation of individuals and organizations the terms accreditation, certification, and certificate are all commonly used and misused. Understanding the differences leads to a better understanding of professional credentialing.  

Accreditation  

Accreditation generally applies to an organization (as opposed to a person).  Accreditation can be awarded to a college, a factory, a laboratory, or in this case – a certification program. The Institute of Credent...

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Gilead Announces Positive Phase II Trial Results for its Leukemia Drug

Gilead Sciences, Inc. recently announced results from a Phase 2 study evaluating its investigational chronic lymphocytic leukemia (CLL) drug.

The Phase 2 study, Study 101-08, evaluated idelalisib, formerly GS-1101, an investigational, targeted, oral inhibitor of PI3K delta, in combination with rituximab for older patients with treatment-naïve CLL. Gilead released data in advance of the American Society of Clinical Oncology (ASCO) Annual Meeting. In the study, the regimen achieved a complete respo...

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