Clinical Intelligence

Arrowhead doses first patient with hepatitis B in phase I/II ARC-521study

Thursday, September 8, 2016

Arrowhead Pharmaceuticals has dosed the first patient in the multiple ascending dose (MAD) portion of its ongoing phase I/II study of ARC-521, the company’s second RNAi-based investigational medicine for the treatment of chronic hepatitis B virus (HBV) infection. To date 24 healthy volunteers have been treated in the study, and the drug safety committee (DSC) approved initiation of the MAD after a planned review of safety data from cohort 3 of the healthy volunteer portion of the study. The MAD is designed to evaluate the safety, tolerability, and antiviral activity of single and multiple doses of ARC-521 in patients with chronic HBV.

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Orexo completes 1,080 patient REZOLV opioid study

Wednesday, September 7, 2016

Orexo has announced that the REZOLV retrospective study (Retrospective Evaluation of Zubsolv Outcomes – A Longitudinal View) has been completed as planned in August. With 1,080 patients, the study is the largest retrospective study completed in the U.S. aimed at optimizing the treatment of opioid dependence.

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Takeda launches global observational study in multiple myeloma

Wednesday, September 7, 2016

Takeda Pharmaceutical has announced that its global non-interventional, observational multiple myeloma study is now enrolling patients. Titled INSIGHT-MM, the study aims to enroll 5,000 patients over three years with a goal of following each patient for a minimum of five years in an effort to track patterns in disease presentation, patient characteristics, treatment and outcomes and thereby enhance the understanding of real world experience of patients with multiple myeloma.

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Mylan to launch generic EpiPen for $300

Tuesday, August 30, 2016

Mylan has announced that its U.S. subsidiary will launch the first generic to EpiPen Auto-Injector (epinephrine injection, USP) at a list price of $300 per generic EpiPen two-pack carton, which represents a discount of more than 50% to the Mylan list price, or wholesale acquisition cost (WAC), of the branded medicine. [Read More]