EMA Grants Orphan Drug Designation to DCR-PH1, Dicerna's Investigational Therapy for the Treatment of Primary Hyperoxaluria Type 1 (PH1)

August 6, 2015

Dicerna Pharmaceuticals, a leading developer of RNAi therapeutics, recognizes this regulatory milestone as important step in bringing this therapy to patients with PH1. PH1 is a severe, rare, inherited liver disorder which has no approved therapies.
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Achillion Announces That Janssen Has Initiated a Phase I Study to Evaluate the Effect of Simeprevir and Odalasvir (ACH-3102) on AL-335 Pharmacokinetics

August 3, 2015

Achillion has granted Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102) and sovaprevir.
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Clovis Oncology Completes U.S. and E.U. Regulatory Submissions for Rociletinib for the Treatment of Advanced EGFR-Mutant T790M+ Non-small Cell Lung Cancer

August 3, 2015

Clovis Oncology announces submission of its New Drug Application to the FDA and Marketing Authorization Application to the EMA for rociletinib. Rociletinib was granted Breakthrough Therapy designation by the FDA in May 2014.
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