Drugs in the Pipeline
The Food and Drug Administration (FDA) has accepted for filing and has granted Priority Review to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of previously untreated patients with unresectable or metastatic melanoma.
The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor; AstraZeneca) tablets for patients with a history of heart attack.
The Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for review for Zinbryta (daclizumab high-yield process; Biogen and AbbVie) in relapsing forms of multiple sclerosis (MS).
The Food and Drug Administration (FDA) has granted Fast Track designation for the development of GZ/SAR402671 (Genzyme), an oral substrate reduction therapy for the treatment of Fabry disease.
The Food and Drug Administration (FDA) has granted Fast Track designation to CRLX101 (Cerulean Pharma) in combination with Avastin (bevacizumab) for the treatment of metastatic renal cell carcinoma (mRCC) following progression through two or three prior lines of therapy.
GlaxoSmithKline announced results from the Phase 3 ZOE-50 trial of HZ/su, an investigational vaccine for the prevention of herpes zoster in older adults.
Enanta announced results from AbbVie's ongoing, Phase 3b RUBY-1 study evaluating Viekirax (ombitasvir/paritaprevir/ritonavir) plus Exviera (dasabuvir) with or without ribavirin (RBV) in treatment naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage 4 or 5), including those on hemodialysis.
Bristol-Myers Squibb announced results from the ALLY-1 Phase 3 clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) infection with either advanced cirrhosis or post-liver transplant recurrence of HCV.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Resolaris (aTyr Pharma), a physiocrine-based product for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to DCR-PH1 for the treatment of primary hyperoxaluria type 1 (PH1).