Drugs in the Pipeline

Drugs in the Pipeline

Viekirax + Exviera Demonstrates Virologic Response in HCV Trial

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.

SVR12 With Combo Hepatitis C Therapy for Cirrhosis Patients in Study

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.

Rare Facial Disorder Drug Designated Orphan Drug Status

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).

Rare Inherited Liver Disorder Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to DCR-PH1 for the treatment of primary hyperoxaluria type 1 (PH1).

Priority Status Granted for Combination Genotype 4 HCV Therapy

The Food and Drug Administration (FDA) has accepted AbbVie's NDA and granted priority review to its all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/R) with ribavirin (RBV) for the treatment of adults with GT4 hepatitis C virus (HCV) infection.

Single Dalvance Dose As Effective for ABSSSI in Phase 3 Trial

Actavis announced results for its Phase 3 DUR001-303 study of single dose Dalvance for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA).

Priority Review Granted for Pradaxa Reversal Agent

The Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for idarucizumab (Boehringer Ingelheim) to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate) in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event.

FDA Designates Cantrixil Orphan Drug for Ovarian Cancer

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Cantrixil (TRXE-002; CanTx Inc.) for ovarian cancer.

Investigational Malignant Melanoma Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to SRX-1177 (SolaranRx) for the treatment of stage IIB to IV malignant melanoma.

Lonafarnib Fast Tracked for Hepatitis Delta Virus Infection

The FDA has granted Fast Track designation to lonafarnib (Eiger BioPharmaceuticals) in combination with ritonavir for treatment of hepatitis delta virus (HDV) infection.