Drugs in the Pipeline
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).
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.
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).
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.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Cantrixil (TRXE-002; CanTx Inc.) for ovarian cancer.
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.
The Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Xalkori (crizotinib; Pfizer) for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC).
The FDA has granted Fast Track designation to lonafarnib (Eiger BioPharmaceuticals) in combination with ritonavir for treatment of hepatitis delta virus (HDV) infection.
The FDA has accepted for filing the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin; Seattle Genetics) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression.
Merck announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer (NSCLC).
MedDay announced results from its Phase 3 MS-SPI clinical trial with MD1003, a highly concentrated pharmaceutical-grade biotin for the treatment of progressive multiple sclerosis.
Bristol Myers Squibb announced results from its Phase 3 CheckMate-057 study of Opdivo (nivolumab) vs. docetaxel in previously treated patients with advanced non-squamous cell lung cancer (NSCLC).
NEPHROLOGY & UROLOGY NEWS
- Acute Kidney Injury (AKI)
- Chronic Kidney Disease (CKD)
- Contrast Nephropathy
- Cardiovascular Disease (CVD)
- Diabetic Nephropathy
- End-stage Renal Disease (ESRD)
- Lupus Nephritis
- Peritoneal Dialysis
- Secondary Hyperparathyroidism (SHPT)