Drugs in the Pipeline
The Food and Drug Administration (FDA) has accepted for filing and granted priority review the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab, Bristol-Myers Squibb) for the treatment of previously treated patients with non-squamous (NSQ) non-small cell lung cancer (NSCLC).
Acadia announced it has submitted to the Food and Drug Administration (FDA) a priority review of the New Drug Application (NDA) for Nuplazid (pimavanserin) for the treatment of Parkinson's disease psychosis (PDP).
Gilead announced that a Phase 3 study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) for the treatment of HIV-1 infection met its primary objective.
Amgen and UCB announced top-line results from the STRUCTURE trial evaluating romosozumab in women with postmenopausal osteoporosis at high risk for fracture previously treated with bisphosphonate therapy.
Boehringer Ingelheim presented positive results of its Phase 3 RE-VERSE AD study for idarucizumab as a reversal agent for the anticoagulant effect of Pradaxa (dabigatran) in patients needing emergency surgery or for life-threatening or uncontrolled bleeding events.
The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Empliciti (elotuzumab, Bristol-Myers Squibb/AbbVie) for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies.
The Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for MCNA (Telesta) as a therapeutic alternative to surgery in high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy.
Gilead Sciences announced positive results from the AMBITION study, a Phase 3/4 trial of first-line combination therapy with Letairis (ambrisentan) and tadalafil in patients with WHO/NYHA functional class II and III pulmonary arterial hypertension (PAH).
The Food and Drug Administration (FDA) has granted SYM-1219 (secnidazole, Symbiomix) Fast Track designation for the treatment of bacterial vaginosis (BV).
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for eteplirsen (Sarepta) for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.
The Food and Drug Administration (FDA) has granted AT001 (Audentes) Orphan Drug designation for the treatment of X-Linked Myotubular Myopathy (XLMTM).
Intarcia Therapeutics has announced that the Phase 3 trial of ITCA 650 (exenatide) demonstrated positive top-line results in reducing HbA1c in patients with type 2 diabetes following a year of treatment.
Genentech announced that the Phase 2 study of atezolizumab met its primary endpoint and shrank tumors in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed PD-L1 (Programmed Death Ligand-1).
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for BromSite (0.075% bromfenac; InSite Vision) for the treatment of inflammation and prevention of ocular pain post-cataract surgery.
The Food and Drug Administration (FDA) has accepted for review the sBLA for Keytruda (pembrolizumab, Merck) for the first-line treatment of unresectable or metastatic melanoma patients.
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)
- Phosphate Binder Adherence Challenging for Dialysis Patients
- Transperineal Prostate Biopsy Better for PCa Risk Statification
- Androgen Deprivation for Localized Prostate Cancer Ups Cardiac Risks
- Upping Shock Wave Frequency Improves Ureteral Stone Clearance
- Prostate Cancer Diagnosis Raises Suicide Risk
- Preop ADT Could Potentially Eradicate High-Risk Prostate Tumors
- PCa Deaths Rare Among Low-Risk Patients on Active Surveillance
- Can Tight Blood Pressure Control Prevent Repeat Hemorrhagic Strokes?
- Joint Pain Linked to DPP-4 Inhibitor Use by Type 2 Diabetics
- Doctor Involvement Improves Obese Patients' Weight-Loss Efforts