Drugs in the Pipeline
The Food and Drug Administration (FDA) has granted Fast Track designation to TXA127 (angiotensin 1-7; Tarix Orphan) to reduce skeletal muscle damage and fibrosis and thereby improve muscle strength in Duchenne Muscular Dystrophy (DMD) patients.
The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to three supplemental New Drug Applications (sNDAs) for Daklinza (daclatasvir; BMS) for use with sofosbuvir with or without ribavirin for the treatment of patients with chronic hepatitis C (HCV) co-infected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV.
Eli Lilly and Incyte announced positive top-line results of RA-BEGIN, the third Phase 3 study evaluating the safety and efficacy of baricitinib for the treatment of patients with moderately-to-severely active rheumatoid arthritis (RA).
The Food and Drug Administration (FDA) has accepted for filing with Priority Review the New Drug Application (NDA) for defibrotide for the treatment of patients with hepatic veno-occlusive disease (VOD) with evidence of multi-organ dysfunction (MOD) following hematopoietic stem-cell transplantation (HSCT).
The FDA has accepted for filing the New Drug Application (NDA) for Ontinua ER (arbaclofen; Osmotica) extended-release tablets for alleviation of spasticity associated with multiple sclerosis.
Lilly announced that the Phase 2 study of Cyramza (ramucirumab) in combination with docetaxel met its primary endpoint for patients with locally advanced or who failed prior platinum-based therapy.
The Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental New Drug Application (sNDA) for eribulin mesylate (Eisai) for the treatment of patients with inoperable soft tissue sarcoma (leiomyosarcoma and liposarcoma) who have received prior chemotherapy for advanced or metastatic disease.
The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the supplemental Biologics License Application (sBLA) for the Opdivo (nivolumab; BMS) + Yervoy (ipilimumab; BMS) regimen to include clinical data from the CheckMate -067 trial of patients with previously untreated advanced melanoma.
Bristol-Myers Squibb announced positive results from CheckMate -025, a Phase 3 study comparing Opdivo (nivolumab) to everolimus in advanced renal cell carcinoma (RCC) after prior anti-angiogenic treatment.
The New Drug Application (NDA) for Dextenza (sustained release dexamethasone; Ocular Therapeutix) 0.4mg Intracanalicular Depot has been submitted to the FDA for the treatment of ocular pain following ophthalmic surgery.
Genentech announced positive results from a pivotal Phase 3 study, ORATORIO, which evaluated the investigational drug ocrelizumab for the treatment of primary progressive multiple sclerosis (PPMS).
The FDA has granted Orphan Drug designation to the investigational cancer immunotherapy avelumab (Pfizer/Merck) for the treatment of Merkel cell carcinoma (MCC).
OptiNose announced positive results from a second phase 3 trial evaluating the safety and efficacy of OPN-375 for the treatment of nasal polyposis and the associated symptoms of the disease.
The FDA has accepted for filing and granted Priority Review to the New Drug Application (NDA) for Narcan (naloxone; Adapt Pharma) Nasal Spray for the emergency treatment of known or suspected opioid overdose.
Amgen and Allergan announced that their biosimilar candidate ABP 215 met its primary and secondary endpoints in a Phase 3 study evaluating its efficacy and safety compared with Avastin (bevacizumab) in adult patients with advanced non-squamous non-small 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)
- Extended Pelvic Lymph Node Dissection Not Linked with ED, Incontinence
- Reduced-Dose Tacrolimus, Everolimus Cut CMV Infection
- New Guidelines Developed for Peri-Op Management of Diabetes
- Taller Individuals Appear More Likely to Develop Cancer
- Restricting Dietary Protein and Phosphorus May Improve CKD-MBD