Drugs in the Pipeline
Pfizer announced top-line results from OCTAVE Sustain, the third Phase 3 study of Xeljanz (tofacitinib citrate) for the potential treatment of patients with moderately to severely active ulcerative colitis (UC).
The FDA has granted Fast Track designation to SHP626 (volixibat; Shire) for the potential treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis
Recro Pharma announced positive results from the Phase 3 study for intravenous (IV) meloxicam (N1539) for the treatment of acute postoperative pain in patients following bunionectomy surgery.
The FDA has granted Fast Track designation to Caladrius Biosciences' product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) for the treatment of Type 1 diabetes mellitus (T1DM).
The FDA has granted Breakthrough Therapy designation to Darzalex (daratumumab; Janssen Biotech) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of multiple myeloma in patients who have received at least one prior therapy.
TauRx Therapeutics announced findings from the Phase 3 trial of LMTX for the treatment of mild or moderate Alzheimer's disease (AD). Results were presented at the 2016 Alzheimer's Association International Conference (AAIC) in Toronto, Canada.
The FDA has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) of Dextenza (dexamethasone insert; Ocular Therapeutix) 0.4mg for the intracanalicular treatment of ocular pain after ophthalmic surgery.
Merck announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational vaccine V920 (rVSV-ZEBOV-GP, live attenuated) for the Ebola Zaire virus.
Sunovion announced positive findings from the GOLDEN-5 safety study evaluating SUN-101 (glycopyrrolate) delivered via an investigational nebulizer system (SUN-101/eFlow) for the treatment of moderate-to-very severe chronic obstructive pulmonary disease (COPD).
Amgen and UCB announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Evoke Pharma announced topline Phase 3 data demonstrating that treatment with EVK-001 for the symptomatic relief of acute and recurrent diabetic gastroparesis in adult women failed to achieve the primary endpoint at Week 4.
The Food and Drug Administration (FDA) has granted Fast Track designation to Keyzilen (AM-101; Auris Medical) for the treatment of acute peripheral tinnitus following cochlear injury or otitis media in adults.
Allergan announced the submission of a de novo application to the Food and Drug Administration (FDA) for the Oculeve Intranasal Tear Neurostimulator device.
ANI announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for nilutamide tablets, the generic version of Nilandron (Covis), indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer.
The Food and Drug Administration (FDA) has granted Orphan Drug designation for mazindol (NLS Pharma) for the treatment of narcolepsy.
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)