Drugs in the Pipeline
Results demonstrated that at 12 weeks after the first dose of fremanezumab, the CM group had reductions of monthly headaches; -4.6 days for the monthly dose, -4.3 days for the quarterly dose and -2.5 for the placebo group (P<0.0001).
"If [the sNDA is] approved, Cabometyx will offer an important new alternative for the treatment of patients with previously untreated advanced RCC," said Michael M. Morrissey, PhD, President and CEO of Exelixis.
ARCH (Active-contRolled FraCture Study in Postmenopausal Women with Osteoporosis at High Risk of Fracture) was a multicenter, international, randomized, double-blind, alendronate-controlled study (n=4,093) in postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history.
Results found that at 52 weeks severe asthma attacks were reduced by 46% in the overall population for the 300mg dose group and by 60% and 67% among those patients with ≥150 eosinophilic cells/microliter or greater and ≥300 eosinophilic cells/microliter, respectively (P<0.001).
A Phase 2, single-arm, open-label clinical trial, EMPOWER-CSCC 1, is now enrolling patients with metastatic CSCC and locally advanced and unresectable CSCC.
Early Phase 1 data has indicated that the treatment drug can be more efficacious than mesalamine/5-ASA treatments alone.
Results from two previously Phase 2 trials of NeuroRx's sequential treatment have shown a 50% reduction in symptoms of depression and a 75% reduction in suicidal ideation in bipolar patients.
Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, was evaluated in two Phase 3 clinical studies in about 1,700 women with moderate-to-severe endometriosis-associated pain.
A total of 66 patients with FCS were enrolled in the year-long APPROACH which met its primary endpoint of reduction in triglycerides at 3 months, with a 77% mean reduction in triglycerides for volanesorsen-treated patients.
"Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly," said Amy Emerson, Executive Director of the MAPS Public Benefit Corporation.
Two year-long studies assessing safety of dasotraline in children, adolescent and adult ADHD patients found the treatment to be generally well tolerated.
The FDA has granted Priority Review to the New Drug Application (NDA) of tezacaftor/ivacaftor (Vertex) for the treatment of patients ≥12yrs old with cystic fibrosis (CF) who have two copies of the F508del mutation or one F508del mutation and one residual function mutation.
The FDA has accepted and granted Priority Review to the Biologics License Application (BLA) of emicizumab (Genentech) for the prophylactic treatment of hemophilia A in adults, adolescents and children with factor VIII inhibitors.
Burosumab is being developed in a collaboration between Ultragenyx and Kyowa Hakko Kirin Pharmaceuticals, based on a license agreement between both companies.
Key secondary endpoints included complete response rate, progression-free survival (PFS), and reduction in the burden of symptoms during treatment.
Renal and Urology News Articles
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- First Metastasis Site Predicts Prostate Cancer-Specific Survival
- High Phosphorus Ups Risk of Kidney Transplant Failure, Death
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)