Drugs in the Pipeline
Janssen said in a statement that they are informing study participants (N>600), trial investigators, health authorities, ethics committees and institutional review boards about the situation.
A Phase 3 clinical trial of patients with travelers' diarrhea demonstrated that Aemcolo was superior to placebo (P=.0008) and non-inferior to ciprofloxacin.
The NDA was supported by data from the Phase 3 inTandem clinical trial program which assessed the safety and efficacy of Zynquista in ~3000 adults with inadequately controlled type 1 diabetes.
In the LEAP 2 study (N=738), patients with moderate CABP received either oral lefamulin 600mg every 12 hours for 5 days or oral moxifloxacin 400mg once daily for 7 days
In this multicenter, double-blind, placebo-controlled trial, patients (N=409) were randomized 1:1:1 to a postoperative regimen of IV tramadol 50mg, IV tramadol 25mg, or placebo administered over 15 minutes at hours 0, 2, 4, and once every 4 hours thereafter (up to 13 doses).
Mecillinam is a beta-lactam antibiotic with a novel site of action which is specific and highly active against Gram-negative bacteria.
During the 52-week trial period, the treatment group received a 400mg dose of CZP subcutaneously at weeks 0, 2, and 4, followed by 200mg of CZP every 2 weeks starting at week 6; or placebo.
A previous Phase 2 trial of 17 patients with EBS showed that 60% of those treated with diacerein cream experienced at least a 40% reduction in blistering after 4 weeks vs 18% on vehicle.
The primary endpoint was the proportion of patients with an IGA score of 0 (clear) or 1 (almost clear) at Week 16.
The episodic cluster headache trial included a total of 106 patients with an average of 17.5 cluster headache attacks per week at baseline.
There are currently no approved pharmacological treatments that address these core symptoms of ASD.
In preliminary preclinical studies, the device has been shown to enhance anti-cancer immune system response without causing adverse effects
CLR 131 is an investigational radioiodinated Phospholipid Drug Conjugate (PDC) drug candidate that delivers cytotoxic radiation directly and selectively to malignant cells.
There are currently no approved treatments or vaccines available for chikungunya, a virus transmitted through mosquito bites.
ACE-083 is currently being studied in a Phase 2 trial for FSHD and another for Charcot-Marie-Tooth (CMT) disease.
Renal and Urology News Articles
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)