Drugs in the Pipeline
Currently, there is a global Phase 3 program comprised of 6 studies involving approximately 7,000 patients with OA, CLBP or cancer pain with inadequate treatment of pain with approved therapies.
Three of the ongoing studies are evaluating the safety and efficacy of BIC/FTC/TAF vs. triple-therapy regimens containing dolutegravir 50mg among treatment-naive patients and among virologically-suppressed patients who are switching from an existing antiretroviral regimen with dolutegravir.
Results from both studies showed Trulance was statistically superior to placebo in achieving the primary endpoint (Study 1: 30.2%, P<0.001 in 3mg and 29.5% in 6mg vs. 17.8% in placebo; Study 2: 21.5% in 3mg and 24.0% in 6mg vs. 14.2% in placebo).
Vyndaqel is approved in Europe and a number of other countries to treat transthyretin familial amyloid polyneuropathy (TTR-FAP) but not in the U.S.
Results showed that the Repatha plus statin group had a statistically significant 20% (P<0.001) reduction in hard major adverse cardiovascular events.
The study's primary endpoint was meaningful improvement in motor function as defined by the Unified Parkinson's Disease Rating Scale—Part III.
The sBLA submission was based on results from the Phase 1/2 CheckMate -040 study.
Vyxeos, or CPX-351, combines cytarabine and daunorubicin in a nano-scale liposome at a 5:1 molar ratio using the CombiPlex platform.
The HALO Clinical Research Program consists of two 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies that compared fremanezumab to placebo in adults with episodic and chronic migraine.
Currently, the only approved treatment for AHP attacks is hemin for injection (Panhematin or Normosang).
In the ZUMA-1 trial 42% of patients demonstrated ongoing response at the 8.7-month follow-up, of which 39% achieved complete response.
Results showed a statistically significant change from baseline to Week 6 in favor of Latuda vs. placebo in the Clinical Global Impression-Bipolar Version, Severity of Illness (CBI-BP-S) score and the Children's Depression Rating Scale, Revised (CDRS-R) score.
In Phase 1 safety studies, CM4620 showed positive activity in vivo in several animal models. CalciMedica plans to begin the first of its patient studies early in 2018.
Ongoing data from two Phase 3 trials, ReSurface 1 and ReSurface 2, which enrolled over 1,800 patients, is included in the BLA.
Overall, 71 of 76 participants (93%) showed detectable CD4+ or CD8+ responses to at least one of the vaccine's four antigens.
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)