Drugs in the Pipeline
Results found that rates of COPD exacerbations were lowest in the 175mcg treatment arm. Also, the adverse events and serious adverse events in the revefenacin group were comparable to the tiotropium group.
Dr. Pascale Richetta, head of bone and executive vice president, UCB, stated, "With all three pivotal romosozumab Phase 3 studies now included in the clinical evidence package, representing data from more than 11,000 patients, we are committed to bringing this important potential new treatment to those people living at risk of fragility fractures."
The Orphan Drug designation was supported by data from preliminary studies showing that ALLN-177 significantly decreased urinary and plasma oxalate in several rodent and porcine models.
VT-1598, an oral fungal CYP51 inhibitor, has shown high potency against pathogens such as molds, yeasts, and multi-drug resistant fungal pathogens (eg, Candida auris).
Data from a Phase 1/2 study in patients with MDS who had disease progression on or after first-line azacitidine treatment showed initial signs of clinical activity with DSP-7888, and that it was well tolerated in study patients.
The NDA included data from two trials, MONARCH 1 and MONARCH 2, which are a part of the comprehensive MONARCH clinical trial program.
Currently, entrectinib is being evaluated in the global, multicenter, open-label, potentially registration-enabling Phase 2 STARTRK-2 trial (Studies of Tumor Alterations Responsive to Targeting Receptor Kinases)
Trevyent contain treprostinil, a vasodilatory prostacyclin analogue. It works primarily through vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation.
According to the Company, SOBI003 is currently in the late pre-clinical phase and its first clinical trial is expected to commence in 2018.
The investigational drug is intended to substitute the deficient PAH enzyme with a PEGylated phenylalanine lyase enzyme to break down Phe.
"We look forward to FDA's review of our application for a potential new treatment option for the millions of people living with OAB," said Bernhardt Zeiher, MD, president of Development at Astellas.
The primary analysis of the study arm showed a statistically and clinically significant reduction in bleeding by 87% (risk rate [RR] 0.13; P<0.0001] with emicizumab prophylaxis.
The proposed indications are for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.
The gel is hormone-free and can be used with other forms of contraception or used alone. The gel, supplied in a pre-filled applicator, can be self-applied.
In the NDA resubmission, the Company included safety and efficacy data from the Phase 3 trial SECURE, the manufacturing information, and a summary response to the CRL.
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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)