Drugs in the Pipeline
Theravance announced that the Food and Drug Administration (FDA) has granted Fast Track designation to to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis.
Novo Nordisk has announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for semaglutide, for the treatment of adults with type 2 diabetes.
Merck announced that the Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for review.
Arsanis has announced that the Food and Drug Administration (FDA) has granted Fast Track designation to ASN100, a novel combination of two fully human monoclonal antibodies to potentially prevent Staphylococcus aureus pneumonia.
Daiichi Sankyo announced that the Food and Drug Administration (FDA) has granted Fast Track designation for DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).
Pfizer announced positive Phase 3 study data that evaluated Lyrica (pregabalin) capsules and oral solution as adjunctive therapy for pediatric epilepsy patients aged 4-16 years with partial onset seizures.
AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to risankizumab (ABBV-066) for the investigational treatment of Crohn's disease in pediatric patients.
Merck and Pfizer announced that the Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for avelumab to treat metastatic Merkel cell carcinoma.
Pfizer announced positive results from the REFLECTIONS B3271002 study that compared the safety and efficacy of Herceptin (trastuzumab; Genentech) and PF-05280014, a potential biosimilar to Herceptin.
Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the expanded labeling of Abilify Maintena (aripiprazole extended-release) for the maintenance treatment of bipolar I disorder in adults.
Momenta has announced their adalimumab biosimilar candidate, M923, has met its Phase 3 primary endpoint of at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment.
Santen has announced positive results from two Phase 3 trials of sirolimus intravitreal injection 440µg (Opsiria) for patients with non-infectious uveitis of the posterior segment.
PhaseRx announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for PRX-OTC for the treatment of ornithine transcarbamylase deficiency (OTCD).
Intellipharmaceutics has filed a New Drug Application (NDA) with the Food and Drug Administration (FDA) for Rexista, a formulation of extended-release oxycodone hydrochloride with abuse-deterrent properties.
Eli Lilly announced that solanezumab did not meet the primary endpoint in the Phase 3 EXPEDITION3 clinical trial in patients with mild dementia due to Alzheimer's 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)