Drugs in the Pipeline
Remedy announced that their investigational treatment for severe cerebral edema in patients with acute ischemic stroke, Cirara, has been granted Orphan Drug Designation.
Allergan and Gedeon Richter announced positive results from the second Phase 3 trial of ulipristal acetate, evaluating its efficacy and safety for the treatment of abnormal bleeding due to uterine fibroids in women.
Shionogi has announced positive results from the APEKs-cUTI* study which evaluated their novel antibiotic, cefiderocol (S-649266), for the treatment of patients with serious complicated urinary tract infection (cUTI) by Gram-negative bacteria.
Heron Therapeutics announced the submission of the New Drug Application (NDA) for Cinvanti (HTX-019) to the Food and Drug Administration (FDA) for the prevention of chemotherapy-induced nausea and vomiting (CINV).
Mylan announced that the Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for their biosimilar to trastuzumab, MYL-1401O
AMAG pharmaceuticals and Palatin Technologies have entered into an agreement for the exclusive North American rights to develop and commercialize Rekynda (bremelanotide), an investigational drug to treat hypoactive sexual desire disorder (HSDD).
ViraCyte announced that the FDA has granted Fast Track designation to its T cell immunotherapy, Viralym-C, for the treatment of refractory cytomegalovirus (CMV) infections in patients following a stem cell transplant.
AbbVie announced positive data from its Phase 3 study of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in Japanese patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection without cirrhosis.
Genentech announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab)
Alexion has submitted a marketing application to the Food and Drug Administration (FDA) to extend the indication for Soliris (eculizumab) to be a treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
Alexion has announced that the Food and Drug Administration (FDA) has granted orphan drug designation to ALXN1210, their candidate treatment for paroxysmal nocturnal hemoglobinuria (PNH).
LFB S.A. announced that the FDA has accepted for review the Biologic License Application (BLA) of its recombinant Coagulation Factor VIIa (eptacog beta, activated) for the potential treatment of congenital hemophilia A or B in adolescents and adults with inhibitors.
The FDA has accepted for review the New Drug Application (NDA) for ADS-5102 (amantadine extended-release capsules; Adamas) for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease.
Acucela has announced that the Food and Drug Administration (FDA) has granted orphan drug designation to their candidate, emixustat (emixustat hydrochloride), for the treatment of Stargardt disease.
Fibrocell Science announced that the Food and Drug Administration (FDA) has granted Fast Track designation to FCX-007 for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB).
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)