Drugs in the Pipeline
Gene therapy showed a significant benefit in lung function in patients with cystic fibrosis, data from a Phase 2 trial has shown.
The Food and Drug Administration (FDA) has granted Fast Track designation to Aerucin (Aridis Pharmaceuticals) for the treatment of hospital-acquired and ventilator-associated pneumonia caused by Pseudomonas aeruginosa.
Genentech announce positive results from two Phase 3 studies evaluating ocrelizumab compared with Rebif (interferon beta-1a) in patients with relapsing multiple sclerosis (MS).
Sarepta Therapeutics announced that it has completed a rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for eteplirsen.
Merck announced results from a Phase 3 study of single-dose Emend (fosaprepitant dimeglumine) for injection in combination with other anti-vomiting medications for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients receiving moderately emetogenic chemotherapy (MEC).
Protein Sciences announced that Flublok Quadrivalent was better at preventing influenza than the traditional influenza vaccine.
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for irinotecan liposome injection (MM-398; Merrimack Pharmaceuticals and Baxalta) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.
DBV Technologies announced that based its meeting with the Food and Drug Administration (FDA), it plans to initiate a global Phase 3 study of its investigational Viaskin Peanut epicutaneous immunotherapy (EPIT) patch for the treatment of peanut allergies.
AbbVie announced results from the Phase 3b TURQUOISE-III study with Viekirax (ombitasvir/paritaprevir/ritonavir) plus Exviera (dasabuvir) without ribavirin (RBV) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis.
Valeant Pharmaceuticals and Progenics Pharmaceuticals announced the submission of a New Drug Application (NDA) to the FDA for Oral Relistor (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
Portola Pharmaceuticals, Bristol-Myers Squibb Company, and Pfizer announced results from the Phase 3 ANNEXA-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors - Apixaban) study with andexanet alfa as a reversal agent for Eliquis (apixaban).
Boehringer Ingelheim announced results from an interim analysis of the Phase 3 RE-VERSE AS patient study with idarucizumab for urgent reversal of the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to ImMucin (Vaxil Bio) for the treatment of multiple myeloma.
The Food and Drug Administration (FDA) has granted Fast Track designation to encenicline (Forum Pharmaceuticals) for the treatment of cognitive impairment in schizophrenia.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AR101, an oral immunotherapy for children and adolescents 4 to 17 years of age who are allergic to peanuts.
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)
- Complications More Likely After Radiotherapy vs. Surgery for PCa
- Metformin Use in Advanced CKD Raises Death Risk
- Heparin-Lidocaine Combo Relieves Interstitial Cystitis Symptoms
- Cholecalciferol May Be Superior for Treating Vitamin D Deficiency
- Laparoscopically Harvesting Right Kidneys from Living Donors Safe