Drugs in the Pipeline
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Avaxia Biologics' investigational therapy, AVX-470 for the treatment of pediatric ulcerative colitis.
Sanofi and Regeneron announced positive results from six Phase 3 ODYSSEY trials that showed alirocumab significantly reduced LDL-C in hypercholesterolemic patients.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to dupilumab (Regeneron and Sanofi) for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.
The FDA has granted Orphan Drug designation to BGB324 (BerGenBio AS) for the treatment of acute myeloid leukemia (AML).
Janssen R&D announced that it has submitted a New Drug Application (NDA) to the FDA, for three-month paliperidone palmitate as treatment for schizophrenia in adults.
Novartis announced new data from the Phase 3 PARADIGM-HF study, in patients who received LCZ696 for heart failure with reduced ejection fraction (HFrEF).
Novartis announced results from the Phase 3 FUTURE 1 and FUTURE 2 studies with secukinumab in patients with psoriatic arthritis (PsA).
AstraZeneca announced top-line results for two pivotal Phase 3 trials investigating lesinurad, when used in combination with xanthine oxidare (XO) inhibitor allopurinol in patients with symptomatic gout not achieving target sUA levels on current allopurinol dose.
Bristol-Myers Squibb Company announced results from the Phase 3 CheckMate-066 study comparing Opdivo, an investigational PD-1 immune checkpoint inhibitor, to dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma.
Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase 3b AVERT trial investigating the use of Orencia (abatacept) plus methotrexate (MTX) in biologic and MTX-naïve CCP-positive early moderate to severe rheumatoid arthritis (RA) patients.
AstraZeneca announced that it has initiated a pre-clinical development program to evaluate the ability of investigational antibody, MEDI2452 to rapidly and specifically reverse the antiplatelet effects of Brilinta (ticagrelor) in rare emergencies, such as urgent surgery or major bleeding.
Synageva BioPharma announced positive data on sebelipase alfa in a clinical study of patients with lysosomal acid lipase (LAL) deficiency at the American Association for the Study of Liver Diseases' AASLD Liver Meeting.
Amgen and AstraZeneca announced results from AMAGINE-3, a Phase 3 trial evaluating brodalumab in patients with moderate-to-severe plaque psoriasis.
Gilead Sciences announced results from three Phase 2 open-label studies investigating the efficacy and safety of an all-oral pan-genotypic regimen containing Sovaldi (sofosbuvir) and GS-5816 for the treatment of chronic hepatitis C virus (HCV) infection.
Enanta Pharmaceuticals announced results from AbbVie's Phase 2b PEARL-I study with ABT-450/ritonavir and ombitasvir, an all-oral, interferon-free investigational treatment combining two direct-acting antivirals with or without ribavirin in patients with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection.
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)
- Optimal PSA Threshold For Targeted Biopsy Identified
- Plant-Based Phosphorus Best for Kidney Disease (CKD) Patients
- Testosterone Replacement Therapy (TRT) Beneficial in Diabetes Mellitus Patients
- Stopping Renal Cell Carcinoma (mRCC) Drugs Induces Tumor Flare
- Red Meat Contributes to Cardiovascular Disease (CVD) Risk Due to Gut Bacteria
- Once Pregnant, Living Kidney Donors More Likely to Have Hypertension
- Have malpractice award caps made any difference in medical practice?
- Erectile Dysfunction (ED) Linked to Early Vascular Disease
- Cost of Diabetes Care Continues to Rise
- 'Jekyll & Hyde' Molecule Could Lead to Aggressive Prostate Cancer (PCa)