Drugs in the Pipeline
Pexidartinib Gets Priority Review for Tenosynovial Giant Cell Tumor
The NDA is supported by data from the Phase 3 ENLIVEN study (N=120) which randomized patients with symptomatic TGCT to receive pexidartinib or placebo to evaluate the safety and efficacy of the treatment.
FDA to Review Two Antibacterial Agents for Potentially Life-Threatening Infections
Both filings have been granted Priority Review by the Agency.
Novel Glioblastoma Treatment Granted Orphan Drug Designation
In preclinical models, the inhibition of phosphorylated STAT3 (p-STAT3) by WP1066 resulted in the direct attack of various tumor cells.
FDA to Review Cenobamate for the Treatment of Partial-Onset Seizures
While the exact mechanism of action of cenobamate is not fully understood, it is believed to work through a dual mechanism.
Baricitinib Beneficial in Two Phase 3 Atopic Dermatitis Trials
Baricitinib, a Janus kinase inhibitor, is currently approved under the brand name Olumiant for the treatment of moderately-to-severely active rheumatoid arthritis.
FDA Rejects Opioid System Modulator NDA for Depression Treatment
Alkermes plans to meet with the FDA to discuss next steps for ALKs 5461.
Investigational Treatment for Multiple System Atrophy Gets Orphan Drug Status
Currently, there are no approved therapies for the treatment of MSA, a rare progressive neurodegenerative disease.
Trials Evaluating Crenezumab in Early Alzheimer Disease Halted
Crenezumab is an investigational monoclonal antibody that preferentially binds to and promotes the removal of neurotoxic oligomers, a form of beta-amyloid.
Novel Combined Oral Contraceptive Effective in Phase 3 Trial
Previous Phase 2 studies confirmed esterol has minimal impact on liver cells and metabolic pathways, as well as on coagulation parameters.
FDA Grants Breakthrough Therapy to 15-Valent Pneumococcal Conjugate Vaccine
Phase 3 studies investigating safety, tolerability, and immunogenicity in both adults and children are currently underway.
Tanezumab Beneficial in Second Phase 3 Osteoarthritis Pain Trial
Tanezumab is a humanized monoclonal antibody that selectively targets, binds to, and inhibits nerve growth factor (NGF).
Dengue Vaccine Candidate TAK-003 Looks Promising in Phase 3 Trial
The TIDES trial is investigating the safety and efficacy of 2 doses of TAK-003 in preventing dengue fever caused by any of the 4 dengue virus serotypes.
Bermekimab Looks Promising for Hidradenitis Suppurativa
This investigational treatment was evaluated in 42 HS patients, of which 24 had previously failed anti-tumor necrosis factor (TNF) therapy.
FDA to Review Pifeltro, Delstrigo for Expanded HIV Indication
Once-daily Pifeltro and Delstrigo were initially approved in August 2018 to treat HIV-1 infection in adults with no prior antiretroviral treatment experience.
First-in-Class Drug for Biliary Atresia Granted Orphan Drug Designation
Currently, there is no FDA-approved treatment for biliary atresia, a rare pediatric liver disease.
Renal and Urology News Articles
- Clinicians Somewhat Favor Shared Decision-Making in Older mCRPC Patients
- Higher Push-Up Capacity Linked to Lower Incidence of CVD Events
- Pembrolizumab Shows Promise for BCG-Unresponsive Bladder Cancer
- Radical Cystectomy Superior to Trimodal Therapy for Muscle-Invasive Bladder Cancer
- Dialysis and Transplant Patients at Increased Risk for Cancer Death
NEPHROLOGY & UROLOGY NEWS
- Acute Kidney Injury (AKI)
- Anemia
- Chronic Kidney Disease (CKD)
- Contrast Nephropathy
- Cardiovascular Disease (CVD)
- Diabetes
- Diabetic Nephropathy
- End-stage Renal Disease (ESRD)
- Hemodialysis
- Hyperphosphatemia
- Hypertension
- Hyperuricemia
- Lupus Nephritis
- Peritoneal Dialysis
- Secondary Hyperparathyroidism (SHPT)
- Transplantation