Drugs in the Pipeline
Zealand Pharma announced that Sanofi has submitted to the FDA updated data for iGlarLixi (insulin glargine and lixisenatide) as part of its New Drug Application (NDA) for the treatment of adults with type 2 diabetes.
The FDA has granted Fast Track designation to the investigational drug AZD3293 (Eli Lilly and AstraZeneca) for the treatment of Alzheimer's disease.
The Food & Drug Administration has granted Orphan Drug designation to PUR1900 (Pulmatrix) for the treatment of pulmonary fungal infections in patients with cystic fibrosis (CF).
The FDA has granted Orphan Drug designation to dusquetide (SGX942; Soligenix) for the treatment of macrophage activation syndrome (MAS), a life-threatening complication of rheumatic disease.
Janssen Biotech announced the submission to the Food and Drug Administration (FDA) of a supplemental Biologics License Application (sBLA), with a request for Priority Review, for Darzalex (daratumumab), seeking to expand its current indication for the treatment of patients with multiple myeloma who have received at least one prior therapy.
The FDA has granted Breakthrough Therapy designation to the investigational compound esketamine (Janssen) for the treatment of major depressive disorder (MDD) with imminent risk for suicide.
The FDA has issued a Complete Response Letter (CRL) to the Biologics License Application (BLA) of AndexXa (andexanet alfa; Portola) as a reversal agent for life-threatening or uncontrolled bleeding due to Factor Xa inhibitors.
Indivior announced positive top-line results from the Phase 3 clinical trial of RBP-6000 (buprenorphine monthly depot) for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support.
AcelRx announced topline results from the Phase 3 SAP302 study of ARX-04 (sufentanil sublingual tablet) for the treatment of moderate-to-severe acute pain associated with trauma or injury in patients presenting to the emergency department.
The FDA has granted Orphan Drug designation to TVN-102 (Tivorsan), previously referred to as recombinant human Biglycan, for the treatment of Duchenne Muscular Dystrophy (DMD).
Fractyl Laboratories announced publication of data from its first-in-human study of Revita DMR (duodenal mucosal resurfacing) for the treatment of patients with Type 2 diabetes.
Acacia Pharma announced positive data from the Phase 3 study of Baremsis (amisulpride) for the potential treatment of post-operative nausea & vomiting (PONV).
vTv Therapeutics announced positive topline results from the Phase 2b AGATA study of the glucokinase activator, TTP399, for the treatment of Type 2 diabetes.
The FDA has accepted for filing and granted Priority Review to the New Drug Applications (NDA) of deflazacort immediate-release tablet and oral suspension formulations for the treatment of Duchenne Muscular Dystrophy (DMD).
Coherus BioSciences announced topline results from an ongoing Phase 3 clinical study of CHS-1420, an adalimumab (Humira) biosimilar candidate, for the treatment of patients with psoriasis.
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)