Drugs in the Pipeline

FDA to Review Additional Data for iGlarLixi, Approval Process Extended

FDA to Review Additional Data for iGlarLixi, Approval Process Extended

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.

FDA Fast Tracks Investigational Alzheimer's Drug

FDA Fast Tracks Investigational Alzheimer's Drug

The FDA has granted Fast Track designation to the investigational drug AZD3293 (Eli Lilly and AstraZeneca) for the treatment of Alzheimer's disease.

Inhaled Antifungal Granted Orphan Drug Status for Cystic Fibrosis

Inhaled Antifungal Granted Orphan Drug Status for Cystic Fibrosis

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).

FDA Designates Dusquetide Orphan Drug for Life-Threatening Immune Disorder

FDA Designates Dusquetide Orphan Drug for Life-Threatening Immune Disorder

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.

Darzalex Combination Tx for Multiple Myeloma Under FDA Review

Darzalex Combination Tx for Multiple Myeloma Under FDA Review

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.

Novel Drug for Major Depressive Disorder Gets Breakthrough Tx Designation

Novel Drug for Major Depressive Disorder Gets Breakthrough Tx Designation

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.

FDA Wants More Data for Anticoagulant Antidote AndexXa

FDA Wants More Data for Anticoagulant Antidote AndexXa

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.

Long-Acting Buprenorphine Formulation Shows Promise for Opioid Dependence

Long-Acting Buprenorphine Formulation Shows Promise for Opioid Dependence

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.

Sublingual Sufentanil Demonstrates Efficacy for Acute Pain in ER Patients

Sublingual Sufentanil Demonstrates Efficacy for Acute Pain in ER Patients

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.

Investigational Muscle Protein Designated Orphan Drug for DMD

Investigational Muscle Protein Designated Orphan Drug for DMD

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).

Duodenal Mucosal Resurfacing Shows Promise as Type 2 Diabetes Treatment

Duodenal Mucosal Resurfacing Shows Promise as Type 2 Diabetes Treatment

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.

Baremsis Demonstrates Efficacy for Post-Op Nausea and Vomiting

Baremsis Demonstrates Efficacy for Post-Op Nausea and Vomiting

Acacia Pharma announced positive data from the Phase 3 study of Baremsis (amisulpride) for the potential treatment of post-operative nausea & vomiting (PONV).

Novel Glucokinase Activator Shown Effective, Safe for Type 2 Diabetes

Novel Glucokinase Activator Shown Effective, Safe for Type 2 Diabetes

vTv Therapeutics announced positive topline results from the Phase 2b AGATA study of the glucokinase activator, TTP399, for the treatment of Type 2 diabetes.

FDA Grants Priority Review to Deflazacort for Duchenne Muscular Dystrophy

FDA Grants Priority Review to Deflazacort for Duchenne Muscular Dystrophy

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).

Positive Results Announced for Adalimumab Biosimilar in Psoriasis Study

Positive Results Announced for Adalimumab Biosimilar in Psoriasis Study

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.