Drugs in the Pipeline

FDA to Review Novel Topical Antibiotic for Impetigo

FDA to Review Novel Topical Antibiotic for Impetigo

Ozenoxacin belongs to a novel generation of non-fluorinated quinolones

Hypertension, Pain Combo Drug Shown Beneficial on Kidney Function

Hypertension, Pain Combo Drug Shown Beneficial on Kidney Function

Kitov Pharmaceuticals announced new study data from the Phase 3 study for KIT-302 (amlodipine besylate/celecoxib) in the treatment of osteoarthritis pain and hypertension, suggesting beneficial effects on renal function.

FDA Grants Napabucasin Orphan Drug Status for Gastric Cancer

FDA Grants Napabucasin Orphan Drug Status for Gastric Cancer

The Food and Drug Administration (FDA) has granted Orphan Drug designation for the investigational compound, napabucasin (Boston Biomedical), for the treatment of gastric cancer, including gastroesophageal junction (GEJ) cancer.

Jakafi Granted Breakthrough Therapy Status for Graft-Versus-Host Disease

Jakafi Granted Breakthrough Therapy Status for Graft-Versus-Host Disease

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Jakafi (ruxolitinib; Incyte) for the treatment of patients with acute graft-versus-host disease (GVHD).

Investigational Drug for Huntington's Disease Granted Orphan Drug Status

Investigational Drug for Huntington's Disease Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to the investigational drug WVE-120101 (Wave Life Sciences) for the treatment of Huntington's disease (HD).

NDA for Potential ALS Treatment Submitted to FDA

NDA for Potential ALS Treatment Submitted to FDA

Mitsubishi Tanabe Pharma announced that a New Drug Application has been submitted to the Food and Drug Administration (FDA) for edaravone (MCI-186) for the treatment of amyotrophic lateral sclerosis (ALS).

Initial NDA for Investigational ALK Inhibitor Submitted to FDA

Initial NDA for Investigational ALK Inhibitor Submitted to FDA

Ariad Pharmaceuticals announced the initiation of the first part of a rolling New Drug Application (NDA) submission to the Food and Drug Administration (FDA) for its investigational agent, brigatinib, for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant to crizotinib.

Company Halts Clinical Program for Ganaxolone in Adult Seizures

Company Halts Clinical Program for Ganaxolone in Adult Seizures

Marinus Pharmaceuticals announced top-line results from the Phase 3 clinical trial of ganaxolone in adults with drug-resistant focal onset seizures.

Follow-on Biologic Insulin Glargine Candidate Similar to Lantus in Two Studies

Follow-on Biologic Insulin Glargine Candidate Similar to Lantus in Two Studies

Merck announced that two Phase 3 studies evaluating MK-1293, an investigational, follow-on biologic insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes, achieved their primary endpoints. Study data was presented for the first time at the 76th Scientific Sessions of the American Diabetes Association.

FDA Rejects Approval of Pain Drug Apadaz

FDA Rejects Approval of Pain Drug Apadaz

KemPharm announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of Apadaz (benzhydrocodone and acetaminophen) for the treatment of moderate to moderately severe acute pain.

Ertugliflozin Monotherapy, Combo Tx Evaluated in T2DM Studies

Ertugliflozin Monotherapy, Combo Tx Evaluated in T2DM Studies

Merck and Pfizer announced that VERTIS Mono and VERTIS Factorial, two Phase 3 studies evaluating the investigational oral SGLT-2 inhibitor, ertugliflozin, for the treatment of patients with type 2 diabetes, met their primary endpoints. Study results were presented for the first time at the 76th Scientific Sessions of the American Diabetes Association.

FDA to Review Deflazacort for Duchenne Muscular Dystrophy

FDA to Review Deflazacort for Duchenne Muscular Dystrophy

Marathon Pharmaceuticals announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for deflazacort for the treatment of patients with Duchenne Muscular Dystrophy (DMD).

Canagliflozin/Phentermine Combo Evaluated in Weight Loss Study

Canagliflozin/Phentermine Combo Evaluated in Weight Loss Study

Janssen announced findings of a Phase 2 proof-of-concept clinical trial demonstrating that combination therapy of canagliflozin and phentermine was effective for weight loss in overweight or obese non-diabetic adult patients. Data were presented as a late-breaking poster presentation at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA).

FDA to Review New Narcotic Analgesic Combo for Pain

FDA to Review New Narcotic Analgesic Combo for Pain

The FDA has accepted for review the New Drug Application (NDA) for CL-108 (Charleston Laboratories and Daiichi Sankyo) for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV).

Two Investigational Drugs Granted Breakthrough Therapy Status for Rare GI Disorders

Two Investigational Drugs Granted Breakthrough Therapy Status for Rare GI Disorders

Shire announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for two investigational drugs for rare diseases: SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2).