Drugs in the Pipeline

Drugs in the Pipeline

FDA Grants QDIP Status to Two Inhalation Products

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to two Bayer Healthcare products, Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation (DPI).

Duchenne Muscular Dystrophy Therapy Designated Orphan Drug

The Food and Drug Administration (FDA) has granted Orphan Drug designation to CAT-1004 (Catabasis) for the treatment of Duchenne Muscular Dystrophy (DMD).

Acute Lymphoblastic Leukemia Drug Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to JCAR015 for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia.

Pediatric Ulcerative Colitis Therapy Granted Orphan Drug Status

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.

Alirocumab Meets Primary Endpoint in Six Hypercholesterolemia Trials

Sanofi and Regeneron announced positive results from six Phase 3 ODYSSEY trials that showed alirocumab significantly reduced LDL-C in hypercholesterolemic patients.

Dupilumab Designated Breakthrough Therapy for Atopic Dermatitis

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.

FDA Grants Orphan Drug Status to Investigational Acute Myeloid Leukemia Treatment

The FDA has granted Orphan Drug designation to BGB324 (BerGenBio AS) for the treatment of acute myeloid leukemia (AML).

NDA Submitted for Three-Month Paliperidone Palmitate

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.

LCZ696 Cuts Sudden Death, ER Visits in Large HF Study

Novartis announced new data from the Phase 3 PARADIGM-HF study, in patients who received LCZ696 for heart failure with reduced ejection fraction (HFrEF).

Secukinumab Demonstrates Efficacy in Psoriatic Arthritis Trials

Novartis announced results from the Phase 3 FUTURE 1 and FUTURE 2 studies with secukinumab in patients with psoriatic arthritis (PsA).