Drugs in the Pipeline

Intepirdine Gets Fast Track Status for Lewy Body Dementia

Intepirdine Gets Fast Track Status for Lewy Body Dementia

The Food and Drug Administration has granted Fast Track status to Axovant Sciences for their investigational New Drug application for intepirdine for the treatment of dementia with Lewy bodies.

Positive Data for Oral Cannabidiol in Lennox-Gastaut Syndrome Study

Positive Data for Oral Cannabidiol in Lennox-Gastaut Syndrome Study

GW Pharmaceuticals announced positive data from the second randomized, double-blind, placebo-controlled Phase 3 trial of Epidiolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).

FDA to Review Imbruvica for Rare Lymphoma Indication

FDA to Review Imbruvica for Rare Lymphoma Indication

Janssen announced the submission of a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib; Janssen and Pharmacyclics) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy.

BLA Submitted for Investigational RA Drug

BLA Submitted for Investigational RA Drug

Janssen Biotech announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for the approval of sirukumab for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

Malaria Vaccine Receives Fast Track Status from FDA

Malaria Vaccine Receives Fast Track Status from FDA

The Food and Drug Administration (FDA) has granted Fast Track designation to Sanaria PfSPZ Vaccine, a preventative vaccine for malaria.

Aerosurf Fast Tracked for RDS in Premature Infants

Aerosurf Fast Tracked for RDS in Premature Infants

The FDA has granted Fast Track designation to Aerosurf (lucinactant for inhalation; Windtree Therapeutics) for the treatment of respiratory distress syndrome (RDS) in premature infants.

Investigational Estradiol for Dyspareunia Under FDA Review

Investigational Estradiol for Dyspareunia Under FDA Review

The FDA has accepted for review the New Drug Application (NDA) for Yuvvexy (17β-estradiol; TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.

Promising Results for Fixed-Dose Combination Eye Drop for Glaucoma

Promising Results for Fixed-Dose Combination Eye Drop for Glaucoma

Aerie Pharmaceuticals announced topline data from the Mercury 1 study, a Phase 3 trial evaluating the fixed-dose combination product, Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, to lower intraocular pressure (IOP) in patients with glaucoma.

Potent Oral Antifungal Granted QIDP Status for Valley Fever

Potent Oral Antifungal Granted QIDP Status for Valley Fever

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to VT-1598 (Viamet) for the treatment of coccidioidomycosis, or Valley Fever.

Investigational Shingles Vaccine Evaluated in Patients 70 Years and Older

Investigational Shingles Vaccine Evaluated in Patients 70 Years and Older

GlaxoSmithKline (GSK) announced the publication of results from The Phase 3 study, ZOE-70, evaluating the investigational shingles vaccine, Shingrix, in patients aged 70 years and older. Detailed study findings were published in the New England Journal of Medicine (NEJM).

Ocrevus Demonstrates Positive Outcomes in RMS, PPMS Patients

Ocrevus Demonstrates Positive Outcomes in RMS, PPMS Patients

Genentech announced new study analyses from ORCHESTRA, the Phase 3 clinical development program for Ocrevus (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

FDA Fast Tracks Potential Treatment for Diabetic Peripheral Neuropathy

FDA Fast Tracks Potential Treatment for Diabetic Peripheral Neuropathy

The Food and Drug Administration (FDA) has granted NYX-2925 (Aptinyx) Fast Track designation for the potential treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN).

FDA Grants Orphan Drug Status to Coversin for Rare Blood Disorder

FDA Grants Orphan Drug Status to Coversin for Rare Blood Disorder

The FDA has granted Orphan Drug designation to Coversin (Akari Therapeutics) for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), an ultra-rare, life-threatening and debilitating hematological disorder.

Oral Antibacterial Granted QIDP Status for C. Difficile-Associated Diarrhea

Oral Antibacterial Granted QIDP Status for C. Difficile-Associated Diarrhea

The FDA has granted MGB-BP-3 (MGB Biopharma) Qualified Infectious Disease Product (QIDP) designation for the treatment of Clostridium difficile-associated diarrhea (CDAD).

Significant A1C Reduction Seen for First-in-Class Dual SGLT Inhibitor

Significant A1C Reduction Seen for First-in-Class Dual SGLT Inhibitor

Lexicon announced positive findings from the pivotal Tandem 1 study, a Phase 3 trial of sotagliflozin for the treatment of type 1 diabetes.