Drugs in the Pipeline

FDA Grants Priority Review to Lofexidine for Opioid Withdrawal Management

FDA Grants Priority Review to Lofexidine for Opioid Withdrawal Management

Lofexidine, an oral tablet, is a selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine.

Cervical Dystonia Drug Candidate Gets Orphan Drug Designation

Cervical Dystonia Drug Candidate Gets Orphan Drug Designation

Treatments for cervical dystonia include oral medications, botulinum toxin injections, surgery, and complementary therapies.

FDA Grants Fast Track Status to Lumateperone for Schizophrenia

FDA Grants Fast Track Status to Lumateperone for Schizophrenia

In two studies, lumateperone showed a statistically significant separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale, or PANSS, total score.

Patidegib Gets Breakthrough and Orphan Designation for Gorlin Syndrome

Patidegib Gets Breakthrough and Orphan Designation for Gorlin Syndrome

Gorlin Syndrome is a rare, genetic disease characterized by mutations in the tumor suppressor gene encoding Patched1.

Agranulocytosis Cases Prompt More Monitoring for Investigational Parkinson's Drug

Agranulocytosis Cases Prompt More Monitoring for Investigational Parkinson's Drug

Dependent on further input from the Data Safety Monitoring Board (DSMB) and the Food and Drug Administration (FDA), the Company stated that they intend on moving forward with the study and expect to report results in the first quarter of 2018.

NDA Submitted for Revefenacin for the Treatment of COPD

NDA Submitted for Revefenacin for the Treatment of COPD

In the Phase 3 trials revefenacine demonstrated statistically significant and clinically meaningful improvements compared to placebo in trough forced expiratory volume in 1 second (FEV1).

Positive Results for Brexanolone in Postpartum Depression Trials

Positive Results for Brexanolone in Postpartum Depression Trials

The Hummingbird Phase 3 program included two Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled trials designed to evaluate the safety and effectiveness of brexanolone in women with moderate and severe PPD.

Novel Malaria Drug Gets Orphan Drug Designation

Novel Malaria Drug Gets Orphan Drug Designation

s well as malaria, they are also evaluating Artemisone for the treatment of human cytomegalovirus (CMV) infections, including stem cell transplant CMV and congenital CMV.

NDA Submitted for Olinvo to Treat Moderate to Severe Acute Pain

NDA Submitted for Olinvo to Treat Moderate to Severe Acute Pain

Olinvo is a next generation IV analgesic for the management of moderate-to-severe acute pain in the hospital and similar settings and has been granted Breakthrough Therapy designation by the FDA.

FDA Accepts NDA for Topical Combination Treatment for Plaque Psoriasis

FDA Accepts NDA for Topical Combination Treatment for Plaque Psoriasis

The Prescription Drug User Fee Act (PDUFA) action date is June 18, 2018.

Long-Term Efficacy Data Show Sustained Pelvic Pain Reduction With Elagolix

Long-Term Efficacy Data Show Sustained Pelvic Pain Reduction With Elagolix

No new safety concerns were identified with elagolix use for the 12-month treatment period

Novel Monoclonal Antibody Targeting Influenza A Gets Fast Track Status

Novel Monoclonal Antibody Targeting Influenza A Gets Fast Track Status

VIS410, a monoclonal antibody, is being developed for single-dose administration to target all known strains of influenza A.

Aemcolo Gets QIDP, Fast Track Designation for Travelers' Diarrhea

Aemcolo Gets QIDP, Fast Track Designation for Travelers' Diarrhea

In Phase 3 clinical trials involving patients with travelers' diarrhea, Aemcolo was found to be superior to placebo (P=0.0008) and non-inferior to ciprofloxacin.

Dupilumab Beneficial for Patients with Severe Steroid-Dependent Asthma

Dupilumab Beneficial for Patients with Severe Steroid-Dependent Asthma

Consistent reductions in asthma attacks and improvements in lung function across a broad population of uncontrolled asthma patients.

Novartis Seeks New Indication for CAR-T Therapy Kymriah

Novartis Seeks New Indication for CAR-T Therapy Kymriah

The latest sBLA is intended for patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).