Drugs in the Pipeline

Ready-to-Use Rescue Pen for Severe Hypoglycemia Moves Closer to Approval

Ready-to-Use Rescue Pen for Severe Hypoglycemia Moves Closer to Approval

The full findings of the trials will not be released until later this year however the Company stated that the trials were a success, with the data already shared with the FDA in a pre-New Drug Application (NDA) meeting.

Rituxan Granted Priority Review for Rare Autoimmune Disease

Rituxan Granted Priority Review for Rare Autoimmune Disease

The disease can be life threatening. Phase 3 study results released last March demonstrated Rituxan substantialy improved pemphigus vulgaris remission rates and successful tapering.

Oral JAK1 Inhibitor Gets Breakthrough Tx Designation for Atopic Dermatitis

Oral JAK1 Inhibitor Gets Breakthrough Tx Designation for Atopic Dermatitis

In December, a Phase 3, randomized, double-blind, placebo-controlled trial (JADE) was initiated to evaluate the safety and efficacy of PF-04965842 in 375 patients aged ≥12 years with moderate to severe AD.

Study Evaluating Verubecestat in Prodromal Alzheimer's Disease Stopped

Study Evaluating Verubecestat in Prodromal Alzheimer's Disease Stopped

APECS is a randomized, placebo-controlled, parallel-group, double-blind Phase 3 clinical trial evaluating the efficacy and safety of verubecestat in people with prodromal AD.

Positive Results for Ixekizumab in the Treatment of Ankylosing Spondylitis

Positive Results for Ixekizumab in the Treatment of Ankylosing Spondylitis

Taltz demonstrated a statistically significant improvement in the signs and symptoms of AS.

Novel Therapy for Major Depressive Disorder Gets Breakthrough Designation

Novel Therapy for Major Depressive Disorder Gets Breakthrough Designation

The Breakthrough Therapy designation is intended to offer a potentially expedited development path and review for promising drug candidates.

Treatment for Smallpox Gets FDA Priority Review

Treatment for Smallpox Gets FDA Priority Review

The treatment was developed under the FDA's 'Animal Rule'; where efficacy is determined in animal studies and human studies determine safety and appropriate dosing. The FDA have stated a target action date for TPOXX of August 8, 2018.

Nymox Plans to Submit NDA for Novel Benign Prostatic Hyperplasia Treatment

Nymox Plans to Submit NDA for Novel Benign Prostatic Hyperplasia Treatment

Fexapotide triflutate 2.5 mg was found to be safe and effective for long-term treatment of BPH.

Positive Results for Ubrogepant in Phase 3 Migraine Trial

Positive Results for Ubrogepant in Phase 3 Migraine Trial

A total of 1,327 migraine patients were treated in the study for a single migraine attack. At 2 hours after migraine attack, 19.2% (n=423) and 21.2% (n=448) of ubrogepant 50mg and 100mg were pain free, respectively.

'Gene Silencing' Drug Under FDA Review for Hereditary ATTR Amyloidosis

'Gene Silencing' Drug Under FDA Review for Hereditary ATTR Amyloidosis

Patisiran has been granted Fast Track Designation, Breakthrough Therapy Designation, and an expanded Orphan Drug Designation for ATTR amyloidosis from the FDA.

Apomorphine Film Effectively Converts OFF to ON State in PD Patients

Apomorphine Film Effectively Converts OFF to ON State in PD Patients

The difference in score change for movement disorder from baseline to 30 minutes post-dose between the apomorphine and placebo group was 7.6 (P=0.0002).

Intranasal Acromegaly Treatment Gains Orphan Drug Designation

Intranasal Acromegaly Treatment Gains Orphan Drug Designation

Octreotide is a somatostatin analog that suppresses excessive growth hormone production from pituitary adenomas.

Extended-Release Oxycodone Prodrug Gets Fast-Tracked

Extended-Release Oxycodone Prodrug Gets Fast-Tracked

A Phase 1 trial of PF614 compared the treatment to Oxycontin in healthy subjects and found that it demonstrated safety and extended-release characteristics of the prodrug delivery.

Zika Vaccine Candidate Gets Fast Track Designation

Zika Vaccine Candidate Gets Fast Track Designation

A total of 240 individuals between the ages 18 and 49 are enrolled in the Phase 1 trial of TAK-426.

Erenumab Effective in Migraine Patients With Multiple Treatment Failures

Erenumab Effective in Migraine Patients With Multiple Treatment Failures

Aimovig is a fully human monoclonal antibody, designed to selectively block the calcitonin gene-related peptide (CGRP) receptor.