Drugs in the Pipeline

Studies Halted for Alzheimer's Candidate Atabecestat Due to Safety Concerns

Studies Halted for Alzheimer's Candidate Atabecestat Due to Safety Concerns

Janssen said in a statement that they are informing study participants (N>600), trial investigators, health authorities, ethics committees and institutional review boards about the situation.

FDA to Review Aemcolo for Treatment of Travelers' Diarrhea

FDA to Review Aemcolo for Treatment of Travelers' Diarrhea

A Phase 3 clinical trial of patients with travelers' diarrhea demonstrated that Aemcolo was superior to placebo (P=.0008) and non-inferior to ciprofloxacin.

Oral T1D Treatment Zynquista to Be Reviewed by FDA

Oral T1D Treatment Zynquista to Be Reviewed by FDA

The NDA was supported by data from the Phase 3 inTandem clinical trial program which assessed the safety and efficacy of Zynquista in ~3000 adults with inadequately controlled type 1 diabetes.

Positive Results Announced for Pleuromutilin Antibiotic in CABP

Positive Results Announced for Pleuromutilin Antibiotic in CABP

In the LEAP 2 study (N=738), patients with moderate CABP received either oral lefamulin 600mg every 12 hours for 5 days or oral moxifloxacin 400mg once daily for 7 days

IV Tramadol Significantly Reduces Post-Op Pain in Phase 3 Study

IV Tramadol Significantly Reduces Post-Op Pain in Phase 3 Study

In this multicenter, double-blind, placebo-controlled trial, patients (N=409) were randomized 1:1:1 to a postoperative regimen of IV tramadol 50mg, IV tramadol 25mg, or placebo administered over 15 minutes at hours 0, 2, 4, and once every 4 hours thereafter (up to 13 doses).

Mecillinam/Pivmecillinam Get QIDP Designation for Complicated UTI

Mecillinam/Pivmecillinam Get QIDP Designation for Complicated UTI

Mecillinam is a beta-lactam antibiotic with a novel site of action which is specific and highly active against Gram-negative bacteria.

Certolizumab Pegol Beneficial in Non-Radiographic Axial Spondyloarthritis

Certolizumab Pegol Beneficial in Non-Radiographic Axial Spondyloarthritis

During the 52-week trial period, the treatment group received a 400mg dose of CZP subcutaneously at weeks 0, 2, and 4, followed by 200mg of CZP every 2 weeks starting at week 6; or placebo.

Topical Treatment for Epidermolysis Bullosa Gets FDA's Rare Pediatric Designation

Topical Treatment for Epidermolysis Bullosa Gets FDA's Rare Pediatric Designation

A previous Phase 2 trial of 17 patients with EBS showed that 60% of those treated with diacerein cream experienced at least a 40% reduction in blistering after 4 weeks vs 18% on vehicle.

Positive Results for Dupilumab in Teen Atopic Dermatitis Trial

Positive Results for Dupilumab in Teen Atopic Dermatitis Trial

The primary endpoint was the proportion of patients with an IGA score of 0 (clear) or 1 (almost clear) at Week 16.

Galcanezumab Effective in Phase 3 Episodic Cluster Headache Study

Galcanezumab Effective in Phase 3 Episodic Cluster Headache Study

The episodic cluster headache trial included a total of 106 patients with an average of 17.5 cluster headache attacks per week at baseline.

FDA Fast-Tracks Treatment for Autism Spectrum Disorder

FDA Fast-Tracks Treatment for Autism Spectrum Disorder

There are currently no approved pharmacological treatments that address these core symptoms of ASD.

Blood-Filtering Device Gets Breakthrough Designation for Cancer Tx

Blood-Filtering Device Gets Breakthrough Designation for Cancer Tx

In preliminary preclinical studies, the device has been shown to enhance anti-cancer immune system response without causing adverse effects

Treatment for Rare Pediatric Cancer Granted Orphan Drug Designation

Treatment for Rare Pediatric Cancer Granted Orphan Drug Designation

CLR 131 is an investigational radioiodinated Phospholipid Drug Conjugate (PDC) drug candidate that delivers cytotoxic radiation directly and selectively to malignant cells.

Vaccine for Chikungunya Prevention Gets Fast Track Designation

Vaccine for Chikungunya Prevention Gets Fast Track Designation

There are currently no approved treatments or vaccines available for chikungunya, a virus transmitted through mosquito bites.

Facioscapulohumeral Muscular Dystrophy Treatment Gets Fast Track Status

Facioscapulohumeral Muscular Dystrophy Treatment Gets Fast Track Status

ACE-083 is currently being studied in a Phase 2 trial for FSHD and another for Charcot-Marie-Tooth (CMT) disease.