Drugs in the Pipeline

First-in-Class Drug Candidate Fast Tracked for Chronic Pain

First-in-Class Drug Candidate Fast Tracked for Chronic Pain

Currently, there is a global Phase 3 program comprised of 6 studies involving approximately 7,000 patients with OA, CLBP or cancer pain with inadequate treatment of pain with approved therapies.

Triple-Therapy, Single Tablet HIV Regimen Submitted to FDA for Review

Triple-Therapy, Single Tablet HIV Regimen Submitted to FDA for Review

Three of the ongoing studies are evaluating the safety and efficacy of BIC/FTC/TAF vs. triple-therapy regimens containing dolutegravir 50mg among treatment-naive patients and among virologically-suppressed patients who are switching from an existing antiretroviral regimen with dolutegravir.

FDA to Review Trulance for IBS-C Indication in Adults

FDA to Review Trulance for IBS-C Indication in Adults

Results from both studies showed Trulance was statistically superior to placebo in achieving the primary endpoint (Study 1: 30.2%, P<0.001 in 3mg and 29.5% in 6mg vs. 17.8% in placebo; Study 2: 21.5% in 3mg and 24.0% in 6mg vs. 14.2% in placebo).

Tafamidis Gets Fast Track Status for Rare Disease Linked to Progressive HF

Tafamidis Gets Fast Track Status for Rare Disease Linked to Progressive HF

Vyndaqel is approved in Europe and a number of other countries to treat transthyretin familial amyloid polyneuropathy (TTR-FAP) but not in the U.S.

FDA to Review New Evolocumab Cardiovascular Outcomes Data

FDA to Review New Evolocumab Cardiovascular Outcomes Data

Results showed that the Repatha plus statin group had a statistically significant 20% (P<0.001) reduction in hard major adverse cardiovascular events.

Inhaled L-dopa Meets Endpoints in Parkinson's Disease Study

Inhaled L-dopa Meets Endpoints in Parkinson's Disease Study

The study's primary endpoint was meaningful improvement in motor function as defined by the Unified Parkinson's Disease Rating Scale—Part III.

FDA to Review Opdivo for Hepatocellular Carcinoma Indication

FDA to Review Opdivo for Hepatocellular Carcinoma Indication

The sBLA submission was based on results from the Phase 1/2 CheckMate -040 study.

Vyxeos Granted Priority Review by FDA

Vyxeos Granted Priority Review by FDA

Vyxeos, or CPX-351, combines cytarabine and daunorubicin in a nano-scale liposome at a 5:1 molar ratio using the CombiPlex platform.

CGRP Targeted Drug Looks Promising for Migraine Prevention

CGRP Targeted Drug Looks Promising for Migraine Prevention

The HALO Clinical Research Program consists of two 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies that compared fremanezumab to placebo in adults with episodic and chronic migraine.

Acute Hepatic Porphyria Therapy Gets Breakthrough Designation

Acute Hepatic Porphyria Therapy Gets Breakthrough Designation

Currently, the only approved treatment for AHP attacks is hemin for injection (Panhematin or Normosang).

Priority Review Granted for Axicabtagene Ciloleucal in NHL

Priority Review Granted for Axicabtagene Ciloleucal in NHL

In the ZUMA-1 trial 42% of patients demonstrated ongoing response at the 8.7-month follow-up, of which 39% achieved complete response.

Lurasidone Benefits Younger Patients with Bipolar Depression in Phase 3 Study

Lurasidone Benefits Younger Patients with Bipolar Depression in Phase 3 Study

Results showed a statistically significant change from baseline to Week 6 in favor of Latuda vs. placebo in the Clinical Global Impression-Bipolar Version, Severity of Illness (CBI-BP-S) score and the Children's Depression Rating Scale, Revised (CDRS-R) score.

New CRAC Channel Inhibitor for Acute Pancreatitis Fast-Tracked

New CRAC Channel Inhibitor for Acute Pancreatitis Fast-Tracked

In Phase 1 safety studies, CM4620 showed positive activity in vivo in several animal models. CalciMedica plans to begin the first of its patient studies early in 2018.

Tildrakizumab to Be Reviewed for Moderate-to-Severe Plaque Psoriasis

Tildrakizumab to Be Reviewed for Moderate-to-Severe Plaque Psoriasis

Ongoing data from two Phase 3 trials, ReSurface 1 and ReSurface 2, which enrolled over 1,800 patients, is included in the BLA.

Novel HIV Vaccine Shows High Immune Response Rate in Study

Novel HIV Vaccine Shows High Immune Response Rate in Study

Overall, 71 of 76 participants (93%) showed detectable CD4+ or CD8+ responses to at least one of the vaccine's four antigens.