Drugs in the Pipeline

Aerucin Awarded Fast Track for HAP/VAP

The Food and Drug Administration (FDA) has granted Fast Track designation to Aerucin (Aridis Pharmaceuticals) for the treatment of hospital-acquired and ventilator-associated pneumonia caused by Pseudomonas aeruginosa.

Investigational MS Tx Reduces Relapse Rate in Trials

Genentech announce positive results from two Phase 3 studies evaluating ocrelizumab compared with Rebif (interferon beta-1a) in patients with relapsing multiple sclerosis (MS).

Eteplirsen NDA Submission Completed for Duchenne Muscular Dystrophy

Sarepta Therapeutics announced that it has completed a rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for eteplirsen.

Emend Efficacious in Preventing Chemotherapy-Induced Nausea and Vomiting

Merck announced results from a Phase 3 study of single-dose Emend (fosaprepitant dimeglumine) for injection in combination with other anti-vomiting medications for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients receiving moderately emetogenic chemotherapy (MEC).

Egg-Free Flu Vaccine Beats Traditional Vaccine, Finds Study

Egg-Free Flu Vaccine Beats Traditional Vaccine, Finds Study

Protein Sciences announced that Flublok Quadrivalent was better at preventing influenza than the traditional influenza vaccine.

FDA to Review NDA for Metastatic Pancreatic Adenocarcinoma Therapy

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for irinotecan liposome injection (MM-398; Merrimack Pharmaceuticals and Baxalta) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

Peanut Allergy Patch Gets Closer to FDA Submission

Peanut Allergy Patch Gets Closer to FDA Submission

DBV Technologies announced that based its meeting with the Food and Drug Administration (FDA), it plans to initiate a global Phase 3 study of its investigational Viaskin Peanut epicutaneous immunotherapy (EPIT) patch for the treatment of peanut allergies.

No Virologic Failures With Combo HCV Tx in Study

AbbVie announced results from the Phase 3b TURQUOISE-III study with Viekirax (ombitasvir/paritaprevir/ritonavir) plus Exviera (dasabuvir) without ribavirin (RBV) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis.

NDA Submitted for Oral Formulation of OIC Drug Relistor

Valeant Pharmaceuticals and Progenics Pharmaceuticals announced the submission of a New Drug Application (NDA) to the FDA for Oral Relistor (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Eliquis Reversal Agent Demonstrates Efficacy in Phase 3 Study

Portola Pharmaceuticals, Bristol-Myers Squibb Company, and Pfizer announced results from the Phase 3 ANNEXA-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors - Apixaban) study with andexanet alfa as a reversal agent for Eliquis (apixaban).

Pradaxa Reversal Agent Works Within Minutes in Phase 3 Study

Pradaxa Reversal Agent Works Within Minutes in Phase 3 Study

Boehringer Ingelheim announced results from an interim analysis of the Phase 3 RE-VERSE AS patient study with idarucizumab for urgent reversal of the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate).

ImMucin Designated Orphan Drug for Multiple Myeloma

The Food and Drug Administration (FDA) has granted Orphan Drug designation to ImMucin (Vaxil Bio) for the treatment of multiple myeloma.

Encenicline Granted Fast Track Status for Cognitive Impairment in Schizophrenia

The Food and Drug Administration (FDA) has granted Fast Track designation to encenicline (Forum Pharmaceuticals) for the treatment of cognitive impairment in schizophrenia.

Peanut Allergy Drug Designated Breakthrough Therapy

Peanut Allergy Drug Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AR101, an oral immunotherapy for children and adolescents 4 to 17 years of age who are allergic to peanuts.

New Drug Class for Migraine Prevention Could Be Coming

New Drug Class for Migraine Prevention Could Be Coming

Clinical trials of a new drug class for preventing high-frequency episodic migraine and chronic migraine have shown promising results, according to several studies presented at the American Headache Society's annual Scientific Meeting.