Drugs in the Pipeline

Anthrax Vaccine Designated Orphan Drug for Post-Exposure Prophylaxis

The FDA has granted Orphan Drug designation to BioThrax (Anthrax Vaccine Adsorbed; Emergent BioSolutions) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis.

Cubist Submits NDA for Combination Antibiotic

Cubist announced that it has submitted a New Drug Application (NDA) to the FDA for its investigational antibiotic, ceftolozane/tazobactam for the treatment of Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI).

Volasertib Designated Orphan Drug for Acute Myeloid Leukemia

The FDA has granted Orphan Drug designation to volasertib (Boehringer Ingelheim) for acute myeloid leukemia (AML).

Otrexup Results Published for Rhuematoid Arthritis

Antares Pharma announced the publication of results from its crossover study comparing the relative bioavailability, safety, and tolerability of Otrexup (methotrexate) to oral methotrexate (MTX) in adults with rheumatoid arthritis in the Annals of the Rheumatic Diseases.

AbbVie Launches Veliparib Trial for NSCLC

AbbVie announced the initiation of a Phase 3 trial evaluating the safety and efficacy of veliparib (ABT-888) in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).

BAX 111 Efficacious in Inherited Bleeding Disorder

Baxter announced results from a Phase 3 clinical trial evaluating the safety, efficacy, and pharmacokinetics of BAX 111, a recombinant von Willebrand factor (rVWF) for the treatment of bleeding episodes in patients with von Willebrand disease.

Two Phase 2 Trials Report Positive Sofosbuvir Data in HCV

Gilead Sciences announced promising efficacy results of sofosbuvir (SOF) in combination with ledipasvir and GS-5816 from two Phase 2 clinical trials on chronic hepatitis C virus (HCV) infection.

Positive Simeprevir Data in Multiple Phase 2 and 3 Studies

Janssen announced positive new data from the simeprevir clinical program, including data from the Phase 2 COSMOS study, the Phase 3 RESTORE, QUEST-1, QUEST-2, and the PROMISE studies.

Combination HCV Therapy Achieves SVR Rates in Trials

Enanta announced results from the Phase 3 SAPPHIRE-I and SAPPHIRE-II studies for AbbVie's investigational three direct-acting antiviral regimen containing Enanta's ABT-450 for the treatment of hepatitis C virus (HCV) genotype 1(GT1) infection.

NDA for New HIV-1 Single Tablet Combination Therapy

Bristol-Myers Squibb and Gilead announced that it has submitted to the FDA a New Drug Application (NDA) for a fixed-dose combination of atazanavir sulfate and cobicistat (Gilead) for use in conbination with other antiretroviral agents for the treatment of HIV-1 infection.