Drugs in the Pipeline

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.

3D Antiviral Regimen Shows Efficacy in Chronic HCV Study

Enanta announced results from AbbVie's pivotal Phase 3 TURQUOISE-II study of the investigational three direct-acting (3D) antiviral regimen for genotype 1 (GT1) chronic hepatitis C virus (HCV) infection with compensated liver cirrhosis.

Investigational Chronic HCV Agents Effective in Phase 2 Study

Merck announced additional data from the ongoing Phase 2 C-WORTHy study evaluating the efficacy and safety of MK-5172 and MK-8742 in patients with chronic HCV genotype 1 (GT1) infection.

All-Oral HCV Therapy Results Released

Bristol-Myers Squibb announced results from its HALLMARK-Dual Phase 3 study of all-oral, interferon- and ribavirin-free regimen of daclatasvir (DCV) and asunaprevir (ASV) in patients with genotype 1b hepatitis C virus infection (HCV).

Eloctate Shows Efficacy in Hemophilia A Trial

Biogen Idec and Swedish Orphan Biovitrum announced positive top-line results for the Kids A-LONG Phase 3 clinical study that evaluated the safety and efficacy of Eloctate (recombinant factor VIII Fc fusion protein) in children with severe hemophilia A.