Drugs in the Pipeline

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

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

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.

Results Reinforce Ampion Use in OAK

Ampio announced results of the 20 weeks extension of the SPRING study of Ampion for the treatment of osteoarthritis of the knee (OAK).

Aripiprazole Lauroxil Shows Efficacy in Schizophrenia Trial

Alkermes announced positive results from its Phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia.

Janssen R&D and Pharmacyclics Submit sNDA for Imbruvica

Janssen R&D and Pharmacyclics Submit sNDA for Imbruvica

Janssen R&D and Pharmacyclics announced the submission of a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib), based on positive data from the Phase 3 RESONATE study in relapsed or refractory chronic lymphocytic leukemia (CLL).