Drugs in the Pipeline

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).

BMS Submits Two NDAs for Hepatitis C Treatment

Bristol-Myers Squibb announced that it has submitted New Drug Applications (NDAs) to the FDA for daclatasvir (DCV) and asunaprevir (ASV) for the treatment of hepatitis C.

Combination Chronic Hep C Therapy Granted Priority Review

The FDA has granted priority review to Gilead's New Drug Application (NDA) for a once-daily fixed-dose combination of ledipasvir (LDV) and sofosbuvir (SOF) for the treatment of chronic hepatitis C genotype 1 infection in adults.

Palbociclib + Letrozole Prolongs PFS in Advanced Breast Cancer Study

Pfizer announced results from the Phase 2 PALOMA-1 study that is investigating the use of palbociclib (PD-0332991) in combination with letrozole in patients with advanced breast cancer.

Amgen Announces Results from Talimogene Laherparepvec Phase 3 Trial

Amgen Announces Results from Talimogene Laherparepvec Phase 3 Trial

Amgen announced top-line results from the primary overall survival (OS) analysis of their Phase 3 trial on talimogene laherparepvec for the treatment of unresected stage IIB, IIIC or IV melanoma.