Drugs in the Pipeline

Drugs in the Pipeline

Harvoni for HCV Genotype 4, HIV Co-Infection Assessed in New Research

Gilead Sciences announced results from ION-4, a Phase 3 study evaluating Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV.

Combo Therapy for HCV, HIV Co-Infection: New Data on Sustained Virologic Response

Bristol-Myers Squibb Company announced results from ALLY-2, a Phase 3 trial evaluating the use of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) co-infected with HIV.

Eribulin vs. Dacarbazine for Soft Tissue Sarcoma: New Data Released

Eisai announced results from a Phase 3 trial investigating the use of eribulin vs. dacarbazine in patients with advanced soft tissue sarcomas.

New Data on Once-Daily Baricitinib for RA From Phase 3 Trial

Eli Lilly and Company and Incyte announced results from a second Phase 3 trial with baricitinib in patients with rheumatoid arthritis.

Breakthrough Therapy for Rare Enzyme Disorder Could Be Approved Even Sooner

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for Kanuma (sebelipase alfa; Synageva BioPharma) for the treatment of lysosomal acid lipase deficiency (LAL Deficiency).

Shorter FDA Review for Tx of Rare Lung Disorder

The Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for Rapamune (sirolimus; Pfizer) for the treatment of lymphangioleiomyomatosis (LAM).

New Oral Combo for Metastatic Colorectal Cancer To Get FDA Review

The Food and Drug Administration (FDA) has accepted Taiho's New Drug Application (NDA) for review for TAS-102 (nonproprietary names: trifluridine and tipiracil HCl) for the treatment of refractory metastatic colorectal cancer (mCRC).

FDA to Review Belbuca for Pain Management

The Food and Drug Administration (FDA) has accepted the NDA for review for Belbuca (buprenorphine HCl; Endo and BioDelivery Sciences) buccal film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

FDA to Review Combination Therapy for Advanced Melanoma

The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.

Adcetris sBLA Submitted for Post-Transplant Hodgkin Lymphoma

Seattle Genetics has submitted a supplemental Biologics License Application (BLA) to the Food and Drug Administration (FDA) for Adcetris (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin lymphoma patients at high risk of relapse.