Drugs in the Pipeline

Drugs in the Pipeline

Avedro Resubmits NDA for Eye Disorders

Avedro announced that it has resubmitted its New Drug Application (NDA) to the Food and Drug Administration (FDA) for riboflavin ophthalmic solution/KXL System for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.

Adcetris Extends Survival in Post-Transplant Hodgkin Lymphoma Study

Seattle Genetics and Takeda announced results from the Phase 3 AETHERA trial with Adcetris (brentuximab vedotin) in patients with post-transplant Hodgkin lymphoma.

Combination Breast Cancer Therapy Extends Overall Survival

Roche announced results from the Phase 3 CLEOPATRA study evaluating the addition of Perjeta (pertuzumab; Genentech) to Herceptin (trastuzumab; Genentech) and docetaxel chemotherapy in patients with previously untreated HER2-positive metastatic breast cancer.

Cobimetinib + Zelborif Increased PFS in Melanoma Trial

Roche announced positive data from the coBRIM Phase 3 study with cobimetinib plus Zelboraf (vemurafenib) in patients with previously untreated BRAF V600 mutation-positive, advanced melanoma.

Phase 3 Results for Tafinlar in Mutant Metastatic Melanoma

GlaxoSmithKline announced updated results for Tafinlar (dabrafenib) from the Phase 3 BREAK-3 study in patients with BRAF V600E mutant metastatic melanoma.

FDA Grants Aldoxorubicin Orphan Drug Designation

The Food and Drug Administration (FDA) has granted multiple Orphan Drug designations to aldoxorubicin for glioblastoma multiforme, small cell lung cancer, and ovarian cancer.

Vesneo Reduces Intraocular Pressure in Trials

Bausch + Lomb announced positive results from the pivotal Phase 3 studies with Vesneo (latanoprostene bunod) for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

Efficacy of Oral Testosterone in Hypogonadal Men Demonstrated in Study

Lipocine announced top-line results from its Phase 3 SOAR clinical trial evaluating the efficacy and safety of LPCN 1021, an oral testosterone agent in hypogonadal men with low testosterone.

Nonalcoholic Steatohepatitis Agent Fast Tracked by FDA

The Food and Drug Administration (FDA) has granted Fast Track designation to aramchol (Galmed) for the treatment of nonalcoholic steatohepatitis (NASH).

Investigational Single Tablet Regimen Noninferior to Stribild for HIV-1 Infection

Gilead announced results from Study 104 and Study 111 evaluating a once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults.