Drugs in the Pipeline

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.

Nosocomial Pneumonia Agent Designated Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track status to MedImmune's investigational monoclonal antibody (mAb), MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

Olaptesed Pegol Designated Orphan Drug for Glioblastoma

The FDA has granted Orphan Drug designation to olaptesed pegol (NOX-A12; NOXXON Pharma) for the treatment of glioblastoma in conjunction with radiotherapy.

Rayaldee Efficacious in Secondary Hyperparathyroidism Trial

OPKO Health announced top-line results from the final Phase 3 trial of Rayaldee for the treatment of secondary hyperparathyroidism (SHPT) in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

Blinatumomab BLA Submitted for Acute Lymphoblastic Leukemia

Blinatumomab BLA Submitted for Acute Lymphoblastic Leukemia

Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for blinatumomab for the treatment of Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Lymphoseek Gains Orphan Drug Designation for Head, Neck Cancer Detection

Lymphoseek Gains Orphan Drug Designation for Head, Neck Cancer Detection

Navidea announced that the Food and Drug Administration (FDA) has granted Lymphoseek (technetium Tc 99m tilmanocept) injection an Orphan Drug Designation for use in sentinel lymph node detection in patients with head and neck cancer.

Xultophy Shows Improved Glycemic Control, Weight Loss in T2DM

Novo Nordisk announced new data from the Phase 3a DUAL clinical trial comparing Xultophy (insulin degludec and liraglutide [IDegLira]) to insulin degludec (Tresiba) and liraglutide (Victoza) alone in insulin-naive and insulin-treated patients.