Drugs in the Pipeline

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.

Head, Neck Cancer Cancer Drug May Overcome Cetuximab Resistance

Head, Neck Cancer Cancer Drug May Overcome Cetuximab Resistance

The investigational drug alpelisib (previously known as BYL719) appears to inhibit activation of the pathway that leads to resistance to cetuximab, an anti-epidermal growth factor receptor agent used in the treatment of head and neck cancer.

Cyramza + Paclitaxel Demonstrates Efficacy in Cancer Trial

Eli Lilly and Company announced results from a global Phase 3 study with Cyramza (ramucirumab) in combination with paclitaxel for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.

Omarigliptin Significantly Lowers HbA1c Levels in Trial

Merck announced results from the Phase 3 clinical program for omarigliptin, once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes.

Eylea Granted Breakthrough Therapy for Diabetic Retinopathy

The Food and Drug Administration (FDA) has granted Eylea (afilbercept; Regeneron) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).

Lynovex Designated Orphan Drug for Cystic Fibrosis

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Lynovex (NM001; NovaBiotics) for the treatment of cystic fibrosis (CF).

Odanacatib Reduces Fracture Risk in Postmenopausal Women

Merck announced results from the Phase 3 LOFT study with odanacatib in postmenopausal women with osteoporosis.

FDA to Review Tuzistra XR NDA for Cough Cold

The Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for review for Tuzistra XR (CCP-01; Vernalis and Tris Pharma) in the acute treatment of cough cold.

Vyvanse Under Review for Binge Eating Disorder

The Food and Drug Administration (FDA) has accepted for filing Shire's supplemental New Drug Application (sNDA) with priority review for Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) for the treatment of adults with binge eating disorder (BED).

Results for Humira in Chronic Skin Disease Trial

AbbVie announced results from the Phase 3 PIONEER 1 study with Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (HS).

FDA Designates Antifungal Agent Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to VT-1129 (Viamet Pharmaceuticals), a selective oral antifungal agent, for the treatment of cryptococcal meningitis.

Rolapitant NDA Submitted for Chemotherapy-Induced Nausea and Vomiting

Tesaro has submitted a New Drug Application (NDA) to the FDA for approval of oral rolapitant for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Nintedanib Efficacious in Idiopathic Pulmonary Fibrosis Trials

Boehringer Ingelheim announced results from a pre-specified, pooled subgroup sensitivity analysis from the Phase 3 INPULSIS-1 and INPULSIS-2 trials that evaluated the use of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) based on the severity of lung function impairment at baseline.

Tiotropium Improves Lung Function in Asthma Patients

Boehringer Ingelheim announced results from its Phase 3 UniTinA-asthma trial program evaluating tiotropium in adults, adolescents, and pediatric patients with different severities of asthma.