News Releases
FDA approves new indication for Promacta
GlaxoSmithKline announced today that the US Food and Drug Administration (FDA) has approved PROMACTA ® for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.
Abraxane Shows Positive Progress for Pancreatic Cancer Treatment
Celgene International Sàrl, a subsidiary of Celgene Corporation today announced that its phase III study of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in treatment-naïve patients with advanced pancreatic cancer met its primary endpoint of overall survival.
New Phase 3 Findings For Psoriatic Arthritis Drug Stelara
Janssen Research & Development, LLC (Janssen) announced today new findings from PSUMMIT II, a Phase 3 investigational study.
FDA advisory panel recommends approval of long acting insulin
Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Applications (NDA) for insulin degludec and insulin degludec/insulin aspart.
Merck Announces New Phase III Data for Suvorexant
Merck, known as MSD outside the United States and Canada, announced new data for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.
Chronic Myelogenous Leukemia Drug Approved
Pfizer Inc. announced the US Food and Drug Administration (FDA) has approved BOSULIF (bosutinib), an Abl and Src kinase inhibitor, for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy.
Pfizer And Astrazeneca Combine for OTC Nexium
Pfizer Inc. announced that it has entered into an agreement with AstraZeneca for the over-the-counter (OTC) rights for NEXIUM (esomeprazole magnesium), a leading prescription drug currently approved to treat the symptoms of gastroesophageal reflux disease (GERD).
Clinical Endpoints Not Met In Alzheimer Drug Study
Pfizer Inc. announced that the co-primary clinical endpoints, change in cognitive and functional performance compared to a placebo, were not met in the Janssen Alzheimer Immunotherapy R&D LLC (Janssen AI)-led Phase 3 trial of intravenous (IV) bapineuzumab in patients with mild-to-moderate Alzheimer’s disease who do not carry the ApoE4 (apolipoprotein E epsilon 4) genotype (Study 301). Pfizer and Janssen AI are partners in the Alzheimer’s Immunotherapy Program (AIP).
Lucentis Injection Approved
Roche announced that Lucentis ( ranibizumab injection) was approved by the U.S. Food & Drug Administration (FDA) for treatment of diabetic macular edema ( DME ), an eye condition in people with diabetes that causes blurred vision, severe vision loss and sometimes blindness.
Humira Approved in Europe for Treatment of Spondyloarthritis
Abbott announced that the European Commission (EC) has approved Humira (adalimumab) for the treatment of adults with severe axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage.