Apotex has announced that the FDA has accepted for filing the company's application for pegfilgrastim, a biosimilar version of Amgen's Neulasta. The product has been jointly developed with Intas Pharmaceuticals. The application was filed under the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA).
The FDA has approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI).
Halozyme Therapeutics has entered into a worldwide collaboration and license agreement with Janssen Biotech for the purpose of developing and commercializing products combining proprietary Janssen compounds with Halozyme's ENHANZE technology.
Anthony Kessel of Public Health England speaks to Hala Gorani about the increasing problem of drug-resistant infections.
Several states are experiencing widespread flu outbreaks just prior to the holidays which could result in even more cases reported. Dr. Richard Besser tracks the growing concerns about the effectiveness of this season's vaccine.
The non-profit New England CRO/CMO Council is open to CROs and CMOs operating in and around Boston, the nation's largest life sciences cluster. The Council is designed to market the cluster and to provide the broader BioPharma community with a means of accessing local CRO’s, CMOs and other suppliers to meet their current and future outsourcing requirements.
A Massachusetts doctor cured of Ebola says he's returning in January to Liberia, the West African country where he contracted the virus, to continue working at a medical mission.
For the first time in three decades, the nation's most common sexually transmitted disease is a little less common.
Representatives with the Eisenhower Center announced yesterday that it will be the primary facility used by the NFL Players Association for treating brain injuries and other neurological issues through the After the Impact program.
Napster co-founder Sean Parker says he missed most of his final year in high school and has ended up in the emergency room countless of times because of his deadly allergy to nuts, shellfish and other foods.
FDA Approves Ipsen's Somatuline® Depot® Injection for the Treatment of Gastroenteropancreatic Neuroendocrine TumorsDecember 17, 2014 8:23 am | News | Comments
Ipsen Biopharmaceuticals announced that Somatuline® Depot® Injection 120 mg (referred to as Somatuline®) was approved by the FDA for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival.
Pfizer has announced enrollment of the first patient in a multicenter Phase II clinical trial of the investigational compound PF-06252616 in boys with Duchenne muscular dystrophy (DMD), a genetic disorder characterized by progressive muscle degeneration and weakness.
Bayer HealthCare has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults.
The world’s leading 30 pharmaceutical companies spent a combined $112 billion on research and development (R&D) in 2013, an increase of $723 million over the previous year, according to research and consulting firm GlobalData.
Lilly has been dealing with a drop in both earnings and revenue due to the loss of patents protecting key drugs from cheaper generic competition. Company executives have said they remained committed to the dividend, despite the financial blows the company was absorbing, but some analysts have questioned whether that commitment might waver.