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FDA Accepts Apotex’ Filing of its Biosimilar Application for Pegfilgrastim

December 17, 2014 11:24 am | News | Comments

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).

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FDA Approves Pathogen Reduction System to Treat Plasma

December 17, 2014 10:24 am | News | Comments

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).    

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Halozyme Therapeutics and Janssen to Develop Subcutaneous Products Using ENHANZE Technology

December 17, 2014 10:11 am | News | Comments

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. 

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Danger of Drug-Resistant Infections

December 17, 2014 9:11 am | Videos | Comments

Anthony Kessel of Public Health England speaks to Hala Gorani about the increasing problem of drug-resistant infections.                      

Flu Spreading Just Ahead of the Holidays

December 17, 2014 9:02 am | Videos | Comments

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.               

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PCI Synthesis Sponsors New England CRO/CMO Council

December 17, 2014 8:54 am | News | Comments

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.

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Massachusetts Doctor Cured of Ebola Returning to Liberia

December 17, 2014 8:47 am | by PHILIP MARCELO, Associated Press | News | Comments

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.            

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Cases of Most Common STD Falls for First Time in 30 Years

December 17, 2014 8:40 am | by MIKE STOBBE, AP Medical Writer | News | Comments

For the first time in three decades, the nation's most common sexually transmitted disease is a little less common.                       

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Brain-Injury Program Working With NFL Players

December 17, 2014 8:35 am | News | Comments

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.   

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Napster Co-Founder to Invest in Allergy Research

December 17, 2014 8:30 am | by OLGA R. RODRIGUEZ, Associated Press | News | Comments

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.        

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FDA Approves Ipsen's Somatuline® Depot® Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors

December 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.

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Pfizer Starts Phase II Study of PF-06252616 in Duchenne Muscular Dystrophy

December 17, 2014 8:14 am | News | Comments

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.

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Bayer Submits BLA Hemophilia Treatment

December 17, 2014 8:11 am | News | Comments

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.

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GlobalData: Top 30 Pharma Companies Spent $112B on R&D in 2013

December 16, 2014 11:36 am | News | Comments

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.    

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Eli Lilly Bumps Dividend for First Time Since 2009

December 16, 2014 10:54 am | News | Comments

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.

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