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December 9, 2014

 
Featured Content
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.

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New single-use bag family Flexsafe
Sartorius Stedim Biotech is introducing a brand-new, scalable range of single-use bags. Its completely new developed product family Flexsafe enables the implementation of single-use bioprocessing throughout all steps of drug manufacture, from process development to production, in upstream and downstream – all using just the one innovative polyethylene film. Learn more
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.

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Top Stories
FDA Issues Draft Guidance to Foster Competitive Access for Bioequivalence Studies
The guidance seeks to help generic and biosimilar drug sponsors gain access to reference products from brand-name manufacturers.

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Sanofi Faces Alleged Kickback Charges
Sanofi executives are being charged in a whistleblower lawsuit for allegedly granting illicit payments to healthcare providers.

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Developing a Comprehensive Tool Kit for Microbial Identification
November 18, 2014
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FDA Approves Amgen Drug for Acute Lymphoblastic Leukemia
Amgen's bispecific T-cell engager (BiTE) antibody constructs help the body fight malignant cancer cells.

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Industry News
CPhI Releases India Market Report
Enhanced R&D efforts and the growing manufacture of finished-dosage drugs in India will shape the country's future success, according to a new report from CPhI.

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FDA Issues Formal Clinical Hold on Aldoxorubicin Trials
CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.

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The Future of Continuous Downstream Processing
December 3, 2014
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Roche Adds Non-Invasive Prenatal Testing to Pipeline with Ariosa Acquisition
Roche announced the acquisition of Ariosa Diagnostics, a molecular diagnostics testing service provider and maker of the Harmony prenatal blood test.

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First Remicade Biosimilar Hits India
Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

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The 7th Annual Biomanufacturing Summit (18-20 February)
Make sure you join companies like UCB, GSK, MEDIMMUNE and GENENTECH to learn how to deliver excellence and efficiency gains through manufacturing, quality and supply chain strategies in Biotechnology. Book using code BIOPP and save 20%
Otsuka Announces Plans to Buy Avanir for $3.5 Billion
Japanese drug maker Otsuka announced plans to buy CNS-specialist Avanir Pharmaceuticals for $3.5 billion in an all-cash tender offer.

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Lung Therapeutics Receives Orphan Drug Designation for Empyema Treatment
Lung Therapeutics announced that it received Orphan Drug Designation for LTI-01, an injectable designed for the treatment of loculated pleural effusion.

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Latest Cyber Threats Aimed at Biotechnology Professionals, Drug Manufacturers
Biotech drug manufacturers' emails may have been hacked by individuals with sophisticated investment banking skills, according to a report from the New York Times.

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Medtronic Gains US and EU Conditional Approval for $43 Billion Acquisition of Covidien
Medtronic announced that it received clearance from both the FTC and European Commission to acquire Covidien for $43 billion.

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Webcasts
The Future of Continuous Downstream Processing
Wednesday, December 3, 2014, at 3 times - 3PM CST (Beijing); 11AM CET (Stockholm); 1PM EST (New York)
Sponsored by GE Healthcare
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Events
PepTalk: The Protein Science Week
Date: January 19-23, 2015
San Diego, CA

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The Society for Laboratory Automation and Screening (SLAS) 2015
Date: February 7-11, 2015

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7th Annual Global Biomanufacturing Summit
Date: February 18-19, 2015

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Reference Library
Elements of Biopharmaceutical Production Series, Fourth Edition
An ideal guide for pharmaceutical professionals involved in advances in large-scale pharmaceutical production and manufacturing. The 4th edition of this book is compiled from a variety of resource materials, led by Anurag Rathore.
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