FDA Approves 35 New Drugs in 2014; Baxter Enters Agreement to Sell Vero Cell Vaccines Platform

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Overcoming Challenges in the Development of Active Drug-Layered Formulations for Multiple Dosage Forms
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Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities
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Sponsored by: Eurofins Lancaster Laboratories

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IVT's Quality Risk Management: Applications to Design, Validation and Automation that Yield Eye-Opening Results
January 21-23, 2015
Orlando, FL USA

Informex 2015
February 03-05, 2015
New Orleans, LA USA

December 18, 2014

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Improving Job Market Creates Opportunity for Change
Bio/pharma employees say they are more secure in their jobs, but may seek better opportunities with other employers.

Year in Review: Trends in Biopharma Manufacturing Outsourcing
Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.

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The Risk and Compliance Paradigm: Risk Management's Impact on QMS
Risk Management is everywhere, and is not some lofty strategic element that is limited to top floor suits making enterprise-wide decisions. Risk Management is becoming an integral part of the compliance process. There are many ways to look at Risk, and each industry has developed different risk based tools to suit their specific business needs.

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Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.

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GMPs for Small-Molecule Drugs in Early Development
The authors explore and define common industry approaches and practices when applying GMPs in early development.

FDA Approves 35 New Drugs in 2014
FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.

Baxter Enters Agreement to Sell Vero Cell Vaccines Platform
Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

EMA Cautions on Experimental Ebola Treatments in Early Stage Development
The agency emphasizes the need for robust scientific assessment and more information on safety and efficacy profiles of Ebola therapies in development.

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Ebola R&D Gets Big Boosts
The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress, as seen in new policies to spur R&D and added funding for these efforts.

Taking a Closer Look into the Life-Science Funding Landscape in Europe and the United Kingdom
The author looks at how life-science research has evolved in Europe and the United Kingdom, and discusses the current funding opportunities for SMEs.

FDA Approves Gardasil 9 for Prevention of Cancers Associated with HPV
FDA announced the approval of Gardasil 9 for the prevention of certain diseases caused by nine types of HPV, five more than the previously FDA-approved Gardasil.

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Safe and cost-effective capsule filling for pre-clinical and first-in-man studies
Monday, December 15, 2014

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Legal Immunity Offered to Makers of Ebola Vaccines in the US
US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

EFPIA Names Joe Jimenez as New President
EFPIA announced that Joe Jimenez, CEO of Novartis, will be its new president.

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Developing a Comprehensive Tool Kit for Microbial Identification
November 18, 2014

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Singapore Unveils Workforce Development Plans for Biopharmaceutical Sector
The Singapore Workforce Development Agency collaborated with governmental groups and industry players to develop a plan to supply biologics-manufacturing workforce demand.

Vetter’s Expansion of Its Chicago Site Completes Company’s Offering in Clinical Syringe Projects
Vetter announced that it added a third cleanroom as part of a US expansion at the Illinois Science and Technology Park in Chicago.

Analytical and Bioanalytical Testing eBook 2014
View technical articles on the best practices and methods for analytical and bioanalytical testing including method transfer during scale up, viral contamination detection, and analytical QbD, as well as a roundup of analytical technology.
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Pharmaceutical Technology Outsourcing Guide
Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations. ... Click here

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