Fujifilm Acquires Kalon Biotherapeutics; EMA Recommends Seven New Medicines

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Enhancing Quality and Process Efficiency Using Continuous Manufacturing Technology for Drug Substance and Drug Product
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February 09-11, 2015
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December 23, 2014

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A Next Generation of Quality Management
The author proposes a quality management system that uses the power of executive management to promote a positive quality culture.

FDA Approves Novel Treatments in 2014
FDA approves treatments for new diseases and drugs that operate by new mechanisms.

Pinpointing the Source of Tablet Spots and Specks
Solving the problem of tablet spots or specks involves prevention and thorough investigation.

Fujifilm Completes Acquisition of Kalon Biotherapeutics
Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.

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EMA Recommends Seven New Medicines for Marketing Authorization
The Committee for Medicinal Products for Human Use recommended seven new medicines at a December 2014 meeting, including weight management and Parkinson’s disease treatments.

Biosimilar Development Moves Forward at FDA
FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

Achieving Long-Term Success in Supply-Chain Security
A global framework of standards enabling collaboration among industry stakeholders is needed to battle the increasing threat of counterfeit medicines.

Locked4Kids, a New Child-Resistant, Senior-Friendly Packaging Concept
Ron Linssen, managing director of Ecobliss, shares insights on a new packaging concept that is child-resistant and senior-friendly. The innovation won the packaging category at this year's CPhI Pharma Awards.

FDA Approves Zerbaxa
FDA announced that it approved a new antibacterial drug, Zerbaxa, for the treatment of complicated intra-abdominal infections and complicated urinary tract infections.

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Merck Acquires Biotechnology Company, OncoEthix
Merck announced that it acquired OncoEthix, a biotechnology company specializing in oncology drug development, for up to $375 million.

EMA Proposes Measures to Lower Risks Surrounding Use of Antibiotics in Animals
The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.

Actavis Announces Senior Leadership Team
Actavis announced a senior leadership team comprised of both Actavis and Allergan leaders designed to facilitate dynamic company growth.

ICH Moves Q3D Impurities Guidance to Implementation Stage
ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.

Hovione’s Loures Facility Completes Successful FDA Inspection
FDA’s pre-approval inspection of Hovione’s facility in Loures, Portugal confirms site to be GMP-compliant.

New England CRO/CMO Council Debuts
New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.

Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity
Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

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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