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PharmTech Europe

18 August 2015

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Chinese Domestic Market Continues to Expand
Xellia Pharmaceuticals Expands Raleigh Site
FDA Issues Guidance on Outsourcing Registration

Top Stories

Merck KGaA’s Acquisition of Sigma-Aldrich Approved by Anti-Trust Regulators

Following a divestiture of certain assets in Europe, the acquisition of Sigma-Aldrich by Merck KGaA will be complete.
/ read more /


CPhI & P-MEC China Indicate Expansion of the Chinese Domestic Market

Unlike pharmaceutical manufacturing in the West, China’s growth is not merely a result of the increasing sales of finished formulations in highly regulated markets.
/ read more /

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eBOOKS


Bioprocessing and Sterile Manufacturing 2015 eBook

This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.

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Bio/Pharma News

Xellia Pharmaceuticals Expands Raleigh Site as New North American Headquarters

The expansion will enable relocation of its North American headquarters from Grayslake, Illinois.
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Medimmune and Inovio Pharmaceuticals Form Cancer Pact

Deal includes rights to Inovio’s INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.
/ read more /


More Bio/Pharma News

Supplier News

Symbiosis Pharmaceutical Services Completes Successful Sterile Inspection

No critical or major observations were noted in the Scotland-based facility following an inspection by the UK’s MHRA.
/ read more /


Innova Biosciences Launches Range of Conjugated Antibodies

This new range includes antibodies conjugated to various enzymes, fluorescent dyes, and colloidal gold, for improved flexibility in experimental design.
/ read more /


More Supplier News

Regulatory News

Regulation of Medical Devices and Companion Diagnostics

The trend towards personalized medicines requires a more integrated framework for the approval of devices and diagnostics.
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FDA Issues Guidance on Outsourcing Registration

The agency issues guidance for companies considering registering with FDA as an outsourcing facility.
/ read more /


More Regulatory News

Industry News

Needle in the Haystack, or Rembrandt in the Attic? Drug Repurposing's New Strategy

More companies are looking to repurpose APIs that had originally been developed for other indications but the industry has only scratched the surface of what might be possible.
/ read more /


Regulators Call for the Revision of Part B Reimbursement Rules for Biosimilars

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.
/ read more /


More Industry News

FEATURED TOPICS

MANUFACTURING

Taking the Pulse of Manufacturing Trends and Equipment Use

The 2015 survey says satisfaction is high and continuous manufacturing and PAT use are growing but may be limited by lack of knowledge and experience.
/ read more /

FORMULATION

Environmental Containment Performance—Is There Accountability?

Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.
/ read more /

INGREDIENTS

The Potential of Perfusion

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.
/ read more /

QUALITY

Limiting Risk in Bio/Pharmaceutical Development

Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.
/ read more /


Product/Service Profile


Shimadzu

Changes Everything – LCMS-8060 triple quadrupole mass spectrometer expands UFMS family
Shimadzu’s new LCMS-8060 is designed to push the limits of LC/MS/MS quantitation for applications requiring the highest sensitivity and robustness while delivering a meaningful solution for routine LC/MS/MS analyses.
/ Read more /



Webcasts

Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins

On Demand

The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
Sponsored by: Patheon


Choosing the Proper Dissolution Method When Testing Solubilization Performance

On Demand

This webcast invites all pharmaceutical scientists and formulators from R&D and analytical departments that have an interest in the solubilization of poorly soluble drugs, and in understanding the importance of choosing a proper dissolution method in the solubilization tests to reveal the full potential of the tested solubilization method.
Sponsored by: BASF


more webcasts

on pharmtech tv

PharmTech TV

Compliance and Technology for Track and Trace

QbD in Excipient Selection for User-Friendly Dosage Forms

Intelligent Approaches Towards Reducing the Costs of Drug Manufacturing

FDA Comments on Continuous Manufacturing

Events

CPhI Korea 2015

September 7–9, 2015 | Seoul, Korea

Particles in Parenterals—State-of-the-art visual inspection of sterile medicinal products

September 16-17, 2015 | Berlin, Germany


more events

REFERENCE LIBRARY

Pharmaceutical Technology Drug Delivery Guides

A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects.  Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
/ Click here /


More Reference Library
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