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PharmTech Europe

24 November 2015

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AstraZeneca Acquires ZS Pharma
Pfizer Transfers Vaccine Technology
FDA Overhauls Inspection Operations

Top Stories

UK Center Installs Protein Purification Technology

The UK’s National Biologics Manufacturing Centre will use Novasep’s BioSC Lab for protein purification.
/ read more /


AstraZeneca Acquires ZS Pharma

AstraZeneca will add ZS Pharma’s leading ion-channel candidate to its pipeline.
/ read more /

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Industry News

Hard Times in Washington for Generic Drugs

Even though rising production and use of generic pharmaceuticals is saving billions for the nation’s healthcare system, policy makers continue to slap the industry with policies it claims will limit product development and sales.
/ read more /


Allotrope Foundation Releases Allotrope Framework 1.0

GSK will implement the Allotrope Framework for use in drug substance release and stability testing.
/ read more /


More Industry News

Bio/Pharma News

Pfizer Transfers Vaccine Technology for Production in South Africa

South Africa’s Biovac Institute launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.
/ read more /


AbbVie CEO: Humira Biosimilars Won’t Reach Market Until at Least 2022

At least 70 patents for Humira will protect the legacy product from biosimilar competitors, according to information presented during the company’s third-quarter earnings call.
/ read more /


More Bio/Pharma News

Supplier News

rlc Invests in New Packaging Center in Switzerland

This investment comes in response to the increasing demand for high quality and safe pharmaceutical packaging.
/ read more /


Recipharm Secures Manufacturing Contract with Daewoong Pharmaceutical

Under the terms of the agreement, Daewoong will annually purchase minimum API quantities of erdosteine of approximately EUR 25 million from Edmond Pharma, a Recipharm Group company.
/ read more /


More Supplier News

Regulatory News

EMA Releases Post-Authorization Efficacy Study Guideline

The European agency presents guidelines for conducting post-authorization efficacy studies.
/ read more /


FDA Overhauls Inspection Operations

New program emphasizes quality, risk, and global collaboration.
/ read more /


More Regulatory News

FEATURED TOPICS

FORMULATION

Demonstrating Therapeutic Equivalence for Generic Topical Products

The determination of topical bioequivalence requires a multi-faceted approach, tailored specifically to the generic-drug formulation.
/ read more /

PEER-REVIEWED

Identifying Causes Of Delamination

Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.
/ read more /

QUALITY

Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.
/ read more /

EUROPEAN REGULATIONS

Risk-Sharing Agreements in the EU and Considerations for Moving Forward

The authors look at key factors driving the risk-sharing agreements that have been implemented to reduce drug expenditures across Europe.
/ read more /


Product/Service Profiles

Agilent

Agilent CrossLab –From Insight to Outcome
Laboratories today face complex scientific and business challenges that require key insights into laboratory operations. Agilent CrossLab Enterprise Solutions provide these insights by leveraging laboratory operations data to help you dramatically improve scientific and business outcomes across your local, regional or global laboratory enterprise. Agilent CrossLab Enterprise Solutions -- focused on your organization’s goals.
/ Read more /

Wickham Laboratories Ltd

Bacterial Endotoxin Testing by LAL
GMP/GLP compliant testing laboratory, Wickham Laboratories Ltd, offers a dedicated in vitro bacterial endotoxin service for clients requiring biocompatibility testing.
/ Read more /


Event Profile

CPhI India

Meet 32,000 Pharma Professionals @South Asia's largest Pharma Expo
1st – 3rd December 2015
Bombay Convention & Exhibition Centre, Mumbai, India
/ Learn more /


Webcasts

Optimizing M&A Integration for Customer Success: The CMO Perspective

On Demand

Merger and acquisition (M&A) trends in the contract services and biopharma space are set to continue in the coming years. Although M&A at contract manufacturing organizations (CMOs) can be a stressful time for clients, customers should know that M&As offer various opportunities for continuous improvement and the service providers that go through M&A integration most frequently are likely to be among the best proponents of the process. Learn best practices in approaching integration planning. Find out why change management is vital during acquisitions and learn what you should be communicating during integrations and when you should betalking to the CMO.
Sponsored by AMRI


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


more webcasts

Events

Vaccines

December 1-2 | Berlin, Germany

Analytical Procedures and Methods Validation

December 8, 2015 - December 10, 2015 | Philadelphia, PA

Stability Testing

December 08–10, 2015 | Philadelphia, PA


more events
 

REFERENCE LIBRARY

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo

A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
/ Click here /


More Reference Library

eBOOKS

Bioprocessing and Sterile Manufacturing 2015 eBook

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

more ebooks
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