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PharmTech Europe

15 December 2015

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Top Stories

FDA Warns of Potential Baclofen API Contamination

FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.
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Mexican Authorities Approve First Vaccine for Dengue

Sanofi Pasteur was granted marketing authorization for Dengvaxia, the first vaccine for dengue fever.
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Industry News

EMA Director Outlines Five-Year Plan

EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.
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Rice University Scientists Develop Method to Control Infectivity of Viruses

Scientists at Rice University have developed a method to control the infectivity of viruses and gene delivery to the nuclei of target cells.
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Bio/Pharma News

Seqirus Opens Corporate Headquarters in the United Kingdom

Seqirus, CSL Limited's influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.
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Adaptimmune and Universal Cells Collaborate to Develop Allogeneic T-Cell Therapies

Adaptimmune Therapeutics and Universal Cells enter into collaboration and license agreement to develop universal allogeneic T-cell therapies.
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Regulatory News

China FDA Reforms Encourage Western Companies to Manufacture in China

Changes in China's FDA drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.
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FDA Releases Guidance on Communication with the Agency

The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.
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Supplier News

PSL Completes Advanced Process Installations for Pharmaceutical Manufacturing in Singapore

PSL has installed several advanced contained filtration and drying facilities as part of an expansion of a pharmaceutical manufacturing plant in Singapore.
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Catalent Secures Manufacturing Contract for Pfizer's OTC Heartburn Treatment

Catalent has entered into an exclusive long-term supply agreement to produce Pfizer's OTC proton-pump inhibitor for heartburn treatment, Nexium 24HR (esomeprazole), which is also marketed as Nexium Control outside the US.
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FEATURED TOPICS

GMPs

Crafting Standard Operating Procedures

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.
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OUTSOURCING

CMO Investors Have More Money Than Places to Spend It

CMO industry consolidation may be frustrated by a dearth of attractive assets.
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REGULATIONS

New Drugs and New Initiatives Shaped 2015

FDA confirmed quality focus while Congress moved to bolster biomedical innovation.
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GLOBAL MARKET

Market Access Outlook for Canada

The author provides an overview of the key aspects of the current Canadian pharmaceutical market.
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Product/Service Profile

Aptar Pharma

APTAR PHARMA PRESENTS A STEP CHANGE IN THE PERFORMANCE OF DF30Plus FOR pMDIs INCORPORATING COC
Aptar Pharma, a global solution provider of innovative and proven aerosol, injection and spray delivery systems for biotech, healthcare and pharma products, presents its latest innovation, DF30Plus with COCe.
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Webcasts

Practical Guidance for Successful Mammalian Cell Banking & Cell Line Characterization

On Demand

Join this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
Sponsored by Eurofins Lancaster Laboratories


Controlling Contamination in Biopharmaceutical Manufacturing

On Demand
In this webcast, experts will review the sources of contamination, regulations and guidance documents on the control of potential contaminants in raw materials, and best practices to guard against the introduction of contaminants in the manufacturing process. The challenges of detecting contaminants, including mycoplasma, assay development, and testing practices will be discussed.
Sponsored by SGS Life Science Services


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Events

Access to Safe Medicines Europe 2016

19–20 January 2016 | London, United Kingdom

Pharmaceutical Microbiology

20–21 January 2016 | London, United Kingdom

Pharmapack Europe

10–11 February 2016 | Paris, France


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REFERENCE LIBRARY

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.
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eBOOKS

Solid Dosage and Excipients 2015 eBook

This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.


Drug Development Application Handbook

Pharmaceutical Technology's Drug Development Application Handbook is a compilation of technical articles from the magazine's archives and application notes, technical information, and educational materials from the handbook's sponsors.

more ebooks
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