FDA Releases Draft Guidance on Biosimilarity; FDA and EMA Updates

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Effective Viral Contamination Testing Programs for Biologics Product Manufacturing
Tuesday, May 27, 2014 at 11:00 AM CET
Sponsored by: SGS Life Science Services

Delivering Biologics with a Difference
Thursday, June 5, 2014 at 11:00 AM EDT
Sponsored by: Baxter Biopharma Solutions

Achieving Raw-Material Transparency in the Pharmaceutical/ Biopharmaceutical Supply Chain Efficiency
On Demand
Sponsored by: SAFC

Risk-Mitigation Strategies for API Manufacturing in Emerging Markets
On Demand
Sponsored by: Neuland

More Webcasts

ISPE-FDA CGMP Conference
June 2-4, 2014
Baltimore, MD

3rd Annual Forum on Manufacturing Execution Systems (MES) for Device and Diagnostics
June 4-5, 2014
San Diego, CA

Bio/Pharmaceutical and Medical Device Product Recalls Summit
June 11-12, 2014
San Diego, CA

Pharma Outsourcing and Procurement Summit 2014
June 11-12, 2014
Berlin, Germany

May 22, 2014

PharmTech.com

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Quality-Technical Agreements
Siegfried Schmitt, principal consultant at PAREXEL, discusses the importance of quality-technical agreements.

Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process Considerations
USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.

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Demand for New Vaccines Spurs Innovation
New formulations and expanded vaccine production are encouraged.

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Complimentary USP Compliance with the Weighing Experts
Designed to further develop the skills you need to successfully navigate GMP guidelines and recent USP changes. We'll help you actualize your SOPs in the most efficient way!.

Your organization and career will benefit from your attending this important event!

East: Philadelphia, PA
Tuesday - June 10, 2014

West: San Mateo, CA
Thursday - June 12, 2014

Hospira Issues Recall Due to Particles from Glass Defects in Vials
Hospira has recalled one lot of labetalol hydrochloride injection, USP, due to visible particulates.

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Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities
On Demand Webcast
To Register free:

www.pharmtech.com/navigating

AstraZeneca Rejects Pfizer's Final Offer
AstraZeneca rejects Pfizer's final offer of $118 billion for a proposed merger of the two companies.

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Overcoming Challenges in the Development of Active Drug-Layered Formulations for Multiple Dosage Forms
On Demand Webcast
To Register free:

www.pharmtech.com/overcomingchallenges

US Marshals Seize Unapproved Drugs
Ascend Laboratories and Masters Pharmaceuticals cited in seizure of $11 million in unapproved drugs.

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Life Cycle Management Opportunities in Softgel Technologies
Live Webinar: Wednesday, May 21, 2014 at 8:00am PDT/ 10:00am CDT/11:00am EDT
To Register Free:

www.pharmtech.com/opportunities

FDA and EMA Join Forces on Treatment of Gaucher Disease in Children
FDA and EMA release a draft joint proposal on the development of new drugs to treat Gaucher disease in children.

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The largest, most influential biotech meeting in the world is coming to San Diego, June 23 – 26, 2014, offering four days of career-boosting opportunities—from targeted education sessions and specialty forums to BIO One-on-One PartneringTM meetings with thousands of companies. Join the global biotech community at BIO 2014. Register now at

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Boehringer Ingelheim to Make Clinical Trial Data Available
Boehringer Ingelheim announced that it is working on a program to make clinical trial data and other related documents more widely accessible for approved products and drug-development programs that have been terminated.

EMA and European Chemicals Agency Strengthen Collaboration
EMA and ECHA sign agreement to share information and work together on risk assessments.

FDA Releases Draft Guidance on Biosimilarity
Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

SGS Announces Appointments at New Facility in California
SGS makes two senior appointments at its new GMP/GLP laboratory in Carson, California.

Advanced Scientifics and Chemic Laboratories Announce Joint Cooperation Agreement
Advanced Scientifics and Chemic Laboratories enter a three-year joint cooperation agreement to collaborate on product development projects.

Novasep Commissions Plant Extension for Highly Potent APIs
New manufacturing capacity at the Le Mans, France facility is being used to scale up antibody drug conjugates.

Merck Sells Ophthalmology Business in Japan to Santen Pharmaceutical
Santen will purchase Merck's ophthalmology products business in Japan and key markets in Europe and Asia Pacific.

AstraZeneca and MRC Laboratory of Molecular Biology Launch Joint Research Fund
AstraZeneca will collaborate with the Medical Research Council Laboratory of Molecular Biology to fund a range of pre-clinical research projects.

What impact do mega-mergers of biopharmaceutical companies have on the development of new drugs?

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Solid Dosage and Excipients
Review emerging trends in the formulation and manufacture of solid dosage drugs, as well as the role of excipients in enhancing the functionality of these drug forms.

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Bioprocessing and Sterile Manufacturing
View technical articles on the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, sterilization procedures, modular manufacturing, and more.

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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

Manufacturing Equipment & Supplies
Filtration and single-use systems solutions and expertise.

Chemicals, Raw Materials, Intermediates, & Excipients
Visit us at www.sonneborn.com for a free sample of any Sonneborn product.

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