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PharmTech Europe

14 July 2015

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in this issue

Pfizer’s Once-Daily Xeljanz Under FDA Review
Horizon Makes Second Offer to Buy Depomed
Hovione Adds Large-Scale Spray-Drying Unit

Top Stories

French Hospital to Drop Remicade in Favor of a Biosimilar

A large health system will use the biosimilar version of infliximab from Hospira after the company offered a discount of 45%.
/ read more /


Pfizer’s Once-Daily Arthritis Tablets Accepted for FDA Review

FDA has accepted for review Pfizer’s new drug application for its modified-release formulation of tofacitinib citrate tablets (Xeljanz).
/ read more /

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Bio/Pharma News

Biogen Plans Biologics Manufacturing Facility in Switzerland

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.
/ read more /


Horizon Makes Second Offer to Buy Depomed, Gets Rejected Again

The offer, valued at $3 billion, represents a 42% increase in Depomed’s share price.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Acts on Unapproved Ear Drop Products

FDA orders unapproved prescription ear-drop products with active ingredients removed from the market.
/ read more /


21st Century Cures Act Gets a Revision

The amendment suggests modifications to the calculation of a drug’s average manufacturing price and to the reimbursement rate for infused medications.
/ read more /


More Regulatory News

Supplier News

Hovione Adds Large-Scale Spray-Drying Unit

Hovione is installing a new large-scale spray-drying unit in Loures, Portugal, specifically designed to handle high potency APIs and a wide variety of organic solvent systems.
/ read more /


Sartorius Stedim Biotech Acquires Cellca

According to Sartorius Stedim Biotech, this acquisition expands its service offering for process development.
/ read more /


More Supplier News

Industry News

Compliance with US and EU Internal Audit Requirements

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.
/ read more /


Data Integrity Questioned at Indian API Manufacturer; Indian Pharma Faces Compliance Challenges

A recent Indian API facility inspection and an Ernst & Young survey highlight the compliance challenges facing Indian pharma.
/ read more /


More Industry News

FEATURED TOPICS

BIOLOGICS

Top Trends in Biopharmaceutical Manufacturing: 2015

Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.
/ read more /

OUTSOURCING

Catalent Licenses Excelimmune’s Antibody Combination Therapy Platform

Catalent's licensing of Excelimmune’s antibody combination therapy platform can enable the manufacture of multiple recombinant antibodies in a single batch culture.
/ read more /

PEER-REVIEWED

Using a Dual-Drug Resinate Complex for Taste Masking

Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.
/ read more /

MANUFACTURING

Volkmann Opens Laboratory to Test Vacuum Conveying of Powders

Vacuum-conveying conditions for powders and other free-flowing solid forms can be simulated in Volkmann's new laboratory..
/ read more /


Product/Service Profiles


Buffers and Biochemicals for Life Science

Based on its exclusive nitroalkane chemistry, ANGUS Chemical Company supplies globally registered buffers and biochemicals to the life science industry, including TRIS AMINO® products for buffering, neutralizing, solubilizing and stabilizing.
/ Read More /


Free White Paper: How Risk Management Tools can Improve Product Quality in Today’s Rapid Lifecycles

With the product lifecycle moving so fast, many organizations may ask the question, “how can we effectively measure quality?” What can an organization do to keep up with this new pace of business while ensuring the visibility that quality deserves? The answer is Risk Management.
/ Read More /


i-series - the new driver of i-volution in HPLC analysis

Shimadzu has introduced the i-series of integrated HPLC and UHPLC systems. The analyzers meet the needs of any analytical environment with high speed, outstanding performance, maintainability and economic efficiency.
/ Read More /


Webcasts

Sample Preparation Technologies for Improved Peptide Quantitation Workflow

On Demand

Peptide quantitative analysis requires workflows that deliver high levels of data quality while balancing the needs of sample throughput and regulatory compliance. Learn how advances in sample preparation can enable greater speed, reproducibility, and improved data quality.
Sponsored by: Thermo Fisher Scientific


Controlling the Physical Properties and Performance of Semi-solid Formulations Through Excipient Selection

On Demand

Are you developing new topical products to meet specific design criteria? Are you seeking to replicate the performance of a reference product? In either case, you can achieve your goals by intelligently employing your toolkit of excipients and exploiting knowledge of how they work on a fundamental level. BASF will introduce you to cases that demonstrate the functionality of their excipients and their use in solving problems or meeting design objectives.
Sponsored by: BASF


more webcasts

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PharmTech TV

Contract Services Market Trends

Addressing Pharma Industry Issues

Pharma & Biopharma Outsourcing Association

Events

29th Annual Symposium of The Protein Society

22–25 July 2015 | Barcelona, Spain

42nd Annual Meeting & Exposition of the Controlled Release Society

26–29 July 2015| Edinburgh, Scotland


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 /

eBOOKS

Bioprocessing and Sterile Manufacturing eBook

The editors examine novel sterile and bioprocessing technologies including single-use systems, aging systems, cleanrooms, and lyophilization.


more ebooks
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