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PharmTech Europe
17 January 2017

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Top Stories

Takeda to Acquire ARIAD

Takeda will acquire ARIAD Pharmaceuticals for approximately $5.2 billion.
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Amgen Links with Immatics to Continue Work on Bispecific T-Cell Therapies

The companies will combine expertise on T-cell therapies with two or more binding domains to create novel oncology medications.
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Industry News

FDA Goes on a Good Guidance Spree

FDA published a flurry of guidance documents in late 2016.
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Pharma's R&D Dilemma: Blockbuster Costs Without Blockbuster Revenues

According to a Deloitte report, the industry's return on its research investment has been steadily slipping for the past six years. The conclusion? Fundamental change may no longer be a given, but a necessity for the industry.
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Regulatory News

European Pharmacopoeia Publishes Chemical Imaging Chapter

The European Pharmacopoeia Commission adopted a chapter on chemical imaging for analytical development, quality control, and manufacturing.
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Wockhardt Limited Receives FDA Warning Letter

The company was cited by FDA for violations of sterile processing GMPs.
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Bio/Pharma News

Astellas Terminates Agreement with UMN Pharma for Influenza Program

The company announced that it has terminated an agreement made with UMN Pharma for the co-development of influenza vaccine programs in Japan.
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Regeneron and Sanofi Ordered to Withdraw PCSK9 Inhibitor Praluent from Market

A judge ruled that Regeneron's mAb be removed from the market after Amgen alleged that the marketing of Praluent hurt its reputation as innovator of this class of drugs.
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Supplier News

Catalent to Develop Softgels for Orphan Drug Candidate

Catalent announces a development agreement with JOT to evaluate softgel options for a resveratrol drug candidate.
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SGS Announces Release of New Influenza Strain

The company made a new strain of the influenza virus available for use as a challenge agent in clinical trials.
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FEATURED TOPICS

QUALITY

Overcoming Low Endotoxin Recovery

Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.
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PEER-REVIEWED RESEARCH

Establishing Acceptance Limits for Uniformity of Dosage Units: Part 1

The Uniformity of Dosage Units test is used to evaluate content uniformity or weight variation or dosage forms such as tablets and capsules. The author introduces two different acceptance value limits (n = 10 and 30) in this article.
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API SYNTHESIS & MANUFACTURING

New Horizons for Cross-Coupling Reactions

Non-precious-metal catalysts are increasingly employed for commercial API synthesis.
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FILL/FINISH

Parenteral Advisory: Outmoded Fill/Finish Technology

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?
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Product/Service Profile

SCHOTT AG, Germany

SCHOTT adapti®Q
SCHOTT has expanded its portfolio of ready-to-use pharma containers to meet growing market demand and allows pharma companies to trim costs while boosting efficiency, leading to higher profits.
/ Read more/


Events

Pharmapack Europe

1–2 February, 2017

Sartorius Research Xchange Forum 2017

22–23 February, 2017

CPhI Istanbul

8–10 March, 2017


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PODCAST

B&W Tek's director of Market and Customer Development, Katherine A. Bakeev, PhD, discusses analysis of pharmaceutical raw materials and the benefits of using laser-induced breakdown spectroscopy (LIBS).

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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.
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More Reference BookS

eBOOKS

Bioprocessing & Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.

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