PharmTech Europe, Weekly Alert
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PharmTech Europe

18 October 2016

PHARMTECH.COM

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Top Stories

Pfizer Comes Up Short in Lyrica Patent Battle

A UK appeals court ruled against Pfizer, saying generic-drug makers did not infringe on Lyrica's pain patent.
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Mylan Reaches Settlement with Department of Justice

Mylan reached a $485-million settlement with the Department of Justice over questions raised about the Medicaid rebate classification of EpiPen.
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EXPERT INTERVIEW

Rajesh M. Dave, distinguished professor at the New Jersey Institute of Technology, sat down with Pharmaceutical Technology to discuss polymer thin films for drug delivery.

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Industry News

Study Demonstrates Potential Method for Treating Congenital Diseases In Utero

A new study proposes a way to potentially treat congenital diseases in utero.
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HHS Sponsors Commercial Manufacturing Tests for Ebola Vaccine

HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.
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Regulatory News

Scottish Company Receives USFDA Warning Letter

Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.
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FDA Warns Swiss Company

Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
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Bio/Pharma News

Crescendo and Takeda Collaborate on Humabody Therapeutics

The companies entered into a collaboration and license agreement for Crescendo's Humabody-based therapeutics.
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Piramal to Acquire Five Janssen Injectables

Piramal entered into an agreement with Janssen Pharmaceuticals to acquire five of the company's injectable products.
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Supplier News

Marken Announces New Depot and Operations Center in Argentina

Marken announced the opening of a new depot and logistics operations center in Argentina.
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Recipharm Launches Serialization Showcase Line

Recipharm launched a showcase line to demonstrate the company's new serialization solutions.
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FEATURED TOPICS

FORMULATION

Excipients for Formulation Success

Excipients play a crucial role in the manufacturing of solid-dosage forms and the performance of the finished drug product.
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PEER-REVIEWED RESEARCH

Impact of Quality by Design on Topical Product Excipient Suppliers, Part I: A Drug Manufacturer's Perspective

This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.
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PACKAGING

Ophthalmic Drug Packaging: Safety Risks and Patient Acceptability Issues

The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
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SUPPLY CHAIN

Chasing a Moving Target for Counterfeiting and Illegal Diversion

As criminals duplicate the latest overt security technologies, pharmaceutical manufacturers are evaluating covert and layered approaches to fight counterfeiting, theft, and illegal product diversion.
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Event Profile

CPhI & PMEC India 2016

Date: 21-23 November 2016
Venue: Bombay Exhibition Centre, Goregaon, Mumbai and MMRDA Grounds, BKC, Mumbai
The Indian pharmaceutical industry is all set to experience South Asia's largest Pharma event CPhI and P-MEC 2016, which will be concurrently held at the Bombay Exhibition Centre (BEC) and Bandra Kurla Complex (BKC) in Mumbai.
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UPCOMING WEBCAST

Get to Clinic Faster: Navigating Complex Biologics through Development and Manufacturing
Live Webinar: Wednesday, November 16 at 1:00pm EST
Register now


ON DEMAND WEBCASTS

Getting the Full Picture Predicting Protein Stability Using Chemical and Thermal Denaturation
On-Demand
Learn more


Employing a Lean Lab Approach to Optimize Lab Processes: Part 2 “Improve Productivity”
On-Demand
Learn more


Don't let your diluent be the weakest link in your drug product
On-Demand
Learn more


Events

PDA Visual Inspection Forum

25–26 October, 2016 | Berlin, Germany

Global Conference on Pharmacy and Pharmaceutical Sciences Education

7-8, November 2016 | Nanjing, China

BIO Europe 2016

7–9 November, 2016 | Cologne, Germany


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.
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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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