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PharmTech Europe

20 September 2016

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Top Stories

Biosimilars Face Repercussions of Drug Pricing Debate

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.
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Merck KGaA Joins the DiViNe Project

The project aims to address challenges facing the development, manufacture, and delivery of vaccines.
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EXPERT INTERVIEW

Chris Procyshyn, CEO of Vanrx, sat down with Pharmaceutical Technology to discuss automation in aseptic processing.

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Industry News

PhRMA Announces Research & Hope Award Winners

The organization announced the winners of the 2016 awards at a dinner on Sept. 13 in Washington DC.
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Opportunities for Pan-European Medicine Product Launches Post-Brexit

Following the United Kingdom’s decision to leave the European Union, there are two areas that demand attention—clinical trials and marketing authorization.
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Regulatory News

Compounder Cited for Sterile Manufacturing Violations

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.
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FDA Issues Guidance on the Use of Plasma Fibrinogen Biomarker

The agency provides a qualified context of use for the biomarker plasma fibrinogen.
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EMA Recommends Approval of 11 Drugs

The agency recommended approval of 11 drugs, including three cancer drugs, in September.
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Bio/Pharma News

Allergan Acquires RetroSense Therapeutics

Allergan acquired clinical-stage gene-therapy company, RetroSense Therapeutics, for $60 million.
/ read more /


Sanofi and Verily Launch Onduo

The companies launched Onduo, a joint venture focused on developing solutions to assist patients with Type 2 diabetes.
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EMA Grants Conditional Approval to Lartruvo

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.
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Getting the Full Picture Predicting Protein Stability Using Chemical and Thermal Denaturation
Live Webinar: Thursday, September 28 at 11:00 am EDT
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Supplier News

Catalent to Acquire Pharmatek

Catalent will acquire Pharmatek, a San Diego-based manufacturer of oral, injectable, and topical products.
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Idifarma Receives Investment from Suanfarma S.A. to Boost International Growth

As part of a planned process to replace venture-capital financial partners, Suanfarma S.A. has acquired a stake in Idifarma.
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Employing a Lean Lab Approach to Optimize Lab Processes: Part 2 “Improve Productivity”
Live Webinar: Tuesday October 11 at 11:00 am EDT
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FEATURED TOPICS

PEER-REVIEWED RESEARCH

Best Practices for Cleaning Validation Swab Recovery Studies

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.
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PROCESS DEVELOPMENT

The Internet of Things for Pharmaceutical Manufacturing

In the pharmaceutical factory of the future, data collected by internet-connected manufacturing equipment improves operational efficiency.
/ read more /

MANUFACTURING

Sterile Injectables Shortages: Can Innovation End A Crisis?

The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?
/ read more /

FACILITIES

How to Get the Most Out of Facility Renovations

Renovating a facility requires careful design and a plan to minimize production interruption.
/ read more /


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Don't Let the Diluent be Your Weakest Link in Your Drug Product
Live Webinar: Thursday, October 13 at 10:00 am EDT
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Product/Services Profiles

Shimadzu

World's first system Fully automated sample preparation module for LC-MS
Shimadzu has released a new and unique fully automated sample preparation module (RUO) connected online for LC-MS to the four major clinical research markets in Europe, i.e. Germany, France, Italy and Spain.
/ Read more/


Event Profile

CPhI Worldwide, ICSE, InnoPack, P-MEC, FDF

Date: Exhibition: 4th-6th October, 2016 Pre-Connect Congress : 3rd October 2016
Venue: Fira de Barcelona Gran Via, Barcelona, Spain
CPhI Worldwide, the world's leading pharmaceutical platform, co-located together with ICSE, InnoPack, P-MEC and FDF, brings together year on year over 36,000 industry experts from 153 countries around the world to meet and greet, do business and shape the future of the global pharmaceutical industry.
/ Read more /


Events

CPhI Worldwide

4-6 October, 2016 | Barcelona, Spain

PDA Visual Inspection Forum

25-26 October, 2016 | Berlin, Germany

BIO Europe 2016

7-9 November, 2016 | Cologne, Germany


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 /


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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