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PharmTech Europe

7 June 2016

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Top Stories

Dutch System to Track Biosimilar Use and Switching Announced

New pharmacovigilance activities seek to support the creation of guidelines for safe switching from innovator products to biosimilars.
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Patheon Appoints Michel Lagarde President

Lagarde will be based out of the company’s Boston office and will lead Patheon’s global corporate and cross-enterprise operations.
/ read more /


Industry News

Pharmapack Europe Launches Start-up Hub

The Start-up Hub is designed to give start-up companies the opportunity to network at Pharmapack.
/ read more /


CHMP Recommends Six Medicines for Approval in EU

During its May meeting the CHMP recommended the approval of six medications in the EU, including three generic drugs, treatments for hepatitis C, and Type 2 diabetes.
/ read more /


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EXPERT INTERVIEW

Barry Holtz, president, iBio CMO sat down with Pharmaceutical Technology to discuss plant models in biopharmaceutical manufacturing.

WATCH NOW
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Regulatory News

CordenPharma Receives FDA Warning Letter

The company received a warning letter at its Latina facility in Sermoneta, Italy following a May 2015 inspection.
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EU Grants Approval to Remicade Biosimilar Flixabi

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.
/ read more /


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Bio/Pharma News

Jazz Pharmaceuticals Acquires Celator

Jazz will acquire Celator for approximately $1.5 billion.
/ read more /


Xellia Builds Testing Services Lab at Budapest Manufacturing Site

Xellia, a generic anti-infective drug manufacturing company, is constructing a laboratory services building at its manufacturing site in Budapest, Hungary.
/ read more /


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Supplier News

Novasep Starts Kilogram-Scale Batch Production at US Facility

Production of kilogram-scale batches of synthetic molecules for early-stage development are now available to US customers.
/ read more /


How the Defend Trade Secrets Act Could Better Protect Manufacturers Who Outsource to CMOs

Pharmaceutical Technology sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.
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Bio/Pharma in China
New Initiatives, New Opportunities

On Demand
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FEATURED TOPICS

VIEWPOINTS

The Value of Saving Lives

Policies for patient access to life-saving therapies must keep pace with biomedical innovation.
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OUTSOURCING

Outsourcing of Biomanufacturing in 2016

Growth may be slowing, but outsourcing activity remains healthy.
/ read more /

QUALITY

Reporting Quality Metrics to FDA

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
/ read more /

STANDARDS & REGULATIONS

Deconstructing the Regulatory Spiral

Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.
/ read more /


Product/Service Profile

Anton Paar

MCP 150 polarimeter
Anton Paar, technology leader and innovator in polarimetry, launches the compact MCP 150. The polarimeter is a one-size-fits-all solution: Although it is compact, it provides full 21 CFR Part 11 compliance, including electronic signature requirements.
/ Read more /

I Holland Limited

Troubleshooting in Tablet Tooling Seminar
I Holland to host ‘Troubleshooting in Tablet Tooling’ Seminar at UK headquarters, as part of their 70th anniversary celebrations. This popular seminar will take place on 23rd and 24th June 2016.
/ Read more /

Shimadzu

Universal solution for automated HPLC method development
Shimadzu’s Nexera Method Scouting system provides an outstanding platform for efficient HPLC method development and implementation. It is based on the Nexera X2 next-generation ultra-high performance liquid chromatograph, an all-round LC system for ultra-high-speed analysis.
/ Read more /


Webcasts

Development Partners for Biopharma: Are you Getting What You Need?

On Demand

Your current contract laboratory and instrument provider may be familiar and comfortable, but, maintaining the status quo doesn’t lead to greater rewards. In fact, it often involves putting up with less-than-desired results. Join us in this web seminar to hear how Ajinomoto Althea develops unsurpassed solutions for biopharma companies, and how a team at Thermo Fisher Scientific has challenged the status quo to deliver uncompromised UHPLC.
Sponsored by Thermo Fisher Scientific


Successful Binding of Peroxide-Sensitive APIs

On Demand
In this live webinar, experts will showcase how to formulate a peroxide-sensitive drug using a binder that combines high binding strength with no peroxide formation at all.
Sponsored by BASF


more webcasts

Events

AAPS Annual Meeting and Exposition

13-17 November, 2016 | Denver, Colorado

PDA/FDA Joint Regulatory Conference

12-14 September, 2016 | Washington DC

ISPE Annual Meeting

18-21 September, 2016 | Atlanta, GA


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 Library

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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