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PharmTech Europe

9 February 2016

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Top Stories

Biopharmaceutical Companies Announce Plans to Develop Zika Vaccine

Several biopharmaceutical companies announce plans to launch R&D into Zika vaccine candidates.
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Valeant and Turing Called Out on Drug Pricing

In a hearing held on Feb. 4, 2016, executives from Valeant and Turing had a hard time explaining their rationales for exorbitant price hikes of older drugs.
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Industry News

ISPE Announces Facility of the Year Awards Category Winners for 2016

The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners for operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.
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Pfizer and Bristol-Myers Squibb Enter Into Agreement with Portola

Pfizer and Bristol-Myers Squibb enter into agreement with Portola to develop and commercialize andexanet alfa in Japan.
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Regulatory News

FDA's Quality Office Promotes Modernization

CDER's Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.
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What Does the Future Hold for the Animal Rule? Examining FDAs Final Guidance

The author reviews FDA's final Animal Rule guidance.
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Bio/Pharma News

Sartorius Group Sales Revenue Jumps 16% in 2015

Sartorius releases financial results for 2015, announcing a 16% increase in group sales revenue.
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Merck: Biosimilar Makers Likely to Target New Patients

Although switching has occurred in European markets for some biosimilars, most biosimilar manufacturers will focus on securing new users, according to Merck.
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Supplier News

LabConnect Builds New Biorepository Facility

LabConnect built a biorepository facility in Tennessee.
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Onyx Scientific Announces Facility Expansion

Planned expansion at Onyx Scientific add laboratories, GMP suites, and storage space.
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FEATURED TOPICS

DRUG DEVELOPMENT

Bio/Pharma Navigates New Routes to Drug Development

Amid corporate restructurings, regulatory initiatives, and aging R&D assets, will drug development accelerate or stall in 2016?
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API SYNTHESIS AND MANUFACTURING

Expedited Approvals and Orphan Drugs Dominated 2015 Novel New Drugs

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.
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FORMULATION

Oncology and Rare Diseases Lead in Innovation

Synthetic biology promises to drive tomorrow's therapies, while continuous processing is already being used in some new drugs.
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US REGULATORY WATCH

Politics and Pricing Will Challenge Manufacturers in 2016

The bio/pharmaceutical industry will face increased scrutiny of product quality and cost drivers.
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Next Generation HPMC Capsules
Bioequivalence and Functional Performance

On Demand
New in-vivo data demonstrating the performance characteristics of the next generation of HPMC capsules.
Read more



Product/Service Profile

ABITEC Corporation

CAPMUL® - Where Formulation Begins™
ABITEC Corporation is dedicated to the advancement of essential bioavailability enhancement and formulation development technology. ABITEC synthesizes and produces lipid based excipients to enhance bioavailability of poorly water soluble and poorly permeable molecules for the pharmaceutical industry.
/ Read more /

Aptar Pharma

Aptar Pharma chosen for the Innovation tour at Pharmapack Europe
Aptar Pharma, a global solution provider of innovative and proven aerosol, injection and spray delivery systems for biotech, healthcare and pharma products, will participate at the Innovation tour organized into the Pharmapack Europe conference, to be held on February 10 and 11, 2016, in Paris Porte de Versailles.
/ Read more /

EtQ, Inc

EtQ is the leading quality, compliance and EHS management software provider for identifying, mitigating and preventing high-risk events through integration, automation and collaboration.
/ Read more /

Shimadzu

The Swiss Knife of analytics
Shimadzu has released its new Nexera UC unified chromatography system. It is the world's first-ever unified and fully automated instrument combining supercritical fluid extraction (SFE) with supercritical fluid chromatography (SFC).
/ Read more /

Veltek Associates, Inc.

VAI produces high quality sterile wipers that are suited for use in any cleanroom environment. Visit our website or contact your local VAI representative for more information.
/ Read more /


Event Profile

BIO-Europe Spring® 2016 — 10th International Partnering Conference
Where the global biotech industry comes to partner
Date: April 4–6, 2016
Location: Stockholm, Sweden
Venue: Kistamässan Convention Center
BIO-Europe Spring® is the premier springtime partnering conference which annually attracts an international "who's who" from biotech, pharma and finance for three days of high caliber networking.
/ Read more /


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IVT's 7th Annual Validation Week EU, taking place 6-8 April in Dublin, is the industry’s best opportunity to gain the most current regulatory updates and ensure you implement the best-in-class validation program enterprise-wide. It has never been more critical to understand up-to-date regulations, trends and procedures in implementing statistics, mobile medical aps, migrating to the cloud, Annex 15 and validation from A to Z.
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Webcasts

Fundamentals of Spray-Dried Dispersion Technology

On Demand

Spray-dried dispersion technology is a proven approach to improve the dissolution rate and bioavailability of low solubility compounds, and helps to bring new medicines to market. Attend this webinar to learn the fundamentals of spray-dried dispersion formulation selection, process development, stability, scale-up, and performance considerations.
Sponsored by Bend Research


Pharma Supply Chain Security: Are You in Control?

On Demand
As global requirements for pharma supply chain safety become more stringent, pharmaceutical manufacturers need to be more proactive in monitoring supply chain partners to ensure security and quality. In this program, an expert shares best practices that will prevent liability and noncompliance, improve quality and boost supply chain efficiency.
Sponsored by Spectrum Chemical Mfg. Corp.


more webcasts

on pharmtech tv

PharmTech TV

Tablet Coating

The Future of Dosage Forms

Drug Development Pipeline Update

Events

Pharmapack Europe

10-11 February, 2016 | Paris, France

BIO Europe Spring 2016

4-6 April, 2016 | Stockholm, Sweden

Global Drug Delivery and Formulation Summit

23-25 May, 2016 | Berlin, Germany


more events

REFERENCE LIBRARY

Pharmaceutical Technology presents its Process Analytical Technology resource guide combo

A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
/ Click here /


More Reference Library

eBOOKS

Bioprocessing and Sterile Manufacturing 2015 eBook

This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.

more ebooks
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