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PharmTech
February 11, 2016
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD

in this issue

Valeant and Turing Called Out on Drug Pricing
Sartorius Group Sales Revenue Up 16% in 2015
FDA Staff Backs Remicade Biosimilar

Top Stories

Pfizer Announces Organizational Changes for Pending Allergan Merger

Pfizer names executive leadership team for combined organization upon close of proposed Allergan transaction.
/ read more /


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.
/ read more /

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The 2016 PDA Annual Meeting provides the latest and most comprehensive information about innovative biopharmaceutical approaches, bioprocessing technologies and manufacturing sciences for development and commercialization. Learn how accelerated product development, expanding access to medicines and personalized treatments will impact the future of manufacturing. Opportunities abound to network with industry and regulatory experts and colleagues from around the world.
Learn more


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.
/ read more /

Danish Companies and University Collaborate on MRSA Vaccine

Barvarian Nordic, Evaxion Biotech, and the Technical University of Denmark announced plans to collaborate on the development of a vaccine for MRSA.
/ read more /


More Industry News

Supplier News

LabConnect Builds New Biorepository
Facility

LabConnect built a biorepository facility in Tennessee.
/ read more /


Onyx Scientific Announces Facility
Expansion

Planned expansion at Onyx Scientific add laboratories, GMP suites, and storage space.
/ read more /


More Supplier News
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The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
In a market where high-demand causes organizations to seek software systems that will fit into their complex business infrastructure, the pressure to find the right system often causes angst to many. Learn key elements to spotting a good FDA Compliance solution and techniques for achieving GMP Compliance.
Download Now


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.
/ read more /


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.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Publishes Blog On Modernizing Generic Drug Review Processes

Stephen Ostroff published a blog on FDA regarding goals to modernize the generic drug review process in an effort to increase patient access to generics.
/ read more /


FDA Staff Backs Remicade Biosimilar

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.
/ read more /


More Regulatory News

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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
LIVE WEBCAST: Wednesday, March 23, 2016 at 8 am PDT / 10 am CDT / 11 am EDT
Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.
Register now


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?
/ read more /


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.
/ read more /

 

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.
/ read more /


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.
/ read more /


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Best Practices for Effective Product Transfer
ON-DEMAND
Understanding all aspects of the product transfer process is critical to a successful transfer and delivery of a quality product. During this one-hour webinar, regulatory and pharma experts will discuss the critical elements and processes needed for an effective, compliant product transfer process and successful end results.
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Webcasts

Best Practices for Effective Product Transfer

On Demand

Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.
Sponsored by Rottendorf Pharma


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

Addressing Pharma Industry Issues

The Future of Dosage Forms

Drug Development Pipeline Update

Events

Fermentation and Separation for the Food & Drug Industries

February 21-25, 2016

2016 PDA Annual Meeting

March 14-16, 2016

INTERPHEX 2016

April 26-28, 2016


more events

REFERENCE BOOKS

Pharmaceutical Technology Solid Dosage Combo

Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
/ Learn more /

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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