Pharmaceutical Technology ePT Weekly
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PharmTech
July 9, 2015
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in this issue

21st Century Cures Act Gets a Revision
Pfizer’s Once-Daily Arthritis Tablets Accepted for FDA Review
DOJ Enters Consent Decree Against Acino Products

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Top Stories

Sartorius Stedim Biotech Acquires Cellca

According to Sartorius Stedim Biotech, this acquisition expands its service offering for process development.
/ read more /


French Hospital to Drop Remicade in Favor of a Biosimilar

A large health system will use the biosimilar version of infliximab from Hospira after the company offered a discount of 45%.
/ read more /

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Industry News

Latvian Government Partners with Pharma in Signing Letter of Intent

The Latvian government and Pharma have signed a letter of intent on June 29, 2015, agreeing on measures and a mutual cooperation in projects that will help improve medicines access and health outcomes in Latvia.
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CPhI Angels Unveils Charity Initiative to Build Classroom in Kenya

CPhI is calling on all its attendees, exhibitors, and the wider pharma community to support this initiative.
/ read more /


More Industry News


Supplier News

Hovione Adds Large-Scale Spray-Drying Unit

Hovione is installing a new large-scale spray-drying unit in Loures, Portugal, specifically designed to handle high potency APIs and a wide variety of organic solvent systems.
/ read more /


Capsugel Completes New Spray-Dried Dispersion Manufacturing Facility

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.
/ read more /


More Supplier News

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eMDR is Coming: How to Enhance Collaboration with the FDA
The FDA is tasked with the job of ensuring that all products produced within medical device, pharmaceuticals, biologics, and all other industries are produced safely and effectively. Learn about benefits of using the FDA's eMDR program and best practices of implementing an eMDR system to meet specific business needs.
Download White Paper Now



Bio/Pharma News

Biogen Plans Biologics Manufacturing Facility in Switzerland

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.
/ read more /


Horizon Makes Second Offer to Buy Depomed, Gets Rejected Again

The offer, valued at $3 billion, represents a 42% increase in Depomed’s share price.
/ read more /


More Bio/Pharma News


Regulatory News

DOJ Enters Consent Decree Against Acino Products

US Court orders New Jersey drug manufacturer and its president to stop distribution of unapproved and misbranded drugs.
/ read more /


21st Century Cures Act Gets a Revision

The amendment suggests modifications to the calculation of a drug’s average manufacturing price and to the reimbursement rate for infused medications.
/ read more /


More Regulatory News

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Just released – Tablet Press Replacement Parts and Accessories Catalogs
In addition to efficient, durable and highly-performing tablet compression tooling, Natoli Engineering Company also offers tablet press replacement parts for most makes and models of machines as well as tablet compression accessories to clean, maintain, analyze, and protect your tooling. Download a PDF of our new catalogs or request a quote online at natoli.com.



FEATURED TOPICS

QUALITY

Microbiologists Contribute to a Quality Culture

Presenters at IVT’s Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.
/ read more /

STANDARDS AND REGULATION

Pfizer’s Once-Daily Arthritis Tablets Accepted for FDA Review

FDA has accepted for review Pfizer’s new drug application for its modified-release formulation of tofacitinib citrate tablets (Xeljanz).
/ read more /

MANUFACTURING

Volkmann Opens Laboratory to Test Vacuum Conveying of Powders

Vacuum-conveying conditions for powders and other free-flowing solid forms can be simulated in Volkmann's new laboratory.
/ read more /

BIOLOGICS

Top Trends in Biopharmaceutical Manufacturing: 2015

Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.
/ read more /

DOSAGE FORMS

FDA Acts on Unapproved Ear Drop Products

FDA orders unapproved prescription ear-drop products with active ingredients removed from the market.
/ read more /

OUTSOURCING

Catalent Licenses Excelimmune’s Antibody Combination Therapy Platform

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable the manufacture of multiple recombinant antibodies in a single batch culture.
/ read more /


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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling

On Demand
Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
Learn More



Webcasts

Sample Preparation Technologies for Improved Peptide Quantitation Workflow

On Demand

Peptide quantitative analysis requires workflows that deliver high levels of data quality while balancing the needs of sample throughput and regulatory compliance. Learn how advances in sample preparation can enable greater speed, reproducibility, and improved data quality.
Sponsored by: Thermo Fisher Scientific


Controlling the Physical Properties and Performance of Semi-solid Formulations Through Excipient Selection

On Demand
Are you developing new topical products to meet specific design criteria? Are you seeking to replicate the performance of a reference product? In either case, you can achieve your goals by intelligently employing your toolkit of excipients and exploiting knowledge of how they work on a fundamental level. BASF will introduce you to cases that demonstrate the functionality of their excipients and their use in solving problems or meeting design objectives.
Sponsored by: BASF


more webcasts

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Practical Guidance for Successful Mammalian Cell Banking and Cell Line Characterization
On Demand
Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
Learn More



on pharmtech tv

PharmTech TV

Contract Services Market Trends

Addressing Pharma Industry Issues

Pharma & Biopharma Outsourcing Association

What to Expect at the 2015 PDA/FDA Joint Regulatory Conference


Events

DCAT Sharp Sourcing 2015

July 16, 2015 | New Brunswick, NJ

29th Annual Symposium of The Protein Society

July 22–25, 2015 | Barcelona, Spain

10th Annual Manufacturing Execution System (MES)

August 12–13, 2015 | Philadelphia, PA


more events

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REFERENCE BOOKS

Analytical Testing Resource Guide Combo

A compilation of articles Pharmaceutical Technology in a three-handbook set covering general analytical testing and stability in the manufacture, packaging, storing, and testing of formulated products.
/ 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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