Pharmaceutical Technology ePT Weekly
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PharmTech
January 14, 2016
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD

in this issue

Shire Acquires Baxalta in $32 Billion Deal
Patheon Appoints New President of Pharmaceutical Development Services
Health Canada Approves AbbVie's Humira

Top Stories

Shire Acquires Baxalta in $32 Billion Deal

Shire's acquisition of Baxalta creates a leading company for rare disease drugs.
/ read more /


Expedited Approvals and Orphan Drugs Dominated 2015 Novel New Therapies

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

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Industry News

FDA Issues Low Number of Violation Letters in 2015

The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.
/ read more /

Patheon Appoints New President of Pharmaceutical Development Services

Patheon announced the appointment of Gilles Cottier as president of the company's pharmaceutical development services.
/ read more /


More Industry News

Supplier News

Charles River Laboratories Acquires WIL Research

Charles River Laboratories entered into a definitive agreement to acquire WIL Research.
/ read more /


Collaboration Seeks to Reduce Animal Testing

BASF and Sumitomo Chemical explore in vitro system for chemical safety evaluation.
/ read more /


More Supplier News
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Bio/Pharma News

Novartis to Collaborate with Surface Oncology on Immuno-oncology Therapies

Novartis enters into alliance and licensing agreement with Surface Oncology.
/ read more /


Health Canada Approves AbbVie’s Humira

Health Canada approved AbbVie's Humira for the treatment of adults with hidradenitis suppurativa.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Releases Draft Guidance on Emerging Manufacturing Technology

FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.
/ read more /


FDA Issues Warning Letter to Indian Manufacturing Company

FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.
/ read more /


More Regulatory News

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FEATURED TOPICS

PARENTERALS

Achieving Balance in Sterile Product Manufacturing

Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.
/ read more /


MANUFACTURING

Overcoming Challenges in Implementing Single-Use Systems

Collaboration between users and suppliers to increase understanding, clearly define user requirements, and mitigate risk is facilitating acceptance by industry and regulators.
/ read more /

 

DRUG DEVELOPMENT

Enhancing New Drug Development

More “me-betters” and more focused breakthroughs could enhance new drug development.
/ read more /


DOSAGE FORMS

EMA Guideline on Setting Health-Based Exposure Limits

The results of an industry workgroup's examination of EMA's guide on shared facilities are presented.
/ read more /


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WebcastS

Optimizing M&A Integration for Customer Success: The CMO Perspective

On Demand

Merger and acquisition (M&A) trends in the contract services and biopharma space are set to continue in the coming years. Although M&A at contract manufacturing organizations (CMOs) can be a stressful time for clients, customers should know that M&As offer various opportunities for continuous improvement and the service providers that go through M&A integration most frequently are likely to be among the best proponents of the process. Learn best practices in approaching integration planning. Find out why change management is vital during acquisitions and learn what you should be communicating during integrations and when you should be talking to the CMO.
Sponsored by AMRI


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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



Thermal Sintering for Controlled Drug Release of Hydrophilic Drugs

On Demand

Proper drug release of high-dose hydrophilic drugs is a challenge for formulators since both the initial drug burst release, as well as the consequent sustained release, need to be controlled. Excipients can provide an answer to drug release challenges when their hydrophobic nature is coupled with thermal sintering. This approach intensifies the retardation of drug release by forming plastic matrices of high mechanical strength, which can withstand dose dumping and achieve controlled release. In this webcast, a formulation expert will discuss BASF's Kolliwax grades and their suitability for thermal sintering; describe how high-dose hydrophilic actives were selected to demonstrate the efficacy of thermal sintering (60-65% w/w) using Kolliwax grades; and present processing parameters to enable customers to reproduce controlled drug release of hydrophilic drugs using thermal sintering.
Sponsored by BASF


more webcasts

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Cost Effective Solutions to Develop and Manufacture Product
INTERPHEX is a premier pharma, bio and medical device development and manufacturing event dedicated to Innovation, Technologies and Knowledge throughout the full product development life cycle. Join us in New York, April 26-29, 2016. Register for your complimentary Technical Education and Exhibit Hall Pass Today at
www.INTERPHEX.com/Register. Discover what's NEW at #INTERPHEX.



on pharmtech tv

PharmTech TV

Addressing Pharma Industry Issues

The Human Element in Pharma Manufacturing

Resolving Drug Shortages

Events

Access to Safe Medicines Europe 2016

January 19-20, 2016

IFPAC Annual Meeting

January 24-27, 2016

InformEX USA 2016

February 2-4, 2016


more events

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Understanding Water Activity to Ensure Microbial Safety and Product Stability
LIVE WEBCAST: Wednesday, January 27, 2016 at 11:00am EST
Register for free


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

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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
LIVE WEBCAST: Thursday, February 11, 2016 at 8 am PST / 10 am CST / 11 am EST
Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.
Learn more


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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