Top Stories
Shire's acquisition of Baxalta creates a leading company for rare disease drugs.
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FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.
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Industry News
The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.
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Patheon announced the appointment of Gilles Cottier as president of the company's pharmaceutical development services.
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Supplier News
Charles River Laboratories entered into a definitive agreement to acquire WIL Research.
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BASF and Sumitomo Chemical explore in vitro system for chemical safety evaluation.
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Bio/Pharma News
Novartis enters into alliance and licensing agreement with Surface Oncology.
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Health Canada approved AbbVie's Humira for the treatment of adults with hidradenitis suppurativa.
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Regulatory News
FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.
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FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.
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FEATURED TOPICS |
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PARENTERALS
Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.
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MANUFACTURING
Collaboration between users and suppliers to increase understanding, clearly define user requirements, and mitigate risk is facilitating acceptance by industry and regulators.
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WebcastS
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.
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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
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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. |
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Addressing Pharma Industry Issues
The Human Element in Pharma Manufacturing
Resolving Drug Shortages
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Events
January 19-20, 2016
January 24-27, 2016
February 2-4, 2016
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Understanding Water Activity to Ensure Microbial Safety and Product Stability
LIVE WEBCAST: Wednesday, January 27, 2016 at 11:00am EST
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REFERENCE BOOKS |
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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.
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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.
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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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