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Top Stories
Can competition block excessive pharma price hikes? EpiPen saga shows it's hard.
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Sandoz won FDA approval for its biosimilar version of Enbrel.
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Subscribers can enjoy each full issue of Pharm Tech in print, or via Pharm Tech apps.
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Industry News
Researchers at the Massachusetts Eye and Ear Infirmary developed a potential drug delivery method using a contact lens to deliver glaucoma medication.
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GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.
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EXPERT INTERVIEW
Barry Holtz, president, iBio CMO sat down with Pharmaceutical Technology to discuss plant models in biopharmaceutical manufacturing.
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Supplier News
Aptar Pharma has signed a license agreement with BD to jointly develop and bring a new autoinjector to market.
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Organization plans networking event at CPhI Worldwide to serve expanding global membership.
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Save thousands during Natoli Engineering's Month of September Sale: All Manesty and Stokes replacement parts are 10% off! No exceptions and no gimmicks. Order in the month of September and receive 10% off our already competitive pricing. In-stock items shipped day of order. Don't delay,
Order from Natoli today! |
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Bio/Pharma News
In Phase Ib trials, Biogen's aducanumab reduced amyloid-beta in the brains of patients with Alzheimer's disease.
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Allergan acquired clinical-stage gene-therapy company, RetroSense Therapeutics, for $60 million.
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Risk Management Guidebook: Strategies, Tools for Success and Other Insights
Regardless of industry, whether you're an enterprise or small to mid-sized business—the common denominator is risk. This guidebook provides you with a selection of our risk-based literature, all in one place. Read on as we bring you risk management tools and strategies and how to integrate risk into standards and processes.
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Regulatory News
FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.
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Enabling Formulation of Water-Soluble and Water-Insoluble Molecules Using a Lipophilic Salt Approach
Live Webcast: Tuesday, September 27 at 11:00 EDT
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DRUG DEVELOPMENT
Barcelona is set to host two well-known pharmaceutical events in the upcoming calendar year: CPhI (October 4–6, 2016) and BIO Europe Spring (March 20–22, 2017). The city is the heart of the BioRegion of Catalonia, believed to be the most dynamic bioregion in Spain and one of the most active in Europe.
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MANUFACTURING
Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.
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New Trends in Hygienic Diaphragm Valves that Improve Reliability
Live Webcast: Thursday, September 22, 2016 at 11:00 am EDT
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PROCESS DEVELOPMENT
A US government report on advanced manufacturing promotes continuous manufacturing of pharmaceuticals, which has had recent commercial success but faces challenges for widespread adoption.
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ANALYTICS
The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.
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Best Practices for Effective Excipient Sourcing and Testing
Live Webinar: Tuesday, September 20, 2016 at 11:00am EDT
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AAPS Planning Guide
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ICDD's material identification databases are designed for rapid materials identification and interfaced with diffractometers and data analysis systems of the world's leading software developers and manufacturers of X-ray equipment. AAPS Booth # 1320
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As a member of Eurofins' BioPharma Product Testing Group--the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide--Eurofins Lancaster Laboratories supports all functional areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control throughout all stages of the drug development process. AAPS Booth # 1221
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Emergent BioSolutions provides contract manufacturing services for the aseptic fill/finish of vials and syringes: liquid and lyophilized products. AAPS Booth # 611
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Sustained-Release Formulation: Overcoming Key Challenges Like Alcohol-Induced Dose Dumping
Live Webcast: Tuesday, September 13, 2016 | 11 am EDT | 10 am CDT | 8 am PDT
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Events
September 18-21, 2016
September 26–28, 2016
October 4–6, 2016
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Understanding the Relationship between Critical Quality Attributes and the Microstructure of Topical Semi-Solid Formulations
Live Webcast: Thursday, September 8, 2016 at 11 am EDT | 10 am CDT | 8 am PDT
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REFERENCE BOOKS |
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A compilation of articles 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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Amorphous Dispersion Drug Formulations: A Modern Simulation-Based Approach
On Demand
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eBOOKS
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Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems. |
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