Top Stories
An advisory panel deemed Amgen's Repatha (evolocumab) to be safe overall.
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In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”
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As FDA advisory committees meet on two potential PCSK9 inhibitors, Prime Therapeutics analyzes the impact that this class of drugs may have on overall drug spending.
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SHARE YOUR KNOWLEDGE PharmTech Europe seeks objective, technical articles and papers from the bio/pharma community.
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Industry News
CPhI Worldwide announces five new categories for the 2015 CPhI Pharma Awards.
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The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.
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Supplier News
The supplier will add Allied Laboratories and AR Brown to its list of global partners.
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A year after its merger with DSM Pharmaceutical Products, Patheon announces that it has filed an IPO.
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Bio/Pharma News
The exclusive manufacturing collaboration will establish production for adeno-associated virus gene-therapy treatments incorporating REGENXBIO's NAV Technology.
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The Green Cross facility in Canada will produce intravenous immunoglobulin and albumin.
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Regulatory News
An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).
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FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.
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FORMULATION
Successful drug delivery via a dry powder inhaler is determined by the API physicochemical properties, the formulation composition and process, and other factors.
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MANUFACTURING
Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.
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PEER-REVIEWED
Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizinedihydrochloride and montelukast sodium in orally disintegrating tablets.
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TROUBLESHOOTING
Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.
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OUTSOURCING
Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.
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Webcasts
Tuesday, June 16, 2015 at 11 am EDT | 8 am PDT | 16:00 BST | 17:00 CEST
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
Wednesday, June 17, 2015, 2 pm EDT | 11 am PDT
Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.
Sponsored by: Tosoh Bioscience LLC
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on pharmtech tv
Focus on Biobetters, Part 1 and 2
Feeding Powders in Pharmaceutical Processes
Reducing the Cost of Drug Manufacturing
FDA Applications and New Guidance Documents
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Events
July 26–29, 2015| Edinburgh, Scotland
June 23–24, 2015 | Bethesda, MD USA
September 28–30, 2015 | Las Vegas, NV USA
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REFERENCE BOOK
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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...
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eBOOKS
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This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.
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