Top Stories
Will new generic drugs bring the cost of medicines down in the way policy makers hope?
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The company said it plans to expand diabetes manufacturing facilities in the United States.
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Industry News
In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.
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FDA approved Dupixent for the treatment of atopic dermatitis amidst a preemptive lawsuit filed by Sanofi/Regeneron involving the drug and an Amgen patent covering IL-4 inhibitors.
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Supplier News
Permira will acquire LSNE, a CDMO for the pharmaceutical and medical device markets.
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Aptar Pharma's ophthalmic squeeze dispenser is the first and only FDA-approved delivery system for prescription eye-treatment formulations without any preservatives.
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Bio/Pharma News
Sanofi and Regeneron are asking a federal court to issue a judgment of non-infringement for Amgen's '487 patent.
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The company has signed two separate agreements with the Agency for Science, Technology, and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline.
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Regulatory News
Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.
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The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs.
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SUPPLY CHAIN
As the November 2017 deadline nears, a surprising number of companies still don't have a serialization plan in place. New programs aim to get them compliant in time.
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QUALITY
Quality metrics are used by FDA and by bio/pharma companies to evaluate manufacturing and fuel continuous improvement efforts.
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FORMULATION
Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity.
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Events
March 30, 2017
April 3–5, 2017
April 24–26, 2017
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REFERENCE BOOKS |
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A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
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eBOOKS
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Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain. |
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