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INTERPHEX 2015
Check out highlights from INTERPHEX 2015 including interviews with industry experts, podcasts, product spotlights, and more!
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Modernizing Scale-Up
Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.
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| Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk Assessment
In-silico design facilitates process optimization and evaluation of process control strategies.
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An Orthogonal Approach to Biosimilarity
In this article, industry experts discuss critical analyses for demonstrating biosimilarity.
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A world-leading tablet compression solutions provider, Natoli Engineering Company uses the highest quality materials to create efficient, durable and highly performing tablet compression tooling. We manufacture all punch configurations including single-tip, multiple-tip, micro tab, exotic shapes, IMA Comprima, die table segments and more, from a variety of high-quality steel types and specialty coatings. Request a quote and view informative content on our website.
 Learn more
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| Teva Proposes $40 Billion to Acquire Mylan
Teva announces that it would pay up to $40 billion in cash and stock to acquire Mylan.
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| US Marshals Seize Unapproved Drugs
US Marshals have seized more than $1.5 million of unapproved prescription drugs from Stratus Pharmaceuticals. FDA discovered during an inspection that the company had been marketing drug products without approved drug applications.
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 Practical Guidance for Successful Maammalian Cell Banking and Cell Line Characterization
Live Webinar: Thursday, May 14, 2015 at 8 am PDT/ 11 am EDT/ 4 pm BST/ 5 pm CEST
Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to
learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
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Pfizer Receives Breakthrough Therapy Designation for XALKORI
FDA grants Pfizer Breakthrough Therapy designation for its treatment of ROS1-positive non-small cell lung cancer.
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| Combination of Yervoy and Opdivo Shrinks Melanoma Tumors Drastically in NEJM Case Report
The combination of two mAb drugs eradicated a large tumor, but also sparked new toxicity concerns associated with immunotherapies.
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GSK Recalls Flu Vaccine
GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.
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Practical Implementation of the New Elemental Impuritites Guidelines
Live Webinar: US: Tuesday, May 5, 2015 at 11:00 am EDT | EU: Tuesday, May 12, 2015 at 15:00 AM CEST
In advance of the implementation dates, companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the regulatory requirements of elemental impurities guidelines, outline practical recommendations to address implementation challenges, and discuss key considerations for analytical testing programs.
 Register for free at www.pharmtech.com/pt/impurities
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| FDA Releases Draft Guidance on Promotional Labeling and Advertising
The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.
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Endolysin Technology Presents an Antibiotic Alternative with Broad Applicability
Endolysin technology targets unwanted bacteria, including resistant strains.
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EMA Finds Scientific Advice Leads to Stronger Trial Design
The European Medicines Agency releases findings from marketing authorization application analysis.
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WHO Pushes for Prompt Reporting and Public Disclosure of Clinical Trial Data
WHO says that results from clinical trials should be reported within 12 months of completion of the study.
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EMA and HMA Reveal Network Strategy for Next Five Years
This is the first time a single strategy document for both EMA and HMA is presented, reflecting the need for a coordinated approach to address the challenges facing the European regulatory system network.
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European Pharmacopoeia Seeks Comments on Eye Preparations Monograph
The European Pharmacopoeia Commission seeks comments as to whether or not the current monograph, which does not set requirements/limits for subvisible particles in eye preparations, should be updated.
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