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Top Stories
Sanofi filed an antitrust lawsuit with a district court in New Jersey alleging Mylan took steps to restrict access to a competing epinephrine autoinjector.
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The agency approved Renflexis, a biosimilar to Janssen's blockbuster rheumatoid arthritis treatment.
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PODCAST
B&W Tek's director of Market and Customer Development, Katherine A. Bakeev, PhD, discusses analysis of pharmaceutical raw materials and the benefits of using laser-induced breakdown spectroscopy (LIBS).
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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
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Industry News
Companies believe that biologics and biosimilars would experience the fastest growth over the next year; there is also interest on increasing market penetration of generic drugs.
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The agency is warning about the potential threat of respiratory depression in children who take medicines with codeine or tramadol.
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Abuse Deterrent Technology
The Grünenthal Group, an independent, research-based, multinational pharmaceutical company, is a pioneer in pain therapeutics and abuse deterrent formulation (ADF) technology. INTAC® is Grünenthal's innovative ADF platform, which protects intended drug action while raising hurdles to abuse.
 For more information on INTAC®, visit www.INTAC.grunenthal.com.
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Supplier News
The company is recalling one lot of 25% Dextrose injection after particulate matter was found within an internal sample syringe.
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The new suite will be used to produce non-sterile dosage forms, such as metered dose inhalers and semisolid topical products, for clinical studies up to Phase II.
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Bio/Pharma News
Amgen asked a judge to issue a judgment of infringement involving Sanofi/Regeneron's drug Dupixent and its use of a mechanism described in Amgen's '487 patent.
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Valeant said the IL-17 inhibitor will be listed at $3500 per month and is expected to be available for sale during the second half of 2017.
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Regulatory News
Sandoz has received positive opinions from EMA's CHMP for its biosimilars rituximab and etanercept for all indications of their respective reference medicines.
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Pharmaceutical Technology spoke with Brad Pedrow and Rajesh Singh of Deloitte Consulting to discuss serialization implementation, and what to expect as the DSCSA deadline approaches.
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FORMULATION
Interpretation of calorimetric data is tricky. The author suggests 10 questions that should be asked of any calorimetric method, along with the rationales behind them.
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ANALYTICS
MDRS differentiates the API from the product matrix and enables measurement of particle size and shape.
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TROUBLESHOOTING
The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.
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MANUFACTURING
The transfer of fluids is governed by different equipment requirements across the medical, biopharma, and cell therapy manufacturing industries.
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New Products and Services
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ABITEC is a global leader in the development and manufacture of specialty lipids and surfactants.
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You deserve a strategic, responsive, and efficient partner for your early-stage drug development.
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Ross Bow Tie Dispersers, or High Viscosity Dispersers, are heavy-duty mixers designed for heavy pastes and viscous liquids up to several hundred thousand centipoise, with stainless steel 304 wetted parts.
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VAI's manufacturing and testing operations mirror current GMP/GLP standards.
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Events
May 1–3, 2017
May 4–10, 2017
May 16–18, 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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