Top Stories
The acquisition will give Bristol-Myers Squibb full rights to Cormorant's HuMax-IL8 antibody program.
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A study shows high levels of ADAs to infliximab at the beginning of treatment were associated with a poor response later on.
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The agency says, for now, it's business as usual.
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EXPERT INTERVIEW
Chris Procyshyn, CEO of Vanrx, sat down with Pharmaceutical Technology to discuss automation in aseptic processing.
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Natoli Institute's Tablet Manufacturing Process Training course, August 21-24, is designed specifically for tablet compression industry professionals: Contract pharmacists, formulators, managers, tablet press technicians and those who want to better understand the tablet manufacture process. Through a series of lectures and hands-on workshops led by top industry experts, attendees learn firsthand about granulation, formulation, coating, compression and powder analysis.
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Industry News
Califf appointed Richard Pazdur as acting director of the Oncology Center of Excellence under the Cancer Moonshot Initiative.
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International-domestic pharma partnerships will drive next wave of growth in China, according to new CPhI report on China.
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Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.
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Supplier News
The company expanded its services to include oligonucleotide API development and manufacturing and received approval for its Caponago manufacturing facility.
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Evonik will acquire Transferra for an undisclosed amount, and the transaction is scheduled to close at the end of July 2016
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Bio/Pharma News
The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.
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The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.
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Regulatory News
The agency has suspended recommendation of Riluzole Alkem due to flawed study results.
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The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.
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DRUG DEVELOPMENT
The author looks at EUCAST’s role in tackling the spread of antimicrobial resistance, by creating definitions for a global consensus.
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The Advantages of a Employing a Lipid-Based Formulation Process in Early Development
LIVE WEBCAST: Tuesday, July 12, 2016 | 11 am EDT
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ANALYTICS
Effective analysis is key for the successful continuous manufacturing of solid dosage pharmaceuticals.
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Compliance is Key Solutions to Decrease the Likelihood of Receiving a Form 483
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Webcasts
On Demand
As single-use systems gain wider use in biopharmaceutical manufacturing, drug owners must understand the risk of potential contaminants from plastics interacting with the drug. Establishing clearly defined standards for acceptable testing protocols and has proven difficult. In this webcast learn about available guidance documents, a risk-based materials qualification process for extractables and leachables studies; and the value of standardized and custom testing protocols.
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On Demand
Capsugel Dosage Form Solutions will present a webinar discussing the aspect of engineering spray-dried dispersion properties, with a particular emphasis on the impact of atomization and drying rate on powder mechanical properties.
Sponsored by Capsugel
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Bio/Pharma in China
New Initiatives, New Opportunities
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Events
August 10-11, 2016
August 17-18, 2016
September 12-14, 2016
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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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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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