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Top Stories
With the spin-off, Alcon will operate as a standalone company, and Novartis will focus on its core innovative medicines.
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Concerto HealthAI's real-world data and artificial intelligence capabilities are expected to accelerate outcomes studies and patient insights for Pfizer's investigational therapies and commercialized therapeutics.
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Industry News
Empty pharmaceutical capsules provider ACG aims to merge science and art with its new art competition worth $5000.
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Scott Gottlieb and Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, expect shortages to ease within six months. Although recycled solvents and materials are a prime concern, questions remain about the sources of contamination.
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Supplier News
Catalent invests $5 million in hot melt extrusion capabilities at Somerset, NJ facility.
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The company will add a cGMP packaging line and a new filler on its existing packaging line at its Mirabel, Québec, Canada, site.
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Bio/Pharma News
Sandoz resubmitted its biologics license application (BLA) for a proposed biosimilar pegfilgrastim to FDA in response to a 2016 complete response letter from the agency.
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Amgen issued a notice of termination of its migraine collaboration agreements with Novartis, against which Novartis filed a lawsuit in response.
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Regulatory News
The agency approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.
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From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.
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MANUFACTURING
Flexibility and well-considered manufacturing approaches could help tablet manufacturers face the increasing pressure resulting from the shifting bio/pharma development landscape.
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EQUIPMENT
Sticking and picking are common problems in tablet manufacturing. Considering tablet compression issues before tablet designs are finalized can prevent unanticipated problems during scale-up and full-scale production.
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FACILITY DESIGN AND ENGINEERING
When specifying an automated powder transfer system for vacuum conveying of pharmaceutical powders, consider material properties, facility constraints, and designs to mitigate explosion.
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Formulations for Poorly Water-soluble Molecules
Ascendia Pharma specializes in formulations for poorly water-soluble molecules and other challenging development projects using a suite of technologies that include nano-emulsions, amorphous solid dispersions, nano-particles and oral controlled release. Ascendia offers cGMP manufacturing for Phase I clinical trials, so formulation optimization can quickly transition to clinical proof-of-concept. Dosage forms for oral, topical or injectable delivery can be developed.
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UPCOMING WEBCASTs
Requirements for Fully-Integrated Service Offerings in a HPAPI and Cytotoxic Environment
Two Live Events: Tuesday, May 28, 2019, at 10am JST | 9pm EDT | 6pm PDT
Tuesday, May 28, 2019, at 5pm JST | 10am CEST
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Patient-Focused Drug Design – A View from the R&D Front Lines
Friday, April 26, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Approaches to Analyze and Understand 1–100 µm Particles/Aggregates in Biotherapeutics
Tuesday, April 23, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Work with the experts in cGMP radiolabeling and custom synthesis.
With world-class scientists and dedicated synthesis suites, Eurofins BioPharma Product Testing provides synthesis and radiolabeling services to ensure complete compliance with regulatory and clinical site standards. Join our network to receive informative radiolabeling resources with up-to-date articles, technical whitepapers, events and more.
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The pharma industry – defined.
Experience the long-standing expertise of CPhI with the convergence of pharma's most motivated buyers, experienced sellers, in addition to an array of networking opportunities at CPhI North America – happening April 30 – May 2, 2019 in Chicago, Illinois. Register now to walk our strategically zoned Expo Hall for free!
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Events
April 14–17, 2019
April 23–24, 2019
April 30–May 2, 2019
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eBOOKS
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The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing. |
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