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Top Stories
Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids.
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Eli Lilly sold rights to two of its legacy antibiotics as well as its Suzhou, China, manufacturing facility, to China-based specialty pharmaceutical company Eddingpharm in a deal worth $375 million.
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Industry News
CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.
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University of Southern California scientists have made an advancement in chimeric antigen receptor (CAR) T-cell therapy that seems to eliminate its severe side effects, making the treatment safer and potentially available in outpatient settings.
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Supplier News
The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.
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The expansion of the CDMO's Skokie, IL facility includes additional refrigeration and freezer space.
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Bio/Pharma News
Seqirus has taken the decision to make its cell-based flu vaccine using a completely cell-based production process.
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Sandoz has signed an agreement with Shionogi for the commercialization rights of Rizmoic (naldemedine) within specific key European markets.
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Regulatory News
The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.
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The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.
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EXCIPIENTS
Supplier vetting and monitoring—plus comprehensive testing—ensure quality of raw materials.
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OUTSOURCING
Pharmaceutical Technology spoke with Roger Croucher, senior manager, R&D projects, at Catalent Pharma Solutions; Daniel M. Bowles, senior director, chemical development, at Cambrex; and Kurt J Kiewel, director, new product development and analytical services, also at Cambrex about best practices for a successful technology transfer.
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SUPPLY CHAIN
Novartis, BMS, and other companies are reducing complexity by thinning out product portfolios. Reducing complexity can reduce waste and improve responsiveness, but it must be done right.
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DRUG DEVELOPMENT
Pharmaceutical Technology Europe spoke with Manuel Leal, business development director for Idifarma, to learn more about spray drying and how it can support patient-centric drug development.
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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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Requirements for Fully-Integrated Service Offerings in a HPAPI and Cytotoxic Environment
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Tuesday, May 7, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Sustainable Sourcing & Supply Chain Engagement in Pharma
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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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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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