Top Stories
The companies intend to jointly develop and commercialize Lenvima (lenvatinib mesylate) as a monotherapy and an in-combination therapy for treating multiple cancer types.
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The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.
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INTERPHEX 2018 Keynote Series
Oral Solid Dosage Manufacturing Keynote Series Planned for INTERPHEX
Oral solid-dosage manufacturing educational sessions on the INTERPHEX show floor will include employing IoT and PAT, an update on PCMM, and a panel discussion on implementing continuous manufacturing.
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Industry News
The European Medicines Agency has published a new tool that gives a transparent overview of the agency's relocation to Amsterdam.
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Emerson will provide Ireland’s National Institute of Bioprocessing Research and Training with technologies to help the institute prepare students for the transition to manufacturing digitization.
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Supplier News
The new 73,000-ft2 facility is one of several expansions to support the company's biologics testing capabilities.
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Hovione plans to continue to expand its sites in Portugal and Ireland for chemical synthesis, spray drying, and laboratory analysis.
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Bio/Pharma News
Biogen will acquire an AMPA receptor potentiator for cognitive impairment associated with schizophrenia in a deal worth approximately $590 million.
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AbbVie and the International Myeloma Foundation will partner to study the role of a genetic mutation in outcomes of patients with multiple myeloma.
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Regulatory News
The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.
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The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.
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FORMULATION
Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
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OUTSOURCING
Robert Iser of PAREXEL Consulting answers questions regarding the regulatory expectations of quality agreements and how companies can ensure the quality and safety of their products.
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SUPPLY CHAIN
Lower costs, fewer opportunities for temperature excursions, and a smaller carbon footprint are making ocean transport more attractive for pharmaceuticals. Poseidon, a new collaborative pharma initiative, seeks to leverage benefits.
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Take the survey
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Participate in BioPlan's 15th Annual Global Biopharmaceutical Manufacturing Study. Share your insight on current global and regional trends affecting biomanufacturing and BioPlan will donate $15 (up to $2,000) on your behalf to global health charities. Participants also receive a free aggregated summary of this year's results and an updated 15 Top Trends in Biopharmaceutical Manufacturing White Paper. |
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Events
April 2–5, 2018
April 17–19, 2018
April 24–26, 2018
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eBOOKS
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Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible. |
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