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Top Stories
The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.
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The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.
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Industry News
Research into an old antibiotic might open the door for new drugs to treat tuberculosis and other related microbial diseases.
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Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.
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Supplier News
Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.
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The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.
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Bio/Pharma News
Cycle and Aprecia will use Aprecia’s 3DP Technology to improve rare disease drug formulations.
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In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.
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Regulatory News
The agency published guidance on the research and development of individualized therapies.
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The draft guidance provides guidance on the development of drugs and biologics in which a nanomaterial is present in the finished dosage form.
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Standards and Regulations
The authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.
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Formulation
Softgel capsules are a popular dosage form among patients but they also provide a number of manufacturing benefits over liquid-filled hardgel capsules.
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Manufacturing
A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.
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Events
February 7–8, 2018
February 11–14, 2018
February 20–22, 2018
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eBOOKS
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New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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