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Top Stories
New HHS proposal would remove the current safe harbor protection from the federal Anti-Kickback Statute for rebates or discounts provided to Medicare Part D drug plans and certain state Medicaid programs.
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The US and pharmerging markets will drive growth in drug spending; number of approvals to increase.
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DCAT Week: Business Development—Networking—Education
DCAT Week is the premier global event for the business of pharmaceutical development and manufacturing (March 18-21 in New York City). Organized by the Drug, Chemical & Associated Technologies Association, its unique model brings together members for high-level strategic meetings with key decision makers, timely educational programs and important networking opportunities.
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Industry News
The company is recalling three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL because of a higher concentration of ibuprofen.
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The 2019 PDA Annual Meeting provides a venue for obtaining the latest and most comprehensive information on a broad range of topics related to pharmaceutical processing, manufacturing, supply chain, and quality control. Take part in plenary sessions, concurrent tracks, topic-specific Interest Group sessions, an exhibition, and networking opportunities to learn about and share knowledge on innovative manufacturing strategies, disruptive technologies, and rapid drug development.
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Bio/Pharma News
Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.
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The company is seeking to expand operations and sales capabilities across the United Kingdom and the United States.
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Exclusive Interview from AAPS
Developing New Technologies in Controlled Release
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Regulatory News
FDA Commissioner Scott Gottlieb announced the agency's plans to publish guidance to promote the development of complex generic drugs.
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FDA staffers will be hard-pressed to process and review the wave of new drug application submissions in pre-established timeframes for action.
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Exclusive Interview from AAPS 2018
Cutting Edge Formulations in Topic Drug Development
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QUALITY SYSTEMS
Intellectual challenge, work/life balance, compensation, and an unclear business outlook create uncertainty among European bio/pharma employees.
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FORMULATION
New approaches seek to address formulation and delivery challenges for these complex molecules.
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Events
March 3–6, 2019
March 11–13, 2019
March 17–21, 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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