Authors
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Economic Considerations For REMSDrug sponsors have options in both how the new FDA risk programs are structured and how to execute them
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Recent US Supreme Court decisions narrow life-sciences patentability claimsIndustry response may be to keep more innovations as trade secrets
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Prilenia Announces Plans to Initiate Global Phase III Study of Novel ALS TreatmentData from prior Phase II study showed signs of pridopidine slowing disease progression in patients with amyotrophic lateral sclerosis.
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How Packaging and Delivery Technologies Influence the Commercialization of Injectable DrugsOften mistakenly considered an afterthought, today’s packaging and delivery systems can powerfully affect the safety, efficacy and commercial success of injectables
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Preparing the Market for a New Drug with an Effective 'Medical Affairs Launch'The Medical Affairs function can play a vital role in today’s product launch process
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Specialty drugs are generating a new paradigm: Commercial InnovationSpecialty drug market success requires patient-focused and therapy-specific channel and services strategies
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Get better at managing clinical trial financialsControl of costs and accounting during clinical trials is a well-known challenge to sponsors. Tools are available
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Use data analytics to monitor 340B discount drug pricingDiscerning how and where products are discounted is an expensive headache for manufacturers
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Regulatory Focus on Off-Label Promotion Is RisingWhile FDA guidance on appropriate medical communication has evolved, US Dept. of Justice attention the practice is intensifying
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Value frameworks are here: What to do about them?A host of evaluation methodologies are defining ‘value’ in drug prices
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Improving Patient Services and Outcomes with Data-Driven Design to Hub ServicesData drawn from collaborating sources can benefit the patient journey
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What Makes a Pharmaceutical Industry Leader?Personality assessments identify the traits that enable some pharma researchers to ascend to leadership roles in industry
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Getting ready for Sunshine Act public dataHow to prepare for reporting and utilizing published data for business and compliance purposes
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Alleviating go-to market challenges faced by small virtual pharma companiesThese organizations are encouraged to consider all alternatives when planning their packaging, serialization and validation strategies
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Grappling with the long-term care marketThe geriatric-dominated LTC market is growing, but has unique constraints
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The Path Forward for Infused Biosimilars in the USVibhu Tewary offers insight on this market segment, including a behind-the-scenes of what goes into designing a report.
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Marching up the channel management curveFinancial and business changes are driving an evolution in channel management strategies
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Laying the foundation for a national system for evidence generationSharing clinical data—EvGen—will improve both drug development and health outcomes analysis
