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Latest:
Clearing Up ‘Clear Evidence’ and Implications for Labeling Post-Merck DecisionIntellectual property attorneys discuss the clarified requirements for when state failure-to-warn claims are pre-empted by FDA regulations after the Supreme Court Merck case.
Latest:
Clearing Up ‘Clear Evidence’ and Implications for Labeling Post-Merck DecisionIntellectual property attorneys discuss the clarified requirements for when state failure-to-warn claims are pre-empted by FDA regulations after the Supreme Court Merck case.
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Congressional Pushback on Drug PricingRick Kelly and Nisha Desai review the proposals in the Pharmaceutical Drug Pricing Reduction Act (PDPRA) with the greatest potential impact.
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Making the Most of Maturing Oncology BrandsA checklist of best practices for mid-life products a few years after launch to help companies with growing oncology portfolios determine not only to see if there’s hidden vitality still left in their aging brands.
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Making the Most of Maturing Oncology BrandsA checklist of best practices for mid-life products a few years after launch to help companies with growing oncology portfolios determine not only to see if there’s hidden vitality still left in their aging brands.
Latest:
Making the Most of Maturing Oncology BrandsA checklist of best practices for mid-life products a few years after launch to help companies with growing oncology portfolios determine not only to see if there’s hidden vitality still left in their aging brands.
Latest:
Making the Most of Maturing Oncology BrandsA checklist of best practices for mid-life products a few years after launch to help companies with growing oncology portfolios determine not only to see if there’s hidden vitality still left in their aging brands.
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NASH: Still WaitingSabina Heinz and Elizabeth Baynton look at how the continued absence of approved products affecting the management of NASH patients.
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Drug Formulary Decisions: Fixing a Broken SystemWhy the time is right for P&T committees to incorporate real-world data and ‘real-world science’ into their product assessments.
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The Argument for External Comparator AdoptionIts use, new data shows, could boost the economic benefit profile of more “common” drugs-and better inform HTA and payer decision-making.
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'Vision’ Quest: Leading Through ChangeExploring the critical go-to strategies for biopharma C-suite executives in navigating organizational disruption and the impact of global change and volatility on their employees and business.
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Transforming PV in Smaller Companies with Standardization and AutomationSmall- and medium-sized pharmas should revisit their pharmacovigilance strategies and adopt smarter end-to-end solutions to keep pace with increased volumes and rapidly changing regulatory requirements, writes Siva Thiagarajan.
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Clinical Evidence Key to Commercializing Life Science ProductsCompanies need to find compelling ways to present facts, rather than slick but insubstantial promotions.
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The Feasibility of Patient Insights Before LaunchObtaining patient perspectives during open-label extension trials.
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The Feasibility of Patient Insights Before LaunchObtaining patient perspectives during open-label extension trials.
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Patient-Centric Trials in China: An Opportunity to InnovateThe opportunities and challenges surrounding patient centricity and patient-centric trials in China.
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Patient-Centric Trials in China: An Opportunity to InnovateThe opportunities and challenges surrounding patient centricity and patient-centric trials in China.
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Patient-Centric Trials in China: An Opportunity to InnovateThe opportunities and challenges surrounding patient centricity and patient-centric trials in China.
Latest:
Patient-Centric Trials in China: An Opportunity to InnovateThe opportunities and challenges surrounding patient centricity and patient-centric trials in China.
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Patient-Centric Trials in China: An Opportunity to InnovateThe opportunities and challenges surrounding patient centricity and patient-centric trials in China.
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The Shrinking Disconnect in Digital TherapeuticsMore signs of alignment between startups, pharma, and payers.
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Using FDA’s ‘PIE’ Recipe to Enhance Patient AccessHow R&D organizations can leverage FDA’s final guidance on pre-approval information exchange (PIE) to engage with payers prior to approval and launch.
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The Revenue Crises: Driving Pharma Companies to Change Revenue Management TacticsMelonie Warfel discusses the challenges organizations are facing when it comes to revenue management and looks at the key areas to optimize.
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Shared Understanding Creates CultureWhile culture may "eat" strategy, shared understanding creates both culture and strategy, write Steve Figman and Sean Robertson.
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Translation Automation: A Viable Solution?Global content management needs are mounting among life sciences organizations, as they expand their market coverage and grapple with multiplying regulatory workloads. Monica Vytiskova asks if can intelligent automation offer a solution.
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Keeping Up with Telehealth: Pharma’s EvolutionIf telehealth is here to stay, how is the industry adjusting?
