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An internal audit of payment practices in Eastern Europe has revealed payments for elaborate travel for government health authorities and state-employed physicians in exchange for approval and prescription of your products. What is the first thing you should do? Lawyer Mara Senn offers some advice.

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A significant change is under way as the industry shifts from passive to active trial master file (TMF) management, writes Rik van Mol.

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What will the ASCO Value Framework mean for the industry? Ram Subramanian from Simon-Kucher & Partners gives six items to think about.

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The merger announcement from Walgreens Boots Alliance and Rite Aid throws up an interesting question, writes Stephen Littlejohn. Will Walgreens be purveyor focused on retail sales or provider engaged with a transforming U.S. healthcare system?

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The case of Amgen v. Sandoz signals that preliminary injunctions will play major role in future patent disputes

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The case of Amgen v. Sandoz signals that preliminary injunctions will play major role in future patent disputes

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Where is US payer formulary management heading-and what can the industry do to help influence its course?

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On June 30, the Centers for Medicare and Medicaid Services (CMS) released the first full year of data under The Affordable Care Act’s transparency program, also known as Open Payments or the "Sunshine Act." This included approximately 11.4 million records totaling about $6.5 billion in payments made to 607,000 physicians and 1,121 teaching hospitals by 1,444 reporting entities during 2014. Combined with CMS’s September 2014 release of 2013 data for the period Aug. 1, 2013 through Dec.

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By implementing integrated content compliance and digital asset management solutions into marketing workflows, life sciences companies can maximize the time and resources, writes David Bennett.

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Measurement is a given in the pharmaceutical industry: dosage charts, chemistry formulas, budgets for testing, and budgets to go to market. When it comes to marketing, particularly through social media channels, measurement of return on investment (ROI) poses its own set of challenges. 

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Pharm Exec profiles its 2023 Emerging Pharma Leaders.

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Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization, writes Susan J. Schniepp.

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There's been much talk of how US health reform will impact physicians, patients, and insurance companies. But how will it affect the often overlooked specialty drug market?

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While the initiation and management of an access program can be challenging and requires careful assessment and planning, the benefits to patients, healthcare providers and sponsoring companies are immeasurable, writes Rob Fox. “Patients will find you.”In his keynote address at this year’s World Orphan Drug Congress, Henri Termeer, the former CEO, chairman and president of Genzyme reminded the audience that patients will actively seek out companies developing new therapeutics for their unmet medical needs.

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The rising focus on difficulties in swallowing tablets spells a big opportunity for pharma.

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Jenna Earl outlines the three most important things to understand about portfolio positioning in pharma.

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Success in today’s rapidly changing market access world depends on understanding your product’s value through the eyes of payers and shaping crucial value communication around the needs of market access stakeholders as much as it does on developing solid evidence of the value of your product.

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Rare Disease Day is a good moment to sound a warning that providers of rare medicines may be the next to land in the hot seat, writes Meg Alexander.

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The UK's National Health Services needs to rethink the ‘sticking plaster’ solution of training replacement staff, writes James Brook.

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Medicine is entering a new era of “gene editing.” Instead of simply being able to “read” our genes, practitioners will be able to adapt and modify DNA sequencing in living cells to treat, cure, and even prevent disease. Defective genes responsible for life-threatening diseases can be rendered harmless by gene editing; it can also be used to develop new, precisely targeted biological drugs based on an individual’s distinct genetic markers. The full list of possibilities, in every area of the life sciences, is simply beyond imagination.

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Medicine is entering a new era of “gene editing.” Instead of simply being able to “read” our genes, practitioners will be able to adapt and modify DNA sequencing in living cells to treat, cure, and even prevent disease. Defective genes responsible for life-threatening diseases can be rendered harmless by gene editing; it can also be used to develop new, precisely targeted biological drugs based on an individual’s distinct genetic markers. The full list of possibilities, in every area of the life sciences, is simply beyond imagination.

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In the past few years, we’ve seen the biopharmaceutical industry begin to shift from a one-size-fits-all blockbuster approach toward an individualized, precision science model. This transformation has propelled companion diagnostics (CDx) into playing a more critical role than ever in the commercialization of biopharmaceutical therapeutics.

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The best approach to getting global brand campaigns to work all over the world

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The best approach to getting global brand campaigns to work all over the world

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The key steps to implementing the "patient access" model of the future