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CMS Announces Medicare Coverage for FDA-Designated Breakthrough Devices. What Does This Mean?

On August 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule change that would automatically provide national Medicare coverage for FDA-designated Breakthrough Devices for a four-year period immediately upon FDA approval.…

Looking To Launch Or Commercialise In The US?

Launching a product is a serious undertaking, requiring a seamless approach to building a commercialisation strategy that includes all the variables needed to maximise the investment across the product’s lifecycle. Nowhere is this more true than…

The Evolving World of Artificial Intelligence: Rare Disease Impact

In his latest white paper, Oodaye Shukla, EVERSANA’s Chief Data and Analytics Officer, outlines the revolutionary impact that artificial intelligence and machine learning can have on improving patient outcomes and access to therapy. Rare disease statistics:…

The Chronic Microcap Trap: How Launch Is The Escape for True Growth

Pre-commercial pharma companies face a common choice: commercialize products independently or collaborate with another pharmaceutical company as a commercialization partner. As the C-suite leaders in these organizations wrestle with the pros and cons of this choice,…

The New Gold Standard of Drug Commercialization

Manufacturers spend >$125MM over three years leading up to launch, yet 66% of drugs don’t meet launch expectations. An unpredictable landscape, coupled with inevitable industry pressures, is forcing manufacturers to seek a more complete commercialization approach…

Why are We Settling for Mediocre Patient Services Programs?

Patient Services Programs Are Falling Short To give credit where credit is due, pharmaceutical manufacturers make a tremendous – and well-intended – effort to alleviate the product access obstacles and burdens patients and providers often endure…

The Importance of Digital Strategy in Pharma in the APAC Region

The Asia Pacific region continues to show great progress in digital health as pharmaceutical companies look at digital technologies as a tool to drive access and to start developing their digital strategies. To understand the strides…

Improving Patient Outcomes Through Digital Health

Digital applications can work cohesively with therapeutics in the treatment of a broad range of diseases, from behavioral health to chronic conditions. In an interview with Debraj Dasgupta, Head of Strategy & Go-to-Market Planning at Nippon…

The Digitalization of Healthcare in Asia Pacific

The digitalization of healthcare in Asia Pacific is being utilized to enhance the patient-centered approach and expanding access to health. In a candid conversation with Abhishek Shah, CEO at Wellthy Therapeutics, Ed Cox, Executive Vice President,…

The Regulatory Landscape in Digital Health

Despite the advances in digital health and digital therapeutics in recent years, there remains an ambiguity in the digital space and uncertainty surrounding regulation and reimbursement of digital technologies applied to pharma, biopharma and medical device…