Tag Archives: Market Access

Patients on the Picket Line

Good science can’t be rushed, even when the lives of patients hang in the balance. But regulatory science, and its relationship to a drug’s commercial success or failure, can inadvertently block access to individual patients in their hour of need.
Posted in Biotech, FDA, healthcare, Legal, Market Access, Regulatory, Safety | Also tagged , , , , , , , , , , , | Leave a comment

Compliance Top Driver of Change, Survey Says

Last year, only two percent of the respondents surveyed by Cegedim cited regulatory and compliance issues as a driver of new technology adoption, and six percent said regulatory and compliance was a primary driver of pharmaceutical business model or process change. A lot can happen in a year.
Posted in compliance, Market Access, Strategy | Also tagged , , | Leave a comment

Former EMA Head Back in the Regulatory Saddle

His decade-long tenure as head of the European Medicines Agency (EMA) may have ended, but Thomas Lönngren is already back in the regulatory saddle as a strategic advisor to NDA Group, an independent consulting group focused on reducing wasted drug development costs, ensuring new medicines get to market faster, and “improving the performance of the […]
Posted in Europe, Global, leadership, Market Access, People, pricing, R&D, Regulatory | Also tagged , , , | Leave a comment

What Can Big Pharma Learn From Other Industries in Emerging Markets?

Building a durable base for growth in emerging markets is top line in pharma’s strategy to compensate for slowing sales in the US and Europe.   Key to success is moving beyond the traditional reliance on serving the smallest, most affluent segment of the market to seed critical mass: expanding resources for health, broadening the customer […]
Posted in Emerging Markets, IP, Market Access, Marketing, Strategy | Also tagged | 1 Comment

A Fine Line Between Regulation and Evolution

The strict regulatory divide between market authorization and price reimbursement is crumbling in the US. Ansis Helmanis asks — is industry prepared to adapt or challenge? On September 17, the FDA and CMS jointly issued a Federal Register (FR) notice that they were establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when […]
Posted in FDA, Market Access, Regulatory | Also tagged , , , | Leave a comment
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