Category Archives: Strategy

FDA, Sponsors Seek Study Endpoints Earlier in Development

As payers demand more evidence documenting medical product value, biopharma companies are responding by moving sooner to decide key clinical outcomes to measure. While clinical trials still have to document product safety, efficacy and quality, sponsors also look to demonstrate suitability for formulary placement and reimbursement. Food and Drug Administration officials support these strategies to […]
Also posted in FDA, Marketing, R&D, Regulatory | Tagged , , , , | 1 Comment

Outlook “Gloomy” for TB Investment

The approval last year of Johnson & Johnson’s (J&J) treatment for tuberculosis (bedaquiline) — at the time the first TB drug approval in 40 years — “remains an exception to the generally gloomy outlook” for investment in TB R&D, writes Andrew Ward in this week’s Financial Times.
Also posted in Emerging Markets, Global | Tagged , , , , , | Leave a comment

“The Secret of Successful Drug Launches”

We love being told secrets especially about something so few know anything about, like how to launch a drug successfully given two-thirds don’t meet expectations. And those new drugs once launched fail to meet prelaunch consensus sales expectations for their first year on the market, and those that fall short typically continue to under-deliver for […]
Also posted in Marketing | Tagged , , | 1 Comment

Digital Summit Preview: Improving Brand Engagement

It’s no secret that the use of digital marketing in the life sciences industry has evolved considerably in recent years. The tools and strategies necessary for pharma brand teams to effectively engage with an increasingly more educated and informed consumer pool are seemingly advancing, or at least being modified, regularly. Throw in other factors such […]
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UK Drug Pricing: An ICER of Zero?

by Leela Barham The incremental cost effectiveness ratio (ICER) – or the threshold for determining whether the costs of a new medicine are worth it – has been controversial since it’s inception. There are those who deny that anyone can put a price-tag on life; those that accept the concept but are happy to let […]
Also posted in Europe, Guest Blog, healthcare, Legal, Market Access, pricing, Regulatory | Tagged , , , , , | Leave a comment
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