Defining Go And No-Go Disease Areas As An R&D Business
Exploring How Unmet Need Effects Decision-Making And How The Term Has Evolved
Some believe unmet need refers only to rare diseases and tiny patient populations. But it is more than this. In 2020, the term sits at the heart of decision-making for drug makers – along with cost, access and value, of course.
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Would You Like Chips With That? High-Tech Alternatives Could Replace Animal Testing
The FDA Modernization Act 2.0 should make it easier for companies to gain regulatory authorization using non-traditional testing methods, like organs-on-a-chip. But biopharma will need to make the leap into technology to help build knowledge and data if the drug development world is to move away from animal testing entirely.
Uncertainty Clouds Pharma Patent Validity As SCOTUS Ruminates On Amgen Case
The pharma and biotech industry is waiting with bated breath for the decision from the US Supreme Court over a contentious case involving Amgen. The result of the SCOTUS decision could have a huge impact on drugmakers’ profits, commercial strategy, and industry innovation.
Solutions To The AMR ‘Silent Pandemic’ Need More Than Just Lip Service
With new antibiotics a rare commodity, persistently inadequate reimbursement for innovations and worthy but often piecemeal pilots, antimicrobial resistance has quietly risen to become a factor in well over a million deaths annually. Now that COVID-19 is not the all-encompassing threat to health it was until fairly recently, AMR is once again moving towards the center of attention. But properly funded actions and mindset changes are needed.