Latest From Ed Silverman
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.
Under Pressure: Are Enhanced Global Efforts Enough For Trial Transparency?
Increasing scrutiny is being placed on trial sponsors and regulators to improve trial data reporting. Researchers complain that, without access to specific data, results cannot be easily duplicated, which inhibits greater understanding of how medicines might work, adversely affecting treatment decisions and health care costs. Are penalties and public reprimands enough to change behavior?
Pharma Versus Hospitals: 340B Battle Continues
Exploring the continued controversy around the 340B US federal drug discount program. As the story moves into 2022, key questions remain unanswered.
Civil Society Groups Use COVID To Build Stronger Narrative For Equal Access
The divide between developed and developing countries for access to health care innovations has been spotlighted by the ongoing COVID-19 pandemic. Civil society groups pile on the pressure.