Latest From Ed Silverman
There are growing demands from government officials, investors and employees for the pharmaceutical industry to reduce emissions and waste, and – most of all – make environmental sustainability a core part of its business.
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.
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.
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.
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?
Exploring the continued controversy around the 340B US federal drug discount program. As the story moves into 2022, key questions remain unanswered.