Stay informed with our regular life science trend tracker series, presenting industry news in a quick, scannable format. Check out recent top stories and explore additional resources to help you respond.
Patients speak – and are heard
The Wall Street Journal reported that Eli Lilly will cap out-of-pocket insulin costs at $35 per month for insured and uninsured patients. The 70% price decrease reflects an important shift in the dynamic between drug developers and patients – as patients take more control over managing their health, drug developers are listening and responding.
The true cost of orphan drug exclusivity
Kaiser Health News reported on a patient living with a rare muscle disease and facing a daunting price increase: a $9,000 copayment for a one-month supply of her medication. 91-year-old Lore Wilkison relies on Firdapse, approved in 2018 by the FDA as an orphan drug, a designation that rewards drug companies for developing treatments for rare diseases.
The designation entitles the company to seven years of exclusive rights to the marketplace, which means the FDA won’t approve another company’s application for a competitive drug for the same use during that period. Now, Wilkinson and other rare disease patients are caught in an ongoing legal and political debate about how the US supports pharmaceutical companies and their research – highlighting how legislation and court decisions affect drug manufacturers and patients.
More machine learning in drug development news
In Forbes, DeepMind shared the unique path that led them to develop algorithms for drug developers to use in determining protein structures, typically a difficult and costly process. Their machine learning processes reportedly have been incorporated into drug discovery programs in various pharma companies and could indicate what lies ahead in using artificial intelligence and ML in drug discovery and research.
FDA to require diversity in clinical trials
The FDA recently announced a significant change in its requirements for late-stage clinical trials, which would mandate researchers and companies seeking approval to submit a plan for ensuring diversity among trial participants. Before the new requirement takes effect, the FDA must finalize draft guidance and provide an opportunity for public comment, a process that could take more than two years. Researchers are concerned about how strictly the FDA will enforce the requirement, as well as the agency’s options if a researcher fails to follow the guidance.
- Why is patient diversity in clinical trials important?
- Infographic: Addressing issues of diversity and inclusion in life science