FDA Alignment Is a Starting Point, Not a Rare Disease Strategy for the European Market
For US biotech companies developing rare disease therapies, decisions about clinical evidence, patient populations and regulatory advice can have consequences in Europe long before a marketing application is submitted.
CareValidate Launches Expanded HRT Offering
CareValidate expanded its HRT offering for telehealth companies, combining hormone therapy with provider access, pharmacy services and AI-powered care coordination.
Lycia Lands a $317M IPO for Inflammation Drugs Based on Nobel Prize-Winning Science
Lycia Therapeutics’ protein-degrading drugs are based on the research of Carolyn Bertozzi, a Stanford chemistry professor and Nobel laureate. Lycia’s lead drug candidate is in development for food allergy, where it could compete against the blockbuster Roche drug Xolair.
Congress’s Patient Matching Fix Won’t Work — Here’s What Would
The MATCH IT Act aims to reduce patient matching errors. But a model used by vital records systems could provide a better solution.
Physician Mental Health and Health System Privacy: Why Doctors Avoid Their Own EHR
In most organizations the default access model was built for patient care, not for protecting colleagues. A nurse on another unit, a resident who rotated with them, a department administrator: any of them may technically be able to open the record, even when policy says they should not.