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For decades, drug safety has depended on one simple but demanding task: turning fragments of information from patients, physicians, and trials into clear signals that protect lives. Today, that responsibility sits at the center of a digital revolution. Artificial intelligence and automation are transforming pharmacovigilance from a manual, reactive discipline into one that is fast,…
Mark Cuban has been chiding self-insured employers for a while, saying that they have more power to change healthcare than any politician. One has to only look at his tweets to know that he has asked employers to stop letting insurance companies and pharmacy benefit managers dictate what they can offer to employees. He has…
A Bayer drug that hits two central nervous system targets to treat moderate-to-severe menopause symptoms has FDA approval, introducing a new non-hormonal therapeutic option that may have an advantage over an Astellas Pharma product that has a two-year head start in this market. The Bayer drug, elinzanetant, is a small molecule formulated as a soft…
Colorectal cancer patients whose disease exhibits certain rare genetic signatures have the option of treatment with immunotherapies. But these targeted cancer treatments haven’t worked for patients with the two subtypes that represent the majority of colorectal cancer cases. The technologies of Cartography Biosciences enable its scientists to find their way to the right targets for…
Patients who have a particular genetic disease whose symptoms include progressively worsening muscle control were able to walk faster following treatment with an experimental Ionis Pharmaceuticals genetic medicine, meeting the main goal of a pivotal study. Based on these results, the drugmaker said it plans a regulatory submission for what could become the first FDA-approved…
A subcutaneously injected version of Merck cancer immunotherapy Keytruda is now FDA approved, a regulatory decision that gives patients a less burdensome dosing option and provides the pharmaceutical giant a way to retain some market share as the original intravenously infused formulation — its top-selling product — faces patent expirations. The approval announced Friday covers…
