Major retail chains like CVS, Walgreens, and Kroger are increasingly entering the clinical trials space, effectively creating a swath of new recruitment sites for clinical research partners. According to COTA CEO and president Miruna Sasu, PhD, there is fertile ground for partnerships between […]
FDA Panel Votes for Limited Approval of AstraZeneca and Merck’s Lynparza
AstraZeneca and Merck’s Lynparza looks set for a narrow approval as part of a combination therapy for metastatic castration-resistant prostate cancer (mCRPC). In an 11 to 1 vote, a Food and Drug Administration (FDA) panel supported approval of the drug in combination with a corticosteroid and […]
ICER Issues Final Report on Alzheimer’s Drug Leqembi
Following a session of public comments, the Institute for Clinical and Economic Review (ICER) has issued its final evidence report on Eisai’s Alzheimer’s drug Leqembi (lecanemab). The independent organization valued the treatment between $8,900 - $21,500 per year. This is notably lower than the […]
FDA Gives Abbvie’s Qulipta the Nod for Chronic Migraine Prevention
The US Food and Drug Administration (FDA) approved the use of Abbvie’s Quilipta as a preventive treatment for chronic migraines. This approval gives AbbVie a leg up on Pfizer, whose migraine drug Nurtec ODT is not officially approved for chronic migraines. The decision was made based on data from a […]
Patient Recruitment Dodges Older Adults to Their Detriment
Despite representing the largest market for new and existing medications, a recent study by the UK-based International Longevity Centre (ILC) finds that adults over 60 are starkly underrepresented or outright excluded from clinical trials. Costs are commonly credited for this disparity, which […]
Embracing Patient-Centered Clinical Trials to Facilitate More Representative Recruitment
Despite recent efforts, patient recruitment for clinical trials is expensive, difficult, and time-consuming. Moreover, the vast majority of clinical trials are far from representative of real patient populations, often severely lacking in people from marginalized ethnic and racial backgrounds. In a […]
FDA Advisory Committee Recommends Rexulti for Alzheimer’s-Related Agitation
Agitation is a common symptom of Alzheimer’s disease, negatively impacting the quality of life for patients and their caregivers. An advisory committee for the US Food and Drug Administration (FDA) has given the nod to expand the indication of Takeda and Lundbeck’s Rexulti, a widely used atypical […]
US FDA Shoots Down Eli Lilly’s Application for Ulcerative Colitis Drug
The US Food and Drug Administration (FDA) has declined to approve Eli Lilly’s ulcerative colitis drug mirikuzimab. The agency credits manufacturing issues for the decision, noting that the drugs efficacy and safety are not in question. A Lilly spokesperson said that they are working closely with the […]
Most Accelerated Approval Confirmatory Studies are Turned in Late
Accelerated approval by the US Food and Drug Administration (FDA) requires drug and device manufacturers to conduct confirmatory studies to support full approval. A newly published paper in JAMA Health Forum found that over half of these studies are turned in late to the agency. These delays were […]
Blueprint’s Experimental Cancer Drug Back in the Clinic After FDA Hold Lifted
New patients will receive Blueprint Medicine’s experimental cancer drug BLU-222 after the US Food and Drug Administration (FDA) lifted a partial hold. The agency paused dosing new patients after some participants reported vision-related adverse events. Blueprint said its updates to its protocols on […]
