The Centers for Medicare and Medicaid Services should require registries maintained by outside organizations that are tracking patients taking Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s drug Leqembi to include all “critical data” that could shed light on safety and outcomes and, importantly, ensure that at least CMS has access to the data, health care providers, patients, physician groups, researchers and policy experts are urging the agency.
Medicare’s Registry Plans For Leqembi Prompt New Calls For Transparency, Rigor
Now that it’s clear the Centers for Medicare and Medicaid Services is moving ahead with the patient registry requirement for the Alzheimer’s drug, experts weigh in on how best to collect useful information.
More from Market Access
More from Pink Sheet
• By
Israel has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition.
• By
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
• By
US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth