EU to Weigh New Safety Data on Biogen, Eisai Alzheimer's Drug
European Union regulators will review new information relating to the safety of Eisai Co. 's and Biogen Inc. 's medicine for Alzheimer's disease, providing a response after a meeting next month.
The drug, Leqembi, can slow the progression of Alzheimer's, the mind-robbing disease that afflicts millions. But it has been linked to brain swelling and bleeding, posing a challenge to regulators who must weigh patients' lack of treatment options against the risk of side effects.
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Newsweek
2 hours ago
- Newsweek
A Doctor's Plea From a Nation Asleep on Brain Disease
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With a median survival of 2-3 years, it strikes about 1 in 300 people in their lifetime, which predicts that over 1 million people now alive in the U.S. will succumb to ALS. Yet, under federal law, it is labeled "rare" because that definition is based on prevalence—a static snapshot of how many people are living with a disease at one time. Because ALS kills its victims so quickly, the number of living patients stays below the 200,000-person "rare" threshold. Its very lethality ensures it is never treated like the mainstream public health crisis it is. This paradox obscures a terrifying forecast: a projected 69 percent global increase in ALS cases by 2040. This illusion of rarity perpetuates a deadly inaction that extends to all brain diseases. Alzheimer's already affects over 7 million Americans and is projected to strike nearly 13 million by 2050, costing our economy $384 billion in 2025—and projected to nearly $1 trillion annually by mid-century. Exterior view of the headquarters of the U.S. Food and Drug Administration (FDA). Exterior view of the headquarters of the U.S. Food and Drug Administration (FDA). Getty Images The failure to confront this crisis stems from a Tale of Two Agencies within the Food and Drug Administration (FDA). In 2017, Congress established the Oncology Center of Excellence (OCE), a dynamic hub that has revolutionized cancer treatment, accounting for 85 percent of all accelerated approvals in the last decade. This success is the result of focused will and resources; National Institutes of Health (NIH) funding for cancer has topped $7.2 billion, compared to $2.8 billion for neuroscience. Neurology has no such center. Lacking an institutional home, it is fragmented, slow, and characterized by a risk aversion unthinkable in oncology. This disparity persists because of the tragic nature of these diseases. In the 1980s, ACT UP activists staged "die-ins" to force a reluctant government to fight AIDS. 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- Axios
After 60,000 miles running, this 75-year-old is ready for an ultramarathon
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The Hill
14 hours ago
- The Hill
Senate panel rejects Trump budget health cuts
The White House budget called for slashing NIH by $18 billion, a decrease of 40 percent. Instead, the committee advanced the bill on a 26-3 vote, delivering a bipartisan rebuke of the administration's efforts to defund medical research. The bill includes a $100 million increase for Alzheimer's disease research, a $150 million increase for cancer research and a $30 million increase for the Office of Research on Women's Health. While funding for other parts of the Department of Health and Human Services (HHS) was left the same, it was still a far cry from the major cuts put forward by the White House. 'To the scientists wondering if there will even be an NIH by the end of this administration: this committee's resounding message is yes,' said Sen. Patty Murray (D-Wash.), the committee's vice chair. The panel also did not include a massive HHS reorganization that would have created a new Administration for a Healthy America (AHA) to focus on chronic disease prevention. The White House budget request called for the new AHA agency to absorb other existing agencies and programs within the Centers for Disease Control and Prevention, as well as the entire Substance Abuse and Mental Health Services Administration, the Health Resources and Services Administration, the Office of the Assistant Secretary for Health, and the National Institute of Environmental Health Sciences. The administration proposed giving the AHA agency a budget of $20 billion. But lawmakers on Thursday never mentioned it. An Appropriations Committee spokesperson told The Hill that HHS never sent Congress the required formal reorganization plan or allow for six months of consideration.
