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US FDA advisers to weigh composition of COVID vaccines for 2025-2026
US FDA advisers to weigh composition of COVID vaccines for 2025-2026

Yahoo

time22-05-2025

  • Health
  • Yahoo

US FDA advisers to weigh composition of COVID vaccines for 2025-2026

By Christy Santhosh and Puyaan Singh (Reuters) -The U.S. Food and Drug Administration's advisory panel is set to vote on Thursday to recommend whether COVID-19 vaccines for the 2025-2026 immunization campaign should target strains of the virus descending from the JN.1 variant. According to the Centers for Disease Control and Prevention, the LP.8.1 strain - a subvariant of the previously recommended JN.1 strain - accounted for 70% of total cases in the U.S. over a two-week period ended May 10. While the LP.8.1 is the predominant circulating strain, other virus subvariants, including LF.7 and XFG, have also been increasingly detected in recent weeks, FDA documents showed earlier this week. Public health experts say that there is no certainty on which strains are going to be dominant. The strain selection process is "intelligent guesswork," Sten Vermund, dean of the University of South Florida College of Public Health, told Reuters ahead of the advisory committee meeting. Top U.S. vaccine regulator Vinay Prasad and FDA Commissioner Marty Makary, both of whom have been critical of U.S. COVID vaccine policies, said the benefit of repeated annual shots for healthy adults remains uncertain after several years of the virus circulation and vaccine availability. Earlier this week, the FDA said it plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65. "You would need a huge clinical trial that is very costly and you wouldn't finish it in time for the COVID virus season," Vermund told Reuters. FDA's Prasad said he was open to hearing the thoughts of the vaccine advisory panel on the new policy. Analysts have said the new clinical trials are reasonable and may help alleviate investor concerns regarding vaccine manufacturers as they maintain the existing framework for older adults and at-risk individuals, who are typically the ones seeking vaccinations.

US FDA clears first blood test to detect Alzheimer's disease
US FDA clears first blood test to detect Alzheimer's disease

Time of India

time16-05-2025

  • Health
  • Time of India

US FDA clears first blood test to detect Alzheimer's disease

Live Events (You can now subscribe to our (You can now subscribe to our Economic Times WhatsApp channel The U.S. Food and Drug Administration said on Friday it had cleared Fujirebio Diagnostics ' blood test to diagnose Alzheimer's disease , making the test the first of its kind to detect the blood test, branded as Lumipulse, will initially likely be used to rule out Alzheimer's, with positive results signaling the need for more advanced which gradually destroys memory and thinking skills, is characterized by certain changes in the brain, including a buildup of amyloid beta plaques that result in loss of neurons responsible for transmitting device measures two specific proteins in the blood, pTau217 and β-amyloid 1-42, and calculates a ratio between ratio is linked to the presence of amyloid plaques in the brain, which is a key sign of Alzheimer' these plaques usually requires a PET brain scan or a spinal tap, which is a more invasive procedure to collect fluid from the only needs a blood draw, making it much easier and more comfortable for patients, the FDA said."Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined," said FDA Commissioner Martin Makary."Knowing that 10% of people aged 65 and older have Alzheimer's and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients."Lumipulse and C2N Diagnostics' PrecivityAD2 were the top two performers when compared with four other commercial blood tests for Alzheimer's, according to a study led by researchers at Washington University School of FDA has approved Biogen and partner Eisai's Leqembi and Eli Lilly's Kisunla for the treatment of this disease. (Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas and Shailesh Kuber)

Zepbound Beats Wegovy in First Head-to-Head Trial
Zepbound Beats Wegovy in First Head-to-Head Trial

Business of Fashion

time12-05-2025

  • Health
  • Business of Fashion

Zepbound Beats Wegovy in First Head-to-Head Trial

Eli Lilly said on Sunday its drug Zepbound was superior to Novo Nordisk's Wegovy across five weight-loss targets such as reducing waist circumference, citing data from a head-to-head trial. Lilly reported in December that its obesity drug had already met the main goal, leading to 47 percent more weight loss than those who received Wegovy. Full data from the study was reported by the company in a press release and presented at the European Congress on Obesity. The data is the first head-to-head trial comparing the wildly popular medicines, and gives Lilly more firepower as it seeks to gain wider insurance coverage in an obesity drug market estimated to reach more than $150 billion annually by the next decade. It comes days after CVS Health's decision to drop Zepbound from some lists of medicines it covers for reimbursement, instead favouring Wegovy. Zepbound helped nearly 25 percent more participants lose more than 15 percent of their weight compared to Wegovy, Lilly said on Sunday. The trial also showed that treatment with Zepbound achieved a superior average waist circumference reduction of 18.4 centimetres, while those treated with Wegovy saw an average reduction of 13 centimetres. While Lilly's drug mimics two gut hormones to help reduce weight, Wegovy has a single mode of action. US approvals for Zepbound and Wegovy were based on separate trials in which Lilly's drug helped patients lose more than 22 percent of their weight after 72 weeks, while Wegovy led to 15 percent weight loss after 68 weeks. By Christy Santhosh; Edited by Leroy Leo Learn more: CVS Drops Lilly's Zepbound as Preferred Drug in Novo Win Starting July 1, Wegovy, not Zepbound, will be preferred on CVS Caremark's standard formulary.

Gilead announces $11 billion in new investments in US
Gilead announces $11 billion in new investments in US

Reuters

time07-05-2025

  • Business
  • Reuters

Gilead announces $11 billion in new investments in US

A Gilead Sciences, Inc. logo is seen outside the company headquarters in Foster City, California, U.S. May 1, 2018. REUTERS/Stephen Lam/File Photo Purchase Licensing Rights , opens new tab May 7 (Reuters) - Gilead Sciences (GILD.O) , opens new tab on Wednesday announced $11 billion in capital and operational investments in the U.S. to supplement an already planned spending of $21 billion in domestic manufacturing and R&D through 2030. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Reporting by Christy Santhosh in Bengaluru; Editing by Shilpi Majumdar Our Standards: The Thomson Reuters Trust Principles. , opens new tab Share X Facebook Linkedin Email Link Purchase Licensing Rights

Vertex Pharmaceuticals: Vertex misses quarterly results on weaker-than-expected demand for cystic fibrosis drug, ET HealthWorld
Vertex Pharmaceuticals: Vertex misses quarterly results on weaker-than-expected demand for cystic fibrosis drug, ET HealthWorld

Time of India

time06-05-2025

  • Business
  • Time of India

Vertex Pharmaceuticals: Vertex misses quarterly results on weaker-than-expected demand for cystic fibrosis drug, ET HealthWorld

Advt Advt Join the community of 2M+ industry professionals Subscribe to our newsletter to get latest insights & analysis. Enter Email Download ETHealthworld App Get Realtime updates Save your favourite articles Bengaluru:: Vertex Pharmaceuticals missed Wall Street estimates for quarterly results on Monday, due to lower-than-expected sales of its cystic fibrosis (CF) drug Trikafta However, the drugmaker raised the lower end of its revenue forecast as it looks to its acute pain drug, Journavx , and newer CF drugs to drive growth beyond its established line of December, the U.S. Food and Drug Administration approved Vertex's next-generation treatment, Alyftrek . This once-daily treatment for a rare and progressive genetic disease further strengthens Vertex's market dominance in CF is an inherited disorder resulting from the absence of a specific protein, which disrupts the movement of salt and water in and out of cells in various the first quarter ended March 31, sales of the company's older CF treatment, Trikafta, rose 2% to $2.53 billion but missed analysts' average expectation of $2.58 billion, according to LSEG has activated more than 65 authorized treatment centers globally and 90 patients have begun cell collection for its gene therapy Casgevy , which treats a rare blood disorder that requires regular blood sees 2025 revenue between $11.85 billion and $12 billion, compared to the previously projected range of $11.75 billion to $12 quarterly revenue rose 2.7% to $2.77 billion, missing analysts' estimates of $2.85 an adjusted basis, the company reported a profit of $4.06 per share for the quarter, compared with analysts' expectations of a profit of $4.32.(Reporting by Sriparna Roy and Christy Santhosh in Bengaluru; Editing by Mohammed Safi Shamsi)

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