Latest news with #PuyaanSingh
Yahoo
22-05-2025
- 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.
Reuters
04-03-2025
- Health
- Reuters
Measles cases rise to 159 in Texas, state health department says
The Texas health department reported 159 measles cases in the state on Tuesday, an increase of 13 cases from its previous count. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Reporting by Puyaan Singh in Bengaluru; Editing by Arun Koyyur Our Standards: The Thomson Reuters Trust Principles., opens new tab
USA Today
21-02-2025
- Health
- USA Today
Generic Wegovy, Ozempic compounds may become harder to get as FDA removes drug from shortage list
Bhanvi Satija, Puyaan Singh, Patrick Wingrove Reuters Hear this story Feb 21 (Reuters) - The U.S. Food and Drug Administration said on Friday there was no longer a shortage of Novo Nordisk's popular weight-loss and diabetes drugs, Wegovy and Ozempic, a declaration that will curtail widespread sales of cheaper copies made by compounding pharmacies. Shares of Hims & Hers Health HIMS.N, which advertised its compounded versions of weight-loss drugs during the Super Bowl this month, plunged 22% to $52, on a day it announced the purchase of a plant to make the class of drugs that includes Wegovy and Ozempic. U.S. regulations allow compounding pharmacies to copy brand-name medicines that are in short supply. Wegovy and Ozempic, both known chemically as semaglutide, were in shortage in the U.S. for much of last year. More on semaglutide compounds:Shortage of popular drugs Wegovy and Ozempic is over, FDA says. Americans who cannot afford Wegovy or have struggled to find it have been turning to often cheaper versions sold by pharmacies and telehealth providers like Hims & Hers and WeightWatchers WW.O. Wegovy has been shown to help patients lose as much as 15% of their weight on average. Need a break? Play the USA TODAY Daily Crossword Puzzle. WeightWatchers shares were up 5.2% at 77 cents. Compounders have 60 to 90 days to stop sales For Hims and other compounders, this development starts the clock on having unfettered market access to Novo's drugs, Leerink Partners analyst Michael Cherny said in a note. The sale of compounded versions of Eli Lilly's LLY.N rival obesity and diabetes drugs, Zepbound and Mounjaro, was banned in December after the FDA found them to no longer be in short supply. The FDA said in a statement that compounding pharmacies would be given a grace period of 60 to 90 days, as was the case when Lilly's drugs were declared out of shortage. Robert Califf, who was FDA commissioner under President Joe Biden, said he did not think the agency's declaration would necessarily end obesity drug compounding. "There so much money to be made. There's just an endless number of tricks that compounders could use," he said in an interview. "So I don't think it's the end of it, but it certainly will bring us into a new era after the time period has passed and all the lawsuits are finished." Pharmacies cry foul Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents compounding pharmacists and technicians, questioned whether the FDA took into account the number of patients who will need to transition from compounded drugs to FDA-approved versions before making its announcement. The Alliance wrote to the FDA last year, saying more than 200,000 prescriptions for semaglutide drugs not manufactured by Novo Nordisk were being filled by U.S. patients each month, and the agency should consider their role in alleviating the obesity drug supply crunch before barring them. Hims CEO Andrew Dudum said in a posting on X that the company was closely monitoring for potential future shortages of the drugs. Novo said in a statement that the FDA's assessment confirmed that the U.S. supply of its drugs now meets or exceeds current and projected demand. U.S. listed shares of the Danish drugmaker rose 6.2% to $88.93. Novo and Lilly have invested billions to ramp up supply of their treatments, which lagged demand for most of last year. All doses of Ozempic and Wegovy were listed as available on the FDA's website in October, but the treatments had not been taken off the official shortage list at the time. The agency usually assesses if all back orders have been filled before deciding on whether a shortage has been resolved. (Reporting by Bhanvi Satija and Puyaan Singh in Bengaluru, and Patrick Wingrove in New York; Additional reporting by Julie Steenhuysen in Chicago; Editing by Arun Koyyur and Bill Berkrot)
