Latest news with #USFoodandDrugAdministration
Time of India
18 hours ago
- Health
- Time of India
US approves Gilead's twice-yearly injection to prevent HIV
The US Food and Drug Administration on Wednesday approved Gilead Sciences ' twice-yearly injection to prevent HIV -- a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus. Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP , have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections. "This is a historic day in the decades-long fight against HIV," Gilead chairman and chief executive Daniel O'Day said in a statement. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like If You Eat Ginger Everyday for 1 Month This is What Happens Tips and Tricks Undo Lenacapavir , marketed under the brand name Yeztugo , has been shown to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents -- making it functionally akin to a powerful vaccine. The company conducted two large clinical trials. The first, involving more than 2,000 women in sub-Saharan Africa, resulted in a 100 percent reduction in infections and demonstrated superiority over the daily oral pill Truvada. Live Events In the second trial, involving over 2,000 men and gender-diverse individuals, only two infections were recorded - a 99.9 percent prevention rate, again surpassing Truvada. Reported side effects included injection site reactions, headache, and nausea. Results from both trials were published in The New England Journal of Medicine, and the journal Science named lenacapavir its 2024 "Breakthrough of the Year." - Price concerns dampen hope - Despite the impressive results, optimism may be tempered by the drug's cost -- a list price of $28,218 per year in the United States, Gilead spokeswoman Blair Baumwell told AFP in an email Wednesday. An earlier long-acting HIV prevention shot -- cabotegravir, which is injected every two months and was approved by the FDA in 2021 -- costs tens of thousands of dollars per year and has yet to make a major global impact. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 annually. Baumwell said the $28,000-plus per year cost for Lenacapavir as a preventive drug is "in line with" those of existing PrEP products and that the company inspects insurers to cover it. "We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage," she said in the email. Activists are urging Gilead to drastically cut the price to help end the HIV pandemic. "Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year," said Andrew Hill of Liverpool University, who led a team of chemists and scientists that found it could be mass-produced and sold for as little as $25 per person per year. "I congratulate Gilead and US partners for advancing this important innovation," added Winnie Byanyima, under-secretary-general of the United Nations. "Lenacapavir could be the tool we need to bring new infections under control -- but only if it is priced affordably and made available to everyone who could benefit." In October, Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of the drug, pending regulatory approval, in 120 low- and middle-income countries. Because it will take time for those countries to begin production, the company also announced a separate deal in December with the Global Fund -- an international partnership established by the United Nations, alongside the US President's Emergency Plan for AIDS Relief (PEPFAR) and others -- to purchase doses for two million people. However, cuts to the PEPFAR program under President Donald Trump's administration have cast uncertainty over the future of that agreement.
Eyewitness News
19 hours ago
- Health
- Eyewitness News
US approves Gilead's twice-yearly injection to prevent HIV
WASHINGTON - The US Food and Drug Administration on Wednesday approved Gilead Sciences' twice-yearly injection to prevent HIV - a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus. Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections. "This is a historic day in the decades-long fight against HIV," Gilead chairman and chief executive Daniel O'Day said in a statement. Lenacapavir, marketed under the brand name Yeztugo, has been shown to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents - making it functionally akin to a powerful vaccine. The company conducted two large clinical trials. The first, involving more than 2,000 women in sub-Saharan Africa, resulted in a 100% reduction in infections and demonstrated superiority over the daily oral pill Truvada. In the second trial, involving over 2,000 men and gender-diverse individuals, only two infections were recorded — a 99.9% prevention rate, again surpassing Truvada. Reported side effects included injection site reactions, headache, and nausea. Results from both trials were published in The New England Journal of Medicine , and the journal Science named lenacapavir its 2024 "Breakthrough of the Year." PRICE CONCERNS DAMPEN HOPE Despite the impressive results, optimism may be tempered by the drug's cost - a list price of $28,218 per year in the United States, Gilead spokesperson Blair Baumwell told AFP in an email Wednesday. An earlier long-acting HIV prevention shot - cabotegravir, which is injected every two months and was approved by the FDA in 2021 - costs tens of thousands of dollars per year and has yet to make a major global impact. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 annually. Baumwell said the $28,000-plus per year cost for Lenacapavir as a preventive drug is "in line with" those of existing PrEP products and that the company inspects insurers to cover it. "We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage," she said in the email. Activists are urging Gilead to drastically cut the price to help end the HIV pandemic. "Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year," said Andrew Hill of Liverpool University, who led a team of chemists and scientists that found it could be mass-produced and sold for as little as $25 per person per year. "I congratulate Gilead and US partners for advancing this important innovation," added Winnie Byanyima, under-secretary-general of the United Nations. "Lenacapavir could be the tool we need to bring new infections under control - but only if it is priced affordably and made available to everyone who could benefit." In October, Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of the drug, pending regulatory approval, in 120 low- and middle-income countries. Because it will take time for those countries to begin production, the company also announced a separate deal in December with the Global Fund - an international partnership established by the United Nations, alongside the US President's Emergency Plan for AIDS Relief (PEPFAR) and others - to purchase doses for two million people. However, cuts to the PEPFAR program under President Donald Trump's administration have cast uncertainty over the future of that agreement.
New Indian Express
a day ago
- Health
- New Indian Express
Rosemary and a breakthrough blood test: The Alzheimer's research that has Bill Gates excited
Microsoft founder and US billionaire Bill Gates recently shared a post on his X handle about a new blood test for Alzheimer's that was approved by the US Food and Drug Administration (FDA) last month, along with other promising advancements in Alzheimer's research. Gates, who has a personal and emotional connection to the disease—his father, William Gates, passed away in 2020 after a long battle with Alzheimer's—said he is genuinely excited about the progress being made in prevention, early diagnosis, and effective treatment. Bill Gates, who wrote about the first blood test approved by FDA to diagnose Alzheimer's, said that; "...breakthroughs like this will make earlier, easier diagnosis possible—bringing us closer to better treatments and, someday, a cure." As reported by The New Indian Express (TNIE Online) last moth the FDA approved the world's first blood test that helps detection of Alzheimer's disease in May. Among the latest breakthroughs aimed at treatment of this yet incurable disease, another emerging name is Rosmarinus officinalis also known as Rosemary herbs -- an aromatic evergreen herb native to the Mediterranean region.
Time of India
a day ago
- Business
- Time of India
USFDA issues Form 483 with 7 observations to Natco's pharma Hyderabad division
Natco Pharma on Thursday said the US health regulator has issued a Form 483 with seven observations after inspecting its pharma division in Hyderabad. The US Food and Drug Administration (USFDA) had conducted an inspection at the company's pharma division located in Kothur, Hyderabad, from June 9-19, 2025, Natco Pharma said in a regulatory filing. "On conclusion of the inspection, the company received seven observations in the Form-483," it said. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Natco said it is confident that it will address the observations within the stipulated timeline and remains committed to being cGMP compliant and supplying high-quality products to its customers and patients globally.
The Hindu
a day ago
- Health
- The Hindu
US approves Gilead's twice-yearly injection to prevent HIV
The US Food and Drug Administration on Wednesday approved Gilead Sciences' twice-yearly injection to prevent HIV -- a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus. Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections. "This is a historic day in the decades-long fight against HIV," Gilead chairman and chief executive Daniel O'Day said in a statement. Lenacapavir, marketed under the brand name Yeztugo, has been shown to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents -- making it functionally akin to a powerful vaccine. The company conducted two large clinical trials. The first, involving more than 2,000 women in sub-Saharan Africa, resulted in a 100 percent reduction in infections and demonstrated superiority over the daily oral pill Truvada. In the second trial, involving over 2,000 men and gender-diverse individuals, only two infections were recorded - a 99.9 percent prevention rate, again surpassing Truvada. Reported side effects included injection site reactions, headache, and nausea. Results from both trials were published in The New England Journal of Medicine, and the journal Science named lenacapavir its 2024 "Breakthrough of the Year." Price concerns dampen hope Despite the impressive results, optimism may be tempered by the drug's cost -- a list price of $28,218 per year in the United States, Gilead spokeswoman Blair Baumwell told AFP in an email Wednesday. An earlier long-acting HIV prevention shot -- cabotegravir, which is injected every two months and was approved by the FDA in 2021 -- costs tens of thousands of dollars per year and has yet to make a major global impact. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 annually. Baumwell said the $28,000-plus per year cost for Lenacapavir as a preventive drug is "in line with" those of existing PrEP products and that the company inspects insurers to cover it. "We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage," she said in the email. Activists are urging Gilead to drastically cut the price to help end the HIV pandemic. "Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year," said Andrew Hill of Liverpool University, who led a team of chemists and scientists that found it could be mass-produced and sold for as little as $25 per person per year. "I congratulate Gilead and US partners for advancing this important innovation," added Winnie Byanyima, under-secretary-general of the United Nations. "Lenacapavir could be the tool we need to bring new infections under control -- but only if it is priced affordably and made available to everyone who could benefit." In October, Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of the drug, pending regulatory approval, in 120 low- and middle-income countries. Because it will take time for those countries to begin production, the company also announced a separate deal in December with the Global Fund -- an international partnership established by the United Nations, alongside the US President's Emergency Plan for AIDS Relief (PEPFAR) and others -- to purchase doses for two million people. However, cuts to the PEPFAR program under President Donald Trump's administration have cast uncertainty over the future of that agreement.
