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☆ FDA OKs first menthol e-cigarettes, citing potential to help adult smokers
▼ + stars: | 2024-06-21 | by ( ) www.cnbc.com time to read: +3 min

The Food and Drug Administration on Friday authorized the first menthol-flavored electronic cigarettes for adult smokers, acknowledging that vaping flavors can reduce the harms of traditional tobacco smoking. The FDA said it authorized four menthol e-cigarettes from Njoy, the vaping brand recently acquired by tobacco giant Altria , which also sells Marlboro cigarettes. "This decision could mean we'll never be able to close the Pandora's box of the youth vaping epidemic," said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes. Njoy is one of only three companies that previously received FDA's OK for vaping products. Altria's data showed Njoy e-cigarettes helped smokers reduce their exposure to the harmful chemicals in traditional cigarettes, the FDA said.

Persons: Meredith Berkman, Vaping, —, vaping, Vuse, Matthew Farrelly Organizations: Drug Administration, FDA, Marlboro, Parents, Nielsen, Reynolds American, FDA's Center for Tobacco Products Locations: U.S

☆ Novo Nordisk's Wegovy wins FDA approval for cutting heart disease risks, in move that could expand insurance coverage
▼ + stars: | 2024-03-08 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Injection pens of Novo Nordisk's weight-loss drug Wegovy are shown in this photo illustration in Oslo, Norway, Nov. 21, 2023. The approval also demonstrates that weight loss drugs have significant health benefits beyond shedding unwanted pounds and regulating blood sugar. The FDA said Wegovy patients should use Wegovy in addition to a reduced calorie diet and increased physical activity. Novo Nordisk expects to receive a similar Wegovy approval in the EU this year. The study tested Wegovy in roughly 17,500 people with obesity and heart disease but who did not have diabetes.

Persons: John Sharretts, Ozempic, Wegovy, Eli Lilly, Zepbound Organizations: Drug Administration, Novo Nordisk, Diabetes, FDA's Center, Drug, Research, FDA, Nordisk Locations: Oslo, Norway, Danish, U.S

☆ Dexcom announces its first-ever over-the-counter CGM Stelo has been cleared by the FDA
▼ + stars: | 2024-03-05 | by ( Ashley Capoot | In | ) www.cnbc.com time to read: +3 min

This means Stelo will be accessible to people who do not have insurance coverage for CGMs, Dexcom said. There are more than 25 million Type 2 diabetes patients in the U.S. that do not use insulin, according to the release from Dexcom. Dexcom shared Stelo's name, as well as the fact that the device had been submitted to the FDA for review in February. Jake Leach, chief operating officer at Dexcom, told CNBC in February that Stelo will have its own unique platform and branding. Leach said as Dexcom is able to demonstrate the benefits of Stelo, the company believes insurance companies will eventually pay for it.

Persons: Dexcom, it's, Dr, Jeff Shuren, Jake Leach, Stelo, It's, Leach Organizations: U.S . Food, Drug Administration, FDA's Center, Devices, Radiological, FDA, CNBC, CNBC PRO Locations: U.S

☆ FDA approves Eli Lilly's tirzepatide for weight loss, paving way for wider use of blockbuster drug
▼ + stars: | 2023-11-08 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +6 min

George Frey | ReutersThe Food and Drug Administration on Wednesday approved Eli Lilly 's blockbuster drug tirzepatide for weight loss, paving the way for even wider use of the treatment in the U.S. The FDA said the approval was based on two of Eli Lilly's late-stage trials on tirzepatide, which evaluated its effects on weight loss after 72 weeks. Higher doses of the drug were associated with even more weight loss, with a 15-milligram dose leading to 22.5% weight loss on average. The bigger issue is that many insurance companies are dropping weight loss drugs from their plans. Preliminary data is already available: A recent late-stage trial found that Novo Nordisk's weight loss drug Wegovy reduced the risk of cardiovascular events such as heart attack and stroke by 20%.

Persons: George Frey, Eli Lilly, John Sharretts, Eli Lilly's, Wegovy, Lilly, Mike Mason, Eli Lilly Diabetes Organizations: Novo Nordisk, Pharmacy, Reuters, Food, Drug Administration, U.S, FDA's Center, Drug, FDA, Obesity Locations: Provo , Utah, U.S, United States

☆ E-cigarette use declines among high school students, FDA and CDC say
▼ + stars: | 2023-11-02 | by ( Stefan Sykes | ) www.cnbc.com time to read: +3 min

Elf Bar disposable vape flavored vaping e-cigarette products are displayed in a convenience store on June 23, 2022 in El Segundo, California. The findings, a part of the 2023 National Youth Tobacco Survey, showed that from 2022 to 2023 e-cigarette use among high school students declined to 10% from 14.1%, a drop representing about 580,000 fewer high schoolers. Current use of any tobacco product by high school students declined by an estimated 540,000 students, to 1.97 million in 2023 from 2.51 million in 2022. E-cigarette usage has been the most commonly used tobacco product among both high school and middle school students for a decade. "The FDA remains concerned about youth tobacco product use, and we cannot and will not let our guard down on this issue," King said.

Persons: Patrick T, FALLON, PATRICK T, Brian King, King, we're Organizations: Juul Labs, US Food and Drug Administration, Getty, Tobacco Survey, Food and Drug Administration, Centers for Disease Control, Prevention, FDA's Center for Tobacco Products, FDA, Esco Locations: El Segundo , California, AFP

A few compounds picked by AI are now in development, but those bets will take years to play out. Reuters interviews with more than a dozen pharmaceutical company executives, drug regulators, public health experts and AI firms show, however, that the technology is playing a sizeable and growing role in human drug trials. The U.S. Food and Drug Administration (FDA) said it had received about 300 applications that incorporate AI or machine learning in drug development from 2016 through 2022. Without AI, Bayer said it would have spent millions more, and taken up to nine months longer to recruit volunteers. Finding real-world patients by mining electronic patient data can be done manually, but using AI speeds up the process dramatically.

Persons: Dado Ruvic, Jeffrey Morgan, Amgen, Badhri Srinivasan, Sameer Pujari, drugmaker Bayer, Bayer, Blythe Adamson, Roche, Richard Pazdur, Gen Li, John Concato, Natalie Grover, Martin Coulter, Julie Steenhuysen, Josephine Mason, David Clarke Organizations: Pharmaceutical Research, REUTERS, Pharmaceutical, Bayer, Novartis, Deloitte, U.S . Food, Drug Administration, Reuters, World Health, Flatiron Health, FDA, European Medicines Agency, FDA's Oncology, Excellence, Medical, FDA's Center, Drug, Research, Thomson Locations: U.S, Johannesburg, Texas, Finland, United States, London, Chicago

☆ FDA approves Opill, the first over-the-counter birth control pill
▼ + stars: | 2023-07-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

HRA Pharma expects a final decision by the FDA this summer on its application for nonprescription sales of Opill, which is generically called norgestrel. The Food and Drug Administration on Thursday approved the first over-the-counter birth control pill, a landmark decision that will allow more women and girls in the U.S. to prevent unintended pregnancies without a prescription. The daily pill, called Opill, was first approved by the FDA as a prescription in 1973. Medical organizations like the American College of Obstetricians and Gynecologists and women's health advocates have pushed for wider access. More than 50 members of Congress in March 2022 also called on FDA Commissioner Dr. Robert Califf to ensure the agency reviewed applications for over-the-counter birth control pills without delay.

Persons: Biden, Wade, –, Welgryn, Robert Califf, Patrizia Cavazzoni, Opill Organizations: HRA Pharma, FDA, Drug Administration, American College of Obstetricians, FDA's Center, Drug, Research Locations: U.S, Paris, Dublin

☆ FDA grants full approval to Pfizer Covid treatment Paxlovid for high-risk adults
▼ + stars: | 2023-05-25 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +5 min

The Food and Drug Administration on Thursday granted full approval to Pfizer's Covid antiviral pill, Paxlovid, for adults who are at high risk of getting severely sick with the virus. The FDA first made Paxlovid available in December 2021 under emergency use authorization for high-risk individuals ages 12 and up. Both Pfizer and the FDA view the treatment as an important complementary tool to vaccination that can help high-risk Americans manage their Covid infections and ultimately save lives. For some doctors, another area of concern is Paxlovid "rebound cases." That's when patients who take the treatment see their Covid symptoms return or test positive shortly after they initially recover.

The deal, which also included Colorado, Illinois, Massachusetts and New Mexico, means that San Francisco-based Juul has now settled with 45 states for more than $1 billion. The various states had accused Juul of falsely marketing its e-cigarettes as less addictive than cigarettes and targeted minors with glamorous advertising campaigns. It previously reached a $439 million settlement with 34 states and territories, as well as settlements with several individual states. As of December, its share of Juul was valued at $250 million, down from $12.8 billion in 2018. The CDC also has said using nicotine in adolescence may raise the risk for future addiction to other drugs.

NEW YORK, April 12 (Reuters) - E-cigarette maker Juul Labs Inc has agreed to pay $462 million to settle claims by six U.S. states including New York and California that it unlawfully marketed its addictive products to minors, the states announced on Wednesday. With the deal, Juul has now settled with 45 states for more than $1 billion. The states had accused Juul of falsely marketing its e-cigarettes as less addictive than cigarettes and targeted minors with glamorous advertising campaigns. As of December, its share of Juul was valued at $250 million, down from $12.8 billion in 2018. The CDC also has said using nicotine in adolescence may raise the risk for future addiction to other drugs.

☆ US FDA to take steps to help gene therapies get accelerated approval
▼ + stars: | 2023-03-21 | by ( ) www.reuters.com time to read: +2 min

March 20 (Reuters) - The U.S. Food and Drug Administration is moving to optimize the development of gene therapies, including encouraging the use of biomarkers to help get accelerated approval of therapies for serious conditions, an agency official said. The FDA will support using biomarkers as substitutes for other biological indicators in gene-therapy clinical trials to help clinch "accelerated approval", the agency's Peter Marks said on Monday. The U.S. health regulator grants the so-called accelerated approval mainly for drugs and therapies targeted at rare diseases or small patient populations that have had no effective treatments available to them. "The FDA views gene therapy as an excellent opportunity to expedite the delivery of potentially life-saving therapies to patients with rare diseases," said Marks, who heads the FDA's Center for Biologics Evaluation and Research, in a statement. The company is seeking approval for its gene therapy under the FDA's accelerated pathway.

☆ FDA authorizes Pfizer's Covid omicron booster as fourth shot for kids under 5
▼ + stars: | 2023-03-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The U.S. Food and Drug Administration on Tuesday authorized Pfizer's omicron booster shot for kids under five years old who were previously vaccinated with three doses of the company's original vaccine. The new shot is bivalent, meaning it targets the original Covid strain as well as omicron BA.4 and BA.5. Pfizer's primary series for young children consists of three doses, while rival drugmaker Moderna's primary series for that same age group is only two. Since December, children in that age group who completed two doses of Pfizer's original vaccine have been eligible to receive the omicron booster as their third shot, or last dose in their primary series. One month after the children received the omicron booster, they demonstrated an immune response to both the original Covid strain and omicron BA.5 and BA.5

☆ FDA says no indication contaminated cough syrups have entered U.S. supply chain
▼ + stars: | 2023-03-03 | by ( ) www.reuters.com time to read: +1 min

March 3 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Friday there was no indication that contaminated cough and paracetamol syrups that caused deaths of children in Gambia last year have entered the U.S. drug supply chain. This comes after an investigation led by the U.S. Center for Disease Control and Prevention and Gambian scientists reported on Thursday that these medicines contaminated with toxic levels of diethylene and ethylene glycol led to acute kidney injury among 78 children in Gambia. "We will continue to monitor the situation and keep the public and health care professionals updated of any changes in status to the U.S. market," Patrizia Cavazzoni, director for FDA's Center for Drug Evaluation and Research, said in a tweet. In October, the World Health Organization sent out an alert saying four cough syrups containing toxic levels of diethylene and ethylene glycol made by India's Maiden Pharmaceuticals Ltd should be withdrawn. Reporting by Mariam Sunny in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ The FDA just approved a new Alzheimer's drug that's set to be a blockbuster
▼ + stars: | 2023-01-06 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +6 min

The FDA just approved a new treatment for Alzheimer's disease from Eisai and Biogen. Alzheimer's disease affects roughly 6.5 million Americans and has no cure. The FDA granted an accelerated approval of the drug, meaning the companies will have to conduct additional follow-up studies. While the drug has been approved, questions about cost remainWhile Leqembi has been approved by the FDA, the drug will have to face other key hurdles before it becomes widely available to patients. Aduhelm, an Alzheimer's drug also developed by Biogen and Eisai and approved by the FDA in 2021, failed to garner support from the Centers for Medicare and Medicaid Services, even after it was approved by the FDA.

☆ Regulators have approved the world's most expensive medicine that costs $3.5 million per patient
▼ + stars: | 2022-11-24 | by ( Ryan Hogg | ) www.businessinsider.com time to read: +3 min

The FDA approved a treatment costing $3.5 million, making it the world's most expensive medicine. Hemgenix effectively treated several patients with the blood condition Hemophilia B in trials. An independent study said a fair price for the drug would be about $2.9 million. download the app Email address By clicking ‘Sign up’, you agree to receive marketing emails from Insider as well as other partner offers and accept our Terms of Service and Privacy PolicyUS regulators have approved a hemophilia drug that will cost $3.5 million per patient, making it the world's most expensive medicine. However, the drug will have a list price of $3.5 million per dose, Managed Healthcare Executive reported, making it the world's most expensive medicine by some distance.

☆ FDA says lab-grown meat is safe for human consumption
▼ + stars: | 2022-11-17 | by ( Emma Newburger | ) www.cnbc.com time to read: +1 min

The Food and Drug Administration for the first time cleared a lab-grown meat product developed by a California start-up as safe for human consumption, marking a key milestone for cell-cultivated meats to eventually become available in U.S. supermarkets and restaurants. The FDA cleared Upside Foods, formerly known as Memphis Meats, to use animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to produce cultured animal cell food. The agency said it evaluated Upside Food's production and cultured cell material and has "no further questions" about the safety of its cultivated chicken filet. The company will be able to bring its products to market once it's been inspected by the U.S. Department of Agriculture. "The world is experiencing a food revolution and the U.S. FDA is committed to supporting innovation in the food supply," FDA Commissioner Robert Califf and Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, said in a statement.

WASHINGTON, Nov 16 (Reuters) - The U.S. Food and Drug Administration (FDA) for the first time cleared a meat product grown from animal cells for human consumption, the agency announced on Wednesday. "We are thrilled at FDA's announcement," said David Kay, UPSIDE's director of communications, in an email. USDA and FDA together regulate cell-cultured meat under a 2019 agreement between the two agencies. USDA will oversee the processing and labeling of cell-cultured meat products. Demand for alternatives to farmed meat has grown alongside awareness of the high greenhouse gas emissions of raising livestock.

☆ U.S. authorizes updated COVID booster shots for children as young as 5
▼ + stars: | 2022-10-12 | by ( ) www.reuters.com time to read: +2 min

Oct 12 (Reuters) - U.S. health regulators authorized the use of Omicron-tailored COVID-19 booster shots from Moderna Inc (MRNA.O) and Pfizer Inc (PFE.N) in children as young as 5, a move that will expand the government's fall vaccination campaign. The U.S. Food and Drug Administration on Wednesday green-lighted Moderna's bivalent vaccine for those aged six and above, while Pfizer's updated shot was authorized in children aged five and above. The U.S. Centers for Disease Control and Prevention also backed the FDA's authorization, clearing the way for the shots to be administered in children. Overall, COVID-19 vaccination rates in the United States have stayed low among kids, with nearly 40% of children aged 5-11 vaccinated with one dose of a vaccine so far. Around 11.5 million people received the updated shots over the first five weeks of the rollout last month, which represents just 5.4% of the people aged 12 or older who are eligible to receive them.

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