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☆ F.D.A. Approves Antibiotic for Increasingly Hard-to-Treat Urinary Tract Infections
▼ + stars: | 2024-04-24 | by ( Andrew Jacobs | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving U.S. health providers a powerful new tool to combat a common infection that is increasingly unresponsive to the existing suite of antimicrobial drugs. The drug will be marketed in the U.S. as Pivya and will be made available by prescription to women 18 and older. It is the first time in two decades that the F.D.A. has approved a new antibiotic for U.T.I.s, which annually affect 30 million Americans. is committed to fostering new antibiotic availability when they prove to be safe and effective.”

Persons: U.T.I.s, Dr, Peter Kim Organizations: Drug Administration, Drug, Research Locations: Europe, U.S

☆ Taiwan earthquake: ‘Roger,’ overly playful dog who failed police academy, becomes star of quake response
▼ + stars: | 2024-04-09 | by ( Chris Lau | Wayne Chang | ) edition.cnn.com time to read: +3 min

While other dogs also played similar roles and were paraded for the media, Roger captured the island’s imagination — partly because of his backstory of an initial career failure. But his ebullient personality and intelligence made him a much better candidate to be a rescue dog, which was the career that was then chosen for him. Kaohsiung Fire DepartmentChen Chih-san, captain of the rescue dog unit of the Kaohsiung Fire Department, told reporters that Roger was transferred to the rescue training school when he was 1 year old. According to the Kaohsiung City Government, Roger was certified by the International Rescue Dog Organization in 2022, an accolade last achieved by a Taiwanese rescue dog in 2019. But retirement is looming for Roger, with the Kaohsiung Fire Department sending rescue dogs to a suitable home once they reach age 9, CNA said, citing Chen.

Persons: Roger, Kaohsiung Fire Department Roger, Chen Chih, “ I’m, ” Chen, ” Roger, Chen Organizations: Taiwan CNN, Central News Agency, CNA, Kaohsiung Fire Department, Kaohsiung Fire, Kaohsiung City Government, Dog Organization Locations: Taipei, Taiwan, lunged, Kaohsiung

☆ Record levels of funding propel Denver-Boulder to the top of the life sciences market
▼ + stars: | 2024-04-08 | by ( Chris Dilella | ) www.cnbc.com time to read: +7 min

The Denver-Boulder region is rapidly emerging as a major hub for the life sciences industry, attracting companies that develop cutting-edge medical treatments and technologies. Life sciences research aims to understand living things, from cells to our planet, to improve health, food and the environment. Founded in 2003, the Bioscience Association supports the growth of life sciences, with a focus on access to capital, education, networking and more. A recent CBRE report found Denver-Boulder to be the top U.S. life sciences real estate market, fueled by record investment from venture capitalists and the National Institutes of Health. Entrepreneurial successThe recent surge in venture capital flowing into Denver-Boulder builds on the area's proven track record of success over the past several decades.

Persons: Tim Schoen, BioMed, Schoen, Elyse Blazevich, Kevin Koch, Koch, Edgewise, We've, Dan LaBarbera, LaBarbera, Dr Organizations: BioMed, CNBC, Blackstone, Flatiron, Enveda Biosciences, Denver, Boulder, Colorado Bioscience Association, Bioscience Association, National Institutes of Health, U.S, Pfizer, Therapeutics, University of Colorado, Edgewise Therapeutics, Research, University of Colorado's Anschutz Medical, Center, Drug, Center for Drug, for Drug, Anschutz Medical Locations: CNBC's, Denver, Boulder, Diego, Boulder , Colorado, San Diego, San Francisco, Seattle, Boston, Cambridge, Massachusetts, Aurora, Rocky, Colorado, Boulder ., Denver'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

☆ This sector offers defensive and growth properties – along with some portfolio income
▼ + stars: | 2024-02-26 | by ( Darla Mercado | Cfp | ) www.cnbc.com time to read: +6 min

The health-care sector of the S & P 500 is up about 8% year to date, marking a sharp comeback from a largely flat 2023. Even as health care is making a comeback this year, investors shouldn't forget its defensive attributes. Back in 2022, when the S & P 500 fell 19.4%, the health-care sector slipped only 3.5% "When markets are challenged, health care can be a good place to be," Lyons added. Some of them speak to the growth aspects of health care and why you can play offense." Merger activity is another driver of growth in health care, as large pharmaceutical companies snap up nimble biotech firms that are at the forefront of developing treatments.

Persons: Dan Lyons, Janus Henderson, shouldn't, Lyons, ImmunoGen, Seamus Fernandez, Sotatercept, Cigna, Cantor Fitzgerald, Sarah James, Fred Imbert Organizations: Big Tech, . Healthcare, Janus, Janus Henderson Investors, U.S . Food, Drug Administration's Center, Drug, Research, FDA, Esai, Pharmaceuticals, CNBC Pro, Merck, Abbott Laboratories, AbbVie, CVS Health Locations: U.S

The FDA approved tirzepatide for weight loss under the brand name Zepbound. It has been available as Mounjaro for type 2 diabetes since 2022 and had increasingly been used "off-label" for weight loss while the obesity approval was pending. Zepbound will be available in the U.S. by the end of the year at a list price of $1,059.87 a month, according to Lilly. That compares with a list of $1,349 per-package for Novo Nordisk's (NOVOb.CO) wildly popular weight-loss drug Wegovy. After Wednesday's FDA approval, Lilly can now promote the drug for weight loss.

Persons: Eli Lilly, Mike Segar, Eli Lilly's, ” John Sharretts, Lilly, Morningstar, Damien Conover, Conover, drugmaker, Robert Kushner, Mounjaro, Patrick Wingrove, Leroy Leo, Bhanvi, Shinjini Ganguli, Bill Berkrot Organizations: Company, REUTERS, U.S . Food, Drug Administration, U.S, FDA, FDA’s Center, Drug, Research, Novo Nordisk's, Reuters, Northwestern University Feinberg School of Medicine, Thomson Locations: Branchburg , New Jersey, U.S, Indianapolis, United States, New York, Bengaluru

☆ 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

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

☆ F.D.A. Approves R.S.V. Shot for Infants
▼ + stars: | 2023-07-17 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Monday approved a shot to protect infants and vulnerable toddlers against respiratory syncytial virus, or R.S.V., offering one of the first protections for an illness that fills children’s hospitals year after year. The monoclonal antibody shot is expected to be available at the start of the fall R.S.V. vaccine by Pfizer for pregnant women that is meant to protect infants from the virus. can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” Dr. John Farley, an official in the F.D.A. “Today’s approval addresses the great need for products to help reduce the impact of R.S.V.

Persons: ” Dr, John Farley, “ Organizations: Drug Administration, Pfizer, Sanofi, AstraZeneca, Centers for Disease Control, Center, Drug, Research

☆ FDA approves first over-the-counter birth control pill
▼ + stars: | 2023-07-13 | by ( Carma Hassan | ) edition.cnn.com time to read: +3 min

CNN —The US Food and Drug Administration on Thursday approved the birth control pill Opill to be available over-the-counter — the first nonprescription birth control pill in the United States. Opill is expected to be available over-the-counter in stores by the end of March 2024. The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers. A recent study showed that it has become harder for women to access reproductive health care services more broadly — such as routine screenings and birth control — in recent years. About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017.

Persons: “, Patrizia Cavazzoni, “, ”, Frederique Welgryn, Opill, Welgryn, Perrigo, Dr, Sanjay Gupta, —, Meg Tirrell Organizations: CNN, Food and Drug Administration, FDA’s Center, Drug, Research, FDA, CNN Health Locations: United States, U.S

☆ 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.

☆ F.D.A. Approves New Drug to Treat Hot Flashes
▼ + stars: | 2023-05-12 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, an official with the F.D.A. Background: Symptoms have long been enduredHot flashes are the most common side effect of menopause for which women typically seek treatment, Astellas said. And the complaints of those who experience severe hot flashes and other symptoms of menopause are often dismissed in the workplace and elsewhere. Because signs of liver damage emerged in some patients during study of the drug, the F.D.A. What’s Next: The drug price may be prohibitiveAstellas said that the drug would cost $550 for a 30-day supply, not including rebates.

Small icons of scientific papers are lined up in a grid, each representing a study of medication abortion. Studies of abortion pills Each icon represents one study that reported serious complications after medication abortion. For pregnant women considering medication abortion, the alternatives would be childbirth or procedural abortion. Almost all patients will experience bleeding and pain during a medication abortion, because the pills essentially trigger a miscarriage. But the study itself notes that bleeding is expected, serious complications are rare and medication abortion is safe.

☆ 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.

☆ 49 arrested as police bust European cocaine ‘super cartel'
▼ + stars: | 2022-11-28 | by ( The Associated Press | ) www.nbcnews.com time to read: +2 min

Europol said 49 suspects have been arrested during the investigation, with the latest series of raids across Europe and the United Arab Emirates taking place between Nov. 8-19. The Netherlands was the country where most of the arrests were made, with 14 suspects arrested in 2021. Dutch authorities said one of the suspects arrested in Dubai allegedly imported thousands of kilos of cocaine into the Netherlands in 2020 and 2021. A 40-year-old Dutch-Bosnian citizen was also arrested in Dubai following an investigation based on intercepted Sky messages, according to Dutch police. He is suspected of importing into Europe cocaine and raw materials for the production of amphetamines.

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