Medical experts divided on whether 2nd FDA-approved Alzheimer's drug provides a benefit
“This is now the second approved treatment that evidence suggests changes the course of Alzheimer’s disease in a meaningful way,” she said. Lecanemab, which will be marketed as Leqembi, is the second Alzheimer’s drug to receive a fast-track approval by the FDA. Some hospital systems across the country have also declined to offer the drug to Alzheimer's patients. Like Aduhelm, the drug lecanemab was developed by Eisai in partnership with fellow drugmaker Biogen. “I do consider it a game changer but in a negative sense for how it will change the clinical and research landscape around Alzheimer’s disease,” Greicius said.wftv.com
Major food brands are adding sesame to items in 'shortcut' after FDA declares the seed a 'major allergen'
The FDA declared sesame a major allergen in the U.S., yet some food brands and manufacturers are taking an 'economic shortcut' by adding more sesame to their food, says FARE's Jason Linde.foxnews.com
Why Lecanemab Sparks Cautious Hope in Alzheimer’s Research
It was long ago — in 1906 — that German psychiatrist Alois Alzheimer first connected a case of dementia to abnormal deposits in the brain. Modern researchers have largely proceeded on the thesis that treatments for the disease named for him would need to clear away these aberrant clumps, consisting of a protein called amyloid, that clog patients’ brains. After many disappointing performances by amyloid-targeting drugs, including one controversially approved by US regulators in 2021, a treatmentwashingtonpost.com
Drugs to keep patients from feeling pain during medical procedures in short supply
ORLANDO, Fla. — Local pediatricians are having a hard time finding a popular drug used to keep patients from feeling pain during surgeries.
A shortage of the drug lidocaine is even forcing some doctors to delay operations.
Doctors nationwide are also feeling the impact of the shortage with pediatricians, podiatrists, and dermatologists really feeling the effects.
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Amgen to buy Horizon Therapeutics in $26.4B deal
Amgen will acquire Horizon Therapeutics, a biopharmaceutical company that focuses on treatments for rare, autoimmune diseases, for about $26.4 billion. A day later, Johnson & Johnson said that it did not intend to make an offer. Amgen said Monday that the Horizon transaction will give it access to a complementary portfolio of medicines from Horizon that address the needs of patients suffering from rare diseases. Horizon Therapeutics PLC, based in Dublin, develops potential treatments for rare, autoimmune and severe inflammatory diseases. Its best-seller, Tepezza, is only approved in the United States and treats eye bulging and double vision from thyroid eye disease.wftv.com
A woman lost 30 pounds in four months on a 'game changer' weight loss drug, but now 'can't stand' Diet Coke and feels full after two alcoholic drinks
One woman who loved drinking socially before using semaglutide, sold as Wegovy and Ozempic, now can't have too much without thinking "meh."news.yahoo.com
FDA and CDC approve new Omicron COVID boosters for children as young as 5
Children as young as 5 are now eligible to receive the new updated COVID-19 boosters, which target the Omicron variant of the coronavirus. Marks noted that while COVID-19 can be less severe in children than adults, many children have been hospitalized throughout the pandemic. The FDA authorized Pfizer-BioNTech's bivalent vaccine for kids ages 5 to 11. The Moderna bivalent booster, which had already been approved for people 18 and older, was cleared for kids 6 through 17. Health experts say it is important for everyone who is eligible, including children, to get the Omicron boosters as soon as possible.wftv.com
New survey suggests little progress against U.S. teen vaping
NEW YORK — (AP) — The latest government study on teen vaping suggests there's been little progress in keeping e-cigarettes out of the hands of kids. The data seems to show more high school students vaping, with 14% saying they had done so recently, according to survey results released Thursday. Anecdotally, the 2021-2022 school year was worse than it was before the pandemic, said Mike Rinaldi, principal of Westhill High School in Stamford, Connecticut. Kids vaping in school bathrooms and stairwells remains "a constant battle,” said Matt Forker, principal of the nearby Stamford High School. Leaders of one advocacy group said they worry the battle to diminish youth vaping is not going well.wftv.com
FDA still skeptical of ALS drug ahead of high-stakes meeting
Typically, FDA approval requires two large studies or one study with a “very persuasive” effect on survival. FDA approval would likely compel insurers to cover the treatment. The group’s founder, Brian Wallach, said ALS patients, physicians and researchers believe that the company’s data warrants approval. In June, Canadian regulators approved the drug for ALS patients, the first country to do so. That decision puts FDA regulators in a “precarious position,” says bioethicist Holly Fernandez-Lynch.wftv.com
Lyons Magnus Expands Voluntary Recall to Include Additional Nutritional and Beverage Products Due to the Potential for Microbial Contamination
Lyons Magnus LLC (“Lyons Magnus” or the “Company”) today announced that following continued collaboration and consultation with the U.S. Food and Drug Administration (“FDA”) and in furtherance of its longstanding commitment to food safety, the Company is expanding its July 28, 2022, voluntary recallwftv.com
Seminole County monoclonal site to remain open, offer another treatment option
After the Food and Drug Administration revised its authorization of the monoclonal antibody treatment Regeneron Monday, a Seminole County site has moved its appointments to another treatment option and will remain open Tuesday.
At-home COVID tests may be less sensitive to omicron, but they’re still useful tools, FDA says
Dr. Anthony Fauci is encouraging people to continue to use at-home COVID-19 antigen tests after the U.S. Food and Drug Administration said Tuesday that the tests may be less sensitive at detecting the omicron variant.
FDA issues alert over arthritis, ulcerative colitis medicine
The FDA required the safety trial, which also investigated other potential risks, including blood clots in the lungs and death. AdIn the release, the FDA said:“Tofacitinib was first approved in 2012 to treat adults with rheumatoid arthritis (RA) who did not respond well to the medicine methotrexate. In 2017, we approved tofacitinib to treat patients with a second condition that causes joint pain and swelling, psoriatic arthritis (PsA), who did not respond well to methotrexate or other similar medicines. In 2018, we approved the medicine to treat ulcerative colitis, which is a chronic, inflammatory disease affecting the colon. Tofacitinib works by decreasing the activity of the immune system; an overactive immune system contributes to RA, PsA, and ulcerative colitis.
The Weekly: Central Florida doctor talks COVID-19, vaccine distribution
ORLANDO, Fla. – While the vaccine has given us hope, the coronavirus continues to surge across the United States. Cases and hospitalizations are spiking, and the country just had its deadliest week on record. As more people get the Pfizer or Moderna vaccine, other companies -- including Johnson and Johnson -- are hoping their versions will get FDA authorization soon. Dr. Kenneth Alexander with Nemours Hospital joined anchor Justin Warmoth on “The Weekly on ClickOrlando.com” to discuss the pandemic, vaccine distribution and what we know about a new variant of the virus.
FDA to consider cutting Moderna vaccine doses in half so more people get shots
Registered nurse Cynthia Banada holds a vial of the Moderna COVID-19 vaccine at Miami Jewish Health, a senior healthcare facility, Monday, Dec. 28, 2020, in Miami. (AP Photo/Lynne Sladky)The FDA is meeting this week to consider giving half-doses of Moderna’s COVID-19 vaccine to people ages 18 to 55. [TRENDING: How to get vaccine in Florida | New attractions coming to Central Florida theme parks]The effort to roll out the vaccine has been slower than expected. The Trump administration had the original goal of vaccinating 20 million Americans by the end of 2020. So far, four million Americans have received their first of the two COVID-19 shots required.
Leaders prepare for mass COVID-19 vaccination sites as first doses are distributed
ORLANDO, Fla. – For the first time, Orlando Health clinicians and non-clinicians at risk received the COVID-19 vaccine, while AdventHealth continued vaccinating frontline health workers on Friday. In Volusia County, leaders are preparing for large-scale vaccination clinics once a vaccine is ready for mass distribution. “This may be in large venues such as the Daytona International Speedway,” Dr. Peter Springer, Volusia County Operational Medical Director, said. “The COVID-19 vaccine is crucial to preventing further spread from the virus but we need to take an effective fact-based approach to stop the spread.”For Gomez, that means continuing precautions this holiday season. “Keep in mind the virus is still out there and when you get a chance, get your vaccine.”
AdventHealth Orlando to receive first shipment of COVID-19 vaccine on Tuesday
After the United States Food and Drug Administration and the Centers for Disease Control and Prevention approved a new COVID-19 vaccine for emergency use, the first shipments will arrive at AdventHealth Orlando on Tuesday, according to Florida Gov. | Pilot killed in Fla. gyroscope crash]“(Tuesday), Jackson Memorial in Miami will receive its shipment, as well as AdventHealth in Orlando,” DeSantis said. U.S. Secretary of Health and Human Services Alex Azar said he expects about 20 million doses to go out across the U.S. this month. Seminole County leaders told News 6 they’re prepping now to possibly receive about 8,000 to 10,000 doses during a second shipment. However, AdventHealth leaders told us there should be more data before children receive it.
‘Relieved:’ US health workers start getting first COVID-19 shots
Relieved,” said critical case nurse Sandra Lindsay after getting a shot in the arm at Long Island Jewish Medical Center in New York. But we also recognize that this end is in sight,” said Dr. Chris Dale of Swedish Health Services in Seattle. Plus, the shots can cause temporary fever, fatigue and aches as they rev up people’s immune systems, forcing hospitals to stagger employee vaccinations. A wary public will be watching closely to see whether health workers embrace vaccination. While effective against COVID-19 illness, it’s not yet clear if vaccination will stop the symptomless spread that accounts for half of all cases.
'Healing is coming': US health workers start getting vaccine
“I feel like healing is coming.”With a countdown of “3-2-1,” workers at Ohio State University's Wexner Medical Center gave initial injections to applause. High-risk health care workers were first in line. It just represents a moral failing,” said Jennifer Nuzzo, a public health researcher at Johns Hopkins. And later this week, the FDA will decide whether to greenlight the world’s second rigorously studied COVID-19 vaccine, made by Moderna Inc. “We’re also in the middle of a surge, and it’s the holidays, and our health care workers have been working at an extraordinary pace,” said Sue Mashni, chief pharmacy officer at Mount Sinai Health System in New York City.
Osceola County plans for mass COVID-19 vaccination sites, drive-up locations
OSCEOLA COUNTY, Fla. – As the Federal Drug Administration edges closer to approving a COVID-19 vaccine, Osceola County leaders are ironing out the final details in its mass distribution plans. Osceola County’s Emergency Management Director, Bill Litton, said Heritage Park will actually serve as their primary site for mass vaccine distribution, once it’s available for the general population. In talking about the Heritage Park testing site, Litton said it provides a lot of area that would allow them to potentially have up to six lanes of vaccine administration. As storing the vaccine seems to be less of a hassle than initially though, Litton tells says for planned mobile sites and drive-up vaccination sites, county leaders are looking at having refrigerators on location. He also added they can recharge the vaccine shipments with dry ice every five days, for up to a maximum of 15 days.
Florida health officials report 9,000 new COVID-19 cases, 80 deaths
The race to create a reliable and safe COVID-19 vaccine continued Friday after one company asked for emergency use of it’s vaccine. Below is information provided by the Florida Department of Health for Friday, Nov. 20. CasesThe Florida Department of Health reported 9,085 new cases on Friday, bringing the state’s overall total to 923,418 cases since March. DeathsThe Florida Department of Health on Friday reported 80 people have recently died from COVID-19. The Florida Department of Health reported 226 recent hospitalizations.
The Latest: S Korea begins stronger limits in some areas
In September, the district reported about 13 new coronavirus cases weekly, mostly involving teachers and staff, when it first opened early childhood education classes. ___ST. PETERSBURG, Fla. — Five Florida mayors are expressing concern about the rising number of coronavirus cases in the state, and are urging Gov. But the state’s rolling seven-day average for new coronavirus cases was more than nine times higher Wednesday than it was than when her first order took effect. Officials began instituting local shutdowns in neighborhoods where coronavirus cases were rapidly rising. There were 5,102 cases reported in Minnesota on Wednesday, along with 67 deaths.
FDA gives emergency OK to Eli Lilly antibody treatment for COVID-19
FDA gives emergency OK to Eli Lilly antibody treatment for COVID-19Published: November 10, 2020, 9:40 amU.S. health officials have allowed emergency use of the first antibody drug to help the immune system fight COVID-19, an experimental approach against the virus that has killed more than 238,000 Americans.o
FDA issues Benadryl warning over TikTok challenge
A TikTok challenge has led to an FDA investigation. Thursday the federal agency announced it is looking into reports of teens participating in the so-called “Benadryl challenge.”The over-the-counter medication is used to treat allergies. According to the FDA, teens have reportedly ended up in emergency rooms with serious injuries and some may have died. The FDA warns that taking too much Benadryl can lead to severe health problems even death. It says it contacted TikTok and is urging the app to remove videos of the challenge from its platform.
FDA: Make sure you arent drinking hand sanitizer even if its in a beer can
With a global pandemic underway, companies have gotten creative to meet the demand for hand sanitizer but the Food and Drug Administration warns some of that creativity may be dangerous to consumers. The FDA issued a warning this week about alcohol-based hand sanitizers being packaged in containers that may look like food or drink items. Recently, the FDA learned of a person who purchased a bottle they thought contained drinking water but it was hand sanitizer. Ingesting hand sanitizer can be toxic and the FDA is reporting an increasing number of cases where people suffer serious symptoms or even death from drinking the germ killer. I am increasingly concerned about hand sanitizer being packaged to appear to be consumable products, such as baby food or beverages.
Peaches linked to salmonella outbreak in 9 states
Tainted peaches could be the cause of a salmonella outbreak in nine states. More than 60 people were sickened from the bad fruit. The bagged peaches were reportedly sold under the Wawona brand name at Aldi stores in 16 states starting in June. The grocery store chain has recalled the peaches in the states affected. The FDA is urging anyone who bought the peaches to throw them out.
FDA clears first fully transparent surgical mask
The U.S. Food and Drug Administration has given the OK for the world’s first fully transparent surgical mask. They're made by ClearMask, an American medical supply company. Traditional surgical masks block mouths, which can sometimes impede effective communication. The company says ClearMask helps improve visual communication while still offering a high level of protection. ClearMask says their masks are especially helpful for people with hearing impairments and during conversations between people who don't speak the same language.