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Stock market today: Nasdaq edges back from its record as chip companies and Eli Lilly slump
Read full article: Stock market today: Nasdaq edges back from its record as chip companies and Eli Lilly slumpU.S. stock indexes edged lower after drops for Eli Lilly and chip companies overshadowed a jump for Google’s parent company.
Kimiko Hahn wins $100,000 award from Poetry Foundation for lifetime achievement
Read full article: Kimiko Hahn wins $100,000 award from Poetry Foundation for lifetime achievementCornelius Eady, Toi Derricotte and Kimiko Hahn are among this year’s winners of awards from the Poetry Foundation, which announced some of poetry's most lucrative prizes.
Amazon Pharmacy delivers insulin to your door at discounted prices but is it safe?
Read full article: Amazon Pharmacy delivers insulin to your door at discounted prices but is it safe?Amazon Pharmacy announced automatic savings on more than 15 insulin brands and diabetes care products. Now, eligible customers can access a wide range of insulin vials and pens for $35 a month and have them delivered free to their door.
Local expert says data back FDA decision to halt monoclonal treatments
Read full article: Local expert says data back FDA decision to halt monoclonal treatmentsThe FDA's move to revoke authorization was not unexpected because the drugmakers said the infusion drugs are less able to target omicron because of its mutations. Omicron now accounts for nearly all U.S. infections.
DeSantis: Additional monoclonal antibody treatment site to open in Jacksonville if feds provide supply
Read full article: DeSantis: Additional monoclonal antibody treatment site to open in Jacksonville if feds provide supplyFlorida is ready to open additional monoclonal antibody treatment sites, including another site in Jacksonville, if the state gets more supply from the federal government, Gov. Ron DeSantis said Tuesday.
UF Health program to get COVID-19 therapy to rural Northeast Florida residents
Read full article: UF Health program to get COVID-19 therapy to rural Northeast Florida residentsA laboratory worker at Eli Lilly prepares a solution used to manufacture bamlanivimab, a new monoclonal antibody therapy for COVID-19. When given within 10 days of a positive COVID-19 test, these man-made antibodies may help lessen the severity of the disease and reduce the need for hospitalization in people most at risk of developing severe COVID-19. GAINESVILLE, Fla. – A University of Florida Health pilot program is planning to bring a new COVID-19 monoclonal antibody therapy to rural communities in North Florida during the coming weeks, the university announced Tuesday. The U.S. Department of Health and Human Services selected UF Health and the UF Clinical and Translational Science Institute to coordinate the distribution and administration of 1,000 doses of bamlanivimab to eligible residents in rural North Florida communities, including those in Columbia County. The pilot program, which will be offered in Columbia County and surrounding rural communities first and later expanded to other counties, with private support from the Sarasota-based Louis and Gloria Flanzer Philanthropic Trust with a $250,000 contribution.
Studies extend hopes for antibody drugs against COVID-19
Read full article: Studies extend hopes for antibody drugs against COVID-19(Eli Lilly via AP)New results extend hopes for drugs that supply antibodies to fight COVID-19, suggesting they can help keep patients out of the hospital and possibly prevent illness in some uninfected people. Separately, Regeneron Pharmaceuticals Inc. said partial results from an ongoing study suggest its drug combo completely prevented symptomatic infections in housemates of someone with COVID-19. The need for an infusion has greatly limited the use of antibody drugs in the pandemic because of health care shortages. U.S. regulators have allowed emergency use of some Lilly and Regeneron antibodies for mild or moderate COVID-19 cases that do not require hospitalization while studies of them continued. Lilly’s new results were from a study of 1,035 non-hospitalized patients recently diagnosed with COVID-19.
Demand is low for COVID-19 antibody drugs but shortages loom
Read full article: Demand is low for COVID-19 antibody drugs but shortages loomFILE - This photo provided by Eli Lilly shows the drug Bamlanivimab, the first antibody drug to help the immune system fight COVID-19. Red tape, staff shortages, testing delays and strong skepticism are keeping many patients and doctors from these drugs, which supply antibodies to help the immune system fight the coronavirus. Ironically, government advisers met Wednesday and Thursday to plan for the opposite problem: potential future shortages of the drug as COVID-19 cases continue to rise. The drugs aim to help right away, by supplying concentrated doses of one or two antibodies that worked best in lab tests. Eli Lilly and Regeneron Pharmaceuticals have emergency authorization to supply their antibody drugs while studies continue.
US allows 1st emergency use of a COVID-19 antibody drug
Read full article: US allows 1st emergency use of a COVID-19 antibody drugWASHINGTON – U.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. The Food and Drug Administration on Monday cleared the experimental drug from Eli Lilly for people 12 and older with mild or moderate COVID-19 not requiring hospitalization. Early results suggest the drug, called bamlanivimab, may help clear the coronavirus sooner and possibly cut hospitalizations in people with mild to moderate COVID-19. Regeneron Pharmaceuticals Inc. also has asked for emergency authorization for an antibody drug it is testing, the one Trump received. FDA regulators authorized the Lilly drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises.
Asian stocks fall on worries over rising virus cases, US aid
Read full article: Asian stocks fall on worries over rising virus cases, US aidPeople wearing face masks walk past a bank's electronic board showing the Hong Kong share index in Hong Kong, Wednesday, Oct. 28, 2020. Asian shares headed lower Wednesday on worries about rising virus counts and Washington's inability to deliver more aid to the economy. (AP Photo/Kin Cheung)Asian shares headed lower Wednesday on worries about rising virus counts and Washington's inability to deliver more aid to the economy. Japan's benchmark Nikkei 225 fell 0.3% in morning trading to 23,420.93, while South Korea's Kospi declined 0.2% to 2,325.22. The U.S. dollar weakened to 104.30 Japanese yen from 104.41 yen late Tuesday.
Lilly antibody drug fails in a COVID-19 study; others go on
Read full article: Lilly antibody drug fails in a COVID-19 study; others go onU.S. government officials are putting an early end to a study testing an Eli Lilly antibody drug for people hospitalized with COVID-19 because it doesn’t seem to be helping them. Independent monitors had paused enrollment in the study two weeks ago because of a possible safety issue. In a statement Lilly notes that the government is continuing a separate study testing the antibody drug in mild to moderately ill patients, to try to prevent hospitalization and severe illness. The company also is continuing its own studies testing the drug, which is being developed with the Canadian company AbCellera. Lilly and Regeneron have asked the U.S. Food and Drug Administration to grant emergency use authorization for their drugs for COVID-19 while late-stage studies continue.
Possible safety issue spurs pause of COVID-19 antibody study
Read full article: Possible safety issue spurs pause of COVID-19 antibody studyThe paused study, called ACTIV-3, started in August and aims to enroll 10,000 hospitalized COVID-19 patients in the United States, Denmark and Singapore. The pause in the Lilly study comes a day after a temporary halt to enrollment in a coronavirus vaccine study. Johnson & Johnson executives said Tuesday that it will be a few days before they know more about an unexplained illness in one participant that caused a pause in its late-stage vaccine study. Johnson & Johnson isn’t disclosing the nature of the illness. He says Johnson & Johnson gave information on the case to the independent monitoring board overseeing the safety of patients in the study, as the research protocol requires.
Drug shows promise in 1st largely minority COVID-19 study
Read full article: Drug shows promise in 1st largely minority COVID-19 studyA drug company said Friday that a medicine it sells to tamp down inflammation has helped prevent the need for breathing machines in hospitalized COVID-19 patients in the first large study that primarily enrolled Hispanics and Blacks. The drug, given through an IV, tamps down a protein called interleukin-6 that’s often found in excess in COVID-19 patients. About 12% given the drug needed a breathing machine or died within 28 days versus about 19% of patients given a placebo. This is the third time this week that companies have announced positive results from studies testing COVID treatments via press releases. On Monday, Eli Lilly reported benefits from a study testing its anti-inflammatory drug baricitinib when combined with the antiviral drug remdesivir.
Study hints antibody drug may cut COVID-19 hospitalizations
Read full article: Study hints antibody drug may cut COVID-19 hospitalizationsA drug company says that partial results from a study testing an antibody drug give hints that it may help mild to moderately ill COVID-19 patients from needing to be hospitalized, a goal no current coronavirus medicine has been able to meet. He had no role in the Lilly study but helps direct antibody studies for a public-private research group the federal government formed to speed testing of these drugs. The study will continue to test the antibody drug in combination with another from a Chinese company, Junshi Biosciences. Lilly has already started manufacturing its antibody drug, hoping to have hundreds of thousands of doses ready by fall if studies give positive results. Another company that developed an antibody drug cocktail against Ebola — Regeneron Pharmaceuticals Inc. — now is testing a two-antibody drug for coronavirus.
Anti-inflammatory drug may shorten COVID-19 recovery time
Read full article: Anti-inflammatory drug may shorten COVID-19 recovery timeA drug company says that adding an anti-inflammatory medicine to a drug already widely used for hospitalized COVID-19 patients shortens their time to recovery by an additional day. Eli Lilly announced the results Monday from a 1,000-person study sponsored by the U.S. National Institute of Allergy and Infectious Diseases. All study participants received remdesivir, a Gilead Sciences drug previously shown to reduce the time to recovery, defined as being well enough to leave the hospital, by four days on average. Those who also were given baricitinib recovered one day sooner than those given remdesivir alone, Lilly said. Lilly said it planned to discuss with regulators the possible emergency use of baricitinib for hospitalized COVID-19 patients.
Companies test antibody drugs to treat, prevent COVID-19
Read full article: Companies test antibody drugs to treat, prevent COVID-19The antibody drugs are very promising and, in contrast, could be available fairly soon," said Dr. Janet Woodcock, a U.S. Food and Drug Administration official who is leading government efforts to speed COVID-19 therapies. One company, Eli Lilly, has already started manufacturing its antibody drug, betting that studies now underway will give positive results. Another company that developed an antibody drug cocktail against Ebola Regeneron Pharmaceuticals Inc. now is testing one for coronavirus. Others working on antibody drugs include Amgen and Adaptive Biotechnologies. All the antibody drugs are given through an IV and must make their way through the bloodstream to wherever theyre needed.