US FDA expands use of allergic reaction nasal spray in people between 15-30 kilograms
March 5 (Reuters) - The U.S. Food and Drug Administration approved the expanded use of ARS Pharmaceuticals' (SPRY.O), opens new tab nasal spray for severe allergic reactions in patients who weigh between 15 and 30 kilograms, the company said on Wednesday.
Shares of the company were up 4.5% in extended trading.
The spray, sold under the brand name neffy, will be dosed at 1 milligram (mg) for the new patient population, compared to the previously approved dose of 2 mg for people who weigh above 30 kilograms.
Neffy, which was first approved by the FDA in August, is seen as an alternative to EpiPen and other autoinjectors that are filled with epinephrine.
It is designed to be given at the first sign of a severe allergic reaction to prevent life-threatening conditions such as anaphylaxis.
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'I donated my mum's body to Alzheimer's research instead she was blown to pieces'
Her son said 'she was strapped in a chair, and a detonation took place underneath her' One Arizona man thought he was donating his mother's body to science after her harrowing descent in Alzheimer's - only to discover he had been sent her cremated arm before the rest of her body was strapped to a chair and blown up. Jim Stauffer cared for his mother Doris throughout her illness before she died at 74 in 2013. He decided to donate her brain to science hoping to contribute to a cure for Alzheimer's disease. The family contacted Biological Resource Center, a local company that brokered the donation of human bodies for research. Within the hour, BRC dispatched a driver to collect Doris. Jim signed a form authorizing medical research on his mother's body. Ten days later, Jim received his mother's cremated remains - but it turns out her ashes were made up of a singular arm sawn off from her body. The rest of her corpse had met a violent fate. Doris' brain never was used for Alzheimer's research. Instead, her body became part of an Army experiment to measure damage caused by roadside bombs, reports the Irish Star. Internal BRC and military records show that at least 20 other bodies were also used in the blast experiments without permission of the donors or their relatives, a violation of U.S. Army policy. Jim had also ticked a box specifically banning any kind of experiments on Doris. BRC sold donated bodies like Stauffer's for $5,893 each. Jim said: "She was strapped in a chair, and a detonation took place underneath her to get an idea of what the human body goes through when a vehicle is hit by an IED. There was wording on this paperwork about performing tests that may involve explosions, and we said, 'No'." Army officials involved in the project said they never received the consent forms that donors or their families had signed. Rather, the officials said they relied on assurances from BRC that families had agreed to let the bodies be used in such experiments. BRC, which sold more than 20,000 parts from some 5,000 human bodies over a decade, is no longer in business. Its former owner, Stephen Gore, pleaded guilty to fraud in 2022. In a statement to Reuters, Gore said that he always tried to honor the wishes of donors and sent consent forms when researchers requested them. Jim said of Gore "He didn't care about the families, he didn't care about the people." Jim learned of the fate of his mother's body from a Reuters reporter and "curled his lip in anger and clutched his wife Lisa's arm. "We did right," Lisa reassured him. "They just did not honor our wishes." No federal law regulates body brokers like BRC, and no U.S. government agency monitors what happens to cadavers pledged for use in medical education and research. "It is not illegal to sell a whole body or the parts of a body for research or education," said University of Iowa law professor Sheldon F. Kurtz, who helped modify the Uniform Anatomical Gift Act, which has been adopted by 46 states. Although the act was updated in 2006, Kurtz said, "the issue of whole bodies or body parts for research or education never came up during our discussions." Since then, the body trade has become big business. Only one state, New York, keeps detailed records on the industry. According to the most recent data available, companies that did business in New York shipped at least 100,000 body parts across the country from 2011 to 2014. Reuters obtained the data, which have never been made public, from the state's health department. "I feel foolish," said Jim. "I'm not a trusting person, but, you have no idea this is going on." Military officials said they took BRC's word that permission had been given. Records show at least 20 more bodies were blown up without consent.
