DIRS.INFO The most relevant business & tech news

☆ FDA approves nasal spray as first needle-free treatment for anaphylaxis
▼ + stars: | 2024-08-09 | by ( Https | Media-Cldnry.S-Nbcnews.Com Image Upload Newscms | ) www.nbcnews.com time to read: +1 min

The Food and Drug Administration has approved ARS Pharmaceuticals’ nasal spray as the first needle-free emergency treatment for potentially fatal allergic reactions, the agency said on Friday. Anaphylaxis is a severe, life-threatening allergic reaction that typically involves multiple parts of the body and is considered a medical emergency. Neffy, a single-dose nasal spray administered into one nostril, was approved for use in adult and pediatric patients who weigh at least 66 pounds. Neffy’s approval is based on four studies in 175 healthy adults without anaphylaxis that measured the epinephrine concentrations in the blood following administration of Neffy or approved epinephrine injection products. Last year, the FDA declined to approve the spray and requested additional testing, in a decision that went against the recommendation from its independent experts.

Persons: ”, Kelly Stone Organizations: Drug Administration, FDA’s Center, Drug

☆ Healthy Returns: Eli Lilly, Novo Nordisk make progress toward boosting weight loss drug supply
▼ + stars: | 2024-05-07 | by ( Eduardo Munoz | ) www.cnbc.com time to read: +3 min

A highly popular group of weight loss and diabetes drugs is still hard to find in the U.S. The dominant manufacturers of those treatments, Eli Lilly and Novo Nordisk , are making progress toward changing that. Patients using current autoinjectors for weight loss and diabetes drugs go through four different pens per month. Eli Lilly expects supply for Zepbound, Mounjaro and other incretin drugs to remain "quite tight" in the near- to mid-term as demand remains high, Ashkenazi said. On the day Eli Lilly reported earnings, shares of the company jumped more than 5% on the raised guidance and supply updates.

Persons: Eli Lilly, Anat Ashkenazi, There's, Ashkenazi, David Ricks, —, Lilly, Chris Schott Organizations: U.S, Novo Nordisk, Nexus Pharmaceuticals, JPMorgan Locations: North Carolina, Indiana, Ireland, Germany, Europe, U.S

☆ Weight loss drugs are still hard to find — but Novo Nordisk and Eli Lilly are trying to change that
▼ + stars: | 2024-02-10 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +8 min

Victoria Klesty | ReutersThe insatiable demand for weight loss drugs is trouncing supply, leaving many patients struggling to find the injectable treatments. The dominant weight loss drugmakers, Novo Nordisk and Eli Lilly , have said supply woes likely won't go away anytime soon, as the popularity of those medicines continues to soar. Some Wall Street analysts project that the weight loss drug market could be worth $100 billion by the end of the decade. But both Novo Nordisk and Eli Lilly gave updates on positive supply developments to investors over the last week. Other forms of weight loss drugs could helpAlternative forms of weight loss drugs could also help alleviate supply constraints in the future.

Persons: Victoria Klesty, Eli Lilly, Cantor Fitzgerald, Louise Chen, Nordisk's Wegovy, Eli Lilly's Zepbound, Goldman Sachs, Jeff Friedman, Novo, Mike Segar, Eli, Catalent, Yves Herman Yves Herman, TD Cowen, Michael Nedelcovych, Anat Ashkenazi, Cantor Fitzgerald's Chen, Morgan Stanley, Eli Lilly's, George Frey Organizations: Novo Nordisk, CNBC, Nordisk's, University of Florida, Pfizer, AstraZeneca, Roche, Food, Nordisk, Company, FDA, Novo Holdings, Wegovy, REUTERS, Reuters, U.S Locations: Oslo, Norway, Novo, U.S, Branchburg , New Jersey, Brussels, Belgium, Catalent, Concord , North Carolina, North, Germany, Indiana, Denmark, France

☆ How Eli Lilly plans to fix the supply snag for its blockbuster diabetes drug
▼ + stars: | 2024-01-26 | by ( Kevin Stankiewicz | In Kevinstankiewicz | ) www.cnbc.com time to read: +8 min

They're also at the heart of our investment thesis in Eli Lilly, a longtime Club holding. Shares of Eli Lilly have soared nearly 80% over the past 12 months, including a more-than-5% gain in January alone. In November, Eli Lilly indicated it was on track to meet the goal, which also was made possible by upgrades to existing facilities. Eli Lilly has used KwikPen technology for other diabetes treatments, such as insulin injections, for many years. Eli Lilly & Co. Mounjaro brand tirzepatide medication arranged at a pharmacy in Provo, Utah, US, on Monday, Nov. 27, 2023.

Persons: Eli Lilly, —, Eli Lilly's, They're, FactSet, Lilly's, Dave Ricks, Ricks, Lilly, there's, Morgan Stanley, Eli, Jim Cramer's, Jim Cramer, Jim, George Frey Organizations: CNBC, FDA, Novo Nordisk, JPMorgan Healthcare Conference, Research, Barclays, RTP, —, U.S, JPMorgan, Bloomberg, Getty Locations: Danish, Indianapolis, North Carolina, Carolina, Concord , North Carolina, Germany, U.S, Australia, Canada, KwikPen, Provo , Utah

☆ When Medical Emergencies Happen in Flight, Which Supplies Should Planes Have to Carry?
▼ + stars: | 2024-01-16 | by ( Jacob Passy | ) www.wsj.com time to read: 1 min

Illustration: ISTOCK (2)Treatment for a life-or-death midair medical emergency can depend on which plane you happen to be on. More than 20 million Americans are estimated to have food allergies, based on data from the National Center for Health Statistics, yet not every commercial plane is stocked with epinephrine autoinjectors. The devices, commonly referred to by the brand name EpiPen, are the most critical treatment for potentially life-threatening allergic reactions known as anaphylaxis, doctors say.

Organizations: National Center for Health Statistics

Many of the patents at issue in the Food and Drug Administration's Orange Book listing of approved products were for devices such as asthma inhalers and epinephrine autoinjectors, the FTC said. "Wrongfully listed Orange Book patents by pharma companies can raise drug prices for Americans, harm fair competition, and delay better drugs," FTC Chair Lina Khan said on X, formerly known as Twitter. The Orange Book identifies drugs and products that the FDA has deemed safe and effective. The FTC says companies sometimes improperly list patents in the Orange Book that can delay market entry of lower priced generics. AbbVie was informed the FTC would dispute four patents in the Orange Book having to do with Restasis Multidose, eye drops used for chronic dry eye.

Persons: Andrew Kelly, Lina Khan, Boehringer Ingelheim, Mylan, AbbVie, Restasis, Diane Bartz, Patrick Wingrove, Bill Berkrot Organizations: Food and Drug Administration, FDA, REUTERS, AstraZeneca, GSK, U.S . Federal Trade Commission, Food, FTC, pharma, Thomson Locations: White Oak , Maryland, U.S, WASHINGTON, Israel, Viatris

☆ How Novo Nordisk makes its weight-loss drug Wegovy
▼ + stars: | 2023-11-01 | by ( Maggie Fick | ) www.reuters.com time to read: +3 min

[1/2] A 0.25 mg injection pen of Novo Nordisk's weight-loss drug Wegovy is shown in this photo illustration in Oslo, Norway, August31, 2023. REUTERS/Victoria Klesty/Illustration/File Photo Acquire Licensing RightsLONDON, Nov 1 (Reuters) - Novo Nordisk (NOVOb.CO) is spending billions of dollars to boost output and ease shortages of its hugely popular, highly effective weight-loss medicine Wegovy. FILL-FINISHNovo has hired Catalent (CTLT.N), a large U.S. contract drug manufacturer, to fill injection pens for Wegovy at two of that company's plants: in Brussels and in Bloomington, Indiana. Novo has also hired another U.S. firm, Thermo Fisher (TMO.N), as a Wegovy pen filler. COMPONENTSThe Wegovy injection pens for the U.S. market slightly differ from those sold in the European markets including Norway, Denmark, Germany and UK, where it has so far launched.

Persons: Victoria Klesty, Catalent, Novo, Wegovy, Maggie Fick, Josephine Mason, Tomasz Janowski Organizations: REUTERS, Novo Nordisk, U.S, Novo, Reuters, PCI Pharma Services, autoinjectors, West Pharmaceutical Services, Stevenato, SCHOTT Pharma, Thomson Locations: Oslo, Norway, August31, Victoria, Danish, Novo, Denmark, U.S, Brussels, Bloomington , Indiana, Greenville , North Carolina, Greenville, Germany, Europe, Swiss

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. The rejection and request for additional testing sharply contrasts the backing from the U.S. Food and Drug Administration's (FDA) independent experts for the spray, neffy, in May. EpiPen-maker Viatris (VTRS.O) had in June petitioned the FDA to require that ARS conduct more trials that closely mimic real-world conditions. It did not test neffy in anaphylaxis, a severe, life-threatening allergic reaction, due to ethical concerns. ARS expects to re-submit its application in the first half of 2024, with an FDA decision likely in the second half.

Persons: Andrew Kelly, William Blair, Tim Lugo, Stacey Saiontz, anaphylaxis, James Tarbox, Christy Santhosh, Sriparna Roy, Jahnavi, Varun Organizations: Food and Drug Administration, FDA, REUTERS, ARS Pharmaceuticals, U.S . Food, Pharma, Regulators, ARS, Texas Tech University Health Sciences Center, Thomson Locations: White Oak , Maryland, U.S, anaphylaxis, Bengaluru

☆ FDA could approve over-the-counter nasal spray, autoinjectors to treat opioid overdoses
▼ + stars: | 2022-11-15 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Naloxone, packaged with instructions, is one of the items given out by the Baltimore Harm Reduction Coalition outreach workers. The Food and Drug Administration on Tuesday indicated it might approve over-the-counter nasal sprays and autoinjectors that prevent opioid overdoses, part of its efforts to expand access to a life-saving drug called naloxone. The FDA, in a preliminary assessment, said nasal spray containing up to 4mg of naloxone and autoinjectors that administer up to a 2 mg dose of the drug might be safe and effective for people to self administer without a prescription. Opioid overdose deaths surged 65% during the Covid-19 pandemic from 47,000 in 2019 to nearly 78,000 in 2021, according to data from the Centers for Disease Control and Prevention. More than 564,000 people have died from opioids in the U.S. since 1999 in three waves — first from prescription opioids, then from heroin and most recently from fentanyl.

Search resuls for: "autoinjectors"

9 mentions found