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☆ Walgreens to offer its own cheaper version of opioid overdose reversal drug naloxone
▼ + stars: | 2024-05-15 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Walgreens on Wednesday said it will offer its own cheaper version of the over-the-counter opioid overdose reversal spray naloxone. The company said it will sell a two-dose pack of "Walgreens Brand Naloxone" for $34.99. That's around $10 cheaper than the over-the-counter branded drug Narcan, which became the first prescription-free version of naloxone to win Food and Drug Administration approval last year. The company said the launch of its prescription-free naloxone nasal spray comes after the FDA's recent approval of the product. Mammen hopes that Walgreens can help reduce the stigma associated with drug overdoses and naloxone use.

Persons: naloxone, Priya Mammen Organizations: Walgreens, Centers for Disease Control, Food, Drug, CNBC Locations: U.S

☆ MDMA therapy could be legalized by summer. Why are so many advocates sounding the alarm?
▼ + stars: | 2024-05-13 | by ( Anna Silman | ) www.businessinsider.com time to read: +52 min

Last summer, thousands of tie-dyed Burners and Patagonia-clad tech founders converged on the MAPS Psychedelic Science conference in Denver. The experience "broke the spell of this trauma, and she was able to rebuild her life," Doblin told The Guardian . The video team's job was to store recordings of every MDMA therapy session performed in the clinical trials. Grof believes in something called an "inner healing intelligence," an innate capacity for self-healing that psychedelic therapy helps unleash. Another time, a patient who had come to an MDMA therapy session later acknowledged they had been under the influence of LSD during treatment.

Persons: Jaden Smith, Aaron Rodgers, bro, Andrew Huberman, Rick Doblin, Doblin, mainstreaming psychedelics, influencers, Johnson, Elizabeth Nielson, Aubrey Marcus, ayahuasca, Matthew Stockman, Helena —, Timothy Leary, —, Hitler, Stanislav Grof, zombified, Brad Burge, Michael Mithoefer, Annie Mithoefer, Oprah, Sen, Joe Biden, MDMA's neurotoxicity, they'd, Albert Hofmann, David Bronner, Dr, Joe's, Bronner, Bronner's, Richard Rockefeller, John D, Rockefeller Jr, Rockefeller, Neşe, Johns Hopkins, who's, Devenot, Rick Friedman, Betty Aldworth, MAPS's multimillionaire, Tim Ferriss, Cody Swift, Zendo, Aldworth, Erica Siegal, Seth Whitelaw, Amy Emerson, JULIE JAMMOT, Ifetayo Harvey, Harvey, Lauren Unger, Unger, Casey Hardison, Harvey didn't, Hardison, Doblin's, Baylee Ybarra Gatlin, Gatlin, negligently, There's, Michael Pollan's, Steve Jurvetson, Elon Musk's who's, Genevieve, Steve Cohen, Alexandra, Mark Zuckerberg's, Dustin Moskovitz, Cari, Gwyneth Paltrow, Paltrow, Sergey Brin, Joe Green, Green, Zuckerberg, Genevieve Jurvetson, Michael Pollan, Jonathan Lubecky, he'd, Rebekah, Robert Mercer, Elizabeth Koch, Charles Koch, Rachel Nuwer, Koch, she'd, MAPS's, Elizabeth Crystal, Joe Rogan, didn't, Jesus Christ, Crystal, Meaghan Buisson, Richard Yensen, Donna, Yensen, Buisson, weren't, Robert, Rebekah Mercer, Sean Zanni, Grof, They've, Kayla Greenstien, it's, George Sarlo who'd, Vicky Dulai, Sarlo's, Dulai, Gul Dolen, Michael Mullette, who'd, Marla Aufmuth, Mullette, Lily Kay Ross, David Nickles, Ross, Greenstien, Rick, Lenny Ignelzi, biostatisticians, Lykos, Peter Thiel, Kara Swisher, Kris Lotlikar, Federico Menapace, Mo Septimus, Handout, Monnica, Williams, Lotlikar, Henry Elkus, Helena ., Elkus, Emerson, ICER Organizations: Science, New York Jets, rockstar, Multidisciplinary Association for Psychedelic Studies, Lykos Therapeutics, and Drug Administration, FDA, Business, Florida's New College, Jewish Telegraphic Agency, Sarasota Herald, Tribune, New College, Guardian, Drug, Harvard's Kennedy School of Government, eBay, Nevada, Doblin, Pentagon, Department of Veterans Affairs, Department of Defense, Staff, Corporation, PBC, pharma, New Yorker, New York Mets, Bloomberg, CBS, Breitbart, CBC News, BI, Porsche, Santa Cruz, New York Times, longtime, Mullette Corporation, New York, Health Canada, Compass, Sciences, Psychedelic Science, Whole Foods, McKinsey, Big Pharma, Vine Ventures, Lucid, Street Journal, Investments, Gawker, Publicly, PBC alums, Numinus, US Army Locations: Patagonia, Denver, Harvard, Colorado, Skokie , Illinois, Ireland, Czech, Sarasota, Arcturus, Florida, Swiss, Vietnam, Washington, Santa Cruz, Chicago, California, Iraq, British Columbia, New York, Hawaii, Santa, Nature, Moderna, Europe, Helena, Yale, Australia, Canada, Israel, Ukraine, ICER, . Upper

But J&J's drug is walking away with a notable edge over its rival. They add more options to a growing arsenal of treatments that have helped improve outcomes for people with multiple myeloma. But the new approvals also give J&J's therapy, which was developed with Legend Biotech, a clear advantage over Bristol Myers's drug. J&J's drug has gradually gained ground over Abecma in the CAR-T market for multiple myeloma, even though it first entered the market a year later. With the new approval on Friday, Jefferies' Shi expects J&J's drug to win the majority of that market share.

Persons: Jonathan Raa, Johnson, Myers's, Bristol Myers, Jefferies, Kelly Shi, Shi, Carvykti, Cantor Fitzgerald, Rick Bienkowski, Kelsey Goodwin, Annika, annikakim.constantino@nbcuni.com Organizations: Nurphoto, Bristol Myers Squibb, Johnson, Food and Drug Administration, FDA, Legend Biotech, Bristol, New York Stock Exchange, NYSE, Reuters, Mount Sinai Hospital, Getty Locations: Bristol, U.S, EU, Japan, Mount Sinai, New York City

☆ Some cancer drugs remain unproven 5 years after FDA's accelerated approval, study finds
▼ + stars: | 2024-04-09 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailSome cancer drugs remain unproven 5 years after FDA's accelerated approval, study findsFormer FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss a new study showing some cancer drugs fast racked by the FDA's accelerated approval program remain unproven 5 years after the approvals, news of bird flu spreading in dairy cows, how worried the public should be, and more.

Persons: FDA's, Scott Gottlieb

☆ FDA authorizes Prenosis software as first AI tool that can diagnose sepsis
▼ + stars: | 2024-04-03 | by ( Ashley Capoot | In | ) www.cnbc.com time to read: +4 min

Prenosis' tool, called Sepsis ImmunoScore, uses 22 different parameters like temperature, heart rate and cell counts to help clinicians assess a patient's risk of sepsis, the company told CNBC. While Prenosis is the first company to receive FDA approval for its AI diagnostic tool for sepsis, several organizations have built and released similar solutions. Epic's sepsis model is used in hundreds of hospitals across the U.S., according to a 2021 study published in JAMA Internal Medicine. Even so, Epic reportedly overhauled its sepsis model the following year in an attempt to improve its performance, according to Stat News. Prenosis said it worked to demonstrate the safety and efficacy of Sepsis ImmunoScore to the FDA for around 18 months.

Persons: ImmunoScore, Prenosis Organizations: U.S . Food, Drug Administration, Wednesday, Centers for Disease Control, CNBC, Johns Hopkins University, Nature Medicine, Systems, Stat News, FDA Locations: U.S, White Oak , Maryland, Chicago

☆ FDA approves Merck's drug for rare, deadly lung condition
▼ + stars: | 2024-03-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

The Food and Drug Administration on Tuesday approved a drug from Merck designed to treat a progressive and life-threatening lung condition in a win for both the drugmaker and for patients suffering from the rare disease. The condition refers to when the small blood vessels in the lungs narrow. He noted that the drug will be a "paradigm shift" for patients living with PAH. That includes reducing the risk of death or worsening of the condition by 84% compared to an existing drug alone. Those trials include late-stage studies on patients with more advanced PAH disease, and those who are within the first year after diagnosis.

Persons: Chris Schott, Eliav Barr, PAH, Barr, Merck Organizations: Merck, Drug Administration, JPMorgan, CNBC, Acceleron Pharma Locations: Rahway , New Jersey, U.S, Winrevair

☆ Neuralink shares video of patient playing chess using signals from brain implant
▼ + stars: | 2024-03-20 | by ( Ashley Capoot | In | ) www.cnbc.com time to read: +5 min

Elon Musk's startup Neuralink streamed a live video on Wednesday that showed a patient using the company's brain implant to move a mouse and play chess on a computer. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Dr. Nader Pouratian, chair of the Department of Neurological Surgery at UT Southwestern Medical Center, said researchers have been developing and studying BCI technology for years. It is not clear how many patients are participating in Neuralink's trial, or what the trial is trying to demonstrate. There is reason to be hopeful about Neuralink's technology, said Dr. Marco Baptista, chief scientific officer of the Christopher & Dana Reeve Foundation, which provides resources to people who have become paralyzed.

Persons: Elon, Noland Arbaugh, Musk, Arbaugh, there's, Neuralink, Nader Pouratian, we've, Pouratian, Marco Baptista, Christopher, Dana Reeve, " Baptista Organizations: BCI, Blackrock, Neuroscience, SpaceX, Department of Neurological, UT Southwestern Medical Center, CNBC, U.S . Food, Drug Administration, Dana Reeve Foundation, PubMed Locations: Brussels, Belgium, Synchron, U.S, Neuralink

☆ Weight loss drug Wegovy is now approved for heart health — but that won't mean broad insurance coverage just yet
▼ + stars: | 2024-03-16 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +12 min

The blockbuster drug — one of a handful of weight loss treatments to skyrocket in popularity over the last year — is now approved in the U.S. for heart health, too. The spokesperson added that state Medicaid programs would be required to cover Wegovy for its new cardiovascular use. But Gremminger said the standard of care for the long-term use of weight loss drugs is "in flux." State employees will no longer have insurance coverage for GLP-1s when used for weight loss at the beginning of next month. Both drugmakers have launched programs to help patients, with or without commercial insurance coverage, afford their weight loss treatments.

Persons: Klesty, John Crable, Wegovy, Jaime Almandoz, Joe Buglewicz, Shawn Gremminger, Hartley, Gremminger, Dale Folwell, We've, Folwell, Phelan M, Eli Lilly, Ceci Connolly, Julie Stich Organizations: Reuters, Novo Nordisk, CNBC, Medicare, Services, FDA, CVS, Aetna, International Foundation of Employee, Drug Administration, University of Texas Southwestern Medical Center, Washington Post, Getty, National Alliance of Healthcare, Taft, Nordisk, Nordisk's Ozempic, GOP, Carolina, Republican Governors Association, AP, Alliance of Community Health, U.S . Health, IFEBP, BMI Locations: U.S, Novo, Dallas, North Carolina, Orlando , Florida

☆ FDA approves Madrigal Pharmaceuticals drug as first treatment for common NASH liver disease
▼ + stars: | 2024-03-14 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

The Food and Drug Administration on Thursday approved the first-ever treatment for a common and potentially deadly form of liver disease that affects millions worldwide. Novo Nordisk and Eli Lilly are testing their respective blockbuster weight loss injections as treatments for the same kind of liver disease, called nonalcoholic steatohepatitis, or NASH. Madrigal's drug, which will be marketed as Rezdiffra, is specifically approved to treat patients with NASH who also have moderate-to-advanced liver scarring. NASH is a serious form of liver disease characterized by excess fat buildup and inflammation in the liver and can lead to liver scarring, also known as fibrosis, along with liver failure and liver cancer. Roughly 6 million to 8 million people in the U.S. have NASH with moderate-to-advanced liver scarring, according to an estimate cited by the FDA.

Persons: Madrigal, Eli Lilly, NASH, Nikolay Nikolov, Rezdiffra Organizations: Madrigal Pharmaceuticals, Drug Administration, Pharmaceuticals, Novo Nordisk, FDA, Immunology Locations: U.S

☆ The new office ritual? Zyn nicotine pouches
▼ + stars: | 2024-03-13 | by ( Sarah Jackson | Tim Paradis | ) www.businessinsider.com time to read: +9 min

AdvertisementShipments of the nicotine pouches in the US in 2023 were up 62% year-over-year. Zyn pouches have found favor with everyone from high-powered Wall Street traders to Tucker Carlson and GOP lawmakers. But after not using nicotine for a while, he wasn't prepared for the hit he got when he popped a 6 mg pouch of Zyn. AdvertisementPalmer sees using Zyn as an important part of his ritual around essential work. "If I could go back and never start using nicotine, I would."

Persons: Clay Coomer, Coomer, Coomer isn't, —, Clay, Zyn, Philip Morris, Tucker Carlson, Raymond Niaura, Niaura, there's, Nate Palmer, wasn't, Palmer, he's, it's, I've, Chandler, I'm, Sam Dashiell, Dashiell, JUULs Organizations: Service, Business, Philip Morris International, Swedish, GOP, New York University, FDA, Labs

☆ 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

Amylyx said Friday it would discuss its plans for Relyvrio with patients and the FDA, which “may include voluntarily withdrawing” the drug. The latest company study showed that the drug did not slow the disease compared with a dummy treatment. Amylyx’s medication is part of a string of drugs for deadly, degenerative diseases that have won FDA approval in recent years despite questionable proof that they work. That commitment seemed to reassure FDA's advisers who voted in favor of the drug's approval, despite the questionable data. In the months before the decision the FDA faced intense pressure from ALS patients, advocates and members of Congress.

Persons: Lou Gehrig’s, Amylyx, ”, “, Relyvrio Organizations: WASHINGTON, Drug Administration, Amylyx Pharmaceuticals, Relyvrio, FDA, Cambridge, Amylyx Pharmaceuticals Inc, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: U.S

☆ Dexcom announces its first-ever over-the-counter CGM Stelo has been cleared by the FDA
▼ + stars: | 2024-03-05 | by ( Ashley Capoot | In | ) www.cnbc.com time to read: +3 min

This means Stelo will be accessible to people who do not have insurance coverage for CGMs, Dexcom said. There are more than 25 million Type 2 diabetes patients in the U.S. that do not use insulin, according to the release from Dexcom. Dexcom shared Stelo's name, as well as the fact that the device had been submitted to the FDA for review in February. Jake Leach, chief operating officer at Dexcom, told CNBC in February that Stelo will have its own unique platform and branding. Leach said as Dexcom is able to demonstrate the benefits of Stelo, the company believes insurance companies will eventually pay for it.

Persons: Dexcom, it's, Dr, Jeff Shuren, Jake Leach, Stelo, It's, Leach Organizations: U.S . Food, Drug Administration, FDA's Center, Devices, Radiological, FDA, CNBC, CNBC PRO Locations: U.S

☆ CVS and Walgreens to start selling abortion pill mifepristone this month
▼ + stars: | 2024-03-01 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

CVS and Walgreens will start selling the abortion pill mifepristone this month at certain pharmacy locations in states where it is legal to do so, spokespeople for the companies told CNBC on Friday. Mifepristone is the first pill used in the two-drug medication abortion regimen. Before the FDA's regulatory change, only a few mail-order pharmacies or specially certified doctors or clinics could distribute mifepristone. The regulatory change will potentially expand abortion access as the Biden administration wrestles with how best to protect abortion rights. Medication abortion is the most common method of terminating a pregnancy in the U.S., according to data from the Centers for Disease Control and Prevention.

Persons: Mifepristone, Biden, Wade Organizations: Alamo Women's, CVS, Walgreens, CNBC, Food and Drug Administration, New York Times, FDA, Drug Administration, Centers for Disease Control Locations: Carbondale , Illinois, Massachusetts, Rhode, New York , Pennsylvania , Massachusetts, California, Illinois, U.S

☆ Musk's Neuralink brain implant company cited by FDA over animal lab issues
▼ + stars: | 2024-02-29 | by ( ) www.cnbc.com time to read: +2 min

The inspectors identified quality control lapses at the company's California animal research facility. Those visits took place last year from June 12-22, and represent the FDA's sole inspections of Neuralink facilities on record. The laboratory problems identified by FDA inspectors included missing calibration records for instruments such as a pH meter used in one of the studies. An animal welfare advocacy group, Physicians Committee for Responsible Medicine, submitted a formal complaint to both USDA and FDA over the alleged breaches. In July, the USDA said it did not find any violations of its animal research rules beyond a 2019 incident that Neuralink had already reported.

Persons: Elon Musk's, Jerry L, Chapman, Lou Gehrig's, Neuralink Organizations: Food, Drug Administration, Elon, Elon Musk's Neuralink, Reuters, Redica Systems, FDA, U.S . Department of Agriculture, Physicians, Responsible Medicine Locations: California, Neuralink's Texas

☆ Family Dollar has agreed to pay $42 million after storing food and medicine in a warehouse with a severe rodent infestation
▼ + stars: | 2024-02-27 | by ( Grace Dean | ) www.businessinsider.com time to read: +5 min

AdvertisementUnder the plea agreement, Family Dollar admitted that it had begun receiving more reports of mouse and pest issues with deliveries from the warehouse in August 2020. AdvertisementThe distribution center shipped FDA-regulated products to more than 400 Family Dollar stores, or over 5% of its total store count. On average, the warehouse shipped 1.3 million cases of product worth $32.3 million each month, per the plea agreement. According to the plea agreement, the facility had operated since 1994, making it Family Dollar's second-oldest distribution center. Family Dollar said in October that it planned to open a "best-in-class" distribution center on the same site in West Memphis by fall 2024.

Persons: —, Dollar, Jonathan D, Ross, Rick Dreiling Organizations: Service, US Department of Justice, Business, FDA, DOJ, Federal Food, Consumers, Eastern, of Locations: Arkansas, West Memphis , Arkansas, US, of Arkansas, West Memphis

— Alex Harring 6:46 a.m.: HSBC sees Snowflake pulling back after rally Snowflake's good news has already been priced in with a recent rally, according to HSBC. Analyst Sara Russo upped her price target by $26 to $72, now implying a smaller downside of 43%. — Alex Harring 6:05 a.m.: Macquarie moves to sidelines on Sony There's reasons for pause on Sony , Macquarie warned. Still, the analyst noted the "many" risks to the stock price, including valuation and if the ETFs become a competitor to Coinbase itself. The bank initiated coverage of the medical technology stock with a buy rating and a price target of $100 per share.

Persons: Ulta, Oppenheimer, Rupesh, Parikh, Alex Harring, Snowflake, Stephen Bersey, Bersey, Bernstein, Sara Russo, Russo, — Alex Harring, Skechers, Jesalyn Wong, Wong, Macquarie, Damian Thong, Thong, deconsolidation, Colin Isaac, Eastman, Isaac, EBITDA, Piper Sandler, Harsh Kumar, Kumar, Kenneth Worthington, Worthington, Sezgi Oezener, Taha Kass, Oezener, Fred Imbert Organizations: CNBC, JPMorgan, HSBC, GE Healthcare, ISI, Distributors, Sony, Macquarie, U.S, Eastman, Eastman Chemical, Nvidia, GE Healthcare HSBC, General Electric, Learning, Amazon, Science & Technology Locations: Wednesday's, Sony's U.S, premarket, Coinbase

☆ What Eli Lilly investors can learn from the slow launch of a competitor's drug
▼ + stars: | 2024-02-15 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +8 min

Club holding Eli Lilly is expecting to get approval for its Alzheimer's treatment in the coming weeks, but investors looking for immediate financial success should temper their expectations. The FDA's decision on Lilly's drug, known as donanemab, is expected by the end of March. In the meantime, Eli Lilly's diabetes and obesity drugs, the heart of our investment thesis, should continue to fuel the lion's share of the company's topline growth. About 2,000 patients are currently taking Leqembi, Biogen said Tuesday, up from 800 at the time of the company's third-quarter report in November. LLY YTD mountain Eli Lilly's stock performance so far in 2024.

Persons: Eli Lilly, drugmaker Biogen, Eli Lilly's, —, Lilly, Biogen, Japan's, Chris Viehbacher, Viehbacher, Morgan Stanley, Lilly's, Donanemab, Mounjaro, Jim Cramer, Leqembi, Jim Cramer's, Jim Organizations: Food and Drug Administration, Drug Administration, Alzheimer's Association, FDA, Club, GE Healthcare, FactSet, Pharmaceutical, CNBC Locations: Indianapolis

☆ Ro, the $7 billion healthcare startup, has a high-stakes strategy to take off-brand Ozempic mainstream
▼ + stars: | 2024-02-07 | by ( ) www.businessinsider.com time to read: +11 min

The $7 billion healthcare startup Ro, which has been prescribing brand-name weight-loss shots since January 2023, now offers compounded semaglutide to patients enrolled in its weight-management program. Nonetheless, Ro is the first prominent healthcare company to effectively endorse compounded semaglutide by prescribing it. A poor-quality compounded drug might simply be a dud and a waste of money. But while compounding pharmacies are subject to FDA and state regulations, states are the main regulators, and their oversight is patchy. Michael Siluk/UCG/Universal Images Group via Getty ImagesIt's hard to know if any given vial of compounded semaglutide is safe.

Persons: Wegovy's, Ro, drugmakers, Eli Lilly's, Eli Lilly's Mounjaro, Scott Gottlieb, Michael Siluk, That's, they've, Ozempic, Eli Lilly, Eric Kastango, they're, Kastango, aren't, Al Carter, Sarah Jones Simmer, Spencer Nadolsky, WeightWatchers, Tim Church, Wondr, it's, hasn't Organizations: Business, Novo Nordisk's Wegovy, US Food and Drug Administration, FDA, Novo Nordisk's Ozempic, Getty, Novo Nordisk, USP, National Association of, Pharmacy, Health Locations: Novo, Massachusetts, Austria, New York City

☆ Eli Lilly results blow past estimates on strong Zepbound launch, surging Mounjaro revenue
▼ + stars: | 2024-02-06 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020. Eli Lilly on Tuesday reported fourth-quarter revenue and adjusted earnings that topped expectations on the strong launch of its new weight loss drug, Zepbound, and higher prices for its blockbuster diabetes drug, Mounjaro. Zepbound, which won approval from U.S. regulators in early November, raked in $175.8 million in sales for the fourth quarter. Shares of Eli Lilly were up 5% in premarket trading Tuesday. With a market cap of roughly $673 billion, Eli Lilly is the largest pharmaceutical company based in the U.S.Eli Lilly will hold an earnings call with investors at 10:00 a.m.

Persons: Eli Lilly, Eli Lilly's, Mounjaro Organizations: LSEG, FactSet Locations: San Diego , California, U.S

☆ Biogen drops controversial Alzheimer's drug Aduhelm to focus on Leqembi, experimental treatments
▼ + stars: | 2024-01-31 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Biogen on Wednesday said it will discontinue the sale and development of its older and highly controversial Alzheimer's drug Aduhelm to refocus the company's efforts to treat the memory-robbing disease. The biotech company will focus on rolling out Leqembi, a newly approved Alzheimer's drug it developed with Japanese drugmaker Eisai . The U.S. Food and Drug Administration greenlit Aduhelm in 2021 under a program that fast-tracks promising treatments. The company said it will redistribute a large portion of the resources associated with Aduhelm to the rest of its Alzheimer's drug portfolio. Among the other Alzheimer's drugs Biogen has in development is BIIB080, which targets a toxic protein called tau in the brain.

Persons: Biogen, Aduhelm Organizations: U.S . Food, Drug Administration, CNBC PRO Locations: U.S, Swiss

WASHINGTON (AP) — The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the company nearly $400 million. Philips executives disclosed the tentative agreement during a quarterly earnings update. Under terms of the agreement, Philips would continue servicing recalled machines in the U.S., but would not be able to sell new ones until meeting several corrective actions laid out by the FDA. In November, the agency issued a new warning that the machines can overheat, in rare cases causing fires. Untreated sleep apnea can cause people to stop breathing hundreds of times per night, leading to dangerous drowsiness and increased heart attack risk.

Persons: ” Philips, Roy Jakobs, Philips, “, ” Organizations: WASHINGTON, Manufacturing, Philips, Food and Drug Administration, Department of Justice, FDA . Company, FDA, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: U.S, Pennsylvania, Canada, Australia, Israel, Chile

WASHINGTON (AP) — The maker of Robitussin cough syrup is recalling several lots of products containing honey due to contamination that could pose a serious risk to people with weakened immune systems. Haleon’s recall covers eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult, which were distributed to stores and pharmacy suppliers. The products have the potential to cause “severe or life-threatening adverse events,” if taken by people with weakened immune systems, such as organ transplant recipients or those with HIV. Several million people in the U.S. have conditions that impair the immune system's ability to fight off infections. Haleon did not disclose the nature of the contamination but said use of the products could result in severe fungal infections.

Persons: Honey, Haleon Organizations: WASHINGTON, Max, Drug Administration, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: U.S, New Jersey

☆ FDA finds new manufacturing lapses at Eli Lilly plant
▼ + stars: | 2024-01-19 | by ( ) www.cnbc.com time to read: +4 min

An Eli Lilly and Company pharmaceutical manufacturing plant is pictured in Branchburg, New Jersey, March 5, 2021. U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by federal investigators, according to government records obtained by Reuters. They included problems in tracking manufacturing process and quality controls, as well as lapses in its calibration of equipment and failure to properly maintain facilities and equipment, the inspection report shows. Yet the Indianapolis-based drugmaker has been cited multiple times for manufacturing problems at its U.S. plants over the last few years, Reuters has reported. Three regulatory experts who reviewed the new inspection report described the most recent lapses as serious.

Persons: Eli Lilly, Lilly, Steven Lynn, Lynn Organizations: Company, U.S, Reuters, The, The U.S . Food, Drug, FDA, U.S . Department of Justice, Justice Department, Manufacturing Locations: Branchburg , New Jersey, The U.S, Lilly's, , New Jersey, U.S, Indianapolis

☆ Recalled WanaBana puree still on Dollar Tree shelves - US FDA
▼ + stars: | 2023-11-22 | by ( ) www.reuters.com time to read: +1 min

Nov 22 (Reuters) - The WanaBana Apple Cinnamon Puree, a product potentially contaminated with lead, was still being sold at Dollar Tree (DLTR.O) stores despite a recall that began last month, the U.S. Food and Drug Administration (FDA) said on Wednesday. In response to the FDA's Wednesday announcement, Dollar Tree said it had already instructed stores to remove the product from shelves and that they no longer sell that flavor on its website. The product was available nationally through multiple retailers including Amazon, Dollar Tree and other online outlets, the FDA said. Wanabana LLC, the maker of the product, and Amazon.com (AMZN.O) did not immediately respond to Reuters requests for comment. The FDA on Oct. 31 shared the results with Wanabana, which then initiated a voluntary recall.

Persons: Ananya Mariam Rajesh, Devika Organizations: U.S . Food, Drug Administration, FDA, North Carolina Department of Health, Human Services, North Carolina Department of Agriculture & Consumer Services, Thomson Locations: U.S, Bengaluru

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