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If approved, it would have been the first new treatment for PTSD in more than two decades. Lykos Therapeutics had asked the FDA to approve the drug as part of a treatment regimen, given alongside talk therapy. Lykos Therapeutics had asked the FDA to approve the drug as part of a treatment regimen, given alongside talk therapy. Lykos added that the agency expressed concerns similar to those raised during the advisory committee meeting in June. Davis Institute for Psychedelics and Neurotherapeutics, said he doesn’t think the FDA decision will hinder the development of psychedelics for mental health disorders, including PTSD.

Persons: “, ”, Holly Fernandez Lynch, Lykos, Amy Emerson, Sarah Silbiger, David Olson, Olson, ” Olson, Brian Barnett, ” Barnett, Joe Biden, Biden, Robert Califf, ” Lynch, psychedelics, David Rind Organizations: Drug Administration, Therapeutics, FDA, Lykos Therapeutics, University of Pennsylvania, Davis Institute for Psychedelics, Cleveland Clinic, Clinical Locations: U.S, White Oak, Md, Ohio

☆ FDA approves new drug that may help stop and even reverse a rare, fatal condition that doctors call a ‘ticking time bomb’
▼ + stars: | 2024-03-26 | by ( Brenda Goodman | ) edition.cnn.com time to read: +15 min

These proteins cause the walls of a person’s blood vessels to keep growing and thicken over time. As the blood vessels narrow, the heart is forced to work harder to pump blood to the lungs. Treatment with a combination of drugs that dilate, or relax, blood vessels can improve this outlook, but they are not a cure. Both groups were also taking the standard medications for the condition, which help relax blood vessels to improve blood flow. But Galiatsatos said that as promising as the drug looks, there are still many unknowns, including whether the drug will benefit all PAH patients equally.

Persons: Katrina Barry, Barry, “, ”, Winrevair, Merck Winrevair, Vallerie McLaughlin, Panagis, Galiatsatos, isn’t, ” Barry, I’m, fanny, She’s, sotatercept, PAH, Sotatercept, “ There’s, Kristin Highland, Highland, ” Merck, Merck, Dr, Sanjay Gupta, Aaron Waxman, Barry’s, he’s, they’ve, Johnson –, Waxman, “ I’ve, “ It’s, who’ve Organizations: CNN, American Lung Association, US Food and Drug Administration, Merck, FDA, University of Michigan, PAH, Johns Hopkins Bayview Medical Center, New England, of Medicine, Cleveland Clinic, Institute, Clinical, CNN Health, Brigham, Women’s Hospital, Johnson Locations: PAH, American, Greece, Boston

☆ F.D.A. Experts Will Vote on Safety of a Cure for Sickle Cell Disease
▼ + stars: | 2023-10-30 | by ( Gina Kolata | More About Gina Kolata | ) www.nytimes.com time to read: +4 min

An estimated 100,000 people in the United States have sickle cell disease, most of whom have African ancestry. will decide on another application for sickle cell gene therapy made by Bluebird Bio. Two other companies and an academic center, Boston Children’s Hospital, are testing their own sickle cell gene therapies. While these therapies could reduce the suffering of sickle cell patients in the United States and other wealthy countries, there is an even greater need for them in some developing countries like Nigeria. One company, Beam, is testing a way to provide gene editing that requires nothing more than a single infusion in a doctor’s office.

Persons: “, Mariah Jacqueline Scott, Scott, ”, Stephan Grupp, What’s Organizations: Institute for Clinical, CRISPR Therapeutics, Children’s Hospital of Philadelphia, Bluebird, Boston Children’s Hospital Locations: United States, Highland Park, N.J, Boston, Nigeria

☆ Pfizer to price COVID treatment Paxlovid at $1,390 per course
▼ + stars: | 2023-10-18 | by ( Michael Erman | ) www.reuters.com time to read: +3 min

The new list price, which does not include rebates and other discounts to insurers and pharmacy benefit managers, is $1,390 per course, Pfizer said in an emailed statement. The U.S. government paid around $530 per course for Paxlovid it has made available to Americans at no cost. The United States purchased around 24 million courses of the oral two-drug treatment from Pfizer, and still had a large supply, but arranged to return 7.9 million courses last week. In 2022, patients were given around 7 million courses of the drug, according to U.S. government data. Through Oct. 1, around 3.4 million courses had been administered in 2023.

Persons: Wolfgang Rattay, Paxlovid, Michael Erman, Bill Berkrot Organizations: REUTERS, Pfizer, for Clinical, Economic, United, Wall Street, Thomson Locations: U.S, United States, Maplewood , N.J

☆ Insight: What happens when a $2 million gene therapy is not enough
▼ + stars: | 2023-08-12 | by ( Deena Beasley | ) www.reuters.com time to read: +13 min

Their experience raises broader questions around other high-cost gene therapies coming to market, sometimes after accelerated regulatory approvals, drug pricing experts said. Gene therapies work by replacing genes – the body's blueprint for its development. The gene Zolgensma delivers instructs the body to make a protein vital for muscle control. If gene therapies do fall short, it becomes harder to justify prices that researchers have argued are already poor value. More recently, the first hemophilia gene therapy approved by the U.S. Food and Drug Administration was priced by CSL Behring at $3.5 million; 26 more gene therapies are in late-stage development, according to IQVIA.

Persons: Elizabeth Kutschke, Ben, Zolgensma, Ben Kutschke, neurologists, Sitra Tauscher, Wisniewski, Ben's, Roger Hajjar, Brigham Gene, Kutschke, Vasant Narasimhan, Stacie Dusetzina, Roche's, Biogen, Roche, Maha Radhakrishnan, Steven Pearson, It's, Sree Chaguturu, Amanda Cook, Weston, Jackson, Cook, Elizabeth, Jerry Mendell, Russell Butterfield, –, Biogen's, Mendell, UMR, Spinraza, Eric Cox, Caroline Humer, Sara Ledwith Organizations: Reuters, U.S, Novartis, IQVIA Institute, Human Data, Novartis Gene Therapies, Mass, Cell Therapy, U.S . Food, Drug Administration, CSL Behring, CSL, Nashville's Vanderbilt University School of Medicine, Clinical, Economic, CVS Health, Aetna, SMA, Nationwide Children's Hospital, University of Utah Health, Children's, UnitedHealth, Thomson Locations: Oak Park, Berwyn , Illinois, Swiss, U.S, Lebanon , Virginia, United States, Columbus , Ohio, Russia, Kazakhstan, Chicago

☆ FDA approves Alzheimer’s drug Leqembi, paving way for broader Medicare coverage
▼ + stars: | 2023-07-06 | by ( Spencer Kimball | ) www.cnbc.com time to read: +8 min

Leqembi is the first Alzheimer's antibody treatment to receive full FDA approval. The antibody, administered twice monthly through intravenous infusion, targets a protein called amyloid that is associated with Alzheimer's disease. Medicare coverage is a crucial step to help older Americans with early Alzheimer's disease pay for the treatment. Costs may vary depending on whether the patient has supplemental Medicare coverage or other secondary insurance, according to the agency. Philipson and his colleagues at the University of Chicago estimated that delaying Medicare coverage of Alzheimer's antibody treatments by one year would result in $6.8 billion in increased spending.

Persons: Joanna Pike, Leqembi, Pike, David Knopman, Knopman, Anna Eshoo of, Nanette Barragan, There's, Tomas Philipson, Bush, Philipson, Sen, Bernie Sanders, Xavier Becerra, Sanders, Eisai Organizations: Drug Administration, Medicare, FDA, Alzheimer's Association, Mayo Clinic, Services, Health, University of Chicago, Senate Health, Human Services, Clinical Locations: U.S, Minnesota, Anna Eshoo of California

☆ Bernie Sanders says price of Alzheimer's treatment is unconscionable, calls on HHS to take action
▼ + stars: | 2023-06-07 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Sen. Bernie Sanders on Wednesday called on the U.S. Health and Human Services Department to take action to ensure seniors can actually afford the expensive Alzheimer's treatment Leqembi. Sanders, who chairs the Senate Health Committee, in a letter to HHS Secretary Xavier Becerra called the $26,500 annual price tag for Leqembi set by drugmakers Eisai and Biogen "unconscionable." Sanders said the "outrageously high price" of Leqembi "will prevent seniors who need this drug from receiving treatment." Most Medicare patients suffering from Alzheimer's would not be able to afford the 20% co-payment of more than $5,000 a year for Leqembi, Sanders said. Co-payments, along with coinsurance and deductibles, are medication and health services costs that patients must personally pay for out of pocket, as opposed to being covered by their health insurance.

Persons: Sen, Bernie Sanders, Sanders, Xavier Becerra, drugmakers Eisai, Becerra, Mr Organizations: U.S, Capitol, U.S . Health, Human Services Department, Health, Medicare, HHS, Services, Leqembi, Democratic, Senate, Clinical Locations: Washington , DC, Vermont

☆ F.D.A. Approves New Drug to Treat Hot Flashes
▼ + stars: | 2023-05-12 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, an official with the F.D.A. Background: Symptoms have long been enduredHot flashes are the most common side effect of menopause for which women typically seek treatment, Astellas said. And the complaints of those who experience severe hot flashes and other symptoms of menopause are often dismissed in the workplace and elsewhere. Because signs of liver damage emerged in some patients during study of the drug, the F.D.A. What’s Next: The drug price may be prohibitiveAstellas said that the drug would cost $550 for a 30-day supply, not including rebates.

☆ People Can't Get Ozempic, New Weight-Loss Drugs Because of Broken Healthcare System
▼ + stars: | 2023-04-13 | by ( ) www.businessinsider.com time to read: +15 min

Wegovy is just one of a wave of revolutionary weight-loss drugs, which also includes the buzzy Ozempic, that represents a watershed moment for obesity treatment. Demand for weight-loss drugs is surgingDoctors and healthcare professionals searched for a healthy, safe, and effective weight-loss solution for years before the drugs, known collectively as GLP-1 agonists, exploded on the scene. If there is one key that could unlock access to expensive weight-loss drugs for Americans, it's Medicare. Expanding coverage for Ozempic and other weight-loss drugs for just a small segment of the population could cost Medicare up to $26.8 billion a year. Patients lose outYears from now, patients may have an easier time getting their hands on weight-loss drugs.

[1/3] A pharmacist holds a bottle of the drug Eliquis, made by Bristol Myers Squibb and Pfizer, at a pharmacy in Provo, Utah, U.S. January 9, 2020. The government will launch the negotiation process in September by naming the first drugs it plans to target. "We couldn't have the other parts of the IRA without this Medicare negotiation," said Sean Dickson, director of the West Health Policy Center, a non-partisan healthcare think tank. Eliquis, which Bristol Myers (BMY.N) shares with Pfizer (PFE.N), Ibrance, and Imbruvica, sold by AbbVie and Johnson & Johnson (JNJ.N), appear on every list. Pfizer, Novo Nordisk and J&J declined to comment on the likelihood their drugs would be included in the first round of negotiations.

☆ Economists warn of costs if Medicare covers new obesity drugs
▼ + stars: | 2023-03-11 | by ( Nancy Lapid | ) www.reuters.com time to read: +3 min

March 11 (Reuters) - The cost of expanding U.S. Medicare prescription drug coverage to pay for expensive, new obesity medications could be catastrophic, health economists warned in a report published on Saturday. Big-selling diabetes drugs have been repurposed as obesity treatments after demonstrating weight loss of more than 20% in clinical trials. While they are far more effective than older drugs, lifetime use might be required to keep lost weight off. But should the bipartisan The Treat and Reduce Obesity Act get reintroduced and passed by Congress, Medicare will be compelled to cover drugs for weight loss. The Medicare health program covers more than 60 million Americans, most over age 65.

A newly approved Alzheimer's drug will be available to patients in the coming days, according to its maker, the Japanese pharmaceutical company Eisai. While Leqembi offers hope to patients and their families, experts say that there are still some key unanswered questions about the drug, including about its safety and effectiveness. Besides questions about who will benefit the most, there are also questions about how long the drug will benefit patients. About 17% of the Leqembi group experienced brain bleeds, compared with 9% in the placebo group. The reports of brain bleeding and brain swelling "may only be the tip of the iceberg," he said.

☆ Drug companies favor biotech meds over pills, citing new U.S. law
▼ + stars: | 2023-01-13 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

The pharmaceutical industry, whose members gathered in the thousands this week in San Francisco for the annual JP Morgan Healthcare conference, opposed the legislation and has begun implementing strategies to mitigate its impact. "In 10 years, we'll have far fewer small molecules being developed than we do today." He questioned the benefit of "rules that really just disincentivize investment in what ends up being convenient drugs, drugs for tough conditions like cancer and drugs that get really cheap when they go generic." Most medicines on the market today are small molecules, which can be taken by mouth, absorbed into the bloodstream and easily penetrate cell membranes. He noted it is not unusual for pharmaceutical companies to choose not to pursue a drug they once thought promising.

A newly approved drug intended to slow the progression of Alzheimer’s disease offers patients hope, but it will come with a steep price tag: $26,500 a year. That drug initially cost $56,000 per year before Biogen slashed the price in half, to $28,000 annually. Dr. David Rind, the institute's chief medical officer, said an appropriate cost for the drug is $8,500 to $20,600 a year. John Domeck, 60, of Aurora, Ohio is currently enrolled in a phase 3 clinical trial testing Leqembi. But right now, the clinical trial for Leqembi shows that the drug provides "modest efficacy at a big, big price," Caplan said.

☆ Most Alzheimer’s patients would pay up to $26,500 per year for new treatment Leqembi
▼ + stars: | 2023-01-09 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

Few seniors with early Alzheimer's disease will have access to the new treatment Leqembi due to its high cost and very limited coverage by Medicare. "Even with Medicare coverage, beneficiaries would still be responsible for 20% coinsurance, and that's not a trivial amount." An investigation by lawmakers in the House concluded that the FDA approval process for Aduhelm was "rife with irregularities." "It's not going to be widely available even to people who are potentially eligible based on whether or not they have mild cognitive impairment related to Alzheimer's disease," Neuman said. CMS plans to provide broader coverage for Leqembi if the treatment receives full FDA approval under the traditional process, according to an agency statement.

☆ Eisai, Biogen's new Alzheimer's drug should be priced below Aduhelm - report
▼ + stars: | 2022-12-23 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Issei KatoDec 23 (Reuters) - An influential drug pricing research group said Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) new Alzheimer's disease treatment lecanemab should be priced lower than the drug Aduhelm that was developed by the companies. Biogen halved the price of its first Alzheimer's drug Aduhelm last year to $28,200 for a person with average weight, amid tepid sales and reimbursement hurdles. Treatment with lecanemab for patients with Alzheimer's appears to be "promising but inconclusive," ICER said. Eisai and Biogen did not immediately respond to requests for comment on the ICER report. Shares of Eisai fell on Friday after a report of a third death in a trial of lecanemab.

☆ U.S. FDA approves Ferring Pharma's first gene therapy for bladder cancer
▼ + stars: | 2022-12-16 | by ( ) www.reuters.com time to read: +1 min

Dec 16 (Reuters) - The U.S. Food and Drug Administration on Friday approved Swiss drugmaker Ferring Pharmaceuticals' first gene therapy for treating adult patients with a type of bladder cancer. The therapy, Adstiladrin, is for patients with an aggressive form of the disease whose current options include having their bladder removed. The treatment, to be administered once every three months into the patient's bladder, triggers the body to make a protein to fight off cancer. Adstiladrin is expected to be commercially available in the United States in the second half of 2023, Ferring said. Bladder cancer is one of the most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) representing about 75% of all such cases.

☆ Regulators have approved the world's most expensive medicine that costs $3.5 million per patient
▼ + stars: | 2022-11-24 | by ( Ryan Hogg | ) www.businessinsider.com time to read: +3 min

The FDA approved a treatment costing $3.5 million, making it the world's most expensive medicine. Hemgenix effectively treated several patients with the blood condition Hemophilia B in trials. An independent study said a fair price for the drug would be about $2.9 million. download the app Email address By clicking ‘Sign up’, you agree to receive marketing emails from Insider as well as other partner offers and accept our Terms of Service and Privacy PolicyUS regulators have approved a hemophilia drug that will cost $3.5 million per patient, making it the world's most expensive medicine. However, the drug will have a list price of $3.5 million per dose, Managed Healthcare Executive reported, making it the world's most expensive medicine by some distance.

☆ FDA approves $3.5 million treatment for hemophilia, now the most expensive drug in the world
▼ + stars: | 2022-11-23 | by ( Deidre Mcphillips | ) edition.cnn.com time to read: +2 min

CNN —The US Food and Drug Administration on Tuesday approved Hemgenix, a new drug to treat hemophilia. Manufacturer CSL Behring set the price at $3.5 million per treatment, making it the most expensive drug in the world. In a recent cost-effectiveness analysis of the drug, weighing health benefits against offset costs, ICER suggested that a fair price for the drug to be between $2.93 million and $2.96 million. According to an analysis by GoodRx, the most expensive drug in the US previously was Zolgensma, which was approved by the FDA in 2019 to treat spinal muscular atrophy and priced at $2.1 million for a course of treatment. FDA approved Hemgenix based on safety and effectiveness evaluated in two studies of about 60 adult men.

☆ Walmart's mission to offer accessible healthcare has been slow going. But as competition heats up from Amazon, it has developed these 5 strategies to disrupt the lucrative industry.
▼ + stars: | 2022-10-17 | by ( Ben Tobin | ) www.businessinsider.com time to read: +9 min

The company has made several big moves on telehealth, clinics healthcare research, and more. The Bentonville, Arkansas-based retailer announced in October the launch of the "Walmart Healthcare Research Institute," an institute geared toward helping underserved communities participate in clinical research. But Walmart has still faced significant challenges, from major leadership departures to a slower than expected rollout of healthcare clinics. Rolling out healthcare clinics nationwideA Walmart Health center. Launching a research institute for clinical trial participationWalmart is seeking to bolster clinical trial participation with its new healthcare research institute.

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