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Showing posts with the label Biotechnology

Medicare pricing deal set to play a key role in Biden's 2024 campaign pitch

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[ad_1] U.S. President Joe Biden speaks about lowering health-care costs, in the East Room of the White House in Washington, D.C., Aug. 29, 2023. Saul Loeb | AFP | Getty Images WASHINGTON — President Joe Biden is placing a priority on reducing individual health-care costs as he seeks reelection in a country where medical spending accounts for 18.3% of the nation's gross domestic product, according to the Centers for Medicare and Medicaid Services. "Boy, we've been fighting Big Pharma for a long time," Biden said Tuesday from the White House. "I promise you I'm gonna have your back and I'll never stop fighting for you on this issue, nor will Kamala." On Tuesday, the White House announced 10 prescription drugs that will be subject to the first-ever Medicare price negotiations, which will go into effect in 2026. The 10 medicines accounted for $50.5 billion, or about 20%, of total Part D prescription drug costs   between June 1, 2022, and May 31,

Bernie Sanders says price of Alzheimer's treatment is unconscionable, calls on HHS to take action

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[ad_1] Sen. Bernie Sanders (I-VT) arrives to the U.S. Capitol Building on June 01, 2023 in Washington, DC. Anna Moneymaker | Getty Images 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." The Vermont independent said the drug's current cost would put a substantial financial burden on Medicare and increase premiums for seniors. Medicare is the federal program that provides health coverage to primarily older Americans. Sanders said the "outrageously high price" of Leqembi "will prevent seniors who need this drug from receiving treatment." The lawmaker wrote that HHS should use its authority to break Leqembi's pa

Appeals court imposes restrictions on abortion pill, but drug will stay on the market for now

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[ad_1] A container holding boxes of Mifepristone, the first medication in a medical abortion, are prepared for patients at Alamo Women's Clinic in Carbondale, Illinois, April 20, 2023. Evelyn Hockstein | Reuters A federal appeals court on Wednesday imposed restrictions on the abortion pill mifepristone, though the ruling will not have an immediate impact. The order by the U.S. 5th Circuit Court of Appeals is almost certain to be appealed to the Supreme Court. Justice Samuel Alito in April preemptively paused any ruling from the appeals court pending a petition for the high court to take the case. If the Supreme Court does not take the case, the restrictions will go into effect. Should the restrictions go in to effect, women would no longer be able to obtain the abortion by mail. Patients would have to receive a prescription from a doctor and have follow-up appointments in person. The restrictions would also shorten the time period when women can take the pill to 49 days into t

U.S. bankruptcy judge halts 40,000 Johnson & Johnson talc and cancer lawsuits

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[ad_1] In this photo illustration, a container of Johnson and Johnson baby powder is displayed on April 05, 2023 in San Anselmo, California. Justin Sullivan | Getty Images A federal bankruptcy judge on Thursday halted roughly 40,000 lawsuits that allege Johnson & Johnson 's baby powder and other talc products caused cancer . The decision is part of J&J's second attempt to settle thousands of talc cases in bankruptcy proceedings. J&J in 2021 spun off its subsidiary, LTL Management, to carry its talc-related liabilities and file for Chapter 11 bankruptcy protections.  Judge Michael Kaplan during a hearing Thursday in U.S. Bankruptcy Court in Trenton, New Jersey, put a temporary hold on the suits that will last through mid-June, The Wall Street Journal reported . J&J won't have to go to trial over any other talc claims during the pause, but new lawsuits can still be filed against the company, The Journal reported. Kaplan said during the hearing that J&a

The ADHD drug market is already stretched thin. Now it's facing a back-to-school supply strain

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[ad_1] Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc. Jb Reed | Bloomberg | Getty Images It's been 10 months since the Food and Drug Administration first announced a nationwide shortage of Adderall — one of the most widely used medications for attention deficit hyperactivity disorder — and the supply strain could potentially worsen in the months ahead. While some supply issues have improved, many Americans are still struggling to find and fill prescriptions for the drug and other medications for ADHD that they often rely on to stay focused and complete daily tasks. Drug-shortage experts told CNBC that it's extremely difficult to forecast how much longer the shortages will last because of the lack of transparency in the pharmaceutical industry — and some are concerned about market conditions as children, who are commonly affected by ADHD, head back to school.  "Unfortunately, we might see the shortage worsen. We are heading into

Pfizer RSV vaccine for infants has 'generally favorable' safety data, FDA staff say

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[ad_1] Blood sample for respiratory syncytial virus (RSV) test Jarun011 | Istock | Getty Images U.S. Food and Drug Administration staff on Tuesday said Pfizer's vaccine that protects infants from respiratory syncytial virus has "generally favorable" safety data. The FDA staff made the conclusion in briefing documents ahead of a meeting on Thursday when a panel of external advisors to the agency will discuss whether to recommend full approval of the RSV shot . The advisors will vote on whether Pfizer's late-stage clinical trial data on the vaccine supports its safety and efficacy. The FDA typically follows the advice of its advisory committees, but is not required to do so. The agency is slated to make a decision on whether to clear the shot in August before RSV season in the fall. If approved, Pfizer's jab would become the world's first vaccine that protects infants against RSV.  RSV usually causes mild, cold-like symptoms. But infants and older ad

New Covid boosters could reach Americans as soon as Thursday – here's what you need to know

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[ad_1] A nurse prepares doses of the Pfizer vaccine during a COVID-19 vaccination event at Josephine's Southern Cooking in Chatham, Illinois, Dec. 30, 2021. Brian Cassella | Tribune News Service | Getty Images A new round of Covid vaccines is finally here in the U.S. The Centers for Disease Control and Prevention cleared single-strain shots from Pfizer and Moderna for all Americans six months and up on Tuesday, following approvals from the Food and Drug Administration on Monday. Those mRNA vaccines are designed to target a relatively new omicron subvariant called XBB.1.5 .  The first doses of the new shots will be available at some pharmacies and other vaccine distribution locations within 48 hours of the CDC's recommendation, agency staff said Tuesday during a meeting of independent advisors to the CDC. That means jabs could reach Americans as soon as Thursday. Meanwhile, the FDA is still reviewing a third updated vaccine from Novavax for people ages 12 and up.  Th

Pfizer, GSK RSV shots for older adults may prevent thousands of hospitalizations, CDC analysis says

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[ad_1] Respiratory syncytial virus vial. Manjurul | Istock | Getty Images Vaccinating one million adults ages 65 and above with a single RSV shot from Pfizer or GSK may prevent thousands of hospitalizations over two seasons of the virus, according to a Centers for Disease Control and Prevention analysis .  A CDC medical officer presented the analysis, conducted by researchers at the University of Michigan, at an advisory committee meeting on Wednesday. The committee recommended that adults ages 60 and older may receive one dose of Pfizer's or GSK's respiratory syncytial virus shot after consulting their doctor.  The analysis found that vaccinating one million adults 65 and older with a single dose of Pfizer's shot may prevent 2,500 hospitalizations and 25,000 outpatient visits over two seasons of the virus. RSV season typically lasts from October to March in the Northern Hemisphere.   The analysis also found that vaccinating one million adults in the same age gr

Decongestant found in many cold, allergy medicines doesn’t actually work, FDA advisors say

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[ad_1] A combination package of Procter & Gamble Co. DayQuil Severe and NyQuil Severe brand cold and flu medicine is arranged for a photograph in Tiskilwa, Illinois. Daniel Acker | Bloomberg | Getty Images The main ingredient used in many popular over-the-counter cold and allergy medications doesn't actually work to get rid of nasal congestion, an advisory panel to the Food and Drug Administration declared Tuesday.  In a unanimous vote, 16 advisors said oral versions of phenylephrine – a nasal decongestant found in versions of drugs like Nyquil,  Benadryl, Sudafed and Mucinex – aren't effective at relieving a stuffy nose.  The FDA typically follows the advice of its advisory committees but it is not required to do so. The agency could potentially move to begin a process that removes phenylephrine from the market, which would force manufacturers to pull widely used cough and cold medications from store shelves and reformulate those products.  That could affect Procter

FDA proposes new lead limits for baby food to reduce potential risks to children’s health

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[ad_1] Jgi/jamie Grill | Tetra Images | Getty Images The Food and Drug Administration proposed new limits Tuesday on lead in baby food, in an effort to reduce exposure to a toxin that can impair childhood development. The lead limits apply to processed food consumed by children younger than two years old. In a statement, FDA Commissioner Dr. Robert Califf said the limits would reduce lead exposure from these foods by as much as 27%. The proposed lead limits are not legally binding on the industry, but the FDA said it would use them as a factor in deciding whether to take enforcement action against a company for selling contaminated food. The agency proposed the following lead concentration limits for baby food: 10 parts per billion for fruits, vegetables, yoghurts, custards and puddings, mixtures, and single ingredient meats. This would reduce exposure by 26%. 20 parts per billion for root vegetables. This would reduce exposure by 27%. 20 parts per billion for dry cereals. This wo

Alzheimer's treatment Leqembi could cost Medicare up to $5 billion per year, study estimates

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[ad_1] The Alzheimer's drug Leqembi is seen in this undated handout image obtained by Reuters on Jan. 20, 2023. Eisai | Reuters The new Alzheimer 's antibody treatment Leqembi could cost Medicare up to $5 billion per year, according to research published in a leading medical journal this week. Medicare would spend about $2 billion per year if around 85,700 patients test positive for the disease and are treated with the Eisai and Biogen product Leqembi, according to the research published Thursday in JAMA Internal Medicine. The program for seniors would spend $5 billion if around 216,500 patients become eligible for the breakthrough treatment, according to the study. The authors said the estimated costs to Medicare are conservative and that spending on Leqembi might increase more than anticipated depending on demand and other factors. The researchers who conducted the JAMA study included physicians and public health and policy experts. They are affiliated with the Univ

Pfizer RSV vaccine for older adults should be monitored for nervous system condition Guillain-Barre, scientists say

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[ad_1] A health worker prepares a flu vaccine shot before administering it to a local resident in Los Angeles, the United States, on Dec. 17, 2022. Xinhua News Agency | Getty Images People who receive Pfizer 's RSV vaccine for older adults should be monitored for Guillain-Barre syndrome, after two people developed the nervous system disorder after they received the shot, scientists said in clinical trial results published in the New England Journal of Medicine. The scientists concluded the vaccine was effective in preventing lower respiratory tract illness in adults ages 60 and older without any evident safety concerns. But they flagged the Guillain-Barre cases as a potential cause for concern moving forward. "If RSVpreF vaccine is approved and recommended, these adverse events warrant close monitoring in future studies and with real-world data and postmarketing surveillance," the scientists wrote. The study, which published Wednesday, was supported by Pfizer. Guill

Medicare will pay for Alzheimer's drug Leqembi. What patients and doctors should know

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[ad_1] The Alzheimer's drug Leqembi is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai | via Reuters Medicare has agreed to pay for the Alzheimer's treatment Leqembi , a major turning point for patients who are diagnosed with the early stages of the disease. Leqembi is the only drug on the market right now that has demonstrated the ability to slow the progression of early stages of Alzheimer's disease in a clinical trial. The monoclonal antibody, administered twice monthly through intravenous means, slowed cognitive decline by 27% over 18 months in the trial. Leqembi is made by Japanese drugmaker Eisai and its partner Biogen , which is based in Cambridge, Massachusetts. Medicare's decision to cover Leqembi, which came moments after the Food and Drug Administration fully approved the drug Thursday, promises to make the treatment more accessible to patients. Medicare coverage is crucial for most patients to have any hope of being