Latest news with #SnehaSK
Time of India
23-04-2025
- Business
- Time of India
Elevance confirms quarterly profit beat, reaffirms 2025 forecast
Bengaluru: Health insurer Elevance Health said on Tuesday its first-quarter profit came above Street expectations, matching the preliminary estimates it released last week after bellwether UnitedHealth's lowered full-year forecast triggered a selloff in the sector. Elevance also reiterated its full-year profit forecast of $34.15 to $34.85 per share, and reported first-quarter adjusted shareholders' net income of $11.97 per share. The company came out with preliminary earnings numbers on Thursday, amid a sharp decline in health insurers after UnitedHealth missed quarterly profit estimates due to elevated patient care costs in its Medicare Advantage business. The company's operating revenue rose 15.4% to $48.77 billion during the quarter. Last week, Elevance said that costs in its Medicare Advantage business, which provides government-backed plans to adults aged 65 and older and those with disabilities, were in line with its expectations and the prices of its plans. Wall Street analysts have said that UnitedHealth's cut likely reflects the healthcare conglomerate's own challenges, and not an industry-wide problem. Elevance is less exposed to government-backed Medicare Advantage plans, and banks more on commercial and Medicaid health plans. For the quarter, the company's medical loss ratio , a closely watched ratio to track costs, was 86.4%, below analysts' average estimate of 86.8%. Companies aim for a ratio close to around 80%. Investors will be closely watching Elevance's post-earnings conference call, scheduled at 8:30 am ET, to get more details on the earnings and the forecast. Sneha S K and Manas Mishra in Bengaluru; Editing by Shinjini Ganguli)
Yahoo
18-04-2025
- Health
- Yahoo
US CDC advisers recommend lowering the age for RSV shots to 50-59 years
By Sneha S K and Mariam Sunny (Reuters) -The U.S. Centers for Disease Control and Prevention's panel of outside experts on Wednesday recommended the use of respiratory syncytial virus vaccines in younger adults who are at increased risk of severe illness from the virus. The 15-member panel voted 14-to-0 to recommend that at-risk adults ages 50 to 59 receive a single dose of RSV vaccine. One of the panel members abstained from voting. The CDC currently recommends the vaccine for adults age 75 and older and at-risk adults ages 60 to 74. "What's swaying me is there clearly are people in that 50 to 59 years age group, for example lung transplant patients, ...that would clearly benefit from having access to this vaccine," Jane Zucker, one of the voting members of the panel, said ahead of the vote. If the recommendation is adopted by the CDC, it would make about 30% of U.S. adults in that age group eligible for the RSV vaccine, according to panelist Michael Melgar. The outside vaccine experts also asked for more data on durability of the shot's benefits as well as the timing for re-vaccination. "I'm a huge proponent of lowering the age as well as making it as simple as possible... and the fact that they kept the risk base as broad as it was," said Jason Goldman, a non-voting panel member. RSV typically causes cold-like symptoms, but is also a leading cause of pneumonia in toddlers and older adults. An estimated 15,000–20,000 annual RSV-associated hospitalizations occur in the U.S. in adults aged 50 to 59, according to the CDC. The CDC director typically signs off on the panel's recommendations before they are implemented, but the agency does not currently have one. President Donald Trump's nomination for the post, Susan Monarez, has yet to be confirmed by the U.S. Senate. The U.S. Food and Drug Administration has approved three vaccines for RSV — GSK's Arexvy, Moderna's mRESVIA and Pfizer's Abrysvo. Arexvy and Abrysvo are approved to prevent RSV-associated lower respiratory tract disease in adults aged 50 to 59 and 18 to 59, respectively, who are at an increased risk from the disease. Moderna's application for at-risk adults aged 18 to 59 is under FDA review. The panel is expected to consider the use of RSV vaccines in adults younger than 50 at its June meeting. The panel also voted to recommend use of GSK's pentavalent meningococcal vaccine and separate vaccines from Bavarian Nordic and Valneva against chikungunya, a mosquito-borne virus. On Tuesday, the panel discussed narrowing recommendations on the use of COVID-19 booster shots for the upcoming immunization campaign.
Yahoo
26-03-2025
- Health
- Yahoo
US FDA approves first treatment for rare genetic disorder Prader-Willi syndrome
By Sneha S K (Reuters) -The U.S. Food and Drug Administration on Wednesday approved Soleno Therapeutics' drug to treat a rare genetic disorder, making it the first treatment available for patients who experience feelings of intense and persistent hunger. The drug, to be called Vykat XR, treats hyperphagia, the hallmark symptom of the Prader-Willi syndrome, a genetic disorder caused by full or partial deletions on chromosome 15 that affect the regulation of gene expression, or how genes turn on and off. The debilitating condition, which affects about 50,000 people in the U.S., impacts everyday aspects of life, such as eating, behavior and mood. Starting in April 2025, Soleno plans to make the drug available in the U.S. for patients aged four years and older who have PWS with hyperphagia. The drug will have an annual average cost of $466,200 and will be dosed as per patients' weight, the company said. The syndrome's symptoms appear immediately, with infants born with low muscle tone and an inability to breastfeed. As patients grow older, children develop hyperphagia, a feeling of insatiable hunger persisting even after meals. This could occur as early as age four but, on average, starts at about age eight and then continues into adulthood. The increased appetite can lead to rapid weight gain and, if not controlled, obesity and related problems such as respiratory difficulties and heart disease. The company estimates the average lifespan of people with the disease is between 21 and 29 years. The drug is a once-daily oral pill designed to target a specific pathway in the brain to help reduce hyperphagia by decreasing the secretion of a peptide that is known to regulate appetite. LONG-AWAITED APPROVAL The long-awaited approval comes after the FDA's extended review of the drug and mixed results from a late-stage trial on its efficacy. The approval was based on data from the study and a randomized withdrawal study. In the late-stage trial involving 127 patients, the drug helped reduce feelings of intense hunger in the group of patients who had severe hyperphagia. The drug, however, did not show a statistically significant change in hyperphagia compared to the placebo group in the study. A long-term follow-up study in patients who had completed the late-stage trial showed the drug significantly reduced hyperphagia after at least one year of treatment. Justice Faith, a 21-year-old from Minneapolis, Minnesota, with PWS, said she is "very excited" that a treatment option may be available soon for hyperphagia. "My experience with hyperphagia, like everyone with PWS, is different from others," she said in an emailed statement ahead of the approval. An increased interest and awareness about food, as well as a generalized increase in anxiety, develop in people with PWS around childhood. Hyperphagia can also lead to a range of disruptive food-related behaviors, including aggressive food seeking. "There are a lot of questions about food, 'When are we going to have lunch? Are you sure it's time for lunch?' It's just non-stop," said Jennifer Miller, professor of pediatric endocrinology at the University of Florida. She was also a principal investigator on the trials for Vykat XR. "One of the patients, when I first started doing this 26 years ago, said to me, 'Imagine the hungriest you've ever been. That's how I feel all the time. I never ever feel like I've eaten.' That's why I started (treating patients), because of that comment," Miller said. Anthony Holland, president of the International Prader-Willi Syndrome Organisation said the IPWSO will work closely with the company as well as other global health bodies to expand access to the drug worldwide. "One of the tasks of our organization will be to campaign for its use more widely," Holland said.
Yahoo
25-02-2025
- Business
- Yahoo
J&J sues Samsung Bioepis over Stelara biosimilar
By Sneha S K and Patrick Wingrove (Reuters) - Johnson & Johnson sued Samsung Bioepis for allegedly breaching a contract agreement over its launch of a biosimilar to Stelara, J&J's blockbuster psoriasis treatment. The lawsuit, filed late on Monday in a New Jersey federal court, involves an unauthorized sublicense deal with a private label provider that J&J declined to identify. The suit seeks a preliminary injunction to bar U.S. sales of the private-label version of Samsung Bioepis' Stelara biosimilar, called Pyzchiva. Samsung and J&J signed a settlement agreement in July 2023 allowing for the launch of Pyzchiva this month. Samsung Bioepis and partner Sandoz announced earlier on Monday that Pyzchiva had been launched in the U.S. J&J in the lawsuit claimed that the agreement did not permit Samsung to introduce an additional private label drug at the expense of J&J market share and fair competition. It also requested a permanent injunction and financial damages as part of its lawsuit. Samsung Bioepis did not immediately respond to a request for comment on the lawsuit. Stelara, introduced in 2009, has been J&J's top-selling drug since 2019, with sales reaching more than $10 billion in 2024. Its patents began to expire in 2023, opening the door to cheaper biosimilars entering the market. Legal agreements aimed at escaping lengthy patent litigation delayed market entry of Stelara biosimilars in the U.S. J&J Chief Financial Officer Joe Wolk has said the Stelara biosimilar market was likely to unfurl similarly to that of AbbVie's blockbuster arthritis drug Humira - once the world's best-selling prescription drug - given contracting practices and doctor and patient resistance to switching medicines. AbbVie held onto almost all of the Humira market for more than a year after close copies of the drug were launched in early 2023. That changed when CVS Health removed Humira from its list of covered drugs and more patients switched to a biosimilar in three weeks than had in the prior 15 months. CVS, which owns a pharmacy benefit manager that negotiates rebates and fees with manufacturers and creates lists of medications, known as formularies, that are covered by insurance, replaced Humira with a biosimilar that was jointly marketed with its Cordavis unit, a private label provider. J&J in its lawsuit said Humira's market erosion was illustrative of the harm Samsung Bioepis' private label deal could have. Stelara biosimilars launched in Europe, Canada and a few other markets last year, and at least seven close copies of Stelara are expected to begin selling in the U.S. this year. Pyzchiva is approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. Teva Pharmaceuticals and Alvotech last Friday launched Selarsdi, a biosimilar to Stelara. The U.S. Food and Drug Administration has allowed the use of Selarsdi as an "interchangeable" Stelara substitute only after April 30, when the exclusive rights for Amgen's version Wezlana expire. Sign in to access your portfolio
