Latest news with #MariamSunny
Yahoo
07-05-2025
- Health
- Yahoo
Europe reviews Valneva's chikungunya vaccine after reports of serious side effects
(Reuters) -The European Union's health regulator said on Wednesday it was reviewing French drugmaker Valneva's chikungunya vaccine after reports of serious side effects in older adults. The European Medicines Agency's (EMA) safety committee has temporarily suspended the use of the vaccine, branded as Ixchiq, in adults aged 65 years and older. The company said it will continue to monitor the reported events and cooperate with health authorities, while actively exploring a potential update to the vaccine's indication. Ixchiq -- the first preventive shot against chikungunya virus to be authorized in the Europe as well as the U.S. -- contains a weakened strain of the virus that triggers the immune system to make antibodies. The vaccine carries the risk of causing severe chikungunya-like adverse reactions, the EMA said in a statement. Chikungunya is a mosquito-borne disease caused by the chikungunya virus. The most common symptoms of the infection are fever and joint pain. About 17 serious adverse events, including two deaths, have been reported so far globally in people aged between 62 and 89 years who had received the vaccine, the agency said. Two men aged 84 years and 77 years who had received the vaccine died in the French overseas territory of La Reunion, where a recent chikungunya outbreak has been reported. The exact cause of the adverse events and their relationship with the vaccine have not yet been determined, the agency said, adding that the affected individuals also had other health conditions. The French government suspended the use of the vaccine in persons aged 65 years and older last month pending investigation. Advisers to the U.S. Centers for Disease Control and Prevention had recommended the vaccine last month for adults traveling to a country or territory where there is a chikungunya outbreak. The recommendation is yet to be signed off by the CDC. (Reporting by Mariam Sunny in Bengaluru; Editing by Tasim Zahid and Shinjini Ganguli)
Reuters
07-05-2025
- Health
- Reuters
Europe reviews Valneva's chikungunya vaccine after reports of serious side-effects in older people
Valneva logo is seen displayed in this illustration taken, May 3, 2022. REUTERS/Dado Ruvic/Illustration Purchase Licensing Rights , opens new tab Companies Valneva SE Follow May 7 (Reuters) - The European Union's health regulator said on Wednesday it has begun a review of Valneva's ( , opens new tab chikungunya vaccine after reports of serious adverse events in older adults, including two deaths globally. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Reporting by Mariam Sunny in Bengaluru; Editing by Tasim Zahid Our Standards: The Thomson Reuters Trust Principles. , opens new tab Share X Facebook Linkedin Email Link Purchase Licensing Rights
Yahoo
30-04-2025
- Business
- Yahoo
Novartis to buy kidney disease drug maker Regulus in up to $1.7 billion deal
By Bhanvi Satija and Mariam Sunny (Reuters) -Novartis has agreed to buy Regulus Therapeutics for up to $1.7 billion, giving the Swiss drugmaker access to an experimental drug to treat a life-threatening kidney disease. Under the deal terms, Novartis will pay $7 per share in cash upfront, or about $800 million, and another $7 per share to Regulus shareholders if the lead drug candidate, farabursen, gets regulatory approval, the California-based biotech said on Wednesday. The offer represents a premium of about 108% to the stock's last closing price. Shares of Regulus more than doubled to $7.8. The deal, expected to bolster Novartis' lineup of kidney disease drugs in development, will also give the company access to Regulus' proprietary platform to develop treatments targeting a type of genetic material called microRNAs. Regulus' drug, farabursen, is expected to enter a late-stage study this year to test it for the treatment of autosomal dominant polycystic kidney disease, which causes fluid-filled cysts in the organ. The deal is a "sensible bolt-on" for Novartis, said Barclays analyst Emily Field. Farabursen is a potential improvement over poorly tolerated standard-of-care therapy, tolvaptan, Field said. Otsuka Pharmaceutical's tolvaptan is the only treatment approved by the U.S. Food and Drug Administration in the country for the condition, but it carries the risk of potentially fatal liver injury. Novartis has recently received U.S. approvals for its drugs Fabhalta and Vanrafia for the treatment of different types of kidney disorders. It had bought Chinook Therapeutics for $3.5 billion in 2023 for its candidate to treat a rare kidney disease. Its agreement with Regulus comes when policy and regulatory changes for the healthcare sector in the U.S. have been stalling large lifescience deals in what was initially expected to be a stellar year for mergers and acquisitions. Novartis said on Tuesday it expects adjusted earnings to grow by "a low double-digit" percentage in 2025. Sign in to access your portfolio
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
15-04-2025
- Health
- Yahoo
US CDC advisers to review vaccine guidelines after months-long delay
By Mariam Sunny and Sneha S K (Reuters) -The U.S. Centers for Disease Control and Prevention's outside expert panel will convene on Tuesday after a nearly two-month delay and expects to review guidelines for several vaccines including recommendations for the next generation of COVID-19 shots. The two-day meeting of the Advisory Committee on Immunization Practices also plans to discuss the ongoing U.S. measles outbreak that has infected over 700 people this year, mostly among unvaccinated people in Texas and New Mexico. The meeting was abruptly delayed in February just days after Robert F. Kennedy Jr., a long-time vaccine skeptic, became head of the U.S. Department of Health and Human Services. CDC, which is part of HHS, said the meeting had been postponed to allow for public comment. Kennedy has denied being "anti-vaccine" and has said he would not prevent Americans from getting vaccinated. His pledges to protect existing vaccination programs helped Kennedy clinch key votes at his Senate confirmation hearing. Louisiana Republican Bill Cassidy, a U.S. senator and physician from Louisiana, said Kennedy had promised to honor decisions by the CDC's ACIP without changes. The panel will discuss and vote on usage recommendations for several vaccines, including for respiratory syncytial virus (RSV) and chikungunya, a mosquito-borne disease. It will also discuss updated COVID shots and whether to narrow recommendations on who should receive them for the 2025-2026 season to a smaller group of people. The agency currently recommends that individuals aged six months and older should be given an updated COVID-19 vaccine, regardless of previous inoculations for the disease. COVID was not on the original agenda for the scheduled February meeting. Dr. William Schaffner, a liaison to ACIP from the National Foundation for Infectious Diseases, said the agenda for the meeting suggests it would be a routine annual discussion. "The bottom line is: so far so good," he said. The expert panel normally holds multiple meetings a year, reviews scientific data and makes recommendations to the CDC director, who must then approve them. "Having regular ACIP meetings allows for vaccine updates to be made, new vaccines be incorporated into the schedule, and allows the American public to take time to listen and to take note if they would like," said committee chair Dr. Helen Talbot.
