Latest news with #GSK.L
Reuters
16-04-2025
- Health
- Reuters
US CDC advisers weigh lower age recommendation for RSV vaccines
April 16 (Reuters) - The U.S. Centers for Disease Control and Prevention's vaccine experts are expected to vote on expanding access to respiratory syncytial virus shots in the second round of their meeting on Wednesday. Guidelines from the Advisory Committee on Immunization Practices help physicians decide what vaccines to recommend to patients and are also used for determining insurance coverage in the U.S. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. The country's health regulator has approved three vaccines for RSV — GSK's (GSK.L), opens new tab Arexvy, Moderna's (MRNA.O), opens new tab mRESVIA and Pfizer's (PFE.N), opens new tab Abrysvo. 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 50–59 years, according to the CDC. The panel was initially due to meet in February but the meeting was delayed just days after Robert F. Kennedy Jr., a long-time vaccine skeptic, became the head of the U.S. Department of Health and Human Services. The session was postponed to allow for public comment, the HHS had said. The experts are due to vote later on Wednesday on whether to recommend a single dose of RSV vaccines to adults aged 50 to 59 years who are at an increased risk of the severe disease. The CDC currently recommends the vaccine for adults 75 years and older and at-risk adults aged 60 to 74 years. The CDC had decided to hold off on recommending RSV shots for adults under age 60 last year. GSK's Arexvy and Pfizer's Abrysvo are approved for the prevention of lower respiratory tract disease caused by RSV in adults aged 50 to 59 and 18 to 59, respectively, who are at an increased risk of the disease. Moderna's application for at-risk adults aged 18 to 59 years is under review by the U.S. Food and Drug Administration. The panel will also vote on recommendations for use of chikungunya, a mosquito-borne disease, and meningococcal vaccines. On Tuesday, it discussed narrowing recommendations on the use of COVID-19 booster shots for the upcoming immunization campaign.
Reuters
16-04-2025
- Health
- Reuters
Health Rounds: Appendectomy appears to reduce ulcerative colitis relapses
April 16 (Reuters) - (To receive the full newsletter in your inbox for free sign up here) Patients with the chronic inflammatory bowel disease ulcerative colitis might reduce their risk of a relapse by having their appendix removed, a new study suggests. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Ulcerative colitis causes inflammation and ulcers in the large intestine and rectum, with diarrhea and abdominal pain. There is no cure. Symptoms repeatedly subside and relapse and can adversely affect quality of life. The appendix is thought to play a role in all of this by producing inflammatory proteins that trigger the body to produce cascades of immune responses, according to a report of the study published in The Lancet Gastroenterology & Hepatology, opens new tab. All 197 adult patients in the current study were in remission at the start but had required treatment for an episode of active disease during the previous year. All of them received the usual standard care. Half also had an appendectomy. A year later, the relapse rates were 36% in the appendectomy group and 56% in the usual-care group, the researchers said. In addition, fewer patients in the appendectomy group later developed more severe disease requiring treatment with biological agents. There were five postoperative complications in the surgery group, including two that were labeled serious. After accounting for patients' individual risk factors, the odds of relapse during the study were 35% lower with appendectomy. 'This significant... reduction suggests that appendectomy might be a viable additional therapeutic option for maintaining remission in ulcerative colitis,' the researchers wrote. 'Furthermore, patients who underwent appendectomy were significantly more likely to maintain lower disease activity, reduce the initiation of biological agents, and improve health-related quality of life compared with patients who received standard medical therapy alone.' An editorial, opens new tab published with the study notes that a separate trial, still underway, is testing the benefit of appendectomy in patients whose ulcerative colitis is not in remission. GSK ANTIBIOTIC SHOWS PROMISE FOR GONORRHEA GSK's (GSK.L), opens new tab new pill for uncomplicated urinary tract infections in women and girls is also showing promise for treating uncomplicated gonorrhea, the company reported on Monday in The Lancet, opens new tab. Gepotidacin, sold as Blujepa, is a first-in-class triazaacenaphthylene antibiotic that acts by inhibiting bacteria's replication of DNA. In a late-stage, multi-nation trial, researchers randomly assigned 628 patients with gonorrhea in the urinary tract or genitals to treatment with gepotidacin or ceftriaxone with azithromycin. Success rates at eradicating Neisseria gonorrhoeae bacteria were statistically similar, at 92.6% with gepotidacin and 91.2% with ceftriaxone plus azithromycin. The gepotidacin group had higher rates of drug-related gastrointestinal adverse side effects, but almost all were mild or moderate, according to the researchers. An editorial, opens new tab published with the report notes that no new antimicrobials have been introduced for gonorrhoea treatment since the 1990s. The authors of the editorial expect N. gonorrhoeae to eventually develop resistance to gepotidacin, too. However, they said gepotidacin should also be tested in patients with gonorrhea of the mouth and throat, which is harder to treat than the urogenital infections seen in the current trial. An editorial in The Lancet Infectious Diseases, opens new tab notes that in a separate late-stage study, the first-in-class spiropyrimidinetrione antibiotic zoliflodacin was just as effective against urogenital gonorrhea as ceftriaxone plus azithromycin. Zoliflodacin is being developed as part of a public-private partnership between Innoviva's (INVA.O), opens new tab specialty therapeutics unit and the Global Antibiotic Research & Development Partnership.
Reuters
03-04-2025
- Business
- Reuters
GSK resolves patent lawsuit against Pfizer over RSV vaccines
April 3 (Reuters) - British pharmaceutical giant GlaxoSmithKline (GSK.L), opens new tab and rival Pfizer (PFE.N), opens new tab have agreed to end a lawsuit that alleged Pfizer's respiratory syncytial virus (RSV) vaccine Abrysvo violated GSK's patent rights in its competing RSV shot Arexvy, according to a Thursday filing in Delaware federal court. GSK and Pfizer said in the filing, opens new tab that they would dismiss the case with prejudice, which means it cannot be refiled. Spokespeople for the companies did not immediately respond to requests for comment and more information, including whether the case was settled. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. GSK, Pfizer and Moderna (MRNA.O), opens new tab have developed RSV shots approved by the U.S. Food and Drug Administration, with GSK's Arexvy responsible for the majority of U.S. RSV vaccine sales. The respiratory disease typically causes cold-like symptoms, but it is also a leading cause of pneumonia in toddlers and older adults. GSK sued Pfizer in 2023, arguing that the New York-based company's vaccine infringed GSK patents related to antigen technology. GSK said in the lawsuit that Pfizer began working on its RSV program around 2013, at least seven years after GSK began developing its shot. Pfizer denied the allegations and argued GSK's patents were invalid. It convinced a London court to invalidate related UK patents owned by GSK in a separate case last year. GSK has also sued Pfizer for patent infringement in the U.S. over technology in Pfizer's blockbuster COVID-19 vaccine Comirnaty. That case is still ongoing.
Reuters
01-04-2025
- Health
- Reuters
European Commission approves Pfizer's RSV vaccine for adults at increased risk of disease
April 1 (Reuters) - The European Commission approved Pfizer's (PFE.N), opens new tab respiratory syncytial virus vaccine for the prevention of lower respiratory tract disease caused by RSV in adults aged 18 to 59 at increased risk of the disease, the company said on Tuesday. The expanded EU approval, applicable in all 27 countries of the bloc, is for Pfizer's Abrysvo vaccine, which was backed by the European Medicines Agency's panel of experts in March. here. It is a blow for rival drugmaker GSK (GSK.L), opens new tab which has not yet won approval for this population for its RSV vaccine. RSV is a common virus that can be deadly and is most dangerous for the very young and the elderly. U.S. drugmaker Pfizer and the UK's GSK are each banking on strong sales of their RSV shots, which they launched in the United States in 2023, as they both face generic competition for their top-selling medicines later this decade. Both companies hit hurdles in that effort. Sales of both shots were down significantly in the U.S., the biggest market for the pharma industry, during the second autumn vaccination season since the companies launched the shots there.
Reuters
25-03-2025
- Health
- Reuters
US FDA greenlights GSK's drug for UTIs in women and girls
March 25 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved GSK's (GSK.L), opens new tab drug for a common type of urinary tract infection (UTI) in women and adolescent girls, one of five new approvals the British drugmaker has been expecting this year. The antibiotic, branded as Blujepa, is approved for women aged 12 years and older to treat uncomplicated UTIs, which are bacterial infections affecting the lower urinary tract in otherwise healthy individuals. here. GSK plans to launch the drug in the U.S. in the second half of the year, and did not disclose details on pricing. GSK is banking on new drugs in its infectious diseases portfolio, including its recently launched respiratory syncytial virus vaccine, to make up for lost revenues from its best-selling medicines and looming patent losses for its HIV treatments. Over half of all women will experience uncomplicated UTIs in their lifetime, and around 30% will suffer at least one recurrent episode, according to GSK. The drug chemically known as gepotidacin is designed to target the most common UTI-causing bacteria such as E. coli, the company said. The drug acts on a different part of the bacteria compared to most other antibiotics, making it effective against organisms resistant to current treatments, according to GSK. The bacteria is also less likely to develop resistance to the drug, as it would need to mutate in both the enzymes that gepotidacin targets, according to GSK. Antimicrobial resistance, where bacteria withstand the drugs designed to kill them, results in over 2.8 million infections annually in the United States, according to the CDC. The approval was based on data from two late-stage trials showing the drug was superior to nitrofurantoin, the standard-of-care medication introduced in the 1950s. In one of GSK's studies, gepotidacin achieved complete disease resolution in 58.5% of patients compared with 43.6% for nitrofurantoin. The drug's development was partly funded by multiple U.S. government grants, GSK said. The FDA in October last year approved another oral antibiotic, Orlynvah, developed by Irish biotech firm Iterum Therapeutics, for the treatment of certain types of bacterial UTIs in adult women. GSK's chief scientific officer Tony Wood said on a call ahead of the FDA approval that the drug's method of action against the main type of bacteria causing UTIs made it competitive against Iterum's medicine. While GSK has not given a sales target for Blujepa, it has said it expects the medicine, along with two other medicines in development, Brexafemme and tebipenem, to generate peak year sales of more than 2 billion pounds ($2.59 billion). ($1 = 0.7721 pounds)
