Latest news with #SiddhiMahatole
Yahoo
22-05-2025
- Health
- Yahoo
GSK's asthma drug wins FDA approval to treat 'smoker's lung'
By Siddhi Mahatole and Sriparna Roy (Reuters) -The U.S. Food and Drug Administration has approved British drugmaker GSK's asthma drug to treat some patients with a chronic lung disease commonly known as "smoker's lung", the company said on Thursday. The approval expands the use of the drug, Nucala, as an add-on treatment for patients with a type of chronic obstructive pulmonary disease. Sanofi and Regeneron's blockbuster drug Dupixent and Verona Pharma's inhaled therapy Ohtuvayre are also approved for the condition, which affects the lungs, causing restricted airflow and breathing problems. GSK's Nucala is a monoclonal antibody that inhibits interleukin-5, which helps regulate eosinophils, a type of white blood cell that causes inflammation in the lungs when overproduced. The regulator had set a target action date of May 7 for its decision on the drug. The approval, however, came two weeks later. This is the latest instance where the drug regulator has missed its deadline after mass layoffs as part of a major overhaul of federal health agencies under Secretary of Health and Human Services Robert F. Kennedy Jr. The approval was based on a late-stage trial, in which patients treated with Nucala and an inhaled maintenance therapy for up to 104 weeks had significantly reduced exacerbations by 21% compared to placebo. "There's a very high burden when you have severe exacerbations and end up being hospitalized. The aim is to keep patients out of the hospital, keep them stable, and keep them at home," GSK's Chief Commercial Officer Luke Miels said ahead of the approval. Nucala recorded 1.78 billion pounds ($2.38 billion) in total sales last year. The disease commonly affects cigarette smokers but can also be caused by air pollution and related occupational hazards. It is the fourth leading cause of death worldwide, according to the World Health Organization.
USA Today
07-05-2025
- Business
- USA Today
WeightWatchers files for chapter 11 bankruptcy to cut debt
WeightWatchers files for chapter 11 bankruptcy to cut debt Show Caption Hide Caption Compounding pharmacies to halt semaglutide sales May 22 Come May 22, compounding pharmacies must stop making semaglutide injections, which serve as a more affordable generic alternative to Ozempic and Wegovy. This decision follows a judge's denial of the pharmacies' request to continue selling the formulation. Fox - 10 Phoenix WW International WW.O, formerly known as WeightWatchers, has filed for Chapter 11 bankruptcy protection on Tuesday in a bid to cut its debt after hugely popular obesity drugs upended its business model. Shares of the company, which once boasted of media mogul Oprah Winfrey as one of its top shareholders, slumped 40% in extended trading after announcing plans to file for bankruptcy as part of a reorganization plan with a group of its lenders. WeightWatchers began as weekly weight-loss support group meeting with 400 attendees, and quickly turned into a worldwide phenomena with millions of members across the globe. In case you missed it: WeightWatchers faces bankruptcy amid financial struggles and declining demand But the rising popularity of GLP-1 drugs such as Novo Nordisk's Wegovy and Eli Lilly's LLY.N Zepbound hit demand for its traditional weight-loss programs. It also acquired a telehealth provider to provide weight-loss drugs in 2023, but reported a loss of $345.7 million last year, while its subscription revenues fell 5.6% year-over-year. WW said the reorganization plan will eliminate $1.15 billion in debt from the company's balance sheet. The company has accumulated substantial debt of around $1.6 billion. The company has estimated assets and liabilities in the range of $1 billion to $10 billion, according to the Chapter 11 petition filed in Delaware bankruptcy court. After its rebranding to WW International in 2018, the company aimed to focus on overall wellness rather than just weight loss. The company's shares have slumped 60% since the Wall Street Journal first reported in April that the company was preparing to file for bankruptcy in the coming months. Reporting by Siddhi Mahatole, Abhinav Parmar and Christy Santhosh in Bengaluru, and Dietrich Knauth in New York; Editing by Sriraj Kalluvila and Leroy Leo
Yahoo
05-05-2025
- Health
- Yahoo
US FDA to convene expert panel for Capricor Therapeutics' DMD cell therapy
By Siddhi Mahatole (Reuters) -Capricor Therapeutics said on Monday the U.S. Food and Drug Administration (FDA) plans to convene a panel of outside experts before deciding on the company's cell therapy for a heart condition related to Duchenne muscular dystrophy (DMD). Shares of the drug developer fell nearly 15% to $10.11 in morning trade. The company is seeking full approval for its experimental cell therapy, deramiocel, as a potential treatment for patients diagnosed with Duchenne muscular dystrophy cardiomyopathy. "We believe today's share weakness is unwarranted," H.C. Wainwright analyst Joseph Pantginis said, adding the opportunity to present at the meeting is "likely to strengthen the therapy's petition". The heart muscle disease is a leading cause of death among patients with DMD, a condition characterized by progressive skeletal and heart muscle weakness. The FDA is set to decide on the therapy by August 31, although the official date for the advisory panel meeting is yet to be set. The mass firings at the FDA under Health and Human Services Secretary Robert F. Kennedy Jr. have sparked concerns about potential delays in the drug review process. However, the FDA Chief Martin Makary said last week there were no plans for major reorganization at the agency and that it will meet its targets for completing reviews of new drugs despite the layoffs. In March, the company said that the FDA had not indicated whether an advisory committee would be necessary but said that it had been actively preparing for one.
