
US FDA approves Nuvation Bio's lung cancer therapy
June 11 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it has approved Nuvation Bio's (NUVB.N), opens new tab therapy for patients with a type of lung cancer.
The once-daily oral drug, with brand name Ibtrozi, is approved to treat ROS1-positive non-small cell lung cancer (NSCLC).
NSCLC affects more than one million people globally, with about 2% having ROS1-positive disease, according to the company.
The drug, taletrectinib, belongs to a class of drugs known as ROS1 inhibitors.

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Daily Mail
an hour ago
- Daily Mail
EXCLUSIVE Tragic twist of fate that set Ananda Lewis and countless others on path of deadly alternative cancer treatments
A Covid-era rule may have played a role in the tragic death of former MTV star Ananda Lewis who lost a seven-year battle with breast cancer this week at age 52. Lewis - who rose to fame as a video jockey for MTV - revealed last year that she was unable to get a mastectomy during lockdown in 2020 because California hospitals deemed it a non-emergency. Your browser does not support iframes.


The Independent
an hour ago
- The Independent
Meet the vaccines skeptics that are now part of RFK Jr.'s vaccine approval committee
Health and Human Services Secretary Robert F. Kennedy, Jr., has announced new members of the Centers for Disease Control and Prevention's vaccine advisory panel. Earlier in the week, the secretary made waves when he purged all 17 former members, citing 'historical corruption at ACIP.' 'The most outrageous example of ACIP's malevolent malpractice has been its stubborn unwillingness to demand adequate safety trials before recommending new vaccines for our children,' he wrote in a post on X. In their place, Kennedy hand picked eight members, who he said were individuals 'committed to evidence-based medicine, gold-standard science, and common sense' and who wouldn't be 'ideological anti-vaxxers.' He noted that each of them have committed to 'demanding definitive safety and efficacy data before making any new vaccine recommendations' and that the committee would review safety and efficacy data for the current schedule. But, the moves have been concerning to experts, who noted that several members have been critical of vaccines. The fired panel members have said that their ousting signaled that scientific expertise was 'no longer of use' under Kennedy and that that decision would 'undermine public trust in the vaccine process,' in a time when vaccine hesitancy has led to the spread of measles and other disease. So, who are the new members Kennedy says will help to restore that trust? Here's what and who to know... Dr. Robert W. Malone Dr. Robert Malone is a former mRNA researcher who has been a close advisory to Kennedy. Kennedy said he has served in advisory roles for the U.S. Department of Health and Human Services and the Department of Defense. He earned a medical degree from Northwestern University in 1991 and has taught at the University of California at Davis and the University of Maryland. He runs a wellness institute and a popular blog, and has been active on social media and in various outlets. He rose to prominence during the pandemic, relaying conspiracy theories about the vaccines and Covid. He has promoted alternative treatments for the virus and measles. He's claimed that millions of Americans were hypnotized into taking the shots and suggested that the vaccines cause a form of AIDS. Malone said in a post on X that he will do his best "to serve with unbiased objectivity and rigor.' 'I have attended many, many ACIP meetings in the past on behalf of clients. I played a key role in enabling advanced development of the Merck Ebola vaccine. I have deep expertise and experience in influenza vaccines and vaccine manufacturing technology, and have spoken on this issue at the WHO by invitation,' he said. Dr. Martin Kulldorff Dr. Martin Kulldorff is a biostatistician and epidemiologist. He's a founding member of the D.C.-based Academy for Science and Freedom at the nonsectarian Christian Hillsdale College. The academy aims to 'combat the recent and widespread abuses of individual and academic freedom made in the name of science' and 'educate the American people about the 'free exchange of scientific ideas and the proper relationship between freedom and science in the pursuit of truth.' Formerly a professor at Harvard Medical School and Brigham and Women's Hospital, Kulldorf wrote in an op-ed that telling the 'truth' had gotten him fired. 'Bodily autonomy is not the only argument against Covid vaccine mandates. They are also unscientific and unethical,' wrote Kulldorff. On LinkedIn, he has said the National Institute of Health had failed Americans during the pandemic. Notably, he was a co-author of the Great Barrington Declaration, along with NIH head Jay Bhattacharya, which was an October 2020 letter maintaining that pandemic shutdowns were causing harm. He has posted on X in support of the positions of Kennedy, Bhattacharya, and new FDA Director of the Center for Biologics Evaluation and Research Dr. Vinay Prasad. Kennedy said Kulldorff has served on the Food and Drug Administration's Drug Safety and Risk Management Advisory Committee and the CDC's Vaccine Safety Subgroup of the Advisory Committee on Immunization Practices. He noted Kulldorff also developed widely used tools such as SaTScan and TreeScan for detecting disease outbreaks and vaccine adverse events, and said he was an advocate for 'evidence-based approaches to pandemic response.' On Thursday, Endpoints News reported that Kulldorff and Malone were paid hundreds of dollars an hour to be a part of cases challenging the safety and efficacy of drugmaker Merck's HPV and MMR shots. Malone confirmed he had done 'expert witness consultation.' A request for comment from Kulldorff was not immediately returned. Dr. Retsef Levi Dr. Retsef Levi is a professor at the MIT Sloan School of Management. He also serves as the faculty leader for Food Chain Supply Analytics. Prior to working at MIT, he spent nearly 12 years as an officer in the Intelligence Wing of the Israeli Defense Forces. An MIT bio page for Levi says he leads several industry-based collaborative research efforts with local hospitals and that he has been on contract to address risk related to 'economically motivated adulterations of food manufactured in global supply chains.' His pinned tweet claims that mRNA vaccines 'cause serious harm including death, especially among young people.' 'We have to stop giving them immediately!' he urged. 'From what I've seen so far, I think it's obvious that these mRNA vaccines should not be given to anybody young or healthy. It is also not at all clear to me that they should be given to anybody, based on the evidence,' he said in a new interview. 'I am honored with this opportunity and humbled by the responsibility,' he wrote. Vicky Pebsworth A registered nurse and a regional director for the National Association of Catholic Nurses, Vicky Pebsworth has been listed as a board member and volunteer director for the National Vaccine Information Center, a group previously described in The Washington Post as ' the oldest anti-vaccine advocacy group ' in the country. She earned a doctorate in public health and nursing from the University of Michigan. She has worked in the health care field in various capacities for more than 45 years. She is a former member of the FDA's Vaccine and Related Biological Products Advisory Committee and the National Vaccine Advisory Committee's 2009 H1N1 Vaccine Safety Risk Assessment Working Group and Vaccine Safety Working Group (Epidemiology and Implementation Subcommittees), according to Kennedy. 'Her son — her only child — experienced serious, long-term health problems following receipt of seven live virus and killed bacterial vaccines administered during his 15-month well-baby visit which sparked her interest in vaccine safety research and policymaking and chronic illness and disability in children,' a bio page for her says. But, there are others on the panel whose vaccine stances aren't as clear. Dr. Joseph R. Hibbeln Dr. Joseph Hibbeln has worked at the National Institutes of Health since the late 1990s. He formerly served as the Acting Chief of of the Section on Nutritional Neurosciences. He is also a psychiatrist and neuroscientist, with work focused on how nutrition affects the brain, including the potential benefits of seafood consumption during pregnancy. He attended the University of Chicago for his undergraduate degree and received his medical degrees from the University of Illinois at Chicago in 1988. He served his residency at UCLA in 1992. He serves as a Captain in the United States Public Health Service. Recently, he wrote to ask another LinkedIn user about their position regarding 'closing nearly all vaccine research' at the Department of Health and Human Services. Dr. Cody Meissner Dr. Cody Meissner is a former member of the committee and a professor of pediatrics at the Dartmouth Geisel School of Medicine. He is the Chief of Pediatric Infectious Diseases at Tufts Children's Hospital and has served as a member of the Human Health and Services (HHS) Tick-borne Diseases Working Group. He has been the principal investigator for numerous vaccine clinical trials and the HHS Chair of the Vaccine Injury Compensation Program. He's held an advisory role at the Food and Drug Administration. Florida Republican Governor Ron Santis has quoted him as saying that closing schools during the Covid pandemic had 'aggravated the issue of inequity in our society.' Dr. James Pagano Dr. James Pagano is an emergency medicine physician with more than 40 years of clinical experience. He also did his residency at UCLA. 'Dr. Pagano served on multiple hospital committees, including utilization review, critical care, and medical executive boards. He is strong advocate for evidence-based medicine,' Kennedy said. Dr. Michael A. Ross Dr. Michael Ross is a Virginia-based obstetrician and gynecologist who previously served on a CDC breast and cervical cancer advisory committee. He is described as a 'serial CEO and physician leader' in a bio page for Havencrest Capital Management, a private equity investment firm where he is an operating partner. He recently started a position as the chief medical officer for the Maryland-based AI start-up Manta Pharma. He is a clinical professor of obstetrics and gynecology at George Washington University and Virginia Commonwealth University. 'He has advised major professional organizations, including the American College of Obstetricians and Gynecologists, and contributed to federal advocacy efforts around women's health and preventive care. His continued service on biotech and healthcare boards reflects his commitment to advancing innovation in immunology, reproductive medicine, and public health,' Kennedy said.


The Independent
an hour ago
- The Independent
This could be the best time exercise for heart and lung health, scientists say
The best time to workout to boost your heart and lung health may be in the morning, researchers say. The reason may be linked to our circadian rhythms, or the body's natural 24-hour clock. The circadian clock helps to regulate certain functions, including the release of hormones and our core temperatures. That indicates that the time of day you're most active could impact how well you perform, Dr. Karyn Esser, the chair of the University of Florida College of Medicine's Department of Physiology and Aging, said, according to In older adults, 'more rhythmic activity behavior and earlier time of peak activity were associated with better cardiorespiratory fitness and walking energetics,' a group of international scientists said late last month. Walking energetics refers to how well the body utilizes energy when you're getting your steps in. Esser was the senior author of the findings published in the journal Medicine & Science in Sports & Exercise. It is important to note that every person has a chronotype, or a natural preference of the body for wakefulness and sleep at certain times of the day, according to The Sleep Foundation. Knowing your chronotype, and timing you activities accordingly, could significantly impact your health and fitness. To reach these conclusions, they examined the health data of 799 adults from the Study of Muscle, Mobility and Aging. The patients, who wore wrist accelerometers over a week to measure their physical activity, had an average age of 76 years. The patients also underwent cardiopulmonary exercise testing. The authors also found that working out at the same time each day was associated with better health outcomes. Still, more research is needed to understand this relationship. The Centers for Disease Control and Prevention recommends that adults get at least 150 minutes of moderate intensity physical activity a week, and two days of muscle-strengthening activity. That will help to reduce the risk of heart disease and stroke, as well as other negative health outcomes. Previous studies have also indicated that morning exercise was associated with a lower risk of cardiovascular disease. But, working out at other times of day also provide benefits. The American Heart Association says what you do may be more important than when you do it. 'While we are living longer, in general, we are not living healthier,' Esser told MedicalNewsToday. 'So it is important to find ways to help people maintain or improve their health while aging, [to] improve quality of life and diminish the impact of age-related chronic diseases.'