Latest news with #drugapproval
Wall Street Journal
4 days ago
- Business
- Wall Street Journal
AstraZeneca's Datroway Approved to Treat Non-Small Cell Lung Cancer in U.S.
AstraZeneca's AZN 0.27%increase; green up pointing triangle Datroway drug has been approved in the U.S. to treat adult patients with non-small cell lung cancer. The British pharmaceutical company said Tuesday that the drug has been approved for patients who have already received chemotherapy.
Reuters
18-06-2025
- Health
- Reuters
Lilly to appeal after UK agency opposes reimbursement for Alzheimer's drug
June 19 (Reuters) - Eli Lilly (LLY.N), opens new tab said on Thursday it would appeal against a UK agency's recommendation to not reimburse the cost of Alzheimer's drug Kisunla, blocking access for patients seeking treatment under the country's state-run health service. The U.S.-based drugmaker plans to appeal on the grounds that the National Institute for Health and Care Excellence's (NICE) recommendation was unreasonable based on the evidence the company, clinical experts and patient groups have submitted. Kisunla was approved in the UK last year to treat mild cognitive impairment and mild dementia caused by Alzheimer's disease. NICE, which determines the cost-effectiveness of treatments paid for by public funds, had at the time deemed Lilly's drug too expensive for wide use. Leqembi, a rival drug from Eisai (4523.T), opens new tab and Biogen (BIIB.O), opens new tab, was also deemed too costly for UK's state-run health service in August last year. NICE's reimbursement recommendation marks another hurdle for Lilly's drug, after the EU medicines regulator in March rejected Kisunla saying the treatment's ability to slow cognitive decline was not significant enough to outweigh the risk of serious brain swelling in patients. Both Kisunla and Leqembi are designed to clear sticky clumps of a protein called amyloid beta in the brain, believed to be a hallmark of Alzheimer's. They entered the market after decades of failed attempts to combat the mind-wasting disease. Adoption of the drugs has been slow in the United States due to the complexities involved with their use, such as the need for extra diagnostic tests and regular brain scans to monitor for potentially serious side effects.
Bloomberg
18-06-2025
- Health
- Bloomberg
Gilead's Twice-a-Year HIV Prevention Shot Wins FDA Approval
By Updated on Save Gilead Sciences Inc. said it won US approval for a drug to prevent HIV that only has to be given twice a year, making it a convenient new way to ward off infection in a wide range of people. In two big international studies published last year, the medicine demonstrated a powerful ability to avert HIV infection. With no vaccine on the horizon, the ultra-long acting shot has been hailed by activists as perhaps the best tool the world has so far to wipe out the virus.
Washington Post
17-06-2025
- Health
- Washington Post
FDA to offer faster drug reviews to companies promoting 'national priorities'
WASHINGTON — U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting 'the health interests of Americans,' under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases . Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to 'challenge assumptions' and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct 'rapid or instant reviews,' pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed. For the new program, the FDA will issue a limited number of 'national priority vouchers' to companies 'aligned with U.S. national priorities,' the agency said in a statement. The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance. Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews. Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews. 'The ultimate goal is to bring more cures and meaningful treatments to the American public,' Makary said in a statement. Makary previously said the FDA should be willing to ease its scientific requirements for certain drugs, for instance, by not always requiring randomized studies in which patients are tracked over time to track safety and effectiveness. Such trials are generally considered the gold standard of medical research, though the FDA has increasingly been willing to accept smaller, less-definitive studies for rare or life-threatening diseases . In several recent cases , the FDA has faced criticism for approving drugs based on preliminary data that didn't ultimately show benefits for patients. The push to rapidly accelerated drug approvals is the opposite approach that Makary and his boss, Health Secretary Robert F. Kennedy Jr. , have taken on vaccines. Promising a 'return to gold-standard science,' Kennedy previously announced that all new vaccines would have to be compared to placebo, or a dummy shot, to win approval. Kennedy and Makary also have announced a stricter policy on seasonal updates to COVID-19 shots, saying they will have to undergo new testing before they can be approved for use in healthy children and most adults. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
The Independent
17-06-2025
- Health
- The Independent
FDA to offer faster drug reviews to companies promoting 'national priorities'
U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting 'the health interests of Americans,' under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA 's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to 'challenge assumptions' and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct 'rapid or instant reviews," pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed. For the new program, the FDA will issue a limited number of 'national priority vouchers' to companies 'aligned with U.S. national priorities,' the agency said in a statement. The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance. Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews. Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews. "The ultimate goal is to bring more cures and meaningful treatments to the American public,' Makary said in a statement. Makary previously said the FDA should be willing to ease its scientific requirements for certain drugs, for instance, by not always requiring randomized studies in which patients are tracked over time to track safety and effectiveness. Such trials are generally considered the gold standard of medical research, though the FDA has increasingly been willing to accept smaller, less-definitive studies for rare or life-threatening diseases. In several recent cases, the FDA has faced criticism for approving drugs based on preliminary data that didn't ultimately show benefits for patients. The push to rapidly accelerated drug approvals is the opposite approach that Makary and his boss, Health Secretary Robert F. Kennedy Jr., have taken on vaccines. Promising a 'return to gold-standard science,' Kennedy previously announced that all new vaccines would have to be compared to placebo, or a dummy shot, to win approval. Kennedy and Makary also have announced a stricter policy on seasonal updates to COVID-19 shots, saying they will have to undergo new testing before they can be approved for use in healthy children and most adults. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
