Latest news with #MRK.N
Reuters
14-05-2025
- Health
- Reuters
US FDA expands use of Merck's cancer drug for adrenal gland tumors
May 14 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it has approved the expanded use of Merck's (MRK.N), opens new tab cancer drug to treat two types adrenal gland tumors. The drug, Welireg, became the first FDA-approved oral treatment for the two tumors — pheochromocytoma and paraganglioma. The regulator's approval was based on a study in which Welireg showed an objective response rate of 20.6%. ORR is the percentage of people who have a partial response or complete response to the treatment within a certain period of time.
Reuters
18-03-2025
- Business
- Reuters
Focus: Big pharma fears best-selling drugs in crosshairs of US-EU tariff spat
LONDON, March 18 (Reuters) - Drugmakers are urging the Trump administration and European Union officials to exclude medical goods from expanding tariff wars, hoping to avert price spikes on top-selling medicines made in Europe from Novo Nordisk's ( opens new tab Wegovy for weight loss to Merck's (MRK.N), opens new tab cancer immunotherapy Keytruda. In conversations with U.S. officials, the pharmaceutical industry argued that tariffs on the EU would increase drug costs and create access barriers for patients, endangering priorities outlined in President Donald Trump's health-related executive orders on drug pricing and increasing life expectancy of Americans, according to more than a half dozen pharma industry sources with direct knowledge of the discussions. here. Some are signalling a willingness to expand manufacturing in the United States, while pressing for tax breaks and regulatory changes that would make it easier to make that happen, according to three of the sources. "We are firmly delivering the message to the Trump administration and to the European Union that patients will pay the price" for tariffs, said a senior executive at a European drugmaker. Industry executives are also pressing their case with officials in Brussels, urging the EU hold off on retaliatory tariffs even if Trump includes medicines in a trade dispute, several of the sources said. Some raised the fact that lifesaving medicines were excluded from sanctions on Russia following its invasion of Ukraine. "We as Western countries have interconnected supply chains in this sector. Interrupting these flows will hurt patient access to lifesaving medicines," said a senior executive at another large European drugmaker. "It's a lose-lose" situation. Pharmaceutical products have long been spared from trade wars due to the potential harms. But Trump's move to increase tariffs on goods from China, including finished drugs and raw ingredients, as well as an initial round of tariffs between the U.S. and EU on goods like steel and bourbon, has raised expectations that medicines will join the list. The majority of medicinal supplies imported from China are of low monetary value. But the U.S. depends on medicines partly produced in Europe that bring in hundreds of billions of dollars in revenue. For example, Novo Nordisk partially makes some of the active pharmaceutical ingredient for obesity injection Wegovy in Denmark, while Merck's mega-blockbuster Keytruda and AbbVie's (ABBV.N), opens new tab wrinkle treatment Botox are made in Ireland. Novo Chief Executive Lars Fruergaard Jorgensen said this month that his company would experience short-term impacts from tariffs, but is moving to produce domestically more of its medicines sold in the U.S. The company last year announced a $4.1 billion investment to expand production in North Carolina. Merck declined to comment for this story. AbbVie declined to comment on where individual medicines are manufactured but said it has a robust manufacturing network globally. The U.S. government, a major buyer of drugs for its massive Medicare and Medicaid health programs, may face higher prices to account for the cost of tariffs, said Simon Baker, head of global biopharma research at Redburn Atlantic. Emily Field, head of European pharma equity research at Barclays, told Reuters that until very recently she thought tariffs on prescription drugs were not a serious threat. Now she is "getting asked about this nonstop by clients," she said. 'NOT BROKEN' Industry sources declined to say how the Trump administration has responded to its messages. The U.S. president has previously announced tariffs on trade partners only to subsequently suspend or delay them or allow exceptions. One source said it was impossible to know which of several trade policy philosophies would prevail in the White House. Trump last week called out Ireland for luring pharmaceutical companies with tax breaks, contributing to a "massive deficit." White House officials did not immediately respond to a request for comment. The European Commission declined to comment. The COVID-19 pandemic highlighted the dependency of the U.S. and EU on China and India for raw ingredients to make critical drugs and hospital supplies, as governments competed for materials used in vaccines and protective gear. Many large drugmakers have since sought to delink supply chains for the Western and Chinese markets. But the notion of separating production ties between Europe and the U.S. was not seriously considered, several of the sources said. Indianapolis-based Eli Lilly (LLY.N), opens new tab recently announced plans to spend at least $27 billion on four new manufacturing plants in the U.S., but many drugmakers would find it difficult to follow suit, several of the sources said. Building a new production facility in the U.S. can cost up to $2 billion and take 5 to 10 years before it is operational, including time and costs related to fulfilling regulatory requirements, according to industry trade group PhRMA. A senior executive from one of the European drugmakers said creating a wholly U.S.-based manufacturing process would mean diverting funds from researching future medicines, and amounts to "fixing something that is not broken."
Reuters
07-02-2025
- Health
- Reuters
Health Rounds: Vaccine keeps advanced kidney cancer from recurring
Feb 7 (Reuters) - Patients with advanced kidney cancer who received an experimental vaccine after their tumors were removed were still cancer-free years later in a small early-stage trial, researchers reported in Nature, opens new tab. These were patients "where you know the risk of the cancer coming back is very high," said Dr. Toni Choueiri of Dana-Farber Cancer Institute in Boston, who helped lead the study. "And after a median follow up of almost four years, none of the nine vaccinated patients has experienced a recurrence from their kidney cancer." Standard treatment for stage III or stage IV clear cell renal cell carcinoma is surgery followed by immunotherapy with Merck's (MRK.N), opens new tab Keytruda. In most patients, however, the cancer recurs, typically within three years, and there are no good treatments at that point. The new vaccine is "personalized," meaning it is designed to train the patient's immune system to recognize and eliminate any remaining cells of that person's cancer. Using tumor samples removed during surgery, the researchers identified neoantigens, which are tiny fragments of mutant proteins that exist in the cancer but not in any other cells in the body. Then they determined which of these neoantigens to include in the vaccine based on the likelihood that the immune system would respond strongly to them. "We pick targets that are unique to the cancer and different from any normal part of the body, so the immune system can be effectively 'steered' towards the cancer in a very specific way," study co-author Dr. David Braun of Yale School of Medicine in New Haven, Connecticut said in a statement. Working with Merck, the researchers are now testing a similar kidney cancer vaccine in a randomized trial with 272 patients. In the meantime, Choueiri said, "We're very excited about these results." AT-HOME URINE TEST SCREENS FOR PROSTATE CANCER A simple at-home urine test is highly accurate at screening for prostate cancer, according to researchers. Traditional prostate cancer screening starts with a blood test to measure levels of prostate-specific antigen (PSA), a protein produced by the prostate gland. But the results are frequently unreliable, often leading to biopsies that turn out to have been unnecessary because no cancer was present. The new test, which analyzes 18 genes associated with prostate cancer, "is highly accurate for ruling out the presence of clinically significant prostate cancers - those that merit treatment - so that patients with a negative test result can confidently avoid having to undergo MRI or biopsy," study leader Dr. Jeffrey Tosoian of Vanderbilt University Medical Center in Nashville, Tennessee, said in a statement. Tosoian and colleagues had previously validated the urine test in men who also underwent digital rectal exams to detect prostate cancer. The new study found the test - MyProstateScore 2.0, from biotechnology startup Lynx Dx of Ann Arbor, Michigan - was just as accurate on its own, they reported in The Journal of Urology, opens new tab. "Rectal exams are no fun," Tosoian said. "These findings will increase the impact of the (urine) test, as it can now be used for at-home testing." In the study of 266 men, including 103 with at least grade group 2, or moderately aggressive, prostate cancer, the noninvasive urine test "would have allowed patients with an elevated PSA to avoid 34-53% of unnecessary biopsies," Tosoian said. If the test is eventually proven to be similarly accurate in patients being monitored for progression of low-risk prostate cancers, it could potentially "eliminate or reduce the need for prostate biopsies during active surveillance," Tosoian said. CONTACT LENSES KEEP NEARSIGHTEDNESS FROM WORSENING IN KIDS Nearsighted children and teens who wear bifocal contact lenses to prevent their vision impairment from worsening do not lose the benefits of the treatment once they stop wearing the lenses, according to new research. Normally, eye length grows quickly in early childhood, then slows down until it stops around age 12. In myopia, or near-sightedness, the eye's axial length grows too quickly and can continue to grow into the late teens. Slowing this elongation can control myopia. In an attempt to keep their nearsighted eyes from growing too much, the 235 youngsters in the study, ages 11 to 17, wore soft multifocal contact lenses with a high level of correction for near vision for two years. The lenses significantly curbed abnormal lengthening of the eyes, and slowed or prevented worsening of the children's near-sightedness. But the researchers wondered whether discontinuing the treatment might cause a rebound of faster-than-normal eye growth that would wipe out the benefit. During a third year when the children switched to wearing single-vision contact lenses, the researchers saw no evidence that the treatment effect declined, they reported in JAMA Ophthalmology, opens new tab. "You don't lose the benefits that you gain with this treatment," study leader Dr. Jeffrey Walline of the Ohio State University said in a statement. The treatment landscape for nearsighted children "is a burgeoning area," Walline said. "The standard of care has switched from providing kids with single-vision glasses or contact lenses to things that slow down the progression of myopia, or the growth of the eye," such as contact lenses or atropine eye drops. With regard to these new treatments, an editorial, opens new tab published with the study noted that "the fundamental question remains: will myopia control treatments in childhood decrease the lifetime risk of visual impairment from sequelae, such as retinal detachment and myopic macular degeneration?" "If so, then we will know that these interventions are truly impactful," it added.
