Latest news with #RocheDiagnostics
WebMD
16-05-2025
- Health
- WebMD
FDA OKs New Treatment for Hard-to-Treat Lung Cancer
May 16, 2025 – The FDA has granted fast-track approval to a first-of-its-kind treatment for a type of advanced lung cancer. The treatment, which is known as telisotuzumab vedotin but sold as Emrelis, is for adults with non-squamous non-small-cell lung cancer (NSCLC) that makes too much of a protein called c-Met and who have received prior therapy. By targeting NSCLC tumors that overproduce c-Met, Emrelis offers a more personalized treatment option based on patients' unique cancer markers, particularly for those who no longer respond to standard therapy. The FDA has also approved a lab test made by Roche Diagnostics to detect high levels of c-Met protein to see if a patient may benefit from Emrelis. Lung cancer is the leading cause of cancer-related deaths, with NSCLC accounting for about 85% of cases. About 25% of people with advanced NSCLC overproduce c-Met, which makes the cancer more aggressive and harder to treat. Emrelis was approved based on a clinical trial that tested how well it worked in 84 previously treated patients with NSCLC whose tumors overproduced c-Met. Results showed that 35% of patients responded to the new treatment, which lasted 7.2 months, on average Continued approval for this use will depend on confirmation of the treatment's benefits in future clinical trials, according to AbbVie, the maker of Emrelis. A global trial is also under way to test Emrelis alone for the same condition. Emrelis is part of a class of medicines called antibody-drug conjugates (ADCs), which are designed to target cancer cells while leaving healthy cells alone. It combines a monoclonal antibody called telisotuzumab, which homes in on a protein called c-Met, with a cancer-fighting drug called monomethyl auristatin E (MMAE). Emrelis attaches to cancer cells that produce too much c-Met and delivers MMAE directly inside them, where it blocks cell division and stops the cancer from growing. The medicine will be given as IV infusion every two weeks, for as long as the treatment works and the side effects are tolerable. "People with c-Met overexpressing NSCLC have poor prognosis and limited treatment options, and Emrelis is a first-in-class ADC that can address a critical unmet need for this patient population," Jonathan Goldman, MD, a professor of medicine and director of thoracic oncology clinical trials at the University of California, Los Angeles, said in a statement. The most common side effects of Emrelis include nerve problems in the hands and feet, fatigue, loss of appetite, swelling in the arms or legs, infusion-related reactions, and changes in blood test results, such as elevated liver enzymes or low levels of hemoglobin, sodium, phosphorus, calcium, and white blood cells. Before starting Emrelis, patients should tell their doctor about their medical history, especially if they have nerve issues, lung or breathing problems (other than lung cancer), eye problems, or liver disease. Emrelis can harm an unborn baby, so women who are pregnant or planning to become pregnant should tell their doctor. Women who can become pregnant should take a pregnancy test before starting treatment and use birth control during treatment and for two months after the last dose. Men with partners who can become pregnant should also use birth control during treatment and for four months afterward. Patients should not breastfeed while taking Emrelis and for a month after the final dose, as it's unknown whether the drug passes into breast milk. It's also important to tell the doctor about any medications, supplements, or vitamins being taken, as some may increase the risk of side effects when combined with Emrelis. Patients should contact their doctor right away if they have numbness, muscle weakness, a hard time walking, trouble breathing, wheezing, chest discomfort, fever or chills, blurred vision, eye pain or swelling, itching, a rash, or headaches.
Newsweek
16-05-2025
- Business
- Newsweek
The New Era of Life Sciences: The Future is Now
When we published our 2024 report, children suffering from Leber Congenital Amaurosis 4 (LCA4)—a severe inherited retinal dystrophy—had only hope that one day they might see the world. Today, thanks to an investigational gene therapy, we know that the 11 children who participated in the trials can, for the first time in their lives, discern a toy, recognize a human face and even spot a grain of sand. The biotech behind this achievement is MeiraGTx, which has now filed its therapy for approval under exceptional circumstances in the U.K., which would expedite the process. Stories like that of MeiraGTx illustrate the transformative power of gene therapies on patients. More broadly, they highlight the potential for rare diseases R&D to emerge as the principal driver of therapeutic innovation. "Rare diseases have become a critical area for exploring new treatment modalities because, in many cases, there is no existing therapy, or even a model. For patients who have no options, innovative approaches are important," shares Marc Dunoyer, the CEO of Alexion, the rare diseases subsidiary of AstraZeneca. Ironically, the very severity and uncommonness of these illnesses can also be a blessing, as it allows for bolder approaches by both researchers and regulators. Moreover, rare disease drugs have historically had higher approval success rates compared to other drugs. The Tufts Center for the Study of Drug Development found that orphan-designated drugs had a Phase-1-to-approval success rate of 17 percent, compared to 7.9 percent for non-orphan drugs. Benefiting from faster approval pathways and enhanced regulatory incentives, entrepreneurs in the field face better odds of innovating successfully. And when they do, the implications of their therapies go far beyond their original target. "Many of the advances seen today, such as gene editing and RNA-based therapies, originated in rare disease research before moving into larger indications," says Dunoyer. Arcturus Therapeutics, for instance, is addressing cystic fibrosis via a new delivery mechanism. "Our cystic fibrosis program is a prime example, where the ability to inhale mRNA safely could have a huge impact on the pharmaceutical industry. The rare disease field offers a shorter regulatory pathway to approval and a higher likelihood of success. This makes it an attractive space for evaluating next-generation technologies like mRNA therapeutics," shares Arcturus' CEO, Joseph Payne, as the company is expecting results from their Phase 2 trials in 2025. Matt Sause, CEO, Roche Diagnostics. Credit: Courtesy of Roche Diagnostics. Matt Sause, CEO, Roche Diagnostics. Credit: Courtesy of Roche Diagnostics. We can perform comprehensive genomic profiling to uncover the molecular basis of a tumor. This allows doctors to provide tailored treatments. Over time, this will enable us to move to a future where we understand the molecular drivers for cancer and can deliver truly personalized healthcare. Jacob Thaysen, CEO, Illumina. Credit: Courtesy of Illumina. Jacob Thaysen, CEO, Illumina. Credit: Courtesy of Illumina. Whether it is providing clarity for families dealing with rare genetic disorders or enabling rapid and precise cancer diagnoses, our goal is to ensure patients receive the answers they need when they need them. This report has been paid for by a third party. The views and opinions expressed are not those of Newsweek and are not an endorsement of the products, services or persons mentioned. Click here to download the full report
Indianapolis Star
12-05-2025
- Business
- Indianapolis Star
Roche will put $550 million facility for glucose monitors in Indianapolis, adding 650 jobs
Roche Diagnostics will invest $550 million in its Indianapolis base to construct a new manufacturing facility for glucose monitoring devices, which will add several hundred jobs and further solidify the company's footprint and presence in Indiana. Swiss-based Roche will refurbish an existing building at its North American Headquarters located along I-69 on the border of Fishers and Marion County. The building will be completed in phases by 2030 and house technology to manufacture continuous glucose monitoring devices, the company announced May 12. If the company decides it needs more space for the operations, it could construct additional buildings. Some 650 high-skill jobs are expected to be added in Indianapolis because of the investment. Roche employs nearly 5,000 people in the Indianapolis area, where the company has had strong roots since the 1960s when Roche established its diagnostics arm. "Indianapolis was a natural choice when we sought a location for this newest investment," said Richeal Cline, Roche head of global operations. "This location has strong manufacturing capabilities and a longstanding history of producing diabetes care products for Roche." The investment is part of a larger $50 billion investment in U.S. manufacturing that Roche announced last month to strengthen the biotech behemoth's production capacity. Eventually Roche plans to export more medicines from the United States than it imports into the country. Roche is the latest pharmaceutical company to take steps to increase drug and medical device production in the United States amid President Donald Trump's ongoing tariff war. On May 12, Roche also announced a $700 million facility in North Carolina to build the next generation of weight-loss medications. Roche executives believe the company is better off than other drugmakers as it has been increasing production in the United States for years. Roche can significantly increase U.S. manufacturing output "overnight," CEO Thomas Schinecker said in an April earnings call. Roche's Indianapolis campus has established itself as a hub for glucose monitors and diabetes research. The site produces approximately 5.2 billion Accu-Chek diabetes test strips each year and serves as one of Roche's two global distribution hubs, helping make Indiana the largest state for advanced manufacturing in the country. Continuous glucose monitors, or CGMs, are wearable devices that record sugar levels just under the skin for 24 hours a day. More than 38 million Americans live with diabetes, a hard disease to manage given its unpredictability, Roche officials said. The investment will help with rising global demand for CGMs and improve diabetes management for millions, President and CEO of Roche Diagnostics Brad Moore said. In choosing to build the facility in Indianapolis, Roche will receive a 10-year tax abatement from the city worth $40 million in addition to a state tax incentive package worth $20 million. Roche will also spend $2 million on community investments. State Secretary of Commerce David Adams said the creation of several hundred in-demand jobs resulted in a generous tax credit package for Roche. When offering incentive packages, the state wants to help companies keep talented employees in Indiana while attracting others to the state who want to work in a strong biotech hub. "We also want to be able to track down talent from around the country as they see the life sciences ecosystem here as a destination location," Adams said. Roche responds to tariffs: As potential tariffs loom, Roche in 'much better' position than competitors, CEO says Since 2012, Roche has poured $450 million into the Indianapolis campus and increased operational space and warehouse capacity by 37%. Roche's $50 billion investment includes several other facilities across the country, including:
Associated Press
12-05-2025
- Business
- Associated Press
Roche announces $550 million investment to expand its Indianapolis diagnostics manufacturing hub
INDIANAPOLIS, May 12, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it plans to invest up to $550 million in its Diagnostics site in Indianapolis by 2030. The site will become a major hub for the manufacturing of Roche's continuous glucose monitoring (CGM) systems – marking a new milestone in Roche's long history of revolutionizing healthcare across the globe. Indianapolis serves as the North American headquarters for Roche Diagnostics, part of the Roche Group – the world's largest biotech company. This latest expansion underscores Roche's commitment to advancing science, driving innovation, and delivering cutting-edge solutions that improve patient outcomes. With more than 38 million Americans living with diabetes,¹ access to effective disease management solutions is crucial. To address this growing need, Roche is investing in a new CGM manufacturing facility in Indianapolis. CGM technologies offer essential support for daily diabetes management, and this investment will help advance Roche's mission to improve patient care through innovation. 'The challenges of diabetes are pervasive, with millions of Americans living with the constant vigilance and countless daily decisions the disease requires,' said Brad Moore, President and CEO of Roche Diagnostics North America. 'By expanding our manufacturing capabilities in Indianapolis, we ensure reliable access to innovative monitoring solutions for individuals living with diabetes in the U.S. and worldwide.' The Indianapolis campus houses key operations, including U.S. research and development, laboratories, manufacturing, distribution, IT and administrative functions. It currently produces approximately 5.2 billion Accu-Chek® diabetes test strips annually and serves as one of two global distribution hubs focused on serving the U.S. market and supporting distribution to 53 countries worldwide. Building on more than $800 million in U.S. investments made at Roche U.S. sites since 2015, this new commitment reinforces Roche's longterm dedication to U.S. operations and highlights the country's central role in the company's global strategy. The expansion is expected to generate hundreds of highly-skilled manufacturing jobs and thousands of construction jobs, providing a significant boost to Indiana's economy. It will also enhance domestic production capabilities and reduce dependency on imports – aligning with national efforts to strengthen local manufacturing. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. References 1. American Diabetes Association, Statistics About Diabetes. Accessed March 26, 2025. For Further Information Roche Diagnostics U.S. Media Relations [email protected] Jen Dial 1-463-867-0232 [email protected] View original content to download multimedia: SOURCE Roche Diagnostics
Yahoo
12-05-2025
- Business
- Yahoo
Roche announces $550 million investment to expand its Indianapolis diagnostics manufacturing hub
An investment of up to $550 million by 2030 will establish the Indianapolis site as a hub for manufacturing of Roche's continuous glucose monitoring solution. Expansion will create hundreds of jobs while also enhancing U.S. production capabilities. Increased access to diabetes management tools will help improve health outcomes for patients in the U.S. and globally. INDIANAPOLIS, May 12, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it plans to invest up to $550 million in its Diagnostics site in Indianapolis by 2030. The site will become a major hub for the manufacturing of Roche's continuous glucose monitoring (CGM) systems – marking a new milestone in Roche's long history of revolutionizing healthcare across the globe. Indianapolis serves as the North American headquarters for Roche Diagnostics, part of the Roche Group – the world's largest biotech company. This latest expansion underscores Roche's commitment to advancing science, driving innovation, and delivering cutting-edge solutions that improve patient outcomes. With more than 38 million Americans living with diabetes,¹ access to effective disease management solutions is crucial. To address this growing need, Roche is investing in a new CGM manufacturing facility in Indianapolis. CGM technologies offer essential support for daily diabetes management, and this investment will help advance Roche's mission to improve patient care through innovation. "The challenges of diabetes are pervasive, with millions of Americans living with the constant vigilance and countless daily decisions the disease requires," said Brad Moore, President and CEO of Roche Diagnostics North America. "By expanding our manufacturing capabilities in Indianapolis, we ensure reliable access to innovative monitoring solutions for individuals living with diabetes in the U.S. and worldwide." The Indianapolis campus houses key operations, including U.S. research and development, laboratories, manufacturing, distribution, IT and administrative functions. It currently produces approximately 5.2 billion Accu-Chek® diabetes test strips annually and serves as one of two global distribution hubs focused on serving the U.S. market and supporting distribution to 53 countries worldwide. Building on more than $800 million in U.S. investments made at Roche U.S. sites since 2015, this new commitment reinforces Roche's longterm dedication to U.S. operations and highlights the country's central role in the company's global strategy. The expansion is expected to generate hundreds of highly-skilled manufacturing jobs and thousands of construction jobs, providing a significant boost to Indiana's economy. It will also enhance domestic production capabilities and reduce dependency on imports – aligning with national efforts to strengthen local manufacturing. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. References1. American Diabetes Association, Statistics About Diabetes. Accessed March 26, 2025. For Further Information Roche Diagnostics U.S. Media Jen View original content to download multimedia: SOURCE Roche Diagnostics Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
