Latest news with #FoodandDrugAdministration-approved
Yahoo
09-07-2025
- Business
- Yahoo
Alvotech expands biosimilars capabilities with Ivers-Lee acquisition
Alvotech, a global biotech company, has announced the acquisition of Ivers-Lee Group, a Switzerland-based provider of assembly and packaging services for the pharmaceutical sector. This strategic move is set to enhance Alvotech's capacity in the assembly and packaging of biosimilar medicines. Founded in 1947 in Burgdorf, Switzerland, Ivers-Lee has established itself as a provider of high-quality packaging services. With a good manufacturing practice-licensed and Food and Drug Administration-approved site in Burgdorf and a strategic business unit in Lörrach, Germany, Ivers-Lee's capabilities will be integrated into Alvotech's Technical Operations division. This integration will include the assembly and packaging of auto-injectors, prefilled syringes, safety devices, and vials. Ivers-Lee's managing director Peter Schüpbach will continue in his role while also joining Alvotech's Technical Operations senior leadership team. Schüpbach said: 'Alvotech offers the Ivers-Lee Group financial strength and development opportunities in a growth market, that we as a founding family cannot offer. This change brings stability both for Ivers-Lee and its employees." Post-deal, Ivers-Lee will maintain its international customer base and continue to offer contract manufacturing services, including blister and stick-pack activities, clinical supplies, and QP services from its Lörrach unit. The expansion of Alvotech's operations is poised to strengthen its position in the global pharmaceutical market. Alvotech founder, chair, and CEO Robert Wessman said: "Ivers-Lee has been an Alvotech preferred partner in assembly and packaging for several years. We know and trust each other very well, having worked closely together. "As Alvotech prepares for the launch of three new biosimilars in 2025 and sales growth in global markets, the integration of Ivers-Lee into our Technical Operations, provides added flexibility and capacity to meet increased global demand for our biosimilars, maintaining the highest level of quality and service." "Alvotech expands biosimilars capabilities with Ivers-Lee acquisition" was originally created and published by Packaging Gateway, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Axios
03-07-2025
- Health
- Axios
Wearables take center stage in RFK Jr.'s personal health push
Health Secretary Robert F. Kennedy Jr. envisions Americans becoming healthier by using wearable health devices that track heart rates, blood sugar and other vitals — offering real-time feedback on how food affects their bodies. Why it matters: It's a buzzy component of a health care agenda that emphasizes self-empowerment — and self-responsibility — over relying on clinicians. But some doctors and ethicists say the push could backfire if the devices spit out faulty data or jeopardize the safety of sensitive, personal health data. Driving the news: Kennedy said he'd like to see every American using wearables within the next four years, while testifying before the House in late June. He later clarified in a statement to Axios that "they are not for everyone because of concerns like cost and personal privacy." Last month, Health and Human Services solicited applications for contractors to design a multimillion-dollar marketing campaign that will include"populariz[ing] technology like wearables as cool, modern tools for measuring diet impact and taking control of your health." The campaign won't be about wearables specifically, Kennedy later told Axios. Rather, HHS is looking for something focused on "inspiring Americans to stop eating ultra-processed foods and reclaim control of their health," he said. "This campaign will empower Americans to take personal responsibility for their health, including choosing what tools are right for them," he added. Zoom out: "Wearables" refer to a wide range of electronics that people wear on their bodies to monitor health metrics — or even aid in diagnosis. Food and Drug Administration-approved wearable medical devices are becoming increasingly common in patient care and provide valuable clinical data for both individual treatment and public health, says Andrew Brightman, a professor of engineering practice at Purdue University who researches biomedical ethics. The wearables umbrella also includes consumer products, like Oura Rings or Fitbits, that track health metrics but in most uses don't require government approval for safety and effectiveness. Between the lines: "Providing individuals with reliable, accurate, useful medical information is critically important to support health and well-being," Brightman says. "But the contrary is providing people with unreliable, inaccurate and confusing information, no matter how digitized or quantified or how sexy the tech looks to people and is fun to use," he says. "It can lead them to make poor choices about their health." For example, a tracker might conclude someone is in good health because they're getting plenty of sleep and exercising. That could give the user a false sense of security and lead them to delay a visit to the doctor. Supporting wearables is a good strategy to promote health and well-being — if it also comes with more resources and funding to bolster government oversight and regulation of the devices in the market, Brightman says. Expanding the use of wearables also increases health data risks. The main federal health privacy law, HIPAA, protects health data when it's used by a covered entity, like a provider or insurer. But when a consumer enters data into a health app or allows a wearable to track health metrics, their data isn't subject to HIPAA, says Lisa Pierce Reisz, a partner at law firm Epstein Becker Green. Companies have to honor the privacy policies they've created, but terms and conditions aren't standardized and can change — and few people stop to read those policies before allowing their data to be collected anyway. "We lose a lot of control of our data once we input it," Reisz says. "People think, 'Oh, it's just my steps,' or 'It's just my heart rate,' but it potentially is so much more when you look at location information, or if you start to add details about menstrual periods." That's sensitive information that, if leaked or exposed, could endanger people's safety or be used against them. The growing threat of cyberattacks also complicates the picture. Hackers could break into wearable device companies' systems and access troves of people's personal health data. "I am fully aware of the dangers mass data collection poses to personal freedoms, and I do not advise anyone to purchase a wearable that does not provide ironclad privacy protections," Kennedy said in his statement to Axios. What we're watching: Not everyone in Kennedy's core "Make America Healthy Again" base is on board with wearables, and some prominent supporters of his agenda are sounding the alarm about the data risks of the devices, The Bulwark reported.
Business Insider
16-06-2025
- Business
- Business Insider
Johnson & Johnson announces new results from Phase 2 RedirecTT-1 study
Johnson & Johnson announced new results from the Phase 2 RedirecTT-1 study evaluating the investigational combination of TALVEY, the first U.S. Food and Drug Administration-approved GPRC5D-directed bispecific antibody, and TECVAYLI, the first FDA-approved BCMA-directed bispecific antibody. The results show a high overall response rate with durability in patients with triple-class exposed relapsed/refractory multiple myeloma who have true extramedullary disease, EMD. EMD is defined as soft tissue/organ-associated plasmacytomas with no contact to bony structures as per International Myeloma Working Group criteria. RedirecTT-1 is the largest study dedicated to patients with EMD to date. These data were featured in a late-breaking oral presentation at the 2025 European Hematology Association Congress. Confident Investing Starts Here:
Business Journals
16-05-2025
- Business
- Business Journals
Charlottesville's Springbok Analytics signs New York Liberty as first WNBA client
A look at the imaging created by Springbok Athletics. Charlottesville's Springbok Analytics has added the New York Liberty to its growing pro sports clientele. It's the first WNBA franchise to sign with the startup. The addition comes after a full deployment with the inaugural Unrivaled basketball season, which ran from January to March. Springbok's Food and Drug Administration-approved imaging services, which use AI to turn 2D MRI scans into 3D interactive analyses, are used by teams across the NFL, NBA, MLB, NHL, Premier League and NCAA. The company's technology analyzes muscle and skeletal structures, providing detailed 3D visualizations and metrics, including muscle volume, composition and fat infiltration. Its technology was invented at the University of Virginia by a team of researchers including Dr. Silvia Blemker, a biomedical engineer at the university and a Springbok co-founder. Springbok Analytics is a former participant of NBA Launchpad participant, the league's initiative to pilot emerging technologies, and has worked with three leagues for various studies: the NBA on knee health, the NFL on hamstring injuries and Major League Baseball on pitcher health. Earlier this year, the company closed a $5 million Series A round that was led by Chicago's Transition Equity Partners and included participation from the NBA, Charlottesville's CAV Angels and Green Bay, Wisconsin's Titletown Tech, among many others. Transition, CAV Angels and Titletown also participated in the company's $3 million seed round in 2023.
Yahoo
15-04-2025
- Health
- Yahoo
RFK Jr. claims 'leaky' measles vaccine wanes over time. Scientists say he's wrong.
Health and Human Services Secretary Robert F. Kennedy Jr. said the measles vaccine is "leaky" because its effectiveness wanes over time, something medical experts dispute. Kennedy, a vaccine skeptic who now oversees the nation's federal health agencies, said the Centers for Disease Control and Prevention is doing a "very good job" of controlling the measles outbreak that has infected more than 700 Americans in 25 states as of April 10. But Kennedy suggested the vaccine effectiveness wanes at a rate of nearly 5% a year – an assertion not backed by scientists. "People get measles because they don't vaccinate," Kennedy said Tuesday during a press conference. "They get measles because the vaccine wanes. The vaccines wane about 4.8% per year ... So, you know, it's a leaky vaccine, and that problem is always going to be around." Kennedy's remarks came during a press event Tuesday with Indiana Gov. Mike Braun and Centers for Medicare & Medicaid Services Administrator Mehmet Oz. The event, titled Make Indiana Healthy Again, touted steps the state was taking to improve health. During a question and answer session with reporters, Kennedy said the doctors need to know how to treat measles, including its attacks on the lungs and body. Measles does not have any Food and Drug Administration-approved treatments, just the vaccine to prevent the disease. "We can't rely simply on the vaccine," Kennedy said. "We also have to know how to treat measles." In case you missed: RFK Jr., West Virginia's governor and why you shouldn't comment on someone's weight Scientists disputed Kennedy's claim that the measles vaccine's effectiveness wanes over time. "He's dead wrong," said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia. "The measles vaccine protects you for the rest of your life. The notion that it's a leaky vaccine is dead wrong." Offit said people who received one dose of the measles vaccine between 1968 and 1989 or two doses of the vaccine since then have lifelong immunity to the highly-infectious disease. He said the vaccine stimulates memory cells, which confer lifelong immunity. Measles was eliminated in the U.S. by 2000 but has resurfaced with periodic outbreaks, mostly among people who are not vaccinated. In the current outbreak, 97% of measles cases occurred in unvaccinated patients or those whose vaccination status is unknown, according to the CDC. Did you see? What experts need you to know about the MMR vaccine The CDC confirmed 712 cases as of Friday but Offit said there are likely far more cases because the disease spreads rapidly among unvaccinated populations. The current outbreak has spread rapidly in a Mennonite community in Texas, and people within the community might be reluctant to seek medical help, Offit said. "I've had more than one public health official, including people on the ground, who said this could be between 3,000 and 5,000 cases," Offit said. "This is the worst measles epidemic we've had in 30 years." This article originally appeared on USA TODAY: RFK Jr. claims measles vaccine is leaky. Experts disagree.
