Teva announces results from a study of treatment patterns of tardive dyskinesia
Teva (TEVA) Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced results from a study of treatment patterns among patients with tardive dyskinesia residing in long-term care facilities, highlighting a critical gap in TD diagnosis and treatment. Key results from the study revealed: Of the residents being treated with antipsychotic drugs, 5.6% had a diagnosis of extrapyramidal syndrome, – a broad term used to describe any drug-induced movement disorder with no wide-treating therapeutic option – while 1.1% had a specific diagnosis of TD. The most common comorbidities observed in residents on APDs at risk for TD included dementia, chronic pulmonary disease and congestive heart failure. Moderate or severe liver disease was observed in less than1% of residents on APDs. Less than half of patients diagnosed with TD residing in LTC settings received the standard of care treatment recommended by the American Psychiatric Association – a vesicular monoamine transporter 2 inhibitor. The majority were treated with a non-FDA approved treatment, primarily benztropine, and a quarter were not treated at all.
Confident Investing Starts Here:
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
21 minutes ago
- Yahoo
FDA approves first AI tool to predict breast cancer risk
The U.S. Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) tool to predict breast cancer risk. The authorization was confirmed by digital health tech company Clairity, the developer of Clairity Breast – a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram. In a press release, Clairity shared its plans to launch the AI platform across health systems through 2025. Ai Detects Ovarian Cancer Better Than Human Experts In New Study Most risk assessment models for breast cancer rely heavily on age and family history, according to Clairity. However, about 85% of cases occur in women who have no family history of breast cancer, likely stemming from genetic mutations that occur because of aging, health agencies report. Read On The Fox News App Traditional risk models have also been built on data from predominantly European Caucasian women, which Clairity said has not been "generalized well" to diverse backgrounds. The AI tool analyzes subtle images from a screening mammogram that correlate with breast cancer risk, then generates a "validated five-year risk score" and delivers it to healthcare providers, the company noted. Ai Detects Woman's Breast Cancer After Routine Screening Missed It: 'Deeply Grateful' Dr. Connie Lehman, Clairity founder and breast imaging specialist at Mass General Brigham, stressed the importance of mammograms in early cancer detection. "Now, advancements in AI and computer vision can uncover hidden clues in the mammograms – invisible to the human eye – to help predict future risk," she said in a press release. "By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere." Dr. Robert A. Smith, senior vice president of early cancer detection science at the American Cancer Society, also commented in a statement that personalized, risk-based screening is "critical to improving breast cancer outcomes, and AI tools offer us the best opportunity to fulfill that potential." "Clairity's FDA authorization is a turning point for more women to access the scientific advances of AI-driven cancer risk prediction," Larry Norton, founding scientific director of the Breast Cancer Research Foundation, wrote in another statement. "Breast cancer is rising, especially among younger women, yet most risk models often miss those who will develop the disease," he said. "Now we can ensure more women get the right care at the right time." More than 2.3 million women are diagnosed with breast cancer globally each year, including more than 370,000 in the U.S., despite "decades of progress," according to the Breast Cancer Research Foundation. Cases have particularly been on the rise among younger women under the age of 50. Click Here To Sign Up For Our Health Newsletter In a Tuesday appearance on "America's Newsroom," Fox News senior medical analyst Dr. Marc Siegel called Clairity's development "profound." "Just looking at a mammogram … sometimes [radiologists] will see things that aren't clear, they have to follow it over time," he said. "AI improves how focused and how predictive it is, [shown] very dramatically in studies." Siegel confirmed that radiologists across the country are generally in support of leveraging AI for cancer detection, especially in areas of the country that are "underserved" in terms of healthcare. For more Health articles, visit "In areas where you're relying on radiologists without special training, this is even more important," he said. "This is the wave of the future. AI is going to be part of the equation, but it's not going to take over."Original article source: FDA approves first AI tool to predict breast cancer risk
Fox News
an hour ago
- Fox News
Nonstick pans face potential ban in New York amid health concerns
Some lawmakers in New York state are looking to ban nonstick pans in the Empire State. Senate Bill S1767 would prohibit the manufacture, sale and use of cookware containing polytetrafluorethylene, which is commonly known as Teflon. Teflon is also a member of PFAS. These are known as "forever chemicals" because they take hundreds – or even thousands – of years to break down in the environment. The chemical coating is commonly used on cookware to make it "nonstick." The bill would ban Teflon cookware – including, but not limited to, pots, pans, skillets, grills, cooking utensils and cooking appliances. The Make America Healthy Again Commission, chaired by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., recently released a report assessing chronic diseases, particularly those suffered by children. In the MAHA report, PFAS are tied to a harmful impact on children's health. The report notes that "high levels of certain types of PFAS exposure [have] been associated with a variety of health effects, including immune suppression and changes in cholesterol in children." "It is also possible for very small amounts of PFAS to enter foods through food packaging, processing and cookware," writes the U.S. Food & Drug Administration (FDA) on its site. The FDA authorizes certain PFAS in cookware and food packaging. "Because exposure to some types of PFAS has been linked to serious health effects, we are working to better understand PFAS in foods," says the FDA. Steve Burns of the Cookware Sustainability Alliance, a nonprofit organization, told Fox News Digital his group has been meeting with many members of the New York state Senate and Assembly. "We've presented that the nonstick coating material used on cookware is the same exact material used to coat a pacemaker and has been approved for use on both products by the U.S. FDA for over 60 years." "The coating is a well-studied, completely stable and inert material that has been shown for decades to be safe, non-toxic and most importantly not water-soluble," he said. "Several other states are following the science for nonstick cookware, and we continue to encourage New York State lawmakers to do the same." In 2022, Australian researchers said that just one surface crack on a Teflon-coated pan could release around 9,100 plastic particles. "Given the fact [that] PFAS [are] a big concern, these Teflon microparticles in our food might be a health concern, [which] needs investigating because we don't know much about these emerging contaminants," University of Newcastle researcher Dr. Cheng Fang – one of the study's authors – said in a release from Flinders University. Fox News Digital reached out to the FDA for comment.
Yahoo
an hour ago
- Yahoo
Immix Biopharma Announces Primary Endpoint Met in positive NXC-201 Interim Results Presented at ASCO, Enabling Path to Best-in-Class Therapy for relapsed/refractory AL Amyloidosis
Immix Biopharma today presented results at ASCO from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201, meeting its primary endpoint. – NXC-201 met primary endpoint with a complete response (CR) rate of 70% (7/10 patients) – – No relapses recorded to-date; no safety signals identified – – Immix plans Biologics License Application (BLA) for FDA approval – – Results were presented by Heather Landau, MD, of Memorial Sloan Kettering Cancer Center – – KOL event to discuss significance Tuesday, June 3, 2025 3:00pm ET after ASCO presentation: – LOS ANGELES, CA, June 03, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. ('ImmixBio', 'Company', 'We' or 'Us' or 'IMMX'), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced meeting its primary endpoint of complete response (CR) rate for cell therapy NXC-201 at an oral presentation of interim results at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago, Illinois. The oral presentation summarized meeting its interim results endpoint in from the U.S. multi-site NEXICART-2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis with a data cutoff of April 11, 2025. A Key Opinion Leader (KOL) event to discuss the significance will be held Tuesday, June 3, 2025 3:00pm ET with live Q&A (register here to participate). 'Meeting primary endpoint at this interim data readout is a testament to the groundbreaking efficacy of NXC-201, as we work toward the first approval in the challenging indication of relapsed/refractory AL Amyloidosis,' said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, 'This inflection point further accelerates our progress toward BLA submission for FDA approval.' Immix's Phase 1/2 NEXICART-2 clinical trial is a U.S. multi-site, single-arm study to evaluate the efficacy and safety of NXC-201 in patients who are refractory to, or relapse on treatment for relapsed/refractory AL Amyloidosis. ASCO Presentation ResultsPrior to NXC-201 treatment, the median lines of therapy was 4 (range: 2-12). All patients had baseline relapsed/refractory AL Amyloidosis organ involvement. After NXC-201 treatment, all patients normalized pathological disease markers. Complete responses (CRs) were observed in 70% (7 out of 10) of patients treated with NXC-201. The remaining 3 patients are bone marrow minimum residual disease (MRD) negative (10-6), predicting future CR (Immix believes remaining three MRD negative (10-6) patients could be confirmed as CRs in the coming weeks and months). Downstream clinical improvement, including cardiac and renal organ responses, were recorded after CRs. There have been no relapses recorded to-date and no safety signals identified. No neurotoxicity has been observed. Only low-grade cytokine release syndrome has been observed. The ASCO presentation contains clinical data as of April 11, 2025. Current treatments typically result in a lower than 10% complete response (CR) rate in relapsed/refractory AL Amyloidosis according to Zanwar, et al 2024, indicating a high unmet medical need. KOL Event to Discuss NXC-201 ASCO Clinical Data PresentationA Key Opinion Leader (KOL) event with lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center, Shahzad Raza, MD of Cleveland Clinic and Jeffrey Zonder, MD of Karmanos Cancer Center will be held Tuesday, June 3, 2025 at 3:00 pm ET to discuss these results. Register here: About NEXICART-2NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy. About NXC-201NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a 'digital filter' that filters out non-specific activation. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. U.S. Phase 1/2 study NEXICART-2 is ongoing. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA. About AL AmyloidosisAL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that circulate in the blood, then build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread organ damage, including heart and renal failure, leading to high mortality rates. The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024. The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research. About Immix Biopharma, Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. NXC-201 is being evaluated in the U.S. multi-center study NEXICART-2 (NCT06097832). NXC-201 has demonstrated no neurotoxicity in AL Amyloidosis, supporting expansion into other serious diseases. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at and Forward Looking StatementsThis press release contains forward-looking statements regarding Immix Biopharma, Inc., its results of operations, prospects, future business plans and operations and the matters discussed above, including, but not limited to, the potential benefits of our product candidate CAR-T NXC-201 and the timing and results related clinical trials. These statements involve risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements also include, but are not limited to, our plans, objectives, expectations and intentions and other statements that contain words such as 'expects', 'contemplates', 'anticipates', 'plans', 'intends', 'believes', 'estimates', 'potential', and variations of such words or similar expressions that convey the uncertainty of future events or outcomes, or that do not relate to historical matters. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the further data from the ongoing Phase 1/2 clinical trials for CAR-T NXC-201 will not be favorably consistent with the data readouts to date, (ii) the risk that the Company may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (iii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iv) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the clinical trials for CAR-T NXC-201, or advance to the initiation of registration-enabling studies, for such product candidates as and when needed and (vii) those other risks disclosed in the section 'Risk Factors' included in the Company's Annual Report on Form 10-K filed with the SEC on March 25, 2025 and other periodic reports subsequently filed with the Securities and Exchange Commission. These reports are available at Immix Biopharma cautions that the foregoing list of important factors is not complete. Immix Biopharma cautions readers not to place undue reliance on any forward-looking statements. Immix Biopharma does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. ContactsMike MoyerLifeSci Advisorsmmoyer@ Company Contactirteam@
