Latest news with #clinicalstudy
Yahoo
4 days ago
- Health
- Yahoo
Satsuma Pharmaceuticals and SNBL Announce Four Abstracts to be Presented at the American Headache Society's 67th Annual Scientific Meeting
DURHAM, N.C., June 19, 2025 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and other debilitating conditions, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced that four abstracts describing efficacy and safety results from Satsuma's Phase 3 clinical study program were selected for presentation at the American Headache Society's (AHS) 67th Annual Scientific Meeting. The 2025 meeting will be held at the Minneapolis Convention Center Minneapolis, MN, from Thursday, June 19 to Sunday, June 22, 2025, including the option of participants attending virtually. Full abstracts are now available on the AHS website and will be published in the journal Headache®. Poster Presentation Details: Title: DHE Plasma Concentration and Clinical Response Relationship – An In-Office PK-PD Study Presenter: Detlef Albrecht, MD Poster: P-305 Date: Friday, June 20, 2025 Time: 5:00 PM – 6:15 PM CT (6:00 PM – 7:15 PM ET) Title: Strong CYP3A4 Inhibitor Itraconazole Does Not Cause Clinically Relevant Interactions with STS101 (Nasal Dihydroergotamine Powder) Presenter: Detlef Albrecht, MD Poster: P-307 Date: Friday, June 20, 2025 Time: 5:00 PM – 6:15 PM CT (6:00 PM – 7:15 PM ET) Title: STS101 Use Reduces Migraine Frequency Over Time Presenter: Stewart Tepper, MD Poster: P-309 Date: Friday, June 20, 2025 Time: 5:00 PM – 6:15 PM CT (6:00 PM – 7:15 PM ET) Title: STS101 (Dihydroergotamine Nasal Powder) Shows Benefit on the Resolution of Cardinal Migraine Symptoms Photophobia, Phonophobia, and Nausea: Results from the Long-Term Phase 3 Open-Label ASCEND Study Presenter: Amaal J. Starling, MD Poster: P-310 Date: Thursday, June 19, 2025 Time: 6:00 PM – 7:30 PM CT (7:00 PM – 8:30 PM ET) About Satsuma and STS101 Satsuma Pharmaceuticals, a wholly owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), is a late-stage biopharmaceutical company that recently received regulatory approval from the U.S. Food and Drug Administration for STS101, with the approved name Atzumi™ (Dihydroergotamine) nasal powder. For more information, please visit Satsuma is headquartered in Research Triangle Park, North Carolina. About SNBL Shin Nippon Biomedical Laboratories, Ltd. ("SNBL") (TSE:2395) is a listed nonclinical contract research organization (CRO) that was founded in Kagoshima, Japan, in 1957. Based on its corporate philosophy of "Committed to the environment, life, and people", and with a proven track record of accomplishment as the oldest and most established Japanese nonclinical CRO, SNBL is proud to offer a comprehensive portfolio of services and solutions for drug discovery and development for pharmaceutical companies, biotech ventures, universities, and research institutions both in Japan and overseas. The SNBL's Translational Research business engages in drug discovery, with the focus on business development and out-licensing of its proprietary intranasal drug delivery technologies and intranasal devices. For further information, please visit Cautionary Note on Forward-Looking Statements Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding SNBL's future business, future position and results of operations, including estimates, forecasts, targets and plans for SNBL. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding SNBL's business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of product candidates; the impact of health crises such as the coronavirus pandemic on SNBL and its clients and suppliers, including foreign governments in countries in which SNBL operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to SNBL's operations and the timing of any such divestment(s); and other factors identified in SNBL's most recent securities report ("YukaShoken Houkokusho") and SNBL's other reports filed with the Financial Services Agency, available on SNBL's website at: or at SNBL does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or related stock exchange rule. Past performance is not an indicator of future results and the results or statements of SNBL in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of SNBL's future results. Medical information This press release contains information about product candidates that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Inquiries:Satsuma Pharmaceuticals, Inc.E-mail: info@ View original content to download multimedia: SOURCE Satsuma Pharmaceuticals, Inc. 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
Yahoo
6 days ago
- Health
- Yahoo
SEEKING DOGS WITH EXTREME FEAR OF THUNDERSTORMS FOR VETERINARY STUDY IN FLORIDA
Multiple Clinics Participating in Study Evaluating an Investigational Medication With the Goal of Achieving the Medication's Approval by FDA RALEIGH, N.C., June 17, 2025 /PRNewswire/ -- Dog owners in Florida—the storm capital of the U.S—now have the opportunity to have their dogs screened for possible inclusion in a clinical study evaluating a potential treatment for severe thunderstorm aversion. The study is evaluating an investigational oral medication given twice-daily during storm season that could offer round-the-clock relief. Participation is free, and qualifying dogs receive all study-related care--including evaluations, diagnostic testing, exams, and medication (or placebo) at no cost. Marilyn Bonner says her dog was "skittish" of storms and loud noises when living in Pennsylvania, but upon moving to Florida, her Boxer developed intense anxiety. "Nothing prepared us for the thunderstorms in Florida. They're so intense and so frequent. As soon as one rolls in, she'll start panting and severely shaking. It's heartbreaking." Dogs With Thunderstorm Aversion Are Suffering Dogs with severe thunderstorm aversion often display their intense fear by hiding, cowering, destructiveness, trembling/shaking, self-harm, and more. Sadly, the fear may begin hours before a storm arrives, and in some cases, take days for dogs to recover. "During a thunderstorm, my dog never leaves my side; she's there shaking, drooling, and practically hyperventilating. There are times I've thought she was going to have a heart attack," says Jill Powers, of Southwest Florida. "I just feel so terrible for her." In a published study, nearly 50% of dog owners reported their dogs show fear when exposed to noises. What Dogs Can Participate?In order to be eligible, dogs must show signs of thunderstorm aversion, weigh at least 8.8 lbs., be in good general health, and meet certain other criteria. Interested dog owners can visit to see if there's a participating veterinary site nearby and complete a short pre-screening questionnaire. Take Action NowThe study only runs a few months during Florida's storm season, so pet owners interested in signing up their dogs should act quickly. Participation offers pet owners a chance to help their dogs, support research that could lead to a medication approved by the Food & Drug Administration's Center for Veterinary Medicine, and benefit generations of dogs in the future. To learn more, visit About VisionaireVisionaire Research & Education supports patient recruitment for veterinary clinical studies, helping veterinary pharmaceutical Sponsors speed new pet medications to market. The Company's number one priority is helping dogs, cats, and horses — and their owners — experience a better quality of life through innovative treatments and solutions. The pivotal studies Visionaire supports can be a way to gain access to quality diagnostics and veterinary care — and investigational therapies that often aren't available anywhere else — all at no cost to pet owners. For more information, visit Contact: Megan Hepp, 919-293-0243 x 202; megan@ View original content to download multimedia: SOURCE Dog Storm Study
Yahoo
11-06-2025
- Health
- Yahoo
CROSSJECT advances on the development of ZEPIZURE® Junior, its solution for epilepsy crises in children
Press release CROSSJECT advances on the development of ZEPIZURE® , its solution for epilepsy crises in children Announces the effective calibration of ZENEO® for the use of ZEPIZURE® in the pediatric population. CROSSJECT completed an echography clinical study allowing to determine and validate the targeted depth of injection in children as compared to adults. Dijon, France 11 June 2025 (07h30 CET) -- CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), the specialty pharma company in advanced phases of development and registration for ZEPIZURE® in adults, is progressing in the development of its pediatric version of ZEPIZURE®, branded ZEPIZURE® Junior. According to the 2022 National Survey of Children's Health and as reported by the U.S. Centers for Disease Control and Prevention (CDC) on its 'Epilepsy Facts & Stats' pages, there are approximately 456,000 children with active epilepsy in the U.S. The active epilepsy population is defined as patients who are diagnosed and actively managed by a caregiver. Under its contract with the Biomedical Advanced Research and Development Authority (BARDA), CROSSJECT completed a clinical echography study in a 90 adults and children (2-18 years old) to measure and compare the anatomical characteristics of thighs, i.e. the thickness of layers from skin to muscle (CJTCDZ2301, NCT06279689). In parallel CROSSJECT conducted studies on its ex-vivo experimental models that reconstitute the skin and the subcutaneous and muscle layers in children. These tests have successfully enabled the calibration of the pressure to be exerted by the ZENEO® device gas generators to expel the drug solution with the suitable penetration depth and confirmed the adequacy of the ZENEO® device in its 'Junior' mode. Previous Human Factors studies had also included a significant number of children above 8 years of age and did successfully demonstrate their ability to use the autoinjector ZENEO® effectively. « We are excited by this incremental innovation and the success in our product development. Pediatrics is strategic to CROSSJECT as we want to establish ZEPIZURE® as the standard of care early in this chronic condition. We look forward to advancing with the Food and Drug Administration (FDA) and having concrete clinical solutions to propose to the pediatric patient community », said Patrick ALEXANDRE, CEO of CROSSJECT. About CROSSJECT CROSSJECT SA (Euronext: ALCJ; is an emerging specialty pharmaceuticals company developing medicines for emergency situations harnessing its award-winning needle-free auto-injector ZENEO® platform. CROSSJECT is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, for which it has a $60 million contract* with BARDA. The Company's versatile ZENEO® platform is designed to enable patients or untrained caregivers to easily and instantly deliver a broad range of emergency drugs via intramuscular injection on bare skin or even through clothing. The Company's other products in developmentmainly include solutions for allergic shocks and adrenal insufficiencies, as well as therapies and other emergency indications. * This project has been supported in whole or in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50122C00031. *** For further information, please contact: Investor Relationsinvestors@ Attachment CROSSJECT advances on the development of ZEPIZURE® Junior
Fast Company
10-06-2025
- Business
- Fast Company
How this Dutch startup is helping paralyzed patients move again
In 2012, when a tree fell on her family's car, Jessie Owen's life transformed. Both of her parents died, and the then-27-year-old Owen was paralyzed. 'I lost everything overnight: my independence, career, home,' she says. 'And it's hard to rank them, but losing my autonomy to control my own body was up there.' Her spinal cord injury left her with some limited movement, but fine motor skills were especially challenging. Then, a few years ago, she took part in a clinical study of new technology: a device called ARC-EX, which temporarily attaches electrodes to the skin to stimulate sensory nerves in the spine. After a few weeks of therapy, Owen could tie her shoes, open a jar of peanut butter, and drink from a glass without a straw. 'There's a quiet dignity in needing less help,' she says. Results of the study appeared in Nature Medicine last year, showing improvements in hand strength or function among 90% of participants. Owen also saw her blood pressure stabilize, and she no longer had neuropathic pain. In the past, after an injury, patients with quadriplegia typically got three months of rehab and were then told nothing more could be done. The study showed it was possible to help people with 34-year-old injuries. The device, which spun out of research at UCLA, became the first of its kind to get FDA clearance last December. Headquartered in the Netherlands, the medical tech company Onward is bringing ARC-EX to market, with plans to use it at 10 clinics before it becomes widely available later this year. The company is also running studies on an implantable version and a third platform with a brain-computer interface that can help people move again using their thoughts. Explore the full list of Fast Company's World Changing Ideas, 100 inspiring projects that are making the world more accessible, equitable, and sustainable for everyone. The final deadline for Fast Company's Next Big Things in Tech Awards is Friday, June 20, at 11:59 p.m. PT. Apply today.
Associated Press
06-06-2025
- Business
- Associated Press
United Health Products Provides Regulatory Application Update
MT. LAUREL, NJ - June 6, 2025 ( NEWMEDIAWIRE ) - United Health Products, Inc. (OTCQB: UEEC) today provided a status update on its discussion with the Food & Drug Administration. As previously disclosed, the review by FDA's Office of Product Evaluation and Quality of its Investigational Device Exemption (IDE) application to conduct the follow-on clinical study of 27 patients undergoing organ space procedures found no deficiencies but stated that the company must address the findings set forth in the assessment of the Bioresearch Monitoring (BIMO) audit of its initial 2019 clinical study. The assessment was issued by the Division of Clinical Policy and Quality on March 24, 2025, and the company submitted its detailed response addressing all findings on April 14. As of the current date, the FDA states that its review of the company's response is ongoing. Pending the resolution of the BIMO Audit assessment, the company has completed all study tasks that can be accomplished prior to the IDE approval so that patient enrollment can begin as soon as possible thereafter. About United Health Products -- UHP has developed and patented a Neutralized Regenerated Cellulose hemostatic agent. CelluSTAT Hemostatic Gauze is an all-natural product designed to control mild to moderate bleeding. UHP is seeking approval to access the human surgical market. For more information on UHP visit the company's new website: or contact the company at [email protected]. The company can also be reached by phone or text message at 475.755.1005. Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words 'believes,' 'expects,' 'anticipates' or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements. View the original release on
