Latest news with #Approval
Telegraph
a day ago
- Climate
- Telegraph
Horse racing tips: Friday, June 13
Our resident horse racing tipster Ron Wood continues to unearth the winners and has a tip at Sandown this afternoon, as well as a NAP selection at Goodwood in the evening. Ron Wood's selections: Odds provided by William Hill and correct at the time of writing. Stars denote strength of selection (max 5). If you already have a William Hill account and are looking for a new bookmaker to use for this week's racing, check out more free bets from the best betting sites, reviewed by our experts. 3.15 Sandown – Class 3 Handicap (1m 2f) APPROVAL has disappointed on both starts this year but he has a tendency to go right in his races, so Redcar, a left-handed track, didn't suit him last time out. He won a decent handicap over this trip at Goodwood last summer, edging out Brioni, who he now meets on 5lb better terms, and this is the selection's first start on a right-handed track since then. Approval is also dropping down from Class 2, sneaking into this contest off joint-top weight. It's Royal Ascot next week. Find the best Royal Ascot free bets and betting offers 7.50 Goodwood - Class 4 Handicap (5f) WHEELS OF FIRE (NAP) is all speed, so this drop back to the minimum distance on a sharp track is good for him. He was well beaten at Ascot last time but that was over a stiff 6f and he was just about the last to come under pressure before fading. On his outing before that, he was second to a big improver who went on to win a decent handicap at Chester next time. Wheels Of Fire won a novice on the Lingfield all-weather, which is also a sharp test, on his only previous race over 5f. Selection: Wheels Of Fire @ 5/2 with William Hill Go to site > Today's racing (Flat unless stated) Sandown 1.00-5.00 Chester 1.40-5.10 York 1.50-5.20 Cork 4.52-8.15 Fairyhouse 5.05-8.30 Newton Abbot (NH) 5.35-9.00 Goodwood 5.30-8.20 Market Rasen (NH) 5.50-8.45 Ron Wood 2025 horse racing P/L (up to and including Thursday June 12) Star ratings explained ⭐⭐⭐⭐⭐ - confident selection ⭐⭐⭐⭐ - strong fancy ⭐⭐⭐ - fair claims ⭐⭐ - tentative choice ⭐ - minimum confidence If you want to find more odds and offers, take a look at our list of the best betting sites and free bets Check out our list of the best casino bonuses in the UK
Associated Press
20-05-2025
- Business
- Associated Press
The FDA (Food and Drug Administration) Drug Approval Process Training Course: Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (ONLINE EVENT: June 11-12, 2025)
DUBLIN--(BUSINESS WIRE)--May 20, 2025-- The 'The FDA (Food and Drug Administration) Drug Approval Process Training Course' training has been added to offering. This programme will be especially beneficial to those responsible for preparing US registration documents (INDs,NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market. The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region. This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments. The comprehensive programme will cover procedures for submission of INDs, NDAs, ANDAs and 505(b)(2), provide a useful insight into the organisation and structure of the FDA and its review processes, and highlight recent changes. The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs. There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning. Benefits of attending: Certifications: Key Topics Covered: Day 1 Pharmaceutical Medicine and Documents FDA History and Organisation Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA) Legal Basis Continued Application and Submissions Types Refusal to File Investigational New Drug (IND) Applications Getting Products to the Market Faster FDA Meetings and Documentation CTD Content - Setting the Scene CTD Content - M1 Day 2 CTD Content - M3 and Corresponding M2 CTD Content - M4 and Corresponding M2 CTD Content - M5 and Corresponding M2 Submission Format and Methods US Amendment Procedures High Level Comparison US vs EU Case Study For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: FDA PHARMACEUTICAL HEALTH SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 05/20/2025 08:25 AM/DISC: 05/20/2025 08:24 AM
Yahoo
20-03-2025
- Business
- Yahoo
BD Announces Milestone in Clinical Trial for Use of Bioabsorbable GalaFLEX LITE™ Scaffold in Breast Implant Revision Surgery
FRANKLIN LAKES, N.J., March 20, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the first patient treated in an Investigational Device Exemption (IDE) clinical trial intended to advance BD's efforts to achieve Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the use of GalaFLEX LITE™ Scaffold in decreasing capsular contracture (CC) recurrence during breast revision surgery. Implant-based breast surgery is among the most common plastic surgery procedures performed each year in the U.S., and capsular contracture, a condition where the scar tissue naturally forming around the implant becomes unusually hard, causing pain and anatomical displacement, is its most frequent complication, with overall incidence ranging from 10% to 20%1-5. At advanced stages, CC necessitates treatment through surgical intervention, and when performed using conventional techniques, the risk of recurrence may be as high as 54%6. This multi-center Study of GalaFLEX LITE™ Poly-4-Hydroxybutyrate (P4HB) Scaffold in Treatment of Capsular Contracture after Breast Implant Augmentation (STANCE) is a pivotal study that aims to evaluate whether GalaFLEX LITE™ Scaffold, when used in breast revision surgery, decreases the likelihood of CC and or malposition. The trial further positions BD as a leader in advanced biomaterial science – driving transformative change in how tissue is reconstructed. "This milestone marks a significant advancement in our efforts to achieve FDA Premarket Approval for our first breast indication for GalaFLEX LITE™ Scaffold and reinforces the company's commitment to improving patient outcomes through innovative technologies that reduce surgical complications," said Rian Seger, worldwide president of the BD Surgery business. "Our team has worked closely with the FDA to help address a critical medical complication arising from implant-based breast surgery, and the first patient treated brings us closer to delivering a much-needed solution." GalaFLEX LITE™ Scaffold is engineered to conform to the desired anatomical structure and provide immediate strength and stability throughout the wound healing period7. It is made from P4HB, a fully absorbable, biologically-derived polymer with more than 10 years of clinical use supporting hernia repair and other plastic and reconstructive procedures where soft tissue weakness or deficiency exists. "Participating in this trial underscores our commitment to innovation and providing the best evidence-based care for patients suffering from capsular contracture, offering them hope and solutions for the future," said Dr. Shawna Kleban, the board-certified plastic surgeon who performed the inaugural procedure. "This trial allows participants to help identify a solution for themselves and for future patients." Dr. Caroline Glicksman, the study's National Principal Investigator from Sea Girt, New Jersey added, "As an early adopter of the P4HB technology, we are excited to see the potential benefits of GalaFLEX™ LITE Scaffold in improving patient outcomes in breast revision surgeries. This study is crucial in providing the data FDA requires for a specific breast indication that will advance our ability to deliver better solutions for breast surgery patients." The following five sites are currently enrolling patients: HKB Cosmetic Surgery (Various Locations, North Carolina) – Principal Investigator: Dr. Bill Kortesis; Sub-Investigators: Dr. Gaurav Bharti, Dr. Shawna Kleban, Dr. Brett Baker Billington Plastic Surgery (St. Petersburg, Florida) – Principal Investigator: Dr. Alicia Billington The Practice Plastic Surgery (Beverly Hills, California) – Principal Investigator: Dr. Kelly Killeen; Sub-Investigator: Dr. Lisa Cassileth Plastic Surgery Institute of New York (New York, New York) – Principal Investigator: Dr. Matthew DelMauro; Sub-Investigator: Dr. Adam Shaffner Newport Plastic and Reconstructive Surgery Associates (Newport Beach, California) – Principal Investigator: Dr. Hisham Seify Essential Medical Research (Tulsa, Oklahoma) – Principal Investigator: Dr. John Tedesco The trial is expected to enroll at least 250 patients across 40 investigative sites and aims to demonstrate the device's safety and efficacy in breast implant revision surgery to treat capsular contracture. BD is committed to scientific rigor and patient safety and aims to continue proactive FDA engagement in developing products that enhance women's health care. STANCE StudySTANCE (NCT05945329) Study is an ongoing prospective, randomized, controlled, multi-center study to assess the safety and efficacy of GalaFLEX LITE™ scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery with no supportive matrix or acellular dermal matrix (ADM). Patients will be randomized 2:1 to receive either GalaFLEX LITE™ Scaffold or standard care (no ADM or matrix placement). About BDBD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit or connect with us on LinkedIn at X (formerly Twitter) @BDandCo or Instagram @becton_dickinson. Forward-Looking StatementsThis press release contains certain forward-looking statements regarding the Premarket Approval clinical trial for GalaFLEX LITE™ Scaffold. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including, without limitation, clinical trial outcomes and progress, obtaining regulatory clearance and approval, including achieving FDA Premarket Approval for the first breast indication for GalaFLEX LITE™ Scaffold, competitive factors, including the development of new technologies or products by other companies, changes in healthcare practices and patient preferences, future regulatory and market conditions, or other factors listed in BD's 2024 Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. BD expressly disclaims any undertaking to update any forward-looking statements set forth herein to reflect events or circumstances after the date hereof, except as required by applicable laws or regulations. References Bachour, Y., Capsular Contracture in Breast Implant Surgery: Where Are We Now and Where Are We Going? Aesthetic Plast Surg, 2021. 45(3): p. 1328-1337. Brown, T., Plane Change Vs Capsulotomy: A Comparison of Treatments for Capsular Contraction in Breast Augmentation Using the Subfascial Plane. Aesthetic Plast Surg, 2021. 45(3): p. 845-850. Hasan, S., et al., Preliminary Outcomes of Hypochlorous Acid as an Adjunct for Pocket Irrigation in Revision Aesthetic Breast Surgery. Aesthet Surg J, 2021. 41(4): p. NP152-NP158. Calobrace, M.B., et al., Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation. Plast Reconstr Surg, 2018. 141(4S Sientra Shaped and Round Cohesive Gel Implants): p. 20S-28S. Boyd, C.J., et al., Systematic Review of Capsular Contracture Management Following Breast Augmentation: An Update. Plast Reconstr Surg, 2023.1 Preclinical data on file. Results may not correlate to clinical outcomes. Hidalgo, D.A. and A.L. Weinstein, Surgical Treatment for Capsular Contracture: A New Paradigm and Algorithm. Plast Reconstr Surg, 2020. 146(3): p. 516-525. Preclinical data on file. Results may not correlate to clinical outcomes. For more information about GalaFLEX LITE™ scaffold, please visit Contacts: Media: Investors: Fallon McLoughlin Adam Reiffe BD Corporate Communications BD Investor Relations 201.258.0361 201.847.6927 View original content to download multimedia: SOURCE BD (Becton, Dickinson and Company) Sign in to access your portfolio
Yahoo
10-03-2025
- Business
- Yahoo
World Premiere: H-UKR Decarbonized Cement 0% Clinker From Hoffmann Green Receives a Technical Approval (ATEc)
CHAILLÉ-SOUS-LES-ORMEAUX, France, March 10, 2025--(BUSINESS WIRE)--Hoffmann Green Cement Technologies (ISIN: FR0013451044, Ticker: ALHGR) ("Hoffmann Green Cement" or the "Company"), an industrial player committed to the decarbonation of the construction sector that designs and markets innovative clinker-free cements, today announced that it has obtained a Technical Approval (ATEc) for its H-UKR cement, a world premiere for a 0% clinker cement, confirming once again the Company's technological leadership in the construction sector. Resulting from more than seven years of research, rigorous testing, collaboration with leading experts and millions of euros invested, this validation confirms that H-UKR cement meets the highest standards of durability and safety. Confirmation of Hoffmann Green's technical and regulatory lead The validation of the first assessments issued since 2021 by the CSTB, thanks to the substantial and impressive feedback from numerous projects, is a key milestone for Hoffmann Green. This Technical Approval (ATEc), covering surface foundation applications in France, confirms the achievement of Hoffmann Green's technical objectives: to offer a 0% clinker cement without compromising on performance. It consolidates Hoffmann Green's technical and regulatory lead in the low-carbon cement market. A strategic opportunity for business development This validation brings new commercial opportunities for Hoffmann Green, broadening the applications of its decarbonized cement, reinforcing its appeal and guaranteeing its insurability to project owners and construction professionals. Thanks to its limited carbon footprint and clinker-free cold manufacturing process, H-UKR cement offers a sustainable industrial solution that is ready for immediate use. H-UKR meets the growing demands for sustainability and is positioned as a concrete alternative to the environmental and regulatory challenges facing the sector, notably the RE 2020 Environmental Regulations. Julien BLANCHARD and David HOFFMANN, Co-founders of Hoffmann Green Cement Technologies, say: "This technical recognition is a world first, and the result of rigorous work aimed at reinventing a cement industry that has remained unchanged for over two centuries. This Technical Approval attests to the reliability and durability of our approach, while guaranteeing compatibility with the practices of construction specialists. Hoffmann Green is thus positioned as a leader in sustainable construction, able to provide concrete, immediately operational solutions to today's climatic and industrial challenges." View source version on Contacts Hoffmann Green Cement Technologies | Telephone : +33 2 51 460 600 | Email : ciments-hoffmann@ / fınances@ Sign in to access your portfolio
Zawya
27-02-2025
- Business
- Zawya
Bybit receives in-principle approval to establish virtual asset platform in the United Arab Emirates
Bybit, the world's second-largest cryptocurrency exchange by trading volume, is proud to announce that it has received its In-Principle Approval (IPA) to set up as a Virtual Asset Platform Operator in UAE from the Securities & Commodities Authority (SCA) of the United Arab Emirates (UAE), dated on Feb 18, 2025. Bybit is also in the final steps to receive its fully operational license soon. This milestone marks a significant step in Bybit's ongoing mission to provide a secure, stable, and compliant platform for crypto traders in the region. This IPA underscores Bybit's commitment to upholding the highest regulatory and compliance standards as it works toward full operational approval from the SCA. This authorization moves Bybit closer to offering a broad range of digital asset services to both retail and institutional clients in the UAE. Bybit's progress in UAE follows its existing regulatory approvals in the Middle East, further solidifying its commitment to compliance in key financial hubs. Ben Zhou, Co-founder and CEO of Bybit, commented on this milestone: 'We are honored to have received the IPA from SCA. This approval marks a crucial step in our journey to providing secure and transparent crypto trading solutions. Bybit remains dedicated to working hand-in-hand with regulators to foster a compliant and innovative digital asset ecosystem to both retail and institutional investors in the UAE.' The UAE has emerged as a leading global hub for cryptocurrency and blockchain innovation, supported by progressive regulatory frameworks that align with Bybit's vision of bridging traditional finance with digital assets. Bybit remains committed to adhering to global compliance standards, including Anti-Money Laundering (AML) and Counter-Terrorism Financing (CFT) protocols, ensuring a safe and trusted trading environment. Beyond UAE, Bybit continues to secure regulatory approvals worldwide, expanding its presence in key jurisdictions such as India, Georgia, Kazakhstan, Turkey, etc, further reinforcing its regulatory commitment. These licenses enable Bybit to expand its reach while maintaining the highest security and compliance standards for its users worldwide.
