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slots login Earlier this year FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for congenital heart disease NEW YORK, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the United States Food and Drug Administration (FDA) has granted its second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell therapy Revascor ® (rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) designation following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congenital heart condition. Mesoblast Chief Executive Silviu Itescu said: "We appreciate FDA's support in designating REVASCOR both RMAT and RPD status, a recognition of the potential impact of our therapy on the long-term adverse outcomes of these desperately ill children. Under the RMAT designation, we plan to meet with FDA to discuss a potential approval pathway in this indication.” Earlier this year, FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for treatment of children with HLHS. RPDD demonstrates that the disease is serious or life-threatening and the manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents, and that the disease is a rare disease or condition. On FDA approval of a BLA for REVASCOR for the treatment of HLHS, Mesoblast may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed for any subsequent marketing application or may be sold or transferred to a third party. RMAT designations aim to expedite the development of regenerative medicine therapies intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition where preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for the disease or condition. An RMAT designation for rexlemestrocel-L provides all the benefits of Breakthrough and Fast Track designations, including rolling review and eligibility for priority review on filing of a Biologics License Application (BLA). Results from a blinded, randomized, placebo-controlled prospective trial of REVASCOR conducted in the United States in children with HLHS were published in the December 2023 issue of the peer reviewed The Journal of Thoracic and Cardiovascular Surgery Open (JTCVS Open). 1 In the HLHS trial conducted in 19 children, a single intramyocardial administration of REVASCOR at the time of staged surgery resulted in the desired outcome of significantly larger increases in left ventricular (LV) end-systolic and end-diastolic volumes over 12 months compared with controls as measured by 3D echocardiography, (p=0.009 & p=0.020 respectively). These changes are indicative of clinically important growth of the small left ventricle, facilitating the ability to have a successful surgical correction, known as full biventricular (BiV) conversion, which allows for a normal two ventricle circulation with the surgically repaired left ventricle taking over circulatory support to the body. Without full BiV conversion the right heart chamber is under excessive strain with increased risk of heart failure, liver failure, and death. About Hypoplastic Left Heart Syndrome (HLHS) HLHS is a severe congenital heart disease in which the left side of the heart does not fully develop and effective pumping of oxygenated blood by the left ventricle to the rest of the body is reduced. Without immediate surgery after birth, the prognosis is dismal with HLHS overall being responsible for 25% to 40% of all neonatal cardiac mortality. 2 In the longer term, surgery that creates a two-ventricle series circulation with the left ventricle (LV) pumping blood to the body and the right ventricle pumping blood to the lungs is the ideal anatomic repair. Unfortunately, achievement of this objective is limited by the inability in most patients for the left ventricle to grow sufficiently to support the circulation to the body. About Revascor ® (rexlemestrocel-L) in Heart Disease REVASCOR is an allogeneic preparation of immunoselected and culture-expanded mesenchymal precursor cells which have been shown previously to have multiple mechanisms-of-action that may be beneficial to children with HLHS including neovascularization, anti-fibrosis, anti-apoptosis, immunomodulation, reduction in inflammation, and reversal of endothelial dysfunction. In the DREAM-HF randomized sham-placebo controlled prospective trial of REVASCOR in 565 randomized adult patients with heart failure with low ejection fraction (HFrEF), a single intramyocardial administration of REVASCOR into the left ventricle resulted in significant improvement in LV ejection fraction at 12 months, 3 indicative of strengthened overall LV systolic function. The greatest treatment benefit was on 2- and 3-Point Major Adverse Cardiovascular Events (MACE), particularly in patients with HFrEF with ischemia and inflammation, who are at highest risk of mortality. 4 About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease, and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast's licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com , LinkedIn: Mesoblast Limited and Twitter: @Mesoblast References / Footnotes This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast's preclinical and clinical studies, and Mesoblast's research and development programs; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast's ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including any future decision that the FDA may make on the BLA for remestemcel-L for pediatric patients with SR-aGVHD), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast's product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast's product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast's ability to enter into and maintain established strategic collaborations; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast's expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast's financial performance; developments relating to Mesoblast's competitors and industry; and the pricing and reimbursement of Mesoblast's product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact:

Gabriel mimics Gyokeres in cheeky goal celebration in Arsenal win over Sporting in Champions LeagueNASSAU, Bahamas — Scottie Scheffler birdied every hole but the par 3s on the front nine at Albany Golf Club on Friday and finished his bogey-free round with an 8-under 64 that gave him a two-shot lead in the Hero World Challenge. Two months off did nothing to slow the world's No. 1 player. Scheffler already has eight victories this year and is in position to get another before the end of the year. Scheffler was at 13-under 131, two ahead of Akshay Bhatia (66) and Justin Thomas (67), both of whom had to save par on the 18th hole to stay in range going into the weekend. Scheffler started with a lob wedge to 2 feet for birdie and never slowed until after he went out in 29 to seize control of the holiday tournament against a 20-man field. Scheffler cooled slightly on the back nine, except it didn't feel that way to him. "Front nine, just things were going my way. Back nine, maybe not as much," Scheffler said. "A couple shots could end up closer to the hole, a couple putts go in, just little things." People are also reading... Asked if he felt any frustration he didn't take it lower — he once shot 59 at the TPC Boston during the FedEx Cup playoffs — Scheffler sounded bemused. "I think in this game I think a lot of all y'all are looking for perfection out of us," he said. "Today I shot 8 under on the golf course, not something I hang my head about. A lot of good things out there — clean card, bogey-free, eight birdies. Overall, I think I'm pretty pleased." Thomas felt his 67 was stress-free, particularly the way he was driving the ball. The wind laid down again, rare for the Bahamas, though it is expected to pick up on the weekend. Thomas wasn't concerned to see Scheffler get off to a hot start, especially with three par 5s on the front nine and a short par 4 that at worst leaves a flip wedge to the green. "You literally can birdie every hole as soft as the greens are," Thomas said. "He's a great player, a great wedge player, and you have a lot of birdie holes to start. I'm honestly surprised he only shot 8 under. It's a sneaky course because if you fall asleep on some shots, you can get out of position. But if you're on and focused and really in control of everything — like these last two days with no wind — you can just make so many birdies." Ryder Cup captain Keegan Bradley had a 67 and was four shots behind. No matter how benign the conditions, it wasn't always easy. Cameron Young, who opened with a 64 for a two-shot lead, followed with a 75 despite making five birdies. That included a double bogey on the final hole when his approach tumbled down the bank into the rocks framing the lake that goes all the way down the 18th hole. Patrick Cantlay was trying to keep pace playing alongside Scheffler, but he had three bogeys over the final seven holes and fell seven shots behind with a 71. The tournament, hosted by Tiger Woods, is unofficial but offers world ranking points to all but the bottom three players because of the small field. It's the weakest field in 25 years, but Scheffler at No. 1 gives it enough cachet. He is the first player since Woods in 2009 to start and finish a year at No. 1 in the world. And even after a layoff — giving him time to tinker with a new putting stroke — it looks like it might be a while before anyone changes that. Be the first to know

Qatar tribune Tribune News Network Doha President of the Qatar Olympic Committee (QOC) HE Sheikh Joaan bin Hamad Al Thani and QOC Secretary-General HE Jassim bin Rashid Al Buenain met with the recently elected President of the International Volleyball Federation (FIVB) President Fabio Azevedo in Doha on Wednesday. During the meeting, the development of volleyball in Qatar was discussed as the QOC expressed its commitment to strengthening cooperation with the FIVB and contributing to the delivery of the FIVB Strategic Plan 2032 with the motto “Together as One”empowering Global Volleyball Movement. The QOC President, HE Sheikh Joaan bin Hamad Al-Thani appreciated Doha’s hosting of the Beach Pro Tour Finals, highlighting its significant role in enhancing the sport’s popularity and elevating its technical and skill standards across all age groups throughout the Middle East. Qatar has a strong history in the sport, particularly beach volleyball, with Doha regularly hosting the Beach Pro Tour.Doha has successfully hosted 2024 WAVA U20 Women’s Beach Volleyball Championship recently and now is hostingthe Beach Pro Tour Finals at Aspire Park. Qatar’s Cherif Younousse and Ahmed Tijan also claimed bronze for Qatar at the Olympic Games Tokyo 2020. President Azevedo was in Doha this week for a number of volleyball initiatives delivered in partnership with the Qatar Olympic Committee, Qatar Foundation, Qatar Volleyball Association (QVA) and FIVB Volleyball Foundation. The ‘Women in Sports: Creating Pathways’ Seminar was held on 2 December in Education City Stadium. Organised in collaboration with Qatar Foundation, QVA, and the FIVB, it featured international administrators, Olympians and Olympic medallists, who came together to discuss important topics surrounding women’s roles in sports. On 3 December a mass participation volleyball event was held for more than 100 children at the Al Gharafa Beach Complex. Copy 05/12/2024 10

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EMERYVILLE, Calif. , Nov. 26, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the Company will present at the 7th Annual Evercore HealthCONx Conference on Tuesday, December 3 at 2:35 p.m. ET . The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at https://investors.dynavax.com/events-presentations . About Dynavax Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S., the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. For more information about our marketed products and development pipeline, visit www.dynavax.com . For Investors/Media: Paul Cox pcox@dynavax.com 510-665-0499 Nicole Arndt narndt@dynavax.com 510-665-7264 View original content to download multimedia: https://www.prnewswire.com/news-releases/dynavax-to-present-at-the-7th-annual-evercore-healthconx-conference-302315117.html SOURCE Dynavax Technologies

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