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NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the Food and Drug Administration (FDA) approved Ryoncil® (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the United States. RYONCIL is the only MSC therapy approved in the U.S. for any indication, and the only approved therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older, including adolescents and teenagers. Transplant physician Dr Joanne Kurtzberg, the Jerome Harris Distinguished Professor of Pediatrics and Professor of Pathology, and Director, Marcus Center for Cellular Cures at Duke University Medical Center (DUMC), said:“Steroid-refractory acute graft versus host disease is a devastating condition with an extremely poor prognosis. From today we are able to offer RYONCIL, the first FDA-approved treatment which will be life saving for so many children and will have a great impact on their families.” Annually in the United States approximately 10,000 patients undergo an allogeneic bone marrow transplant, 1,500 of whom are children. Approximately 50% develop aGvHD and almost half of those do not respond to steroids, the recognized first-line treatment.1-5 In a single-arm multi-center Phase 3 trial of children with SR-aGvHD, 89% of whom had high severity Grade C or Grade D disease, 70% achieved an overall response by Day 28 of treatment with RYONCIL, a measure that predicts survival in aGVHD. RYONCIL treatment was not discontinued or interrupted in any patient for any laboratory abnormality, and the full course was completed without interruption in more than 85% of patients. The full Phase 3 clinical study results are available in Biology of Blood and Marrow Transplantation.6 “We are very pleased that the FDA has granted approval of RYONCIL® and are proud of the company's commitment to the GVHD community in bringing this important new treatment to children and families with no other acceptable options,” said Dr. Silviu Itescu, Chief Executive of Mesoblast.“With RYONCIL approval by FDA, Mesoblast has demonstrated the ability to bring the first MSC product to market. We will continue to work closely with FDA to obtain approval of our other late-stage products, including REVASCOR® for cardiovascular diseases and rexlemestrocel-L for inflammatory pain indications, as well as expanding the indications for RYONCIL in both children and adults with inflammatory conditions.” RYONCIL will be available in the United States at transplant centers and other treating hospitals. Please see the full Prescribing Information at . The FDA's approval press release is available here . What is RYONCIL (remestemcel-L) RYONCIL is an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. The recommended dosage of RYONCIL is 2 × 106 MSC /kg body weight per intravenous infusion given twice per week for 4 consecutive weeks. Response is assessed 28 ± 2 days after the first dose and further treatment administered as appropriate. Important Safety Information Contraindications: Known hypersensitivity to dimethyl sulfoxide (DMSO) or porcine and bovine proteins. Adverse reactions: Serious adverse reactions included pyrexia (9%), respiratory failure (9%), pneumatosis intestinalis (7%) and staphylococcal bacteremia infection (
In addition to the impressive yield rate, TSMC has also reported smooth progress in the trial production of the 2nm chips. The company's state-of-the-art manufacturing facilities and rigorous quality control measures have contributed to the successful validation of the chip design and production processes. This smooth trial progress is a crucial step towards achieving high-volume production and meeting the growing demand for advanced semiconductor solutions.
The ice sheet at TRIA Rink was slightly more crowded than in recent weeks on Thursday morning as the Minnesota Wild held their pregame skate in preparation for the Oilers first visit of the season. The two extra bodies on the ice represented some good news for a team that has made winning, despite significant injuries, its competing storylines this season. ADVERTISEMENT Specifically, veteran defenseman Jonas Brodin and top-line forward Mats Zuccarello were in full uniform, skating with their teammates for the first time in a long time. And while neither was expected back in the lineup just yet, having numbers 25 and 36 on the rink was a notably positive sight. “Really good just in the sense that they were able to skate, so we’ll do some extra work after practice and then probably skate again tomorrow and then we’ll see,” Wild coach John Hynes said. “I don’t have a timeline on them yet other than they’ve progressed well to get in the team setting. So, now we’ll see what they do. They’ll need some contact and some extra work and see how they respond.” Brodin has missed nine games this season, including the previous seven in a row, while dealing with an upper body injury. Zuccarello last played in a home win over Montreal on Nov. 14, when he was hit below the belt by a teammate’s shot and suffered a lower body injury that required surgery. Having both players back on the ice was a meaningful step for their teammates, as the Wild have persevered and gotten to the top of the Western Conference standings despite those losses, and the ongoing absence of center Joel Eriksson Ek. Brodin especially is a key player on the team’s blue line. ADVERTISEMENT “It’s exciting for everyone. He’s an important part of our team and such a factor every time he’s on the ice,” defenseman Declan Chisholm said. “He’s missed for sure and we’re excited to get him back soon.” Hynes added that during a player’s recovery from an injury, after they have begun working out and skating on their own, that first time stepping back onto the practice rink with teammates in full uniform can be a notable psychological boost. “It’s important because usually you go through that stage of the off-ice treatments and then recovery, weight room, skate on your own, and they’ve been skating together for a couple days,” the coach said. “But to get in the team setting where you’re with other guys on the ice, you’re back with the team, there’s a lot more going on, and you’re reading and reacting in certain situations, it’s a good step to get back in the team setting.” Eriksson Ek has not yet begun skating on his own as he recovers from a lower body injury suffered in overtime of a win versus Vancouver last week. ADVERTISEMENT Hockey fans in the holiday spirit of helping those in need will have two opportunities to contribute to toy drives organized by the Wild in advance of Christmas. Prior to the Saturday, Dec. 14 game versus Philadelphia and the Friday, Dec. 20 game versus Utah, fans coming to Xcel Energy Center may bring new, unwrapped toys, games and cash which will be collected at the arena’s entrances. Personnel from the Salvation Army will distribute the donated items to needy families in the Twin Cities. ______________________________________________________ This story was written by one of our partner news agencies. Forum Communications Company uses content from agencies such as Reuters, Kaiser Health News, Tribune News Service and others to provide a wider range of news to our readers. Learn more about the news services FCC uses here .Title: 83-Year-Old Woman Gets Lost and Walks 18 Kilometers, Breaks Down in Tears, Rescued by Street VendorFormer Primary School Principal Zhong Moyan Sentenced for Accepting Bribe of 9.49 Million RMB
Cover Five: With pressure rising, Matt Rhule delivers Nebraska a bowl bid in Year 2
As the trial stretched into its second day, tensions mounted in the courtroom. Emotions ran high as the prosecution and defense presented their closing arguments, each side painting a starkly different picture of what had happened on that fateful night.SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates AVAV, CTV, AE, PLL on Behalf of Shareholders
FORT LAUDERDALE, Fla. (AP) — Republican senators pushed back on Sunday against criticism from Democrats that Tulsi Gabbard , Donald Trump’s pick to lead U.S. intelligence services , is “compromised” by her comments supportive of Russia and secret meetings , as a congresswoman, with Syria’s president, a close ally of the Kremlin and Iran. Sen. Tammy Duckworth, an Illinois Democrat and veteran of combat missions in Iraq, said she had concerns about Tulsi Gabbard, Trump’s choice to be director of national intelligence . “I think she’s compromised,” Duckworth said on CNN’s “State of the Union,” citing Gabbard’s 2017 trip to Syria, where she held talks with Syrian President Bashar Assad. Gabbard was a Democratic House member from Hawaii at the time. “The U.S. intelligence community has identified her as having troubling relationships with America’s foes. And so my worry is that she couldn’t pass a background check,” Duckworth said. Gabbard, who said last month she is joining the Republican Party, has served in the Army National Guard for more than two decades. She was deployed to Iraq and Kuwait and, according to the Hawaii National Guard, received a Combat Medical Badge in 2005 for “participation in combat operations under enemy hostile fire in support of Operation Iraqi Freedom III.” RELATED COVERAGE Senators took down one Trump Cabinet pick. But the fight over their authority is just beginning Trump’s Republican Party is increasingly winning union voters. It’s a shift seen in his labor pick An influx of outsiders and money turns Montana Republican, culminating in a Senate triumph Duckworth’s comments drew immediate backlash from Republicans. What to know about Trump’s second term: Staffing the administration: Here are the people Trump has picked for key positions so far. Plus, a look at recess appointments and how could Trump use them to fill his Cabinet. Follow all of our coverage as Donald Trump assembles his second administration. “For her to say ridiculous and outright dangerous words like that is wrong,” Sen. Markwayne Mullin, a Republican from Oklahoma, said on CNN, challenging Duckworth to retract her words. “That’s the most dangerous thing she could say — is that a United States lieutenant colonel in the United States Army is compromised and is an asset of Russia.” In recent days, other Democrats have accused Gabbard without evidence of being a “Russian asset.” Sen. Elizabeth Warren, a Massachusetts Democrat, has claimed, without offering details, that Gabbard is in Russian President Vladimir “Putin’s pocket.” Mullin and others say the criticism from Democrats is rooted in the fact that Gabbard left their party and has become a Trump ally. Democrats say they worry that Gabbard’s selection as national intelligence chief endangers ties with allies and gives Russia a win. Rep. Adam Schiff, a California Democrat just elected to the Senate, said he would not describe Gabbard as a Russian asset, but said she had “very questionable judgment.” “The problem is if our foreign allies don’t trust the head of our intelligence agencies, they’ll stop sharing information with us,” Schiff said on NBC’s “Meet the Press.” Gabbard in 2022 endorsed one of Russia’s justifications for invading Ukraine : the existence of dozens of U.S.-funded biolabs working on some of the world’s nastiest pathogens. The labs are part of an international effort to control outbreaks and stop bioweapons, but Moscow claimed Ukraine was using them to create deadly bioweapons. Gabbard said she just voiced concerns about protecting the labs. Gabbard also has suggested that Russia had legitimate security concerns in deciding to invade Ukraine, given its desire to join NATO. Republican Sen. Eric Schmitt of Missouri said he thought it was “totally ridiculous” that Gabbard was being cast as a Russian asset for having different political views. “It’s insulting. It’s a slur, quite frankly. There’s no evidence that she’s a asset of another country,” he said on NBC. Sen. James Lankford, another Oklahoma Republican, acknowledged having “lots of questions” for Gabbard as the Senate considers her nomination to lead the intelligence services. Lankford said on NBC that he wants to ask Gabbard about her meeting with Assad and some of her past comments about Russia. “We want to know what the purpose was and what the direction for that was. As a member of Congress, we want to get a chance to talk about past comments that she’s made and get them into full context,” Lankford said.
In a recent interview with the Portuguese media, former Manchester United winger Nani opened up about his past discussions with Benfica and Porto before ultimately choosing to join Sporting CP. The 34-year-old, who returned to his homeland in 2018 after a successful spell in Major League Soccer, explained that his decision to sign with Sporting was driven by loyalty to the club where he began his professional career.
TOMS RIVER, N.J. (AP) — A U.S. senator has called for mysterious drones spotted flying at night over sensitive areas in New Jersey and other parts of the Mid-Atlantic region to be “shot down, if necessary,” even as it remains unclear who owns the unmanned aircraft. “We should be doing some very urgent intelligence analysis and take them out of the skies, especially if they’re flying over airports or military bases,” Sen. Richard Blumenthal of Connecticut said Thursday, as concerns about the drones spread across Capitol Hill. People in the New York region are also concerned that the drones may be sharing airspace with commercial airlines, he said, demanding more transparency from the Biden administration. The White House said Thursday that a review of the reported sightings shows that many of them are actually manned aircraft being flown lawfully. White House National Security spokesman John Kirby said there were no reported sightings in any restricted airspace. He said the U.S. Coast Guard has not uncovered any foreign involvement from coastal vessels. “We have no evidence at this time that the reported drone sightings pose a national security or a public safety threat, or have a foreign nexus,” Kirby said, echoing statements from the Pentagon and New Jersey Gov. Phil Murphy. Pentagon spokesperson Sabrina Singh has said they are not U.S. military drones. In a joint statement issued Thursday afternoon, the FBI and the Department of Homeland Security said they and their federal partners, in close coordination with the New Jersey State Police, “continue to deploy personnel and technology to investigate this situation and confirm whether the reported drone flights are actually drones or are instead manned aircraft or otherwise inaccurate sightings.” The agencies said they have not corroborated any of the reported sightings with electronic detection, and that reviews of available images appear to show many of the reported drones are actually manned aircraft. “There are no reported or confirmed drone sightings in any restricted air space,” according to the statement. The drones appear to avoid detection by traditional methods such as helicopter and radio, according to a state lawmaker briefed Wednesday by the Department of Homeland Security. The number of sightings has increased in recent days, though officials say many of the objects seen may have been planes rather than drones. It’s also possible that a single drone has been reported more than once. The worry stems partly from the flying objects initially being spotted near the Picatinny Arsenal, a U.S. military research and manufacturing facility, and over President-elect Donald Trump’s golf course in Bedminster. In a post on the social media platform X, Assemblywoman Dawn Fantasia described the drones as up to 6 feet (1.8 meters) in diameter and sometimes traveling with their lights switched off. Drones are legal in New Jersey for recreational and commercial use but are subject to local and Federal Aviation Administration regulations and flight restrictions. Operators must be FAA certified. Most, but not all, of the drones spotted in New Jersey appeared to be larger than those typically used by hobbyists. Sen. Cory Booker of New Jersey said he was frustrated by the lack of transparency, saying it could help spread fear and misinformation. “We should know what’s going on over our skies,” he said Thursday. John Duesler, president of the Pennsylvania Drone Association, said witnesses may be confused about what they are seeing, especially in the dark, and noted it’s hard to know the size of the drones or how close they might be. “There are certainly big drones, such as agricultural drones, but typically they are not the type you see flying around in urban or suburban spaces,” Duesler said Thursday. Duesler said the drones — and those flying them — likely cannot evade detection. “They will leave a radio frequency footprint, they all leave a signature," he said. "We will find out what kind of drones they were, who was flying them and where they were flying them.” Fantasia, a Morris County Republican, was among several lawmakers who met with state police and Homeland Security officials to discuss the sightings from the New York City area across New Jersey and westward into parts of Pennsylvania, including over Philadelphia. It is unknown at this time whether the sightings are related. Duesler said the public wants to know what's going on. “I hope (the government agencies) will come out with more information about this to ease our fears. But this could just be the acts of rogue drone operators, it’s not an ‘invasion’ as some reports have called it,” Duesler said. “I am concerned about this it but not alarmed by it.” Associated Press reporters Mark Scolforo in Harrisburg, Pennsylvania; and reporter Darlene Superville and videojournalists Serkan Gurbuz and Nathan Ellgren in Washington, D.C., contributed to this report.Salah's incredible form was instrumental in helping Liverpool secure important victories in the English Premier League. His clinical finishing, dazzling footwork, and impeccable timing were on full display as he tormented opposing defenders with his skill and pace.
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NAPLES, Fla. (AP) — Down by two shots with two holes to play, Jeeno Thitikul knew exactly what was needed to capture the biggest prize in women's golf history. Read this article for free: Already have an account? As we navigate through unprecedented times, our journalists are working harder than ever to bring you the latest local updates to keep you safe and informed. Now, more than ever, we need your support. Starting at $14.99 plus taxes every four weeks you can access your Brandon Sun online and full access to all content as it appears on our website. or call circulation directly at (204) 727-0527. Your pledge helps to ensure we provide the news that matters most to your community! NAPLES, Fla. (AP) — Down by two shots with two holes to play, Jeeno Thitikul knew exactly what was needed to capture the biggest prize in women's golf history. Read unlimited articles for free today: Already have an account? NAPLES, Fla. (AP) — Down by two shots with two holes to play, Jeeno Thitikul knew exactly what was needed to capture the biggest prize in women’s golf history. And another eagle-birdie finish — for the second straight day — made it happen. Thitikul claimed the record-setting $4 million first-place check by winning the CME Group Tour Championship on Sunday. It’s the biggest money prize in women’s golf history, bigger than even the winner’s shares in three of the four men’s major championships this year. “Today, standing here with the trophy, it’s more than I can ask for,” Thitikul said. Thitikul shot a 7-under 65 on Sunday and finished the week at 22 under, one shot ahead of Angel Yin (66). Yin had a two-shot lead walking to the 17th tee, only to wind up settling for the $1 million runner-up check. Yin — who missed the start of the season after breaking her leg over the winter — hardly sounded defeated after finishing second and more than doubling her 2024 earnings in four days. “I’m pretty awesome. ... I’ve learned that I just need to believe my myself and that’s what I did,” Yin said. Brooke Henderson (66) of Smiths Falls, Ont., tied for eighth at 13-under overall. The win and the massive check came down to the 18th hole, Thitikul and Yin tied at 21 under after a back-and-forth day atop the leaderboard — both knowing a mistake would likely come at a $3 million cost. Both hit the fairway on 18. Thitikul’s approach was nearly perfect, stopping about 5 feet from the cup. Yin’s response stopped maybe 15 feet away, giving Thitikul the edge as they walked up the fairway. She was smiling broadly as she approached the green, almost as if she knew what was about to happen. Yin’s birdie putt just missed. Thitikul’s was dead center. And history was hers. Her plans for all that cash? “Definitely spend it,” Thitikul said. “That’s an honest answer, for sure. Definitely going to spend it for a little while.” She already had clinched a $1 million bonus this week through the Aon Risk-Reward Challenge, a competition based on how players score on a designated hole each week. In the end, it wound up as a whopping $5 million week for the 21-year-old from Thailand — and going 8 under on the Nos. 17 and 18 over the four days at Tiburon Golf Club made the difference. “All the hard work paid off,” said Thitikul, whose eagle-birdie close to Saturday’s round pulled her into a tie for the lead with Yin going into Sunday at 15 under. It didn’t take long on Sunday for Thitikul to jump in front, with birdies on two of the first three holes to grab a two-shot edge. Her lead vanished with a two-shot swing on the par-4 fourth; Yin made birdie, Thitikul bogey. It seemed like Yin grabbed control on the par-3 16th. Her birdie putt from across the green — about 25 feet — rolled in for a two-shot lead with two holes to play. But her second shot at the par-5 17th missed the green right, and the door was opened for Thitikul. The eagle-birdie finish Saturday gave her hope. The eagle-birdie finish Sunday gave her so much more — even though, it turns out, the second shot on the par 5 wasn’t one that she caught flush. It worked out anyway. “Just lucky enough,” Thitikul said. Olympic gold medalist Lydia Ko (63) finished third at 17 under, her nine birdies coming in a 13-hole span. “I’m excited to be able to work hard this offseason and have another great 2025,” Ko said. Ruoning Yin (68) was alone in fourth at 16 under, and LPGA player of the year Nelly Korda (66) finished at 15 under along with Narin An (68). Ayaka Furue finished at 13 under, good enough to give her the Vare Trophy as the LPGA’s season-long scoring champion over Haeran Ryu. “I feel very happy to have this trophy in my hands,” said Furue, the first Japanese player to win the Vare. Lexi Thompson — a 15-time winner as a pro who plans to step away from full-time golf — finished at 2 under. It’s not clear how often Thompson plans to play in 2025 and beyond; that said, she returns to Tiburon the week of Dec. 9 for the Grant Thornton Invitational, where she’ll team with Rickie Fowler in the event featuring PGA Tour and LPGA Tour players. “I’m not going anywhere, guys.” Thompson said. “I’ll be back in two weeks.” There were two players who said they were retiring after Sunday’s round: Marina Alex, who shot 66 to finish at 12 under, and Ally Ewing, who closed with a 68 to wrap up the week at 11 under. “I’m happy to have ended on my best,” said Alex, a bottle of sparkling wine in her right hand, a bouquet of flowers in the other. Added Ewing: “I’ve been at peace with my decision. It’s just so nice to be able to share the walk with my family this week.” But in the end, the week belonged to Thitikul. And as the sun was setting over Tiburon on Sunday, she was ready for her offseason to begin with a well-deserved celebration. “Anybody hungry?” she asked. “I am.” With Sunday’s check in her pocket, she can dine anywhere she wants for a while. ___ AP golf: https://apnews.com/hub/golf Advertisement Advertisement
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