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Plans Required to Cover Treatment for SOD1-ALS ARLINGTON, Va. , Dec. 11, 2024 /PRNewswire/ -- The Centers for Medicare & Medicaid Services (CMS) has announced a first-of-its-kind directive requiring Medicare Advantage plans to approve coverage for Qalsody, a treatment for people living with genetic SOD1-ALS. This decision reflects the ALS Association's commitment to ensuring that people living with ALS have access to promising ALS treatments without delay. "This is a victory for the entire ALS community," said Calaneet Balas, president and CEO of the ALS Association. "It's critical that FDA-approved treatments are made accessible rather than being labeled as 'experimental.' We are grateful to everyone in our community who helped make this day happen." Balas added: "We hope this sends a message to the entire rare disease community and pharmaceutical industry that new treatments can be developed and made accessible to those who will benefit from them. We need to ensure more ALS treatments are developed and approved that will help everyone living with ALS." The ALS Association played a key role in the historic CMS directive by participating and advocating for the research, approval, and accessibility of Qalsody for people living with ALS. In 2004, the ALS Association was the first to fund research into ALS-specific antisense oligonucleotide (ASO) technology, investing over $1.3 million in groundbreaking studies that laid the foundation for the development of Qalsody. This early commitment supported preclinical studies, safety trials, and the first-in-human phase 1 trial, which established SOD1 as a viable therapeutic target. In 2023, Qalsody became the first gene-based therapy approved for ALS , thanks in part to the ALS Association's efforts, including a united push from the ALS community for FDA accelerated approval. This new CMS directive provides precedent for state regulators to issue similar actions for other private insurers. According to the Valor study published in 2022 , Qalsody, which was developed specifically to target the RNA produced by mutated SOD1 genes, has demonstrated significant promise in clinical trials and real-world studies. In the phase 3 VALOR trial, Qalsody reduced levels of mutated SOD1 proteins in cerebral spinal fluid by 35% within eight weeks and decreased bloodstream levels of neurofilament light chain (NfL)—a key biomarker of neurodegeneration—by 50% within 12-16 weeks. These biological changes translated into measurable clinical benefits, including slower disease progression, improved respiratory function, and enhanced quality of life after 52 weeks of treatment. Real-world data has since validated these findings, with some patients stabilizing or even experiencing improvements in motor function and quality of life. When insurance companies began denying access to Qalsody, labeling it as "experimental," the ALS Association took decisive action, working directly with CMS to launch an investigation into these unjust denials. By presenting evidence of widespread insurance rejections and demonstrating the critical need for immediate intervention. In addition to working with CMS, the ALS Association actively engaged policymakers, held strategic meetings with state and federal legislators, and served as a staunch advocate for patients, ensuring their voices were heard and their rights to life-changing treatment were upheld. The ALS Association urges anyone previously denied Qalsody by their Medicare Advantage plan to contact their ALS specialist immediately to begin the process of securing access to this critical treatment. For more information on the CMS directive visit als.org About the ALS Association The ALS Association is the largest ALS organization in the world. The ALS Association funds global research collaborations, assists people with ALS and their families through its nationwide network of care and certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association is working to make ALS a livable disease while urgently searching for new treatments and a cure. For more information about the ALS Association, visit our website at www.als.org . About ALS Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. Over the course of the disease, people lose the ability to move, to speak, and eventually, to breathe. The disease is always fatal, usually within five years of diagnosis. Few treatment options exist, resulting in a high unmet need for new therapies to address functional deficits and disease progression. View original content to download multimedia: https://www.prnewswire.com/news-releases/groundbreaking-directive-ensures-als-patients-on-medicare-advantage-gain-access-to-qalsody-302329525.html SOURCE The ALS Association

The Pittsburgh Steelers beat the Cleveland Browns to stay top of the AFC North and the Minnesota Vikings dominated the Atlanta Falcons. The Philadelphia Eagles closed in on a play-off berth with a 22-16 win over the Carolina Panthers at Lincoln Financial Field. Quarterback Jalen Hurts bundled over from a yard to set the Eagles on their way and a touchdown late in the second quarter from Devonta Smith saw NFC East leaders Philadelphia in front 14-10, only for Chuba Hubbard to drive in from a yard out and edge the visitors ahead again. Hopes of an upset, though, were dashed when tight end Grant Calcaterra took a four-yard pass and Saquon Barkley’s conversion saw the Eagles maintain their position as the number two team in the NFC, behind the Detroit Lions. The Pittsburgh Steelers ran out 27-14 winners over AFC North rivals the Cleveland Browns. The Steelers took a 13-7 half-time lead following a Najee Harris touchdown and two Chris Boswell field goals, and further touchdowns from Van Jefferson and Pat Freiermuth made the game safe despite David Njoku’s brilliant touchdown catch. The Minnesota Vikings improved their record to 11-2 with a sixth straight win, 42-21 over the Atlanta Falcons. Jordan Addison caught three touchdowns and Justin Jefferson two, the latter ending a two-month drought, before Aaron Jones ran in to put the result beyond doubt. Quarterback Sam Darnold threw for a career-high 347 yards. The Tampa Bay Buccaneers took the outright lead of the NFC South with a 28-13 win over the Las Vegas Raiders at Raymond James Stadium, where Baker Mayfield threw for 295 yards and three touchdowns. Jalen McMillan and Rachaad White scored twice each while Raiders QB Aidan O’Connell ran in a one-yard score but was later forced off injured and replaced by third-stringer Desmond Ridder. The Miami Dolphins kept their outside play-off hopes alive after battling to a 32-26 win over the New York Jets after overtime at Hard Rock Stadium. An early touchdown from De’Von Achane and three field goals from Jason Sanders – one from 57 yards – had the Dolphins ahead 15-13 at half-time. Davante Adams responded as the Jets looked to end an eight-game losing streak but Tyreek Hill’s score helped extend the game into overtime, when Tua Tagovailoa picked out Jonnu Smith to seal a dramatic victory. The New Orleans Saints ground out a 14-11 win over the New York Giants while the Jacksonville Jaguars edged AFC South rivals the Tennessee Titans 10-6 in Nashville to snap a five-match losing streak.

2 Growth Stocks Set to Skyrocket in 2025 and BeyondNearly a month into a federal investigation of unexplained aircraft witnessed nightly in New Jersey, Pennsylvania and New York, the White House and FBI have minimized concerns about the reports of suspected drones. Federal authorities “have not been able to corroborate any of the reported visual sightings," which number in the hundreds since the middle of November, White House spokesperson John Kirby said Thursday at a press briefing . MORE : Monopoly-themed boutique hotel to be built in Atlantic City "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. Federal investigators have used various electronic detection methods to gain a better understanding of the aircraft, which have been reported to appear in clusters during the night. Kirby said state and local law enforcement also have not been able to conclusively explain the sightings, and federal officials believe many of the sightings are routine air traffic. "Upon review of available imagery, it appears that many of the reported sightings are actually manned aircraft that are being operated lawfully," Kirby said, adding the U.S. Coast Guard has not found any evidence that foreign vessels are involved in deploying aircraft. Feds say people are mistaking airplanes for drones In a joint statement, the FBI and the Department of Homeland Security echoed many of the remarks that came from the White House on Thursday. "Historically, we have experienced cases of mistaken identity, where reported drones are, in fact, manned aircraft or facilities," the agencies said . "We take seriously the threat that can be posed by unmanned aircraft systems (UAS), which is why law enforcement and other agencies continue to support New Jersey and investigate the reports. To be clear, they have uncovered no such malicious activity or intent at this stage." The statement appears to backtrack from comments made by the FBI's Newark office, which said witnesses had spotted "the cluster of what look to be drones and a possible fixed wing aircraft" at various points along the Raritan River in North Jersey. Kirby said reports about the aircraft highlight "gaps in authorities" that point to the need for Congressional action to boost preparedness against threats that drones could pose to critical infrastructure. During a Wednesday press briefing, the Pentagon said the aircraft seen on the East Coast are not U.S. military drones. Pentagon officials also shot down claims by U.S. Rep. Jeff Van Drew (R-N.J.) that the aircraft are coming from an Iranian ship off the Atlantic coast. Van Drew, who represents much of South Jersey, including the shore, had called for the aircraft to be shot down, a measure only the federal government would have the authority to do. N.J., Pa. politicians demand 'more concrete' info aircraft sightings Some elected officials in New Jersey, Pennsylvania and New York have grown increasingly alarmed by the lack of answers about the aircraft entering their communities. U.S. Sen. Andy Kim (D-N.J.), who was sworn into office this week, spent Thursday night in Hunterdon County observing dozens of aircraft in the sky over a two-hour period. He posted videos of the aircraft he saw Friday morning on social media. Last night I went out with local police to spot drone flying over New Jersey, here’s what I saw. We drove to Round Valley Reservoir and the officer pointed to lights moving low over the tree line. Sometimes they were solid white light, others flashed of red and green.THREAD pic.twitter.com/ly7kUUDWDn "This has gone on for weeks. It's hard to understand how with the technology we have we aren't able to track these devices to determine origin and this makes me much more concerned about our capabilities more broadly when it comes to drone detection and counter measures," Kim said. Earlier in the week, Kim joined Senate Majority Leader Chuck Schumer (D-N.Y.), Sen. Kirsten Gillibrand (D-N.Y.) and Sen. Cory Booker (D-N.J.) in sending a letter requesting more help from the FBI, DHS and the Federal Aviation Administration. On Friday, New Jersey Gov. Phil Murphy said he wrote to President Joe Biden seeking increased federal resources for the investigation. "New Jersey residents deserve more more concrete information about these (unmanned aircraft system) sightings and what is causing them," the letter said. "The continued reporting of UAS activity has raised more questions than answers and prompted an outcropping of conspiracy theories across social media and other platforms." Pennsylvania Gov. Josh Shapiro spoke briefly about the unidentified aircraft during an unrelated event in Scranton on Friday. He said he's directed Pennsylvania State Police to fly helicopters to observe any unusual activity, adding that the agency has been conducting exercises focused on the aircraft. "I can't speak for the rest of the nation, but we're focused on it here in Pennsylvania. We've been told, again, by our federal partners, it does not pose any kind of national security or personal security risk," Shapiro said. "But you know, as the old saying goes, trust but verify." In New Jersey, state and local lawmakers met Wednesday at New Jersey State Police Headquarters for a law enforcement briefing on New Jersey's probe of drone activity. In a social media post , state Rep. Dawn Fantasia (R-24) recapped the meeting and said it was premature to conclude there are no threats to the public. "We know nothing. PERIOD," Fantasia wrote. "To state that there is no known or credible threat is incredibly misleading, and I informed all officials of that sentiment." Fantasia said reports of suspected drones ranged between four and 180 sightings per night, usually from dusk until 11 p.m. She said many of the aircraft appear large — up to 6 feet in diameter — and seem to avoid detection by traditional methods. In Pennsylvania, where sightings have increased since the start of December, U.S. Rep. Brian Fitzpatrick (R-1) said Friday he was concerned about reports of drone activity overseas near a U.S. military base in Ramstein, Germany. Unidentified drones also were spotted late last month above U.S. bases in the United Kingdom, the BBC reported. Fitzpatrick had called Wednesday for more transparency from federal investigators. "(It's) an unacceptable threat to our security," Fitzpatrick said. "Enough is enough. We need answers. We need action. Now."

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Bronny James is going to play in at least one road game in the G League after all. James, 20, the son of NBA all-time leading scorer LeBron James, is scheduled to play his first road game for the South Bay Lakers on Thursday in Phoenix against the Valley Suns, a league source confirmed to The Athletic , which represents a reversal from a previous decision for Bronny to play only in home games. Advertisement “That was the decision at the time,” said a league source with knowledge of the young James’ plans, confirming multiple media reports that Bronny would indeed play in Phoenix with South Bay. It was quite a day for James family news around the Lakers. At practice Wednesday, Los Angeles coach JJ Redick told reporters that LeBron was not currently with the team for an “excused absence.” LeBron missed his first game of the 2024-25 season Sunday — a win over the Trail Blazers — and the Lakers don’t play again until Friday at Minnesota. Redick said LeBron was “taking some time.” The last time James took a leave of absence from his team during the season was nearly 10 years ago when he decided not to play on his birthday in a game in Atlanta and wound up taking two weeks off from the Cavs to clear his mind and allow nagging injuries to heal. LeBron, who turns 40 on Dec. 30, is averaging 23 points on 49.5 percent shooting, 9.1 assists and 8.0 rebounds. His scoring average is the lowest since his rookie season 21 years ago. Bronny, meanwhile, is averaging 8.7 points and 2.7 assists in three G League games this season. He’s appeared in seven contests with the Lakers and has scored four total points on 1-of-8 shooting from the field. A late second-round pick who missed half of his lone college season at the University of Southern California last year, James is now going to be available for at least some South Bay road games because “more reps are good,” the league source said. The same source said Bronny’s availability for road games in the G League would still be selective. South Bay plays 24 home games this season — not a huge chunk of games for a young player who needs experience. When The Athletic reported the initial decision for James to only play home games for South Bay (who holds their games at the L.A. Lakers’ training facility in El Segundo, Calif.), the door was left ajar for Bronny to appear in at least two road games — in Cleveland, where the Cavs have a G League team that hosts South Bay just after Christmas and where James’ grandparents live. Advertisement Bronny’s contract with the Lakers is not a “two-way” deal, which is more common for players drafted as low as he was, or for undrafted players, who show promise to their NBA parent club but need seasoning in the minors. Players on “two-way” deals must split time between the NBA and G League. Bronny’s deal — worth $7.9 million over four years, with the first three seasons fully guaranteed — is an NBA contract. He takes one of the Lakers’ 15 roster spots reserved for players on NBA contracts . Required reading (Photo: Adam Pantozzi / Getty Images)

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