Biogen hits snag after Alzheimer’s drug fails to win support from FDA panel

first_img– Advertisement – A Food and Drug Administration panel on Friday unexpectedly declined to endorse Biogen‘s experimental Alzheimer’s drug aducanumab in a setback for the pharmaceutical company.In an 8-1 vote, the panel said Biogen’s late-stage study didn’t provide “strong evidence” showing that aducanumab effectively treated Alzheimer’s. Two other panelists said it the data was “uncertain.”The FDA could still approve the drug, which would make it the first drug approved to slow cognitive decline in people living with the disease and the first new treatment for Alzheimer’s in nearly 20 years.- Advertisement – Biogen headquarters on Binney Street on Thursday, March 21, 2019 in Cambridge, Massachusetts.Nicolaus Czarnecki | MediaNews Group | Getty Images Biogen’s intravenous drug targets a “sticky” compound in the brain known as beta-amyloid, which is hypothesized to play a role in the devastating disease. Biogen has previously estimated about 1.5 million people with early Alzheimer’s in the U.S. could be candidates for the drug, according to Reuters.Some Alzheimer’s experts and Wall Street analysts have been skeptical about the drug’s benefits, especially after Biogen reversed its decision to seek regulatory approval in 2019.The company shocked investors in October of that year by announcing it was seeking regulatory approval after all after pulling the plug on the drug in March. Biogen scientists said at the time that a new analysis of a larger data set showed that aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”There are currently no drugs cleared by the FDA that can slow or reverse the mental decline from Alzheimer’s, which is the sixth leading cause of death in the United States. The U.S. agency has approved Alzheimer’s drugs aimed at helping symptoms, not actually reversing or slowing the disease itself.During the meeting on Friday with the Peripheral and Central Nervous System Drugs Advisory Committee, Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said there was an “enormous unmet medical need.” “Currently approved treatments do not target the underlying pathology of Alzheimer’s disease and their beneficial effects are modest,” he said, adding there has not been an approval of a treatment for the disease since 2003.In a letter sent to the FDA ahead of the meeting, the Alzheimer’s Association said the publicly released data so far “justifies approval accompanied by a Phase 4 post-marketing surveillance study.”“The alternative, requiring completion of an additional Phase 3 trial, would deny broad access up to four years while it is completed. A four-year delay is too long to wait for millions of Americans facing a progressive, fatal disease. A four-year delay is too long to wait for millions of American caregivers,” the organization said.The FDA’s final decision on Biogen’s drug is expected by March.This is a developing story. Please check back for updates.center_img Shares of Biogen were halted Friday ahead of the meeting of outside experts.Biogen shares had surged Wednesday after FDA staff gave a positive review of the drug. In a 343-page document, the FDA said results from Biogen’s late-stage trial were “highly persuasive” and the study was “capable of providing the primary contribution to a demonstration of substantial evidence of effectiveness” of aducanumab. “Based on the considerations above, the applicant has provided substantial evidence of effectiveness to support approval,” the FDA added.Alzheimer’s disease is a progressive neurodegenerative disorder that slowly destroys memory and thinking skills. The Alzheimer’s Association estimates more than 5 million Americans are living with the disease.- Advertisement – – Advertisement –last_img read more

Docklands building peaks

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Some Astros are likely to draw boos during World Series rematch with Dodgers

first_imgThe Astros acquired Osuna from the Toronto Blue Jays while he was serving a 75-game suspension for violating MLB’s domestic violence policy. The 23-year-old pitcher began a minor league assignment Thursday and will reportedly be reinstated once he’s eligible Sunday.“I’m sure it’s an interesting move in the clubhouse,” Wood said. “Their quote, unquote, zero-tolerance policy; that was a pretty interesting thing as well. It’s a crazy dynamic. It’s hard to understand or know how that clubhouse will react.”Wood was referring to the apparent contradiction between a prepared statement by Astros general manager Jeff Lunhow citing the team’s “zero tolerance policy” toward domestic abuse, and their acquisition of an alleged domestic abuser.Wood also questioned how two Astros players would react to having Osuna as their teammate. When video showed a former Astros prospect beating his girlfriend in a stairwell earlier this year, Verlander and McCullers publicly condemned the player on Twitter.“If that organization can accept the backlash from trading for someone in that situation, that’s for them to deal with,” Wood said. “It’s hard to speak on the clubhouse aspect of it without ever dealing with that situation, but I’m sure it will be an interesting part of the rest of their season for sure.”UTLEY LANDS ON DLIn order to activate third baseman Justin Turner, the Dodgers placed veteran second baseman Chase Utley on the 10-day disabled list with left wrist inflammation.“It is going to be a short-term thing,” Roberts said. “It’s one of those things where you have players all year long who are dealing with things. When you have an excess of players and you want them to play – whether it’s a Justin Turner or a John Axford coming – there’s certain things where now we can appreciate or recognize something, nurse it, get them back to health. That’s what we’re trying to do.”The Dodgers did not announce the transaction until after Roberts briefed the media Thursday afternoon, so he did not directly address Utley’s injury. The manager said the move was delayed because the team was also contemplating placing a relief pitcher on the 10-day disabled list.Axford, who was acquired from the Toronto Blue Jays at the trade deadline, will be added to the Dodgers’ roster on Friday. Roberts said it’s possible that the ailing reliever could join Utley on the DL then.ALSOMaking his first minor league rehabilitation appearance, Hyun-Jin Ryu threw four scoreless innings for Class-A Rancho Cucamonga. The left-hander did not walk a batter and struck out four. Of Ryu’s 47 pitches, 34 were strikes, including two hits (both singles). … Ryu has not pitched since May 2 because of a strained left groin. … Left-hander Zac Rosscup (left middle finger inflammation) threw a scoreless inning in relief of Ryu. … Andre Ethier’s retirement ceremony is scheduled for 6:45 p.m. on Friday at Dodger Stadium. Actor Jason Bateman will emcee the ceremony, which will include tributes from teammates past and present. … Kevin Hart and Kourtney Kardashian were on the field prior to batting practice, filming segments for Hart’s YouTube series “What The Fit.” Some Dodger players made cameos.UP NEXTDodgers (LHP Alex Wood, 7-5, 3.68 ERA) vs. Astros (RHP Justin Verlander, 10-6, 2.24 ERA), Friday, 7 p.m., SportsNet LA (where available), ESPN+ (out of market only)Related Articles Fire danger is on Dave Roberts’ mind as Dodgers head to San Francisco Dodgers’ Max Muncy trying to work his way out of slow start Newsroom GuidelinesNews TipsContact UsReport an Error Dodgers hit seven home runs, sweep Colorado Rockies How Dodgers pitcher Ross Stripling topped the baseball podcast empire LOS ANGELES — The last time the two most recent World Series participants were granted a regular-season rematch was 2016, when the New York Mets took three of four games against the Kansas City Royals. The Dodgers will try to turn the tables on the Houston Astros similarly this weekend.At least one player Thursday afternoon did not want to offer a preview, professing that looking ahead would violate his one-game-at-a-time mantra. Dodgers manager Dave Roberts suggested it isn’t always that easy.“For what that’s worth, yeah, each game is one game, but you do want to bring your best playing against a championship team,” Roberts said. “When you get that opportunity to play them again, we know we have to play our best to beat them. We’re going to see some very good pitching.”Sign up for our Inside the Dodgers newsletter. Be the best Dodger fan you can be by getting daily intel on your favorite team. Subscribe here.The Astros will send Justin Verlander, Lance McCullers Jr. and Gerrit Cole to the mound in that order. The Dodgers will counter with Alex Wood, Kenta Maeda and Walker Buehler. Cody Bellinger homer gives Dodgers their first walkoff win of season “It’ll be fun to see those guys, have some of those feelings from last October, November creep back into our clubhouse,” Wood said. “It’s always fun to play teams like that.”Several of last fall’s familiar faces will not be on the field. Astros second baseman Jose Altuve went on the 10-day disabled list July 25 with knee discomfort, joining shortstop Carlos Correa (back) and catcher Brian McCann (knee). World Series MVP George Springer was benched because of a sore shoulder Tuesday but did not go on the DL.Yuli Gurriel is healthy, and the Astros’ first baseman was booed roundly the last time he came to Dodger Stadium. After hitting a home run against Yu Darvish in Houston during Game 3, Gurriel made a gesture toward the Japanese-born pitcher that many interpreted as racist. Gurriel apologized after the game, but animus among Dodger fans followed him to Los Angeles.Gurriel served a five-game suspension without pay at the outset of the 2018 season. Darvish signed with the Chicago Cubs after last season, but Dodger fans are unlikely to forget the incident. When Milwaukee Brewers pitcher Josh Hader’s name was announced at Dodger Stadium on Monday, less than two weeks after his series of offensive Twitter comments were publicized during the All-Star Game, boos were audible throughout Chavez Ravine.The series finale will offer fans another conspicuous target: Roberto Osuna.last_img read more