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U.S. Supreme Court seeks Biden views on Harvard admissions dispute
  + stars: | 2021-06-14 | by ( Lawrence Hurley | ) sentiment -0.97   time to read: +2 min
The U.S. Supreme Court on Monday asked President Joe Biden's administration to give its views on whether the justices should hear a challenge to Harvard University's consideration of race in undergraduate student admissions. The lawsuit accused Harvard of discriminating against Asian American applicants in violation of a landmark 1964 federal civil rights law. The Supreme Court has a 6-3 conservative majority. Harvard, one of the world's most prestigious schools, has said that the number of Black and Hispanic students would drop by nearly half if its affirmative action program were to be struck down. Students for Fair Admissions has said its members include Asian American applicants rejected by Harvard.
Persons: Joe Biden's, Edward Blum, Blum Organizations: U.S, Supreme, Harvard, Fair, Asian, University of Texas, Circuit, Appeals, Ivy League, Civil, Thomson Locations: Boston, Cambridge , Massachusetts
Washington University's Olin Business School has been ranked a top program for entrepreneurship. Insider asked the associate dean of graduate enrollment and Olin students for tips on how to get in. Out of 131 schools, Olin's MBA program currently ties with Notre Dame's Mendoza College of Business for 30th place in US News & World Report's 2021 Best Business Schools for its full-time MBA and 12th for its part-time MBA. Nnakwue reached out to Olin students on LinkedIn and introduced himself as a prospective student interested in learning more about the Olin experience. "I got to learn about the Olin experience from those who were experiencing it and shaping it firsthand," Nnakwue said.
Persons: Washington, Olin, Louis, Quants, Ruthie Pyles, Pyles, Bryanna Brown, Brown, Jessica Voss, Jessica, Franklyn Nnakwue, Nnakwue, who'd, Duckenson Joseph, Duckenson Joseph Duckenson Joseph, Joseph Organizations: Olin Business School, Washington University, Stanford, Harvard, University of Michigan's Ross School of Business, Quants, Inc, Notre Dame's Mendoza College of Business, US, Business Schools, Olin, LinkedIn, St, Washington University's Locations: St, Barcelona, Paris, Lima, Peru, Haiti, United States
Such a move is often a prelude to the court ultimately deciding to hear a case, though not always. In addition, Chief Justice John Roberts, who wields some influence over the court, has expressed views fiercely antagonistic to affirmative action. Biden's Justice Department is likely to urge the justices not to hear the case, and to leave the lower court opinion standing. The Justice Department and the solicitor general's office did not return a request for comment. Now retired-Justice Anthony Kennedy, who delivered the opinion of the court in that case, warned that affirmative action polices would likely require continual refinement.
Persons: Joe Biden's, Elizabeth Prelogar, Monday's, Edward Blum, Donald Trump, John Roberts, William Consovoy, Trump, Yale, Anthony Kennedy, Kennedy Organizations: Joe Biden's Department of Justice, Harvard University, of Harvard, Fair, Civil, Court, U.S, Circuit, Harvard, Justice Department, Yale, Trump, University of Texas Locations: United States, Austin
Four at Toshiba Resign Over Campaign to Thwart Foreign Shareholders
  + stars: | 2021-06-13 | by ( Peter Landers | Megumi Fujikawa | ) sentiment -0.85   time to read: +1 min
TOKYO— Toshiba Corp. said two executives and two outside directors would resign after they were accused of working with the government against foreign shareholders, the first fallout in a scandal that has highlighted Japan’s business-government ties. Sunday’s announcement came three days after a report by outside lawyers depicted wide-ranging cooperation between Toshiba management, the head of the Toshiba board’s audit committee and officials at the Ministry of Economy, Trade and Industry to block foreign shareholders from gaining board influence. It was the latest blow to the reputation of a company once known world-wide for its laptop computers, television sets and medical equipment. Shareholders based outside Japan now control more than half the company after injecting capital in late 2017 to repair Toshiba’s finances. The outside lawyers’ report, commissioned by shareholders after a push by the foreign activists, suggested that Toshiba executives and government officials shared concern over the activists’ power.
Persons: , Organizations: TOKYO — Toshiba Corp, Toshiba, Ministry, Economy, Trade, Industry, Harvard Locations: Japan, U.S
TOKYO (Reuters) -Toshiba Corp’s second-biggest shareholder on Sunday demanded the board chairman and three other directors immediately resign after an investigation found the company had colluded with the Japanese government to pressure foreign investors. FILE PHOTO: The logo of Toshiba is seen as a shareholder arrives at an extraordinary shareholders meeting in Chiba, Japan, March 30, 2017. REUTERS/Toru HanaiThe letter, seen by Reuters, is from 3D Investment Partners, which owns a 7.2% stake in Toshiba. It is likely to heighten scrutiny into governance at Toshiba, a renowned industrial conglomerate in crisis sparked by Thursday’s report. Major shareholder advisory firms recommended against some of the candidates, including the four addressed in the 3D letter.
Persons: Toru Hanai, Thursday’s, Osamu Nagayama, Organizations: Toshiba, REUTERS, Reuters, Investment Partners, Harvard Locations: TOKYO, Chiba, Japan
TOKYO, June 13 (Reuters) - Toshiba Corp’s second-biggest shareholder on Sunday demanded the board chairman and three other directors resign immediately after an investigation found the company had colluded with the Japanese government to pressure foreign investors. It is likely to the deepen a crisis sparked by last week’s report, which marked an explosive turn in a long battle between the Japanese company’s management and foreign shareholders. These include activist investors and Harvard University’s endowment fund. The revelations in the shareholder-commissioned report “are deeply troubling and represent one of the most prominent and shocking corporate governance failures among large public companies anywhere in the world in the last decade,” the 3D letter says. The letter, addressed to board chair Osamu Nagayama and three current audit committee members, describes Nagayama as “ultimately responsible for Toshiba’s recent governance failures, including the flawed internal investigation and the board’s determination to oppose an outside, independent investigation.” (Reporting by Makiko Yamazaki; Editing by William Mallard)
Persons: , Osamu Nagayama, Makiko Yamazaki, William Mallard Organizations: Toshiba, Reuters, Investment Partners, Harvard Locations: TOKYO
The logo of Toshiba is seen as a shareholder arrives at an extraordinary shareholders meeting in Chiba, Japan, March 30, 2017. The letter, seen by Reuters, is from 3D Investment Partners, which owns a 7.2% stake in Toshiba. It is likely to heighten scrutiny into governance at Toshiba, a renowned industrial conglomerate in crisis sparked by Thursday's report. The company was holding an emergency meeting on Sunday to discuss reassigning the candidates for three key board committees ahead of a June 25 shareholder meeting. Major shareholder advisory firms recommended against some of the candidates, including the four addressed in the 3D letter.
Persons: Toru Hanai, Toru Hanai Toshiba Corp's, Thursday's, Osamu Nagayama Organizations: Toshiba, REUTERS, Toru Hanai Toshiba, Reuters, Investment Partners, Harvard, Thomson Locations: Chiba, Japan
And each hour earlier that you wake up, the better the benefit, according to the study. Morning people tend to have "better alignment with typical work-rest schedules," whereas night owls might have a harder time adapting, Vetter says. Physiologically, people who wake up earlier also get higher and earlier light exposure, which may affect their wellbeing, Vetter says. Your chronotype is genetic, but there are some things that you can do to "hack" your body clock to wake up earlier, Vetter says. The U.K. study also used data from 451,025 people involved in the U.K. Biobank.
Persons: Celine Vetter, Vetter Organizations: University of Colorado, Broad Institute of MIT, Harvard Locations: University, University of Colorado Boulder, University of Colorado , Boulder, Morning
Ray McGuire is a former Wall Street executive who is running for New York City mayor. McGuire wants to enact a job accelerator program that would bring back 50,000 positions at small businesses. New York City may be a preeminent global financial capital, but the city runs on its small businesses. "I want to have the greatest, most inclusive comeback in the history of New York City," he said. There'd be a shot clock, which would put some discipline into when the city responds to applications from small businesses.
Persons: Ray McGuire, McGuire, Merrill Lynch, He'd, Morgan Stanley, Bill de Blasio, You've, David Dee Delgado, We'll, Red, they're, I've, de Blasio, de, hasn't Organizations: Wall Street, New York City, City, New, Partnership, Democratic, Harvard University, Citigroup, Mayoral, Network's, Asian, doer Locations: New York, New York City, Dayton , Ohio, . New York, York City, Queens, Coney, Brooklyn, Lower Manhattan
As law firms and their clients seek to digitize and streamline work, VCs have been opening their wallets to the growing legal-tech space. Launched in 2017, Athennian is used by nearly 200 legal departments and law firms, including Dentons, Fastkind, and Paul Hastings, to automate documents like board minutes, stock certificates, and shareholder consents. Founded in Copenhagen in 2017, Contractbook uses data to automate documents, offering an end-to-end contracts platform for small- and medium-sized businesses (SMBs). As attorneys have been propelled to work remotely amid the pandemic, data security and streamlined work processes are top-of-mind for law firms, leading them to adopt cloud technology. BlackBoilerBlackBoiler is an automated contract markup software that's used by Am Law 25 firms and several Fortune 1000 companies.
Persons: VCs, Adrian Camara, Athennian, Paul Hastings, Jack Newton, Jerry Ting, Fried Frank, Niels Brøchner, Jarek Owczarek, Viktor Heide, Contractbook, inbox, Kiwi Camara, Dan Broderick, Broderick Organizations: Arthur Ventures, Touchdown Ventures, Clio's, Round13 Capital, Atlantic, Amity Ventures, Vertex Ventures, Harvard Law School, Venture Partners, Kiwi, Georgian Partners, VC titans, Bessemer Venture Partners, LiveOak Venture Partners, Am Law, Law Locations: PitchBook, manila, inbox, Denmark, Copenhagen, Houston
But the opposite isn't true: Even if the virus didn't undergo any laboratory manipulation, that wouldn't rule out a lab escape. However, the people who do think the coronavirus might have been engineered focus on a few particular areas of its genome. One of those labs, he said, is the Wuhan Institute of Virology (WIV), where researchers studied bat coronaviruses before the pandemic. Accidents do happenAn aerial view of the campus of the Wuhan Institute of Virology in China's Hubei province on May 27, 2020. Guards stand outside the Wuhan Institute of Virology on February 3, 2021.
Persons: Joe Biden, Dr, Francis Collins, Saul Loeb, Steven Quay, what's, David Baltimore, Nicholas Wade, Wade, Xia Junjun, Robert Redfield, Redfield, John Doench, Anthony Fauci, it's, That's, Fauci, Doench, we're, Hector Retamal, Peter Ben Embarek, Ben Embarek Organizations: National Institutes of Health, Atossa Therapeutics Inc, Street Journal, Wuhan Institute of Virology, Blue Sky, Theatre, Getty, CNN, Broad Institute of MIT, Harvard, National Institute of Allergy, State Department, Wall Street, World Health Organization, WHO, Wuhan Institute, Virology, Department Locations: Wuhan, China, Baltimore, China's Hubei, AFP, Taiwan, Singapore, Beijing
In this article LLYBIIBAduhelm by Biogen Source: BiogenThe FDA's approval of Biogen's Alzheimer's drug Aduhelm was a landmark moment in the life of Dr. Paul Aisen. One immediate challenge facing other teams working on a wider Alzheimer's drug pipeline, he said in a recent video call, would be to retain participants in ongoing trials, let alone attract new ones. "In most cases," he explained, many Alzheimer's sufferers will drop out of other drug studies to pursue treatment with the newly approved Aduhelm. The controversy surrounding the Biogen drug, including its potential cost, comes against a landscape of massive, unmet need for dementia treatment and a disease that costs the U.S. as much as $259 billion annually. That is why some dementia drug experts are focusing on the renewed attention and fresh financing rather than the potential negatives from the Biogen approval, according to Dr. Jeffrey Cummings, a neurologist at the University of Nevada, Las Vegas, who publishes an annual review of the Alzheimer's drug development pipeline.
Persons: Aduhelm, Dr, Paul Aisen, Aisen, Aaron Kesselheim, aducanumab, , Boehringer, Biogen, Jeffrey Cummings, Cummings, Eli Lilly's donanemab, Roche's, Eli Lilly, David Ricks, Biogen's Aduhelm, Lilly Organizations: Biogen, Therapeutic Research, USC, and Drug Administration, FDA, Harvard Medical School, Pfizer, Alzheimer's Association, University of Nevada, National Institutes of Health, pharma, CNBC Locations: San Diego, Las Vegas
Critical Race Theory has become one of the most animating issues for Republicans nationwide. What is critical race theory? "Critical race theory is a practice. Republicans in a number of states have pushed to ban critical race theory from schools, misleadingly contending that the concept teaches kids to hate the US and each other. Coverage of critical race theory dominates Fox News coverage across daytime, primetime, and online.
Persons: George Floyd, Kimberlé Crenshaw, Andrew Hartman, Jelani Cobb, Cobb, Ron DeSantis, Hartman, Donald Trump, Trump, Joe Biden, Hillary Clinton, Barack Obama Organizations: Republicans, Fox News, GOP, UCLA, Columbia University, CNN, Republican, Illinois State University, Columbia Journalism School, Florida Gov, Harvard Law, Management, Federal, The New York Times, Fox
This researcher is trying to flip the script about student loan forgiveness
  + stars: | 2021-06-12 | by ( Annie Nova | ) sentiment -1.00   time to read: +2 min
The odds of student loan forgiveness happening have never been greater, experts say. Officials at the U.S. Department of Education and the U.S. Department of Justice are currently trying to find answers to that question. And if they decide he doesn't, will Democrats, despite their razor-thin majority, manage to pass legislation forgiving student debt? A number of critics of broad student loan forgiveness say the policy would direct taxpayer dollars to people who are already relatively well-off, since college degrees lead to higher earnings. Now a group of scholars at the Roosevelt Institute, a progressive think tank, have published research they hope will change the minds of Biden and other critics when it comes to student loan forgiveness.
Persons: Joe Biden, Biden Organizations: U.S . Department of Education, U.S . Department of Justice, Penn, The New York Times, CNN, Harvard, Yale, Roosevelt Institute Locations: Invest
Live Covid Live Updates: China's Doctors Warn Cases Are More Severe in Its Latest Outbreak The warnings, delivered on state-run television, match trends in other countries where the Delta variant is spreading. In China’s latest outbreak, doctors say the infected get sicker, faster. Patients are becoming sicker and their conditions are worsening much more quickly, doctors told state-run television on Thursday and Friday. Four-fifths of symptomatic cases developed fevers, they said, although it was not clear how that compared with earlier cases. China’s National Health Commission announced on Friday that nine new cases had been found in Guangzhou the previous day.
Persons: Fauci, Guan Xiangdong, , Chen Bin, Albee Zhang, Paul Ratje, Tom Shimabukuro, Shimabukuro, Immunizations, Kaiti Sullivan, Joseph Allen Organizations: Getty, University, Delta, World Health Organization, Alpha, Health Commission, Guangzhou Municipal Health Commission, Pfizer, Moderna, The New York Times Federal, BioNTech, Centers for Disease Control, The New York Times, Harvard, of Public Health Locations: Wuhan, China, Guangzhou, Britain, Brazil, India, Delta, Seychelles, Mongolia, Shenzhen, Foshan, Albuquerque, U.S, United States, Chan
“Stateless" follows Rosa Iris Diendomi, a young Dominican attorney and immigration advocate of Haitian descent, as she struggles to run for Congress in the Dominican Republic. Though the government, amid international pressure, took measures in 2014 to allow children born in the Dominican Republic and certain others to apply for citizenship, thousands have been deported from the Dominican Republic, including many with valid claims to Dominican citizenship. On camera, Stephenson connects the racial tensions from the island’s past with the current racial politics of the Dominican Republic. It describes the 1937 Perejil Massacre that executed thousands of Haitians and Dominicans of Haitian decent living in the Dominican Republic. “The number of stateless individuals in the Dominican Republic is zero,” he said.
Persons: Michèle Stephenson, Stephenson, Rosa Iris Diendomi, , ” Diendomi, Diendomi, Moraime, , Trujillo, Sténio Vincent, , Danilo Medina, Americas —, “ It’s, Napoleon’s, ” It’s, It’s Organizations: Tribeca, NBC News, Dominican Supreme, Associated, The New York Times, Dominican State Department, Dominican, Thomas Aquinas University, Santo, Harvard University, Blacks, el gran libertador, NBC, Facebook, Twitter Locations: Dominican Republic, Haiti, Canada, Argentina, Americas, Panamanian, Haitian, Dominican, Hispaniola, , U.S, Blacks, Santo Domingo, Jamestown, Latin America, United States, el gran, Spanish
Yet the U.S. is now leaning on the state to transform the economy by giving trillions of dollars to consumers and even taking a more direct hand in industrial planning. In government-loving Europe, political limitations may prevent a comparable economic boost. Analysts expect Europe to bounce back strongly from Covid-19 but, unlike in the U.S., they forecast permanent economic damage. Spanish officials believe it could boost economic growth by 2 percentage points a year. Investors should welcome Europe’s turn away from austerity policies, but remain skeptical of fixes for its lopsided economy.
Persons: Alexander Hamilton’s, , Alberto Sibaja, Sweden’s Northvolt Organizations: European Union, Treasury, Manufactures, U.S . Senate, EU, Harvard Kennedy School of Government’s, Economic, Zuma Locations: U.S, Europe, European, Covid, Spain, Italy, offshoring, China, East Asia, underdevelopment, Northern Europe, India, Turkey, Barcelona, Madrid
Four Toshiba directors call for board and management shake-up
  + stars: | 2021-06-11 | by ( Makiko Yamazaki | ) + 0.00   time to read: +3 min
The logo of Toshiba Corp. is seen at the company's facility in Kawasaki, Japan June 10, 2021. REUTERS/Kim Kyung-Hoon/File photoFour of Toshiba Corp’s (6502.T) independent directors called on Friday for a shake-up of the Japanese conglomerate’s management and board, accusing them of “unacceptable” actions directly against the interests of shareholders. The public criticism is the clearest sign yet of the fallout from the shareholder-commissioned report released on Thursday, which has put Toshiba's management and Japan's powerful trade ministry under scrutiny and renewed concerns about governance. Earlier on Friday, U.S. proxy advisory firm Glass Lewis urged shareholders at this year's AGM to vote against the re-appointment of Toshiba board chairman Osamu Nagayama and four others nominated by the company for the 13-member board. The independent investigation found Toshiba had devised a plan to exert undue influence on Singapore-based Effissimo Capital Management, Toshiba's top shareholder, to withdraw its proposed board nominees.
Persons: Kim Kyung, Toshiba Corp’s, Jerome Black, Paul Brough, Ayako Weissman, George Zage, Glass Lewis, Osamu Nagayama, Hiroshi Kajiyama Organizations: Toshiba Corp, REUTERS, Toshiba, Effissimo Capital Management, Harvard, Ministry, Thomson Locations: Kawasaki, Japan, Singapore
A third member of an FDA expert panel has resigned over the agency's accelerated approval of a new Alzheimer's drug. A third member of a Food and Drug Administration expert panel has resigned over the approval of a controversial new Alzheimer's drug. In a resignation letter obtained by CNBC, Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency's decision to approve Biogen's new Alzheimer's drug, Aduhelm, "was probably the worst drug approval decision in recent US history." "The FDA, in using the accelerated approval mechanism, they could not endorse any evidence of demonstrable clinical benefit. Neurologist Dr. Joel Perlmutter of Washington University in St. Louis also resigned from the panel on Monday.
Persons: Aduhelm, Aaron Kesselheim, Kesselheim, David Knopman, Insider's Allison DeAngelis, Knopman, Dr, Joel Perlmutter, Louis Organizations: FDA, Drug Administration, CNBC, Harvard Medical School, Drugs Advisory, Mayo Clinic, Washington University Locations: St
The logo of Toshiba Corp. is seen at the company's facility in Kawasaki, Japan June 10, 2021. REUTERS/Kim Kyung-Hoon/File photoJapan's trade ministry on Friday denied its officials directed an adviser to contact Toshiba Corp (6502.T) shareholders as part of a plan to pressure them to support management in a key vote on board membership. Among its findings, the investigators' report said the trade ministry "effectively asked" a government adviser, described as "Mr. M", to negotiate with Harvard University's endowment fund to change its voting behaviour. "Ministry officials have informed me that it's not true that any request was made to engage with individual investors," Trade Minister Hiroshi Kajiyama told a regular press briefing. As one of the industrial conglomerates that modernized Japan and helped its post World War Two economic recovery, Toshiba enjoys close ties with government.
Persons: Kim Kyung, management's, Hiroshi Kajiyama, Hiromichi Mizuno, Mizuno, Elon Musk, Yoshihide Suga, Suga Organizations: Toshiba Corp, REUTERS, Toshiba, Harvard, Ministry, Reuters, Tesla Inc, Investment Fund, United Nations, Innovative Finance, Sustainable Investment, Effissimo Capital Management, Investment Partners, Nikkei, Thomson Locations: Kawasaki, Japan, Britain, Tokyo
Lee Jun-Seok, new chairman of the main opposition People Power Party (PPP) speaks after elected for leadership race at party headquarters in Seoul, South Korea, June 11, 2021. Kim Min-Hee/Pool via REUTERSA 36-year-old South Korean startup founder will challenge President Moon Jae-In for the top job next March, hoping to win over voters increasingly disillusioned with traditional rough-and-tumble politics. Lee Jun-seok became the youngest leader of any major political party in democratic South Korean history when he was elected to lead the conservative main opposition People Power Party on Friday. "Our biggest task is to win the presidential election," Lee said in an acceptance speech. "His victory is a wake-up call for established politicians across the spectrum," said Lee Tae-woo, a 35-year-old architect who perceives him as centrist.
Persons: Lee Jun, Kim Min, Moon Jae, seok, Lee, Jae, Moon, Na Kyung, Na, Lee Tae Organizations: People Power Party, REUTERS, Harvard University, Thomson Locations: Seoul, South Korea, South
The logo of Toshiba Corp. is seen at the company's facility in Kawasaki, Japan June 10, 2021. REUTERS/Kim Kyung-Hoon/File photoFour Toshiba Corp (6502.T) directors called on Friday for a shake-up of its management and board, in a sign of revolt after an investigation found the conglomerate colluded with the Japanese government to "beat up" foreign shareholders. The investigators detailed one email among top Toshiba managers about the company's largest shareholder, Singapore-based hedge fund Effissimo Capital Management. It doesn't mean they're perfect yet," said Brian Heywood, CEO of Taiyo Pacific Partners, an activist fund that has operated in Japan for 20 years. As a result, activist investors are estimated to account for 25% of Toshiba's shareholder base.
Persons: Kim Kyung, Jerome Black, Paul Brough, Ayako Weissman, George Zage, METI, Yoshihide Suga, Suga, Hiroshi Kajiyama, Hiromichi Mizuno, Mizuno, Brian Heywood, Glass Lewis, Osamu Nagayama, Nobuaki Kurumatani Organizations: Toshiba Corp, REUTERS, Japan Inc, Ministry, Economy, Trade, Industry, Toshiba, Capital Management, Investment Partners, Harvard, Reuters, Tesla Inc, Investment Fund, Innovative Finance, Sustainable Investment, JAPAN, Taiyo Pacific Partners, CVC Capital, Thomson Locations: Kawasaki, Japan, Singapore, Tokyo
Opinion | How to Think Outside Your Brain
  + stars: | 2021-06-11 | by ( Annie Murphy Paul | ) + 0.00   time to read: +7 min
The body is also uniquely capable of grounding abstract concepts in the concrete terms that the brain understands best. Catch up with students from Odessa High School, which was the subject of a Times audio documentary series. Without any further instruction, these students sketched their way to a more accurate understanding of the systems they drew. This suite of human strengths, honed over eons of evolution, is wasted when we sit still and think. Rather, the mind extends into the world and augments the capacities of the biological brain with outside-the-brain resources.
Persons: Michael Barbaro, Daniel Reisberg, Frédéric Vallée, Gaëlle, , Tourangeaus, Lisa G, Guthrie, Hugo Mercier, Dan Sperber, Mercier, Daniel Wegner, , Linda Argote, Andy Clark, David Chalmers Organizations: Daily, Odessa High School, Kingston University, Harvard, Carnegie Mellon University, Locations: Britain, Kingston
Third member of FDA advisory panel resigns over Alzheimer's drug approval
  + stars: | 2021-06-10 | by ( ) sentiment -1.00   time to read: +1 min
Aaron Kesselheim, a Professor of Medicine at Harvard Medical School who had served on the FDA’s advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel. He cited FDA's decision to approve Sarepta Therapeutic Inc's drug, eteplirsen, for Duchenne muscular dystrophy in 2016 as another example of the regulator approving a drug against the recommendations of its advisory committee. On Tuesday, a member of the advisory group who voted against the approval, Washington University neurologist Dr. Joel Perlmutter, resigned from the committee, citing the FDA's approval of Aduhelm. The 11-member committee voted nearly unanimously in November that Biogen's drug should not be approved, citing inconclusive evidence that the drug was effective. The FDA on Monday gave the drug "accelerated approval,” based on evidence that it can reduce a likely contributor to Alzheimer’s, rather than proof of a clear benefit against the disease.
Persons: Aaron Kesselheim, Kesselheim, Dr, Joel Perlmutter, David Knopman Organizations: U.S . Food, Drug Administration, Medicine, Harvard Medical School, Reuters, Stat News, Washington University, Mayo, FDA, Monday Locations: U.S
A prominent Harvard drug researcher on Thursday became the third member of a Food and Drug Administration advisory committee to resign over the agency’s decision to approve a drug for Alzheimer’s, questioning whether the drug works. Harvard Medical School professor Aaron S. Kesselheim called the FDA’s approval of the Biogen Inc. drug Aduhelm “probably the worst drug approval decision in recent U.S. history.”The outside advisory committee that he served on—the FDA’s panel on peripheral and central nervous-system pharmaceuticals—had rejected supporting the drug, known generically as aducanumab, saying the company needed to conduct further study. The resignations follow criticism of the FDA decision from some Alzheimer’s researchers and doctors. The FDA issued the approval over the doubts among some researchers and doctors who questioned its efficacy. The agency said the drug showed benefit in reducing amyloid plaque, which may play a role in Alzheimer’s, which ravages memory and thinking skills.
Persons: Aaron S, Kesselheim, Aduhelm “, , David S, Joel S, Perlmutter, Louis, , hasn’t, Janet Woodcock, Biogen, Thomas M, Burton Organizations: Harvard, Drug Administration, Harvard Medical, Biogen Inc, Mayo Clinic, Washington University, FDA, Health Locations: St, Alzheimer’s, tom.burton
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