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Third member of prestigious FDA panel resigns over approval of Biogen’s Alzheimer’s drug

Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug

A sign for the Food and Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.

Sarah Silbiger | Getty Images

A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm, CNBC has learned.

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history,” according to his resignation letter obtained by CNBC.

“At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to help patients with Alzheimer’s disease,” he wrote in resigning from the FDA’s Peripheral and Central Nervous System Advisory Committee.

He wrote it was “clear” to him that the agency is not “presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.”

Shares of Biogen surged 38% Monday after the FDA approved the biotech company’s drug, the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

The agency’s decision was a departure from the advice of its independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At the time, the panel also criticized agency staff for what it called an overly positive review of the data.

This is a developing story. Please check back for updates.

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Business

New York Publish Reporter Who Wrote False Kamala Harris Story Resigns

New York Post Reporter Who Wrote False Kamala Harris Story Resigns

Ms. Italiano, a veteran postal journalist and long-time chronicler of the New York Courts, is a popular figure on the newspaper’s newsroom. She did not respond to inquiries about her resignation or the making of the Harris Article. Post officials did not respond to calls and emails on Tuesday evening.

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April 27, 2021 at 5:49 p.m. ET

Her sudden exit underscored some of the tensions currently plaguing the Post, a classic militant city tabloid that served as a means of reporting for former President Donald J. Trump many times during his tenure.

Mr Murdoch, who spoke to Mr Trump frequently, installed a new editor at the tabloid last month, Keith Poole, who previously held a top position in Mr Murdoch’s London newspaper The Sun. At least eight journalists from The Post recently left, including a White House correspondent Ebony Bowden.

Fox News and The Post have long shown a certain symbiosis due to their joint ownership of Murdoch. (Just last week, The Post published a gossip article complaining that Glamor magazine didn’t write articles about female Fox News stars.)

Fox News presenters like Tucker Carlson, Greg Gutfeld and Martha MacCallum discussed the Post article about their programs on Monday. Fox News White House correspondent Peter Doocy quoted “a report in the last few days in the New York Post” before asking White House press secretary Jen Psaki on Monday whether Ms. Harris made “money on her books.” “allegedly distributed in the shelters. Ms. Psaki said she “definitely needs to check” what The Post described in a follow-up story when Ms. Psaki offered “no answers”.

On Tuesday’s Fox & Friends, co-host Ainsley Earhardt told viewers the allegations about the Harris Book were “incorrect” and quoted the Washington Post that morning’s fact-checking column. Also on Tuesday, Fox News updated its article on the Harris Book to determine that only a single copy was seen at the shelter and that it was being shipped as “part of a citywide book and toy drive.”

Fox News has come under fire in the past few days for another false claim aired on the network: President Biden planned to cut American red meat consumption as part of his plan to combat climate change. An on-air graphic from Fox News declared “Bye-Bye Burgers Under Biden’s Climate Plan,” sparking a cycle of outrage from conservative commentators.

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Politics

Kim Potter resigns for police capturing

Kim Potter resigns for police shooting

Officer Kim Potter of the Brooklyn Center Police Department in 2007.

Bruce Bisping | Star Tribune via Getty Images

Police officer Kim Potter resigned Tuesday, two days after he fatally shot and killed Daunte Wright, an unarmed black man who fled a traffic obstruction in a Minneapolis suburb.

Brooklyn Center Police Chief Tim Gannon also resigned Tuesday, the day after it was revealed that Potter probably shot Wright under the mistaken belief that she was holding a taser and not her pistol.

Potter, who served with the Brooklyn Center Police Department for 26 years, said she liked being a cop but resigned because “I believe it is in the best interests of the community, the department, and my colleagues for me to resign immediately” . According to a letter posted on Twitter by several news outlets.

Her resignation came after Vice President Kamala Harris said Wright should be “still alive today” as demand for police reform increased following the recent controversial murder of a black by the Minnesota police.

Harris also said that there should be “justice and healing” for Wright’s death and that “law enforcement must be subject to the highest standards of accountability”.

Former President Barack Obama said his and Michelle Obama’s “hearts are heavy” over Wright’s death.

Obama also argued that the recent police death of a black underscores the need to redefine policing in the United States.

Wright, 20, was driving an SUV when police stopped it on Sunday afternoon because license plates had expired and an air freshener was hanging on his rearview mirror.

Police arrested Wright on a pending no-show arrest warrant in a criminal case accusing him of carrying a gun without permission and escaping from police in June.

Activist Jonathan Mason holds a Daunte Wright sign in front of the crowd of demonstrators who have gathered to protest the police murder of Daunte Wright on April 13, 2021 at the Brooklyn Center in Minnesota, USA.

Christopher Mark Juhn | Anadolu Agency | Getty Images

Video from Potter’s body camera shows Wright turning away and ducking into his car when another cop tried to handcuff him.

Potter then shot a single shot in Wright’s chest with her pistol after repeatedly desperately saying “Taser!”

Gannon told reporters on Monday, “I think the officer intended to use his taser but instead shot Mr. Wright with a single bullet.”

Potter’s apparent confusion about which weapon she was holding has received much criticism. Tasers are colored yellow, unlike a black pistol Potter held in his hand, and are usually kept on the side opposite a police officer’s dominant shooting hand.

Both of these precautions are designed to prevent a police officer from pulling out a gun when attempting to use a taser to force a suspect to comply or to avoid injuring someone else.

Prior to her resignation, Potter, who had served as president of her town’s police union, had been on administrative leave pending an investigation by the Minnesota Bureau of Criminal Apprehension.

Gannon has been replaced by Commander Tony Greuning, a 19 year old veteran in the Brooklyn Center Police Department, who will serve as deputy chief.

Wright’s shots were followed by protests and looting at Brooklyn Center and nearby Minneapolis.

The location of his shooting is approximately 14 miles from where George Floyd was killed last year by Minneapolis police officer Derek Chauvin after Floyd was arrested on suspicion of using a forged bill.

Prosecutors suspended their case in Chauvin’s ongoing murder trial on Tuesday morning.

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Floyd’s death sparked a wave of national protests and called for police reform.

Obama noted the coincidence of Wright’s death and Chauvin’s trial in his statement describing Floyd’s death as a “murder,” although the jury has not yet passed a verdict on the case.

“The fact that this could happen while the city of Minneapolis is going through the trial of Derek Chauvin and reliving the heart-wrenching murder of George Floyd shows not only the importance of conducting a full and transparent investigation, but also how we do it urgently need to redefine police and public safety in this country, “said Obama.

“Michelle and I, along with the Wright family, mourn their loss,” Obama said in a statement.

“We feel drawn into the pain that black mothers, fathers and children feel after another senseless tragedy,” said Obama, who became the first black US president in 2009.

“And we will continue to work with all fair Americans to address historical inequalities and bring about national changes that are so long overdue.”

Floyd and Wright’s families, along with civil rights attorney Ben Crump, were due to hold a press conference in Minneapolis on Tuesday.

Crump said in a statement, “Daunte Wright is another young black man killed by those who swore to protect and serve us all – not just the whitest of us.”

“As Minneapolis and the rest of the country continue to grapple with the tragic assassination of George Floyd, we must now also mourn the loss of this young man and father. This level of lethal violence was totally avoidable and inhuman,” said Crump.

Former United States President Barack Obama speaks during a drive-in rally during the campaign for Democratic candidate Joseph Biden on October 21, 2020 in Philadelphia, Pennsylvania.

Michael M. Santiago | Getty Images

Minneapolis police said they arrested about 40 people Monday night for behavior ranging from curfew violations to rioting.

The looting in the city was sporadic and limited to five retail stores, police said.

Booker Hodges, deputy commissioner for the Minnesota Department of Public Security, told reporters early Tuesday, “We just want to say thank you for all of the people who have come out and peacefully exercised their first adjustment rights.”

“Unfortunately, there have been those who have chosen not to do this. And the plans we have drawn up over the past few months have been carried out,” he said. “For months we have been saying that seditious behavior simply will not be tolerated, and unfortunately these are some of the things we have encountered tonight.”

President Joe Biden said Monday that he had not spoken to Wright’s family, “but my prayers are with the family.”

“It’s really a tragic thing that happened,” said Biden. “But I think we’ll have to wait and see what the investigation shows – and the entire investigation. You’ve all seen, I suppose, as I did, the film, which is … pretty graphic. The question is, was it an accident “Was it intended? That has yet to be determined through a full investigation.”

Biden added, “I want to make it clear once again that there is absolutely no justification, none for looting, no justification for violence.”

“Peaceful protests, understandable, and the fact is we know that the anger, pain and trauma that exist in the black community in this environment are real, serious and consistent,” the president said. “But it won’t justify violence and / or looting.”

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Politics

Teen Vogue editor-in-chief Alexi McCammond resigns over outdated racist tweets

Teen Vogue editor-in-chief Alexi McCammond resigns over old racist tweets

Alexi McCammond speaks at Politicon 2018 at the Los Angeles Convention Center on October 20, 2018 in Los Angeles, California.

Michael S. Schwartz | Getty Images

Alexi McCammond said Thursday she would step down as editor-in-chief of Teen Vogue – just days before its launch – after being angry about her decades of racist tweets about Asians.

“My past tweets have overshadowed the work I’ve done to highlight the people and topics that matter to me – topics that Teen Vogue has worked tirelessly on to share with the world,” McCammond said on Twitter.

McCammond said she and Teen Vogue publisher Conde Nast “decided to split”.

The 27-year-old’s big promotion and immediate resignation came after severe setbacks – also reportedly within Teen Vogue itself – over the racist and homophobic tweets she posted in 2011, some of which carried offensive stereotypes about Asians.

Conde Nast reportedly announced the news of McCammond’s departure in an internal email on Thursday.

“After speaking with Alexi this morning, we agreed that it would be best to part ways so as not to overshadow the important work at Teen Vogue,” Chief People Officer Stan Duncan wrote in an internal memo, reported Mediaite.

The resignation came a month after McCammond’s friend TJ Ducklo was suspended from the White House and then left the White House after he reportedly threatened a journalist about his relationship with McCammond and making a name for herself as a political reporter made at Axios.

Jonathan Swan, a noted political reporter and former McCammond colleague at Axios, defended McCammond later Thursday.

“I’ve worked with [McCammond] For four years, “Swan tweeted.” I know her well and I can say this clearly: the idea that she is racist is absurd. “

“Where the hell are we as an industry if we can’t accept a person’s sincere and repeated apology for tweets as a teenager?” he wrote.

As pressure increased on Conde Nast over McCammond’s tweets, Ulta Beauty reportedly paused a seven-figure ad purchase on Teen Vogue.

McCammond, named Emerging Journalist of the Year by the National Association of Black Journalists in 2019, previously apologized for the tweets and regretted her regret in her statement on Thursday.

“I became a journalist to raise the stories and voices of our most vulnerable communities. That’s why, as a young woman of color, I was so excited to lead the Teen Vogue team on its next chapter,” said McCammond.

“I shouldn’t have tweeted what I did and I took full responsibility for it. I look at my work and my growth over the past few years and have my commitment to growth in the years to come, both as a person and as a Professional doubled. “

“I wish the talented Teen Vogue team all the best for the future. Your work has never been more important and I will put down roots for you.”

“There are still so many stories to tell, especially about marginalized communities and the problems that affect them. I hope to have the opportunity to rejoin the ranks of the tireless journalists who shed light on important issues every day.” ” She said.

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Business

White Home Press Aide Resigns Over Name to Reporter

White House Press Aide Resigns Over Call to Reporter

WASHINGTON – White House deputy press secretary TJ Ducklo resigned Saturday after it was reported that he was using abusive and sexist language with a reporter who was working on an article about his romantic relationship with a journalist from another publication would have.

White House press secretary Jen Psaki announced the resignation in a statement Saturday night, the day after he said Mr Ducklo would be suspended for a week without pay.

“We accepted TJ Ducklo’s resignation after speaking to him tonight,” said Ms. Psaki, noting that Ron Klain, the White House chief of staff, approved the decision. “We strive every day to strive to meet the standard set by the President, to treat others with dignity and respect, with courtesy and with value to others through our words and actions.”

Ducklo, 32, had served as national press secretary during Biden’s presidential campaign, dealing frequently with reporters and serving as campaign spokesman. During the transition, Mr. Ducklo served as spokesman and was appointed deputy press officer.

His quick departure suggests that Mr. Biden was keen to avoid his communications office sinking into protracted controversy in the early days of his tenure. Several reporters asked Ms. Psaki on Friday how Mr. Ducklo could work effectively with reporters.

The resignation follows a report by Vanity Fair on Friday that reported an exchange he allegedly had with Tara Palmeri, a reporter from Politico, who contacted him about his relationship with Alexi McCammond, which was about the Biden Campaign for the online publication Axios reported.

According to the Vanity Fair report, which was later confirmed by the New York Times, Mr. Ducklo told Ms. Palmeri that if she published an article about the relationship, he would “destroy” her. He also reportedly told her that she was “jealous” of Ms. McCammond and was following the story. He used vulgar language, according to two people who knew the call.

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Apr. 14, 2021 at 12:05 am ET

Ms. Psaki said Friday that Mr. Ducklo spoke to Ms. Palmeri and apologized and later sent a message apologizing again. Ms Psaki also said White House officials had advised senior editors at Politico that Mr Ducklo’s behavior was unacceptable.

When Mr Ducklo returned to work, he said he would not be allowed to interact with Politico reporters.

“And that was, from our point of view, a – was an important step in getting the message across that we didn’t find it acceptable,” she said at the time. She also called the week-long suspension a “severe punishment”.

However, this position did not last longer than a day.

In a statement late Saturday, Mr. Ducklo acknowledged the circumstances surrounding his release and regretted that he had used language that was “disgusting, disrespectful and unacceptable”.

“This incident is not representative of who I am as a person,” he said, “and I will be determined to regain the trust of everyone whom I have disappointed because of my intolerable actions.”

In part, the rapid change reflected the red line that Mr Biden himself had laid down for his personal conduct in his administration.

On inauguration day, the president forwarded indictments to hundreds of his political officials as he swore them in, warning that he would fire anyone he heard was disrespectful.

“If you ever work with me and I hear that you are treating another colleague with disrespect, speak to someone, I promise I will fire you immediately,” said Mr. Biden. “No ifs and buts. Everyone has the right to be treated with decency and dignity. That has been very missing in the last four years. “

When asked Friday whether Mr Ducklo’s behavior met this standard, Ms. Psaki said, “It is not our standard – it is not the President’s standard.” But she refused to say at the time why he shouldn’t be released.

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Health

Hahn Resigns as F.D.A. Commissioner; Woodcock Named Interim Chief

Hahn Resigns as F.D.A. Commissioner; Woodcock Named Interim Chief

Dr. Stephen M. Hahn, who became Commissioner for the Food and Drug Administration just weeks before the coronavirus pandemic began, resigned on Wednesday when President Biden’s administration began.

Dr. Janet Woodcock, longtime director of the FDA’s Center for Drug Evaluation and Review, will serve as acting commissioner, according to an agency official.

From May, Dr. Woodcock has been tasked with Operation Warp Speed, the previous government’s program to accelerate vaccine and treatment development for the coronavirus.

She has been with the FDA since 1986 and has served in a number of key roles including Chief Medical Officer and Assistant Commissioner.

The Biden administration has not yet appointed a permanent commissioner, but Dr. Woodcock is one of the contemplated candidates, according to several advisors to the new president’s transition team. Dr. Amy Abernethy, Deputy Chief Commissioner, is also being considered, as is Dr. Joshua Sharfstein, a former agency officer who is the vice dean of public health practice and community involvement at Johns Hopkins University.

The resignation of Dr. Hahn was expected to be part of the routine departure of senior political figures that comes with the assumption of office of a new administration. In a farewell message to FDA staff on Wednesday, he wrote: “As a nation and as a health agency, we have faced major challenges and turbulent times over the past year, particularly due to the Covid-19 pandemic. Throughout all of this, FDA staff have been instrumental in responding to the disease with very real scientific advances like the approval of the first non-prescription OTC [over the counter] Covid test, the approval and approval of an antiviral agent, and the first two FDA-approved Covid-19 vaccines. “

Dr. Hahn received considerable criticism in the course of the pandemic. He has been accused of bowing to political pressure from President Trump and the White House to issue emergency clearances for unproven treatments such as hydroxychloroquine that did not provide evidence of their effectiveness. For the past few months, he has led reviews of the first vaccine against the virus, Pfizer and Moderna products.

In the past, 72-year-old Dr. Woodcock among other presidential administrations in the race for the top position of the FDA. It was first introduced by Dr. David Kessler, the former FDA commissioner who was named chief science officer for the Biden Administration’s vaccination efforts, no longer referred to as Operation Warp Speed, to the FDA’s Drugs Division.

The Biden administration did not specify when an FDA commissioner would be appointed.

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World News

Dutch Authorities Resigns After Advantages Scandal

Dutch Government Resigns After Benefits Scandal

Dutch Prime Minister Mark Rutte, one of Europe’s longest-serving leaders, and his cabinet resigned on Friday over a report highlighting his government’s systematic failure to protect thousands of families from overzealous tax inspectors.

Mr Rutte and his cabinet will continue to lead the government as caretakers. The general elections are planned for March. His center-right party is currently leading the polls. The other parties in his coalition that were also affected by the scandal are not expected to call for earlier elections because of the coronavirus pandemic.

“Mistakes have been made at all levels that have resulted in great injustice for thousands of families. Innocent people were criminalized and their lives were destroyed, “said Rutte in a press conference. “This cabinet has taken full responsibility.” Mr Rutte said the report that led to the downfall of the cabinet was “tough as nails” but “fair”.

Mr Rutte submitted his resignation and that of his entire cabinet after cycling to see King Willem-Alexander van Oranje. He had served his third term as Prime Minister and had headed the Netherlands since 2010. If his party receives the largest share of the vote in the upcoming election, he can take up a fourth term.

The report, the result of an investigation that also interviewed Mr Rutte, concluded that innocent families had suffered “unprecedented injustice”, some of whom were forced to repay large amounts of childcare benefits immediately.

In many cases, an administrative error such as a missing signature was enough for the tax authority to label parents as fraudsters and fine families with up to tens of thousands of euros, the report says.

“Basic principles of the rule of law have been violated,” she concluded, blowing up both government and parliament for creating “rock-hard laws” that had little room for individual cases to be fairly considered.

The chairman of the parliamentary committee that led the investigation, Chris van Dam, said the system put in place to track down benefit fraud is “a mass process with no room for nuance”.

In a separate investigation, the Dutch data protection authority came to the conclusion that tax inspectors had discriminated against citizens with dual nationalities.

Former Vice President of the Dutch State Council, Herman Tjeenk Willink, added to the allegations of systematic failure by calling on parliamentarians to also take responsibility for voting in the strict laws.

“You should look yourself in the mirror,” he wrote in a comment in the NRC Handelsblad, “and question your own role in the matter.”

Insiders expected that Mr. Rutte would easily shake off any criticism. “Yes, it’s a shame this happened under Rutte’s responsibility,” said Joost Vullings, a political commentator, “but if anyone knows how not to be ashamed, it’s our prime minister.” He will go all out to win the upcoming elections. ”

Mr Rutte said last month that the tax campaign described in the December report was “shameful” and that the government had announced that nearly 10,000 families will receive compensation of € 30,000 or about $ 36,500 each. Earlier this week, Mr Rutte insisted that the government should not resign as it could weaken the nation’s response to the pandemic.

The Netherlands has been grappling with the coronavirus since March, and its inability to contain the spread of the disease has highlighted what many are calling systemic problems with overregulation. Like many countries in Europe, the Netherlands is also blocked.

A November report ranked the government as one of the world’s leading tax havens for large companies, so the persecution of individuals for relatively small amounts did not go unnoticed.

This duality and others in Dutch politics underscore the drawbacks of the Dutch polder model, a system where every important decision is reviewed by every institution, representative or even person involved. The result is always a compromise.

“This matter is an example of a systematic error that has emerged from our coalition policy where each party scores points for its own supporters,” said Sheila Sitalsing, a commentator for de Volkskrant, “but the final compromise can no longer be implemented . ” for those who have to work with it every day. ”

Ms. Sitalsing also said voters have been rewarding politicians who promise stricter rules for two decades. “So that’s what you get,” she said of the child benefit scandal.

Families referred to by the tax authority on Tuesday increased pressure on Mr Rutte by asking his cabinet to step down in an open letter published in the Trouw newspaper.

“What needs to be done is clear: everything should be fixed and cleaned up,” said a group of families. “We don’t think the current cabinet is capable of that.”

In a move that is unique in the Netherlands, the families filed criminal charges this week against five politicians, including Finance Minister Wopke Hoekstra and Economy Minister Eric Wiebes, for their role in the matter. If convicted, they face up to six months in prison.

“We have brought criminal charges because the victims I represent have been ruined. Some became homeless as a result of these guidelines. These politicians have been extremely negligent, ”said Vasco Groeneveld, a lawyer who represents 20 victims. “Every time I open your files, shivers run down my spine. These people were treated terribly. “

Mr Wiebes, who was finance minister in a previous cabinet, will resign immediately and not stay in the caretaker government, NOS reported.

On Thursday, opposition leader Lodewijk Asscher, a former minister of social affairs, resigned for his role as leader of the Dutch Labor Party. His resignation increased the pressure on Mr. Rutte to reconsider his position.

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Politics

Mick Mulvaney resigns from Trump administration, expects others to comply with

Mick Mulvaney resigns from Trump administration, expects others to follow

WASHINGTON – Former President Donald Trump’s Chief of Staff and current Special Envoy for Northern Ireland said Thursday that he is stepping down from his diplomatic post.

“I called [Secretary of State] Mike Pompeo last night to let him know I’ve resigned from it. I can’t do it, I can’t stay, “Mick Mulvaney told CNBC in an exclusive interview.

“Those who choose to stay, and I’ve spoken to some of them, choose to stay because they fear the president might make someone worse,” said Mulvaney. But he said other officials couldn’t stay.

Trump encouraged thousands of supporters to march to the Capitol during a rally outside the White House Wednesday to protest the historically ceremonial practices. Trump returned to the White House after his speech and later said in a tweet video to supporters, “You have to go home now,” but he did not condemn the violence.

On Wednesday, members of Trump’s cabinet in the US Capitol issued tough reprimands of chaos, forcing Congress to halt the process of declaring Joe Biden’s victory in the presidential election. However, officials stopped criticizing the president, who urged his supporters to take action.

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