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Congress slams FDA approval of Adholm as ‘riddled with irregularities’

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Approval process by US health officials Biogen Congressional investigators have said Inc.’s controversial Alzheimer’s drug is “riddled with irregularities,” raising serious concerns about protocol loopholes at the agency.

The Food and Drug Administration cooperated excessively with Biogen while evaluating the drug, called Aduhelm, according to an 18-month investigative report released Thursday by the House Committees on Oversight and Reform and Energy and Commerce.

Aduhelm was acquitted despite the objections of a group of outside medical experts who advised the FDA not to allow the drug on the market, citing conflicting results from trials of its efficacy; Three members of this team resigned after approval. US Medicare later restricted payment for Aduhelm, and Biogen halted its marketing efforts.

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The report “describes an incredibly troubling pattern of behavior around the approval of this drug,” said Aaron Kesselheim, a professor at Harvard Medical School who left the advisory panel after Adholm’s approval. “The Food and Drug Administration is the most important public health regulator in the world, but when it takes steps like this, it destroys its credibility and the trust patients and clinicians have in it.”

Adholm I got a pass in June 2021, not by showing its effectiveness against brain wasting, but its ability to reduce amyloid plaques in the brain, a physical marker associated with the disease. Another experimental amyloid-reducing drug, Eisai’s lecanemab, which is being developed in collaboration with Biogen, returned with positive results In slowing down the disease in September.

Frequent interactions

Biogen said it has been committed to researching and developing treatments for Alzheimer’s disease for more than a decade, and that it stands by the integrity of its actions. The FDA said it remains committed to the integrity of its approval process and that its internal review found that employees’ work with Biogen was appropriate.

“It is the agency’s job to interact frequently with companies in order to ensure that we have sufficient information to inform our regulatory decision-making,” the FDA said in a statement.

Biogen viewed Aduhelm as an “unprecedented financial opportunity,” according to a congressional report that criticized Biogen for setting an unjustifiably high price of $56,000 per year for the product. The report said the company developed aggressive launch and marketing plans designed to increase revenue, despite recognizing that the treatment would be costly for patients and a burden on Medicare.

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Since then Biogen Cuts Aduhelm is priced at $28,200 in order to reduce out-of-pocket costs for patients and reduce “potential financial impacts to the US health care system.” The report said that this decision was taken only after a violent public reaction.

wide label

The FDA initially approved the treatment with a marker that would allow it to be used in a broad swath of Alzheimer’s patients, rather than the very early-stage patients in whom the drug was studied. Investigators found that even as the company accepted the broader usage statement, there were internal concerns about a lack of evidence to support it. The report said Biogen only later sought to narrow the drug’s terms of use after public criticism.

Documents obtained by congressional committees found that the FDA and Biogen held “at least 115 substantive meetings, calls, and email exchanges” during the 12-month period as Biogen worked to complete and submit its application to Aduhelm. This may have been an understatement, since the FDA didn’t have a clear record of its meetings with Biogen.

The Food and Drug Administration has also used a controversial path, called accelerated approval, to evaluate Aduhelm. Critics said this path allows many drugs to hit the market on the basis of questionable data.

The FDA said it will continue to use fast track where appropriate, because it allows the agency to provide early access to serious, life-threatening conditions.

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Representative Caroline Maloney of New York, chair of the Committee on Oversight and Reform, said in a statement that the report’s findings should serve as “a wake-up call for the Food and Drug Administration to reform its practices.”

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Commuters from the Southwest threatened arrest at Christmas in a viral video

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Southwest Airlines He already had it Terrible end of the year After a massive winter storm forced it to cancel flights that had outsold its industry competitors. Then, somehow, the PR nightmare got worse.

At Nashville International Airport on Christmas Eve, a police officer threatened to arrest stranded Southwest passengers if they did not leave a secure area of ​​the airport. A video of the incident went viral on social media after it happened Posted by passenger to TikTok. Other videos circulating on social media also captured parts of the incident.

In the video, which has been viewed more than 910,000 times since it was posted two days ago, the officer warns passengers that they must leave the area or they will be “arrested for trespassing.”

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“Now,” he continued. “Everyone to the unsafe side. The ticket counter will help you answer any questions you have.”

Shelly Morrison, who was among the passengers with her three daughters, was queuing at the southwest gate hoping to get more information about what was going on with her flight, to me the Tennessee.

After she and others waited nearly an hour for an explanation, one of the workers announced via the intercom that she was leaving – and called security. Morrison told the local newspaper that he did not tell a passenger that they had to leave if they had a canceled ticket.

“The Southwest is calling us”

Soon, two police officers from the airport’s Department of Public Safety arrived at the scene, just as Morrison’s daughter, Amani Robinson, began recording a video.

An officer tells passengers in the video, “If you don’t have a ticket, you don’t have to be on the safe side.” To someone who said they had tickets, he replied, “Your tickets just got cancelled.”

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Morrison asked the officer again if he might be stopped, and he repeated to him: “If you don’t have a valid ticket and you’re on the safe side and you refuse to leave, you’ll be arrested… If your ticket’s canceled, they don’t have a ticket anymore. You understand that, right?”

He added, “Right now, Southwest is calling us because you guys are congregating here, and they’re trying to close that gate.”

The officer grew impatient when Morrison again tried to “establish a legal connection,” as she puts it in the video, and told him she was an attorney.

“Do you refuse to leave the safe side?” he asked clearly.

She replied, “No, I don’t refuse to leave.” “I ask for additional information. Can you mention the statue to me?”

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He replied, “It is the security of airports and planes.”

“Don’t you have a department?” she asked.

“I don’t need to give you the code. If you’re a lawyer, you can look it up.”

Morrison thanked him and went with the others to where he had indicated.

Southwest responds

when called luckA Southwest spokesperson said that employees “did not request that customers be escorted outside the gate area.” Instead, the company required “that local law enforcement be present at the gate to assist with crowd control efforts while our team works with customers.”

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A spokesperson for Nashville International Airport, also known by the airport code BNA, responded:

“The sheer number of flight cancellations over the past week has caused great stress for our passengers, and included an unfortunate incident involving a passenger, airline staff and an LNA officer. We are very sorry this happened and we take this situation very seriously. We are working with Southwest Airlines and our other airlines to promote better communication between team members so that every traveler enjoys the optimal experience at BNA:

luck She also contacted the Ministry of Transport regarding the airport incident, but did not receive any immediate response.

Southwest passengers trying alternative routes faced higher fares from other airlines, some of which — faced public backlash —Announce a price cap on the affected roads.

The Department of Transportation said this week it would open an investigation into Southwest Airlines. He. She he wrote in a tweet It was “concerned by Southwest’s unacceptable rate of cancellations, delays, and reports of a lack of prompt customer service. The department will study whether cancellations are manageable and whether Southwest is complying with its customer service plan.”

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This article has been updated with responses from Southwest Airlines and the airport.

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Why Trump didn’t want you to see his tax returns

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What was he hiding?

We’re finally starting to find out, now that the House Ways and Means Committee has released six years of Donald Trump’s personal and business tax returns. Trump’s returns are complex and it could take weeks for experts to realize whether Trump cheated or used overly aggressive tactics to lower his tax bill. The committee did not release any tax documents for some of Trump’s business entities, so puzzles may remain.

But a few things soon emerge from the assessment of the leading figures in Trump’s comeback. When Trump announced his candidacy for the presidency in 2015, he described himself as a builder and businessman who could go to Washington and fix what politicians had destroyed. Trump’s stated status was as a political outsider and business titan crucial elements in his appeal to voters.

But Trump’s tax returns suggest his businesses are always losing money, while raising questions about how he manages to fund a gilded lifestyle. In each of the six years from 2015 through 2020, DJT Holdings, one of Trump’s main business entities, lost millions of dollars. The smallest loss was $34 million in 2015. The largest loss was $64 million in 2016. Combined, these losses totaled $314 million from 2015 through 2020.

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This is not an entirely new revelation. Glimpses of Trump’s finances have long revealed that Trump is capitalizing heavily on losses incurred in one part of his business portfolio, to offset gains elsewhere and significantly reduce his tax bill. Documents leaked to the New York Times in 2016 showed that Trump declared a loss of $916 million in 1995. lowered his tax bills for nearly two decades. When Trump began earning millions from The Apprentice TV show in the 2000s, losses from faltering real estate ventures, such as his casinos in Atlantic City, helped keep his income tax payments down. These practices are generally legal, although some tax experts believe Trump could have expanded the legal boundaries.

Members of the US House of Representatives Ways and Means Committee move boxes of documents after a panel meeting to discuss former President Donald Trump’s tax returns on Capitol Hill in Washington, US, December 20, 2022. REUTERS/Jonathan Ernst

When Trump ran for president in 2016, he said he would release his tax returns once the IRS finished auditing them. Of course Trump never released any tax returns, and the IRS audit wouldn’t have stopped him from doing so in the first place. Ways and Means Committee Finally got Trump’s payout from the IRS on Dec. 20, after Trump lost a four-year legal battle to keep them secret. He found justices all the way up to the Supreme Court Congress had the right to see the proceedsbecause it can contribute to legislative activity.

[Follow Rick Newman on Twitter, sign up for his newsletter or sound off.]

If Trump had released his comeback in 2015 while running for president in 2016, journalists and political opponents would have been mired in what appears to be huge business and personal losses. His return to DJT Holdings shows total revenue of $25.1 million but a net loss of $34.1 million. It is reasonable for a company to incur losses greater than revenue, since tax code allows for carry-over losses from prior years. But it’s very bad looks to tell voters you’re a business owner while reporting large losses to the IRS.

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Trump and his wife Melania’s 2015 comeback undermines his commercial credibility. Trump’s adjusted gross income in 2015 was $31.8 million. In other words, he supposedly lost $31.8 million, because he was allowed to claim losses from his business against his personal income. His taxable income was $0 and he owed $0 in federal income tax. It is difficult for average workers who earn most of their income from work to declare passive income, unless they have capital losses or other types of losses beyond what they earn from their employer.

Hillary Clinton, Trump’s Democratic opponent, She released her tax return for 2015 on August 12, 2016. The report showed that she and her husband, Bill Clinton, had an adjusted gross income of $10.6 million, and paid $3.6 million in federal income tax, for an effective tax rate of 34%. While the return showed the Clintons wealthy, they claimed no mysterious tax breaks except for a small capital loss of $3,000. Trump was the nominee going after meat-and-potatoes voters in 2016, but Clinton’s taxes were more involved.

DJT Holdings reported business losses for each of the next five years, through 2020. In terms of Trump’s personal returns, his adjusted gross income has been negative for three years and positive for two years. Over the six years combined, those business losses have pushed Trump’s total adjusted income – $53.2 million, or a loss of $53.2 million. His taxable income was $0 for four out of six years.

Trump has hit one snag with regard to federal income tax payments — the alternative minimum tax, which raises the tax liability of some, mostly wealthy, depositors who use the deductions to significantly lower their taxable income. During four of those six years, the federal tax code started to push Trump’s federal tax bill. Including regular income tax and AMT payments, Trump appears to have paid about $4.1 million in federal income taxes from 2015 through 2020.

If voters had been able to see several years of Trump’s tax returns during the 2020 presidential election, it would have been clear that Trump’s corporations lose money every year and that Trump as an individual loses more money than he earns, overall. This isn’t really how it works. Trump has very few regular sources of income, such as millions of dollars in interest each year, and the capital gains that would come from the countless deals to license the Trump name. This income appears to be constant and recurring, while losses may occur in a particular year or two, but are spread across many years, for tax purposes.

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Trump has sometimes bragged about the low taxes he’s paid, saying he’s drastically undercutting his tax bill It makes him smart. Maybe so. It will be interesting to see if that makes him more or less electable.

Rick Newman is a senior columnist for Yahoo Finance. Follow him on Twitter at @tweet

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Chinese education files Ruanyun Edai to raise up to $35 million via US IPO (pending: RYET)

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da-cook

Chinese education technology Ruanyun Edai Technology (Rhett) Apply to raise up to $35 million through an initial public offering in the United States.

Ruanyun said in file that she was considering offering 5 million common shares at between $5 and $6 a share, which might happen

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