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Drug Approvals Hit an FDA Wall

Drug Approvals Hit an FDA Wall

Does Food and Drug Administration Commissioner Marty Makary want to accelerate life-saving drugs as he claims? The agency's recent torpedoing of an immunotherapy shot for advanced melanoma and slow-rolling a treatment for a rare disease raise big questions.
The FDA's approval of new drugs has notably slowed this year. Annual novel drug approvals averaged 52 in the first Trump Presidency and 48 under Joe Biden, but there have been only 22 in the first seven months of this year. On current trend that would make 38 for the year.
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The US plans to build a $750M fly factory in Texas to stop a flesh-eating cattle parasite
The US plans to build a $750M fly factory in Texas to stop a flesh-eating cattle parasite

Yahoo

time33 minutes ago

  • Yahoo

The US plans to build a $750M fly factory in Texas to stop a flesh-eating cattle parasite

The U.S. plans to build a $750 million factory in southern Texas to breed billions of sterile flies, ramping up its efforts to keep flesh-eating maggots in Mexico from crossing the border and damaging the American cattle industry. Secretary Brooke Rollins announced Friday that the U.S. Department of Agriculture hopes to be producing and releasing sterile male New World screwworm flies into the wild within a year from the new factory on Moore Air Base outside Edinburg, Texas, about 20 miles (32 kilometers) from the border. She also said the USDA plans to deploy $100 million in technology, such as fly traps and lures, and step up border patrols by 'tick riders' mounted on horseback and train dogs to sniff out the parasite. In addition, Rollins said the U.S. border will remain closed to cattle, horse and bison imports from Mexico until the U.S. sees that the pest is being pushed back south toward Panama, where the fly had been contained through late last year through the breeding of sterile flies there. The U.S. has closed its border to those imports three times in the past eight months, the last in July, following a report of an infestation about 370 miles (595 kilometers) from the Texas border. American officials worry that if the fly reaches Texas, its flesh-eating maggots could cause billions of dollars in economic losses and cause already record retail beef prices to rise even more, fueling greater inflation. The parasite also can infest wildlife, household pets and, occasionally, humans. 'Farm security is national security,' Rollins said during a news conference at the Texas State Capitol in Austin with Texas Gov. Greg Abbott. 'All Americans should be concerned. But it's certainly Texas and our border and livestock producing states that are on the front lines of this every day.' The pest was a problem for the American cattle industry for decades until the U.S. largely eradicated it in the 1970s by breeding and releasing sterile male flies to breed with wild females. It shut down fly factories on U.S. soil afterward. The Mexican cattle industry has been hit hard by infestations and the U.S. closing its border to imports. Mexico's Agriculture ministry said in a statement Friday that Mexico Agriculture and Rural Development Secretary Julio Berdegué Sacristán and Rollins signed a screwworm control action plan. It includes monitoring with fly-attracting traps and establishing that livestock can only be moved within Mexico through government-certified corrals, the statement said. And on the X social media platform, Berdegué said, 'We will continue with conversations that lead to actions that will permit the reopening of livestock exports." The new fly-breeding factory in Texas would be the first on U.S. soil in decades and represents a ramping up of the USDA's spending on breeding and releasing sterile New World screwworm flies. The sterile males are released in large enough numbers that wild females can't help but mate with them, producing sterile eggs that don't hatch. Eventually, the wild fly population shrinks away because females mate only once in their weekslong lives. In June, Rollins announced a plan to convert an existing factory for breeding fruit flies into one for breeding sterile New World Screwworm flies, as well as a plan to build a site, also on the air base near Edinburg, for gathering flies imported from Panama and releasing them from small aircraft. Those projects are expected to cost a total of $29.5 million. The Panama fly factory can breed up to 117 million flies a week, and the new Mexican fly factory is expected to produce up to 100 million more a week. Rollins said the new Texas factory would produce up to 300 million a week. She said President Donald Trump's administration wants to end the U.S. reliance on fly breeding in Mexico and Panama. 'It's a tactical move that ensures we are prepared and not just reactive, which is today what we have really been working through,' Rollins said. ___ Hanna reported from Topeka, Kansas. Associated Press writer Fabiola Sánchez in Mexico City contributed reporting. Solve the daily Crossword

Who really suffers from Trump Derangement Syndrome?
Who really suffers from Trump Derangement Syndrome?

Boston Globe

time40 minutes ago

  • Boston Globe

Who really suffers from Trump Derangement Syndrome?

Get The Gavel A weekly SCOTUS explainer newsletter by columnist Kimberly Atkins Stohr. Enter Email Sign Up Two decades on, Krauthammer's coinage has been appropriated, rebranded, and defined down — way down. 'Trump Derangement Syndrome' is now flung at anyone who objects to President Trump's conduct or opposes his policies. The term is no longer reserved for over-the-top expressions of revulsion — like actor Robert De Niro using a televised appearance at the Tony Awards to Advertisement No — today 'Trump Derangement Syndrome' is used as an all-purpose put-down to deride any Trump critics, including those who stick to serious, fact-based analysis. I've lost count of all the times I've been Advertisement A woman seen at the Iowa State Fairgrounds on July 3, when President Trump was speaking there. Scott Olson/Getty The word 'syndrome' notwithstanding, this is merely political trash talk, popularized by Trump and his allies as a way to wave off criticism without having to engage it. Instead of refuting arguments or defending policy, the magic letters 'TDS' turn disagreement into proof of mental defect. Yet if 'derangement' means the loss of proportion and judgment Krauthammer was getting at, then the most severe cases aren't among Trump's critics. They're in the ranks of his most ardent loyalists. The real Trump Derangement Syndrome shows up in three telltale symptoms. First is the cult-like worship that treats Trump as infallible — his acolytes profess adoration not only for what he does, but for whatever could flow from him. Emblematic of that mindset are the Advertisement Second is the abandonment of principles that once seemed non-negotiable. Conservatives and Republicans who used to champion free trade A man with a MAGA tattoo on his stomach attended a rally at Macomb Community College in Warren, Mich., to mark President Trump's 100th day in office on April 29. EMILY ELCONIN/NYT Third is the unsettling delight so many supporters take in Trump's most outrageous behavior — a kind of giddy worship that equates offensiveness with authenticity. Such brazenness has been a hallmark of his political career — from mocking John McCain's Vietnam War heroism to charging undocumented immigrants with ' Advertisement Meanwhile, they reflexively use 'TDS!' as a go-to put-down for anything from mild disagreement to serious moral critique, framing opposition not as argument but as pathology — an easy, cheap discredit. Yes, plenty of Trump-haters go overboard — but in MAGA circles, the 'TDS' tag is sprayed far wider, hitting thoughtful critics just as readily as the genuinely unhinged. What is truly alarming is how some have sought to legalize that insult by casting dissent as disease. In Minnesota this spring, five Republican senators proposed a bill that would Krauthammer's original point in 2003 was that derangement is the breakdown of proportion and prudence. That breakdown isn't found among critics who quote Trump accurately and challenge his claims. The most alarming political derangement today affects those who cannot conceive that there are legitimate reasons to be appalled by the president, and so explain anti-Trump dissent as a sign of mental weakness. If reason is the measure, then those who shout 'TDS!' the loudest are the ones most in need of treatment. Jeff Jacoby can be reached at

Donald Trump and Prince Andrew Were 'Swapping Tales About Women'—Author
Donald Trump and Prince Andrew Were 'Swapping Tales About Women'—Author

Newsweek

time41 minutes ago

  • Newsweek

Donald Trump and Prince Andrew Were 'Swapping Tales About Women'—Author

Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Donald Trump and Prince Andrew were overheard "swapping tales about women" by a diplomat in New York, a royal author told Newsweek. The two men have both been under fire over their respective friendships with Jeffrey Epstein, the New York sex trafficker who died in jail in August 2019. The president denied knowing Andrew that same year despite having previously said, in 2000, that he was a "lot of fun to be with." Now, historian Andrew Lownie argues in his new biography Entitled that the pair did enjoy each other's company and were seen together by diplomats. Steven Cheung, the White House communications director, told Newsweek: "It seems like this random individual wrote a book of fiction that belongs in the bargain bin of a discount bookstore." Donald and Melania Trump and Prince Andrew pose at Mar-a-Lago, Palm Beach, Florida, on February 12, 2000. Donald and Melania Trump and Prince Andrew pose at Mar-a-Lago, Palm Beach, Florida, on February 12, It Matters Prince Andrew's reputation disintegrated due to allegations by Virginia Giuffre that she was forced to have sex with him by Epstein and Epstein's former girlfriend, Ghislaine Maxwell, as a 17-year-old sex trafficking victim. Trump has denied knowing about Jeffrey Epstein's crimes, but their friendship has been haunting him in recent weeks, since botched promises to release the Epstein files this year. Trump administration officials had hinted at major revelations and even new charges in the case after the president ordered a review of the files. Yet in July, the D.O.J. and FBI released a memo saying there was no "Epstein client list" to release, there would be no new investigations and there was no evidence the financier blackmailed prominent figures. What to Know Lownie said in an upcoming episode of Newsweek's The Royal Report podcast: "I had this fascinating lunch with the diplomat at the New York consulate, who had stories of Trump and Andrew swapping tales about women, swapping notes about masseurs, talking about golf. "They have all these interests, golf, sex and money. So, I mean, it was amazing that Trump subsequently denied having any knowledge of Andrew, having any contact with him, when of course there's plenty of pictures of them together in London, in Mar-a-Lago and elsewhere. "They were all fishing in the same waters. But I can understand why they may want to distance themselves now." Newsweek representatives of Prince Andrew for comment. What Donald Trump Said About Andrew After Prince Andrew's car crash interview in 2019, Trump denied knowing the royal: "I don't know Prince Andrew, but it's a tough story, it's a very tough story." Yet he told People at a party in October 2000: "He's not pretentious. He's a lot of fun to be with." The magazine's article read: "Attending a Halloween costume party hosted by model Heidi Klum at the chic Hudson Bar, the teetotaling Andrew sipped bottled water and chatted with Maxwell, who wore a leopard-print jacket and platinum wig, as well as with Donald Trump and his girlfriend, model Melania Knauss [as the First Lady was then known]." Months earlier, that February, Andrew was photographed chatting with the Trumps at Mar-a-Lago. Epstein and Maxwell were at the same event and were also pictured socializing with both Andrew and Trump. Melania Trump, Prince Andrew, Gwendolyn Beck and Jeffrey Epstein at a party at the Mar-a-Lago club, Palm Beach, Florida, February 12, 2000. Melania Trump, Prince Andrew, Gwendolyn Beck and Jeffrey Epstein at a party at the Mar-a-Lago club, Palm Beach, Florida, February 12, Happens Next The Epstein-shaped storm swirling around Trump has moved to questions about Ghislaine Maxwell, who had meetings over two days with Todd Blanche, deputy U.S. Attorney General, in July. Shortly afterward, she was moved to a minimum security prison to continue serving her 20-year sentence for sex trafficking related offences. Maxwell was convicted over allegations that she groomed girls for Epstein to sexually abuse. Democrat Senator Sheldon Whitehouse has requested documents relating to the transfer, telling Newsweek it "reeks of a coordinated protection racket run at taxpayer expense to shield the president." Lownie said he was concerned Maxwell could be a flight risk: "I think she'll disappear. I mean, we may assume that she's in the American prison service but I think she'll be sunning herself on the beach somewhere." And on her transfer, he added: "The victims must feel very strongly about this, that you know, here's someone who had a very serious sentence, was charged and convicted on several counts, and, it was clear from the trial, had been deeply involved in what Epstein was doing. "And yet, you know, here she is with a 20-year sentence being basically given a get out of jail free card." Jack Royston is chief royal correspondent for Newsweek, based in London. You can find him on X, formerly Twitter, at @jack_royston and read his stories on Newsweek's The Royals Facebook page. Do you have a question about Charles and Queen Camilla, William and Kate, Meghan Markle and Harry, or their family that you would like our experienced royal correspondents to answer? Email royals@ We'd love to hear from you.

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