By John Miller ZURICH (Reuters) - Roche Holding and partner AC Immune SA called a halt to two late-stage clinical trials of their crenezumab drug for early Alzheimer's, the latest in a string of failures to find a treatment for the progressive brain disease. The announcement from Roche and its Swiss-based partner AC Immune came after an interim analysis indicated it was unlikely to be effective, the Swiss drugmaker said on Wednesday. Nasdaq-listed shares of AC Immune fell 65 percent in response. Alzheimer's, a fatal disease which affects memory and language as it progresses, is a compelling target for drugmakers as the numbers affected across the globe swell with an ageing population, but experimental Alzheimer's drugs have had a dismal track record, with more than 100 failures. About 5.7 million Americans are living with Alzheimer's and the number is projected to rise to nearly 14 million by 2050, according the U.S. Alzheimer's Association. Drugmakers such as Eli Lilly, AstraZeneca Plc and Johnson and Johnson have all abandoned trials testing their experimental drugs. The trial failures have undermined the so-called amyloid beta, or abeta, treatment hypothesis, in which protein plaques in the brain are believed to play a pivotal role in the disease. Roche said an Alzheimer's Prevention Initiative (API) study of crenezumab among healthy individuals with a genetic disposition to develop the disease in Colombia would continue. Roche added it remained committed to ongoing clinical studies of Alzheimer's disease, including separate late-stage trials with gantenerumab and a mid-stage anti-tau trial. Crenezumab was discovered by AC Immune and is being developed by Roche under a license agreement. AC Immune Chief Executive Officer Andrea Pfeifer said the company was "extremely disappointed" and the readout might provide evidence that beta amyloids need to be used during earlier stages of the disease to be effective. "Monotherapy might only be applicable in very earlier populations. In later stage populations… we have to think about combination therapy," she said in a phone interview, adding that the Colombia trial should shed light on that. Roche shares were largely unchanged. Shares of companies who are still developing Alzheimer's treatments, including Biogen Inc, were down in early trading. Biogen and Eisai's amyloid-based Alzheimer's treatment was last year shown to slow cognitive decline at the highest dose tested but investors voiced doubt the results were strong enough to translate into commercial success. AC Immune, which specializes in neurodegenerative disease, is also working on different Alzheimer's treatments, known as anti-tau drugs, a field that has attracted drug majors such as Merck & Co . "This latest failure is yet another setback for the anti-Abeta hypothesis and could also impact others working in this space," Brokerage Jefferies analysts wrote in a client note. Regulators announced plans last year to encourage testing of medicines for early stage Alzheimer's and help pharmaceutical companies win approval for drugs to treat the disease. James Pickett, head of research at the UK-based Alzheimer's Society charity, said it was "hugely disappointing" to hear that another drug trial for Alzheimer's had failed, but added; "We're far from losing hope". "Increasingly, research shows us that while amyloid plays an important part in Alzheimer's, it's not the only issue," he said in an emailed statement. (Additional reporting by Michael Shields in Zurich, Kate Kelland in London, Ludwig Burger in Frankfurt and Manas Mishra in Bengaluru; editing by Maria Sheahan and Elaine Hardcastle)
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The U.S. Food and Drug Administration said Wednesday that Johnson & Johnson’s one-shot COVID-19 vaccine appeared safe and effective in trials, paving the way for its widespread, emergency use.The White House's COVID-19 response coordinator Jeffrey Zients said Wednesday that the U.S. expects to allocate three to four million doses of the vaccine next week, pending approval. “We're working with the company to accelerate the pace and time frame by which they deliver the full 100 million doses, which is required by contract by the end of June.” The additional vaccine will help President Joe Biden’s administration in its goal of ramping up vaccination across the country as it seeks to control the pandemic that has cost more than 500,000 lives in the U.S. and pummeled the economy. The J&J vaccine is administered in a single dose and can be stored in normal refrigerators, in contrast to the Pfizer and Moderna shots which need two doses and must be kept in freezers.J&J executive Richard Nettles this week told Congress his company’s vaccine is highly effective.“Twenty-eight days after vaccination, the vaccine provided complete protection against COVID-19 related hospitalization and death. The vaccine was 85% effective overall in preventing severe disease, including across countries with newly emerging variants. The vaccine was 72% effective in the United States at preventing moderate to sever disease.”The FDA’s panel of independent experts meets on Friday to decide whether to approve the shot. While it’s not bound to follow the advice of its experts, the FDA did so when authorizing the Pfizer and Moderna vaccines.
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William Nylander tied it with 1:28 left in regulation and scored 1:06 into overtime to give the NHL-leading Toronto Maple Leafs a 2-1 victory over the Calgary Flames on Wednesday night. Nylander took a pass from Auston Matthews in the extra period and beat goalie David Rittich high for his seventh of the season. “Nice to be able to score,” Nylander said.
The World Health Organization's global vaccine-sharing scheme COVAX delivered its first COVID-19 shots on Wednesday, as the race to inoculate the world's poorest people and tame the pandemic accelerates. Almost a year after the WHO described the novel coronavirus as a global pandemic, a flight carrying 600,000 doses of the AstraZeneca/Oxford vaccine produced by the Serum Institute of India landed in Ghana's capital Accra. Local representatives of the WHO and the United Nations children's agency UNICEF described the vaccines' arrival as a "momentous" step.
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Paul McCartney is finally ready to write his memoirs, and will use music — and a Pulitzer Prize-winning poet — to help guide him. McCartney, 78, will trace his life through 154 songs, from his teens and early partnership with fellow Beatle John Lennon to his solo work over the past half century. Irish poet Paul Muldoon is editing and will contribute an introduction.
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Four vehicles caught fire overnight in a garage in Somerville.
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President Joe Biden's pick to be the top U.S. trade envoy is promising to work with America's allies to combat China's aggressive trade policies, indicating a break from the Trump administration's go-it-alone approach. Fluent in Mandarin, Tai served several years as head of China enforcement at the trade representative's office.
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Lloyds Banking Group has a plan to restore profitability. It's going to take advantage of the trend for working at home, and slash office space. The lender plans to reduce its total footprint by a fifth within three years. The move comes after a big plunge in earnings. On Wednesday (February 24) the bank reported full-year pretax profits of 1.7 billion dollars. That was less than a third of the previous year's level, though it still beat analyst forecasts. The bank blamed mounting bad loans, which forced it to set aside billions of pounds to cover possible defaults. To turn things around the firm is investing in its insurance and wealth management operations, as well as aiming to cut costs. Wednesday also saw bleak numbers from rival Metro Bank, which saw losses multiply. It too warned that loan defaults would mount in the months ahead, as government support for businesses winds down. As for office space, commercial property firms will be watching developments with alarm. Earlier in the week bigger rival HSBC said it would cut its offices by 40%.
The White House said it was not prepared to withdraw President Joe Biden's pick for budget director, Neera Tanden, whose nomination stalled on Capitol Hill on Wednesday after controversy over tweets that upset lawmakers. Two Senate committees postponed scheduled meetings to consider Tanden's nomination, a clear sign she was struggling to get the votes to be approved and could thus become the first high-profile Biden nominee to be rejected. But Biden, a Democrat, still supports Tanden, an Indian American who would be the first woman of color to lead the agency.
The U.S. mail system is losing $10 billion a year and urgently needs reform and legislative relief from Congress, U.S. Postmaster General Louis DeJoy told lawmakers on Wednesday. "I would suggest that we are on a death spiral," DeJoy told the U.S. House Oversight and Government Reform committee at a hearing, who did not rule out changing first-class deliver standards or other significant changes. DeJoy, a supporter of former President Donald Trump appointed to head the Postal Service last year, suspended operational changes in August after heavy criticism over postal delays.
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While President Biden visits storm-torn Texas, Sen. Ted Cruz will be giving a speech on 'cancel culture' in Florida
The president will tour the state with Gov. Greg Abbott.
Billie Eilish's documentary gives an intimate look at her secret relationship with rapper 7: AMP - and why she decided to end it
They began dating in late 2018, when Eilish was 16. The film chronicles her frustration with his "lack of effort" and "self-destructive" behavior.
How a woman lives in a 500-square-foot apartment with 2 roommates, a dog, 100 houseplants - and zero clutter
Maximalist Bruna Mello lives in a sunny, vibrant tiny apartment in South London, and she doesn't let the small space keep her from collecting things.
- The Week
Journalist Tim O'Brien, who's seen Trump's taxes, thinks Trump's accountant will now flip in D.A. inquiry
Bloomberg's Tim O'Brien, one of the few journalists who has seen former President Donald Trump's tax returns, told MSNBC's Lawrence O'Donnell on Thursday night he will sleep better now that Manhattan District Attorney Cy Vance finally has eight years of Trump's financial documents, from 2011 to 2019. Trump "is very afraid of what's in these documents, I think," because they put him in serious criminal jeopardy, O'Brien said, but he isn't the only one implicated. O'Brien went on to explain why he thinks it's likely Trump's chief accountant, Allen Weisselberg, is likely to flip on Trump. "The thing to really focus in on here is that it's not just the tax records that Cy Vance has now," O'Brien said. "He probably has reams and reams of the accountant's work product. This is a criminal case, they're going to need to prove criminal intent on the part of Trump, his three eldest children, Allen Weisselberg, and anyone else in the Trump Organization who's fallen under the parameters of this investigation. And if there are email and notes and other records of communication about what they intended to do when they inflated the value of buildings so they could get loans against them and then turned around and deflated the value of the buildings so they could pay lower taxes on them, and there's a communication around that that predates any of these tax entries, that is gold for a prosecutor." A few hours earlier, O'Brien told MSNBC's Nicolle Wallace that the particular eight years of documents Vance's team has "is important, because it predates Trump's ascent into the White House, and I think helps build the narrative around the money trail and Trump's motivations for his destructive and obscene dance with people like Vladimir Putin. It's a shame they couldn't go back further — think this is one of the tragic misses of Robert Mueller's investigation, he could have gone back further, I think, than Cy Vance is able to into Trump's finances." O'Brien also underscored that the investigation implicates at least Eric Trump and Ivanka Trump, and "it also targets people inside the Trump Organization who might flip on Trump if they're exposed to criminal liability," but "the brass ring in all of this is that if Trump has a criminal conviction, he cannot run for president again, and that's looming over this entire thing as well." More stories from theweek.comDemocrats should take the Romney-Cotton proposal seriouslyThe MyPillow guy might be Trump's ultimate chumpThe GOP's apathy for governing is being exposed
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Coinbase says the entire crypto market could be destabilized if Bitcoin's anonymous creator is ever revealed or sells their $30 billion stake
Satoshi Nakamoto owns about 5% of the bitcoin market. If their 1.1 million cache was transferred, bitcoin prices could plummet, Coinbase said.
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The Department of Defense said the strikes were carried out at the president's direction following attacks on the US military in Iraq.
- The Week
In the race to get former President Donald Trump's tax records, New York prosecutors have won. While it was more of a marathon than a sprint, the Manhattan District Attorney's Office confirmed Thursday that it had received Trump's tax records a year and a half after first requesting them. Manhattan DA Cyrus Vance and his team will now be able to dig through what sources tell CNN are "millions of pages" of documents spanning January 2011 to August 2019. Vance got the documents, which include financial statements and engagement agreements, from Trump's accounting firm Mazars USA. The transfer happened within an hour of the Supreme Court ordering that Mazars hand over the documents on Monday, Vance's spokesperson told reporters. Forensic accountants and analysts are now prepared to root through the records to find potential fraud or wrongdoing by the former president. But because the records were handed over as part of a grand jury investigation, they're unlikely to ever be made public. Democrats in the House had meanwhile been trying to access Trump's tax returns from the time they gained a majority two years ago. Courts had ruled both for and against the Democrats' subpoenas, but the U.S. Court of Appeals for the D.C. Circuit ultimately decided in December not to rule in the case, essentially letting Trump run out the clock. It's unclear if Congress will try to pursue Trump's records again now that he's out of the White House. More stories from theweek.comDemocrats should take the Romney-Cotton proposal seriouslyThe MyPillow guy might be Trump's ultimate chumpThe GOP's apathy for governing is being exposed
Acting U.S. Capitol Police chief Yogananda Pittman testified on Thursday that cellphone records show former USCP chief Steven Sund requested National Guard support from the House sergeant-at-arms as early as 12:58pm on Jan. 6, but he did not receive approval until over an hour later.Why it matters: Sund and former House sergeant-at-arms Paul Irving clashed at a Senate hearing on Tuesday over a dispute in the timeline for when Capitol Police requested the National Guard during the Capitol insurrection.Stay on top of the latest market trends and economic insights with Axios Markets. Subscribe for freeIrving insisted that he has no recollection of receiving the request until after 2pm. Lawmakers are looking for accountability over that hour of lost time, when pro-Trump rioters were able to breach and ransack the Capitol."I did not get a request at 1:09 that I can remember," Irving, who resigned after the insurrection, testified. "The first conversation I had with chief Sund in that timeframe was 1:28, 1:30. In that conversation, he indicated that conditions were deteriorating and he might be looking for National Guard approval."Details: Pittman testified to a House subcommittee that Sund's phone records show the former chief first reached out for National Guard support to Irving at 12:58pm.Sund then spoke to former Senate sergeant-at-arms Michael Stenger to make the same request at 1:05pm, per Pittman.Pittman says Sund repeated his request to Irving at 1:28pm, then spoke to him again at 1:34pm, 1:39pm and 1:45pm.Go deeper: Pittman testifies officers were unsure of lethal force rules on Jan. 6Like this article? Get more from Axios and subscribe to Axios Markets for free.
TikTokers are freaking out after learning that Imagine Dragons made demos for disastrous Spider-Man musical
Multiple viral TikToks circulated about Imagine Dragons working on the Spider-Man musical, with many commenting on the 2012 hit song "Radioactive."
- The Independent
The building was closed for two days out of an abundance of caution
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Marjorie Taylor Greene escalates LGBTQ rights debate with attack on colleague's transgender daughter
A debate on the House floor over a bill that would extend civil rights protections to the LGBTQ community spilled over into the halls of Congress on Wednesday.