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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo Acquire Licensing RightsCompanies Regeneron Pharmaceuticals Inc FollowAug 18 (Reuters) - The U.S. Food and Drug Administration approved a higher dose version of Regeneron Pharmaceuticals' (REGN.O) drug Eylea for treatment of a disease that is a leading cause of blindness among the elderly, the company said in a statement on Friday. Eylea is normally given in doses of 2 mg every eight weeks. Two late-stage trials had shown Eylea was as effective as the lower dose version when given at 8 mg at longer intervals without any additional safety issues. In June, the FDA declined to approve the higher dose version of Eylea and said it had outstanding questions, citing an ongoing review of inspection findings at a third-party filler of the higher dose.
Persons: Andrew Kelly, retinopathy, Regeneron, Eylea, Jahnavi, Sandra Maler, Rosalba O'Brien Organizations: Food and Drug Administration, FDA, REUTERS, Regeneron Pharmaceuticals, U.S . Food, Drug Administration, Thomson Locations: White Oak , Maryland, U.S, Bengaluru
MrBeast, whose real name is Jimmy Donaldson, contracted Virtual Dining Concepts, based in Orlando, Florida, to launch the MrBeast Burger concept in 2020 during the Covid-19 pandemic. The MrBeast burger, of the virtual food delivery chain driven by YouTube celebrity Jimmy Donaldson, in New York, Feb. 24, 2021. Because of that harm, the lawsuit claims Donaldson has the right to end the breached contract and shut down the MrBeast burger business. For example, MrBeast Burger in New York has 2.1 stars on Yelp. In 2022, a physical MrBeast Burger opened at the American Dream mall in New Jersey, sending fans swarming the store on its debut.
Persons: MrBeast, MrBeast Burger, Jimmy Donaldson, Adam Friedlander, Donaldson, it’s, Burger, He’s, ” Donaldson, , Organizations: New, New York CNN, Court, of, Concepts, YouTube, The New York Times, Beast Investments, Burger, European Union, Investments Locations: New York, Southern, of New York, Orlando , Florida, European Union Canada, Thailand, Singapore, Mexico, Malaysia, New Jersey
The AI tools being applied to healthcare can generally be divided into two main categories. The first encompass large language models that are applied to administrative functions like processing medical claims or creating and analyzing medical records. In fact, up to 30 percent of radiology practices have already adopted AI tools. Right now, there are only a few clinical language models, and even the largest ones possess a relatively small number of parameters. As the quality and scope of clinical data available for training these large language models continue to grow, so will their capabilities.
Persons: Scott Gottlieb, ChatGPT, Amazon's, retinopathy, IBM's, Watson, they're, William J Organizations: CNBC, Pfizer, Aetion Inc, Cruise Line Holdings, Harvard, FDA, Oncology, Google, Healthcare
A software engineer asked users on work discussion app Blind for advice on how to date an intern. The engineer told Insider he was surprised by the backlash, but still plans to ask out the intern. A software engineer asked an online forum for advice on how to date an intern — and users promptly roasted him. Blind users responded to his question — How can I ask her out? In just one day, dozens of Blind users commented on the post to express their disapproval over the engineer's ulterior motives.
Persons: , he'd, couldn't, he'll, Microsoft didn't Organizations: Morning, Microsoft, Blind, Oracle, Society for Human Resource Management Locations: American
Amanda Goh/InsiderThe couple's apartment is part of the new Bidadari housing estate that was launched for sale in November 2016. Amanda Goh/InsiderThe couple designed their home in a modern Scandinavian style, with plenty of wood accents. It's also kind of expanded — we moved a wall inside just to open up the space," Teo said. Amanda Goh/InsiderThe couple collected the keys in June 2022 and started renovations a month later. Amanda Goh/InsiderThe couple also created a pie chart of the cost breakdown so they knew how much they spent on each room.
Persons: Vanessa Tan, Shannon Teo, , It's, Tan, Teo —, they're, Teo, Amanda Goh, they'd, we're Organizations: Service, Board, Housing Locations: Singapore, Woodleigh, , Instagram
A view of the Regeneron Pharmaceuticals headquarters in Tarrytown, New York. Shares of Regeneron fell nearly 9% Tuesday after the U.S. Food and Drug Administration declined to approve a higher-dose version of the company's blockbuster eye disease treatment. Regeneron said the rejection was "solely due to an ongoing review of inspection findings at a third-party filler." That suggests the drug could potentially win approval down the road. But a delay won't help the company fight off threats to its Eylea drug franchise, which is facing competition from Roche Holdings ' eye drug, Vabysmo.
Persons: Regeneron Organizations: Regeneron Pharmaceuticals, U.S . Food, Drug Administration, Roche Holdings Locations: Tarrytown , New York, U.S
The Food and Drug Administration cited an ongoing review of inspection findings at a third-party filler of the higher dose for the decision. Eylea, which recorded $9.65 billion in global sales last year, has been hit since Roche's (ROG.S) rival treatment Vabysmo was approved last year for wet AMD. Two late-stage trials had shown Eylea was as effective as the lower dose version when given at 8 milligrams at longer intervals without any additional safety issues. The two trials included treatment of patients with wet AMD and diabetic macular edema (DME). An estimated 1.1 million people in the U.S. have wet AMD, while 1.2 million are estimated to have DME, according to Regeneron.
Persons: Vabysmo, Regeneron, Eylea, Raghav Mahobe, Krishna Chandra Eluri, Maju Samuel, Sriraj Organizations: Regeneron Pharmaceuticals, Drug Administration, FDA, AMD, biosimilars, Thomson Locations: U.S, Bengaluru
Lydia Polgreen on ‘Survivor’ - The New York Times
  + stars: | 2023-06-20 | by ( Lydia Polgreen | ) www.nytimes.com   time to read: +4 min
America Is ... We asked 17 columnists topick the one piece of culture thatbest captures the country. The show had grand ambitions: Jeff Probst, the host, repeatedly referred to “Survivor” as “the greatest social experiment.”Scroll to watch and read moreIt’s also a uniquely American experiment. Most strikingly, the show takes on — admittedly, in a ham-fisted way — the biggest divides in American society: gender, sexuality, race, age, class. One of the most admired and rewarded feats on “Survivor” is the blindside: voting off someone who thinks you are an ally. “Survivor” reminds us that living in our panopticon, with cameras in every pocket, we are content creators all, delivering a performance of ourselves.
Persons: topick, , Jeff Probst, MeToo, Probst, can’t, Erving Goffman Organizations: Survivor Locations: America
Yet not everyone has given the host glowing reviews, including the major’s reigning champion Matt Fitzpatrick. And following Saturday’s third round, Fitzpatrick – whose hopes of becoming the first player to defend the US Open title since Brooks Koepka look slim – again spoke about the quality of the course and the atmosphere. Fitzpatrick added: “I’ve seen Brooks’ comments and I tend to agree with what he feels like that about this golf course. Yet firmer greens and fairways brought fresh criticisms of the course, and atmosphere, from Fitzpatrick on Saturday. “Very poor … It’s disappointing on the USGA side,” said Fitzpatrick of the atmosphere, according to Barstool Sports journalist Dan Rapaport.
Persons: Matt Fitzpatrick, England’s Fitzpatrick, , Fitzpatrick –, Brooks, I’d, Koepka, Fitzpatrick, “ I’m, ” Koepka, I’ve, Brooks ’, you’ve, , ” Fitzpatrick, Matt York, Padraig Harrington, ” Harrington, ” Brooks, Scottie Scheffler, ” Scheffler, Rickie Fowler, Xander Schauffele, Dan Rapaport, Collin Morikawa, Tom Kim, ” Kim, can’t Organizations: CNN, Los Angeles Country Club, Sky Sports, ESPN, United States Golf Association, USGA, Barstool Sports, Los Locations: American, LA, Los Angeles, Korean
A blind man is suing three rail companies after he fell onto the tracks at a station in England. A blind man is suing a railway company and two train operators after falling onto railway tracks in England. He said the lack of tactile paving at the train station meant he wasn't alerted to the platform edge. Charity the Royal National Institute of Blind People said last year that 40% of major rail stations in the UK lacked tactile paving. A jury found that the lack of tactile paving "more than minimally" contributed to his death, Metro reported.
Persons: Abdul Eneser, He's, Eneser, it's, Cleveland Gervais Organizations: Morning, Manchester Piccadilly, Network Rail, Northern Rail, Guardian, Royal National Institute of Blind People, Metro Locations: England, Avanti West Coast, Eden, London
[1/5] Abdessalem Maraouni, a Tunisian university student displays a medicine box of "Celluvisc" at his home in Tunis, Tunisia May 29, 2023. Tunisia imports all medicine through the state-owned Central Pharmacy, which provides drugs to hospitals and pharmacies around the country which offer them to patients at a subsidised rate. Amira said the Central Pharmacy owed about 1 billion dinars ($325 million) to suppliers. Tunisia's Health Ministry and Central Pharmacy did not respond to requests for comment. MEDICINE EXCHANGEFrom the roof of his Tunis house, retired soldier Nabil Boukhili has opened an unofficial medicine exchange for his neighbourhood in coordination with local doctors.
Persons: Maaoui, Faourati, Kais Saied, Naoufel Amira, Amira, Nabil Boukhili, Boukhili, I've, Najia, Abdessalem Maraouni, Kamal, Tarek Amara, Jihed Abidellaoui, Angus McDowall, Ros Russell Organizations: REUTERS, Monetary Fund, Central Pharmacy, Tunisia's Syndicate, Tunisia's Health Ministry, Reuters, Thomson Locations: Tunis, Tunisia, TUNIS, Europe
Can Formula 1’s Season Still Take a Turn?
  + stars: | 2023-05-28 | by ( Andrew Das | Josh Katz | ) www.nytimes.com   time to read: 1 min
A dark tunnel and then a burst of blinding light along the waterfront. The famed Circuit de Monaco, which first hosted a grand prix race in 1950, is one of the most iconic stops on Formula 1’s schedule. But the bling and the boats disguise an open secret: it is incredibly narrow, incredibly hard to pass, and an incredibly easy place to find trouble. Just ask Lewis Hamilton, who saw his car lifted off the circuit by a crane after his own accident on Saturday. Or just ask Fernando Alonso, who qualified second but now must find a way to get past Max Verstappen if he is to taste victory.
[1/2] The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland January 30, 2020. Quarterly group revenue fell to 15.3 billion Swiss francs ($17.2 billion), the company reported on Wednesday, beating market expectations of 14.8 billion francs. The company, which does not report earnings for its first and third quarter, reiterated that pandemic-related sales - mainly lab testing, antibody treatment Ronapreve and repurposed arthritis drug Actemra - would drop by 5 billion francs this year. "We are very happy with the very rapid and significant uptake in the different markets around the world," he said on a media call. Sales and core earnings per share were still expected to decrease at a "low single-digit" percentage in 2023, the pharmaceuticals and diagnostics company added.
"It felt like nothing could get in the way of all that," said a former engineer who attended the party. For this report, CNBC spoke with 16 current and former Peloton employees, the majority of whom declined to be identified because they are not permitted to speak publicly about the company. Foley, meanwhile, spoke briefly with CNBC by phone, saying that while Peloton's stock has fallen, the company has not. Peloton's stock price was slowly sliding down, and employees began to panic as they saw their paper wealth evaporate. By June 30, the end of Peloton's fiscal year, the company's full-year net loss ballooned to $2.83 billion.
Blind members verify that they work at a particular company by signing up with a work email address. Now, Blind is filled with posts from workers comforting each other about how to get through periods of unemployment. (Some tech workers have also lamented the pay cut they’d have to take by switching industries.) “We just all realized that there’s a need for communication that is kind of independent of company control,” Kim said. While Blind is not exclusively for tech workers, it has become incredibly popular in the industry amid the recent turmoil.
Hong Kong CNN —Millions of players in China have lost access to the iconic “World of Warcraft” franchise and other popular video games, as Blizzard Entertainment’s servers in the country went offline after two decades. That was underscored in recent days, as Chinese fans expressed their disbelief over the loss of their longtime pastime in social media posts. Those deals had covered the publication of several popular Blizzard titles in mainland China, including “World of Warcraft,” “Hearthstone,” and “Diablo III,” since 2008. In a LinkedIn post Monday, Simon Zhu, president of global investments and partnerships of NetEase Games, detailed how he grew up with Blizzard games in China, including older “Warcraft” and “Diablo” titles. “Only [a] few hours before Blizzard Games servers shut down in China, and that is a very very big deal for players in China,” he wrote.
It's like the start of a joke: What do Google and slime mold have in common? A lot, says a memo from an ex-Googler comparing the org to a "slime mold." (A key difference: Stanford grads aren't desperate to intern at a slime mold.) But with ChatGPT setting off alarm bells inside and outside the org, Google should probably move faster and with more intention than slime mold. The most memorable part of the memo compares Google's bottom-up organizational structure to a "slime mold," highlighting how both Google and a slime mold can work independently but still come together to solve complex problems.
Researchers have discovered a way to revive eyes from organ donors after death, an advance that opens doors to progress against age-related macular degeneration, glaucoma and other major causes of blindness. The accomplishment, which many experts hadn’t thought possible, gives scientists the ability for the first time to conduct experiments on a functioning human retina, potentially unlocking a treasure trove of new information about the chemistry of vision and what goes wrong in the intricate network of retinal cells when people start losing their sight.
Meta staff wrote in a Blind post that CTO Andrew Bosworth doesn't want them posting on the site. Close to 3,000 Meta employees signed up to Blind the day before it announced mass layoffs. Blind told Insider it has more than 64,000 Meta employees signed up on its platform, which it said was more than three quarters of the workforce. It also said that close to 3,000 Meta staff joined Blind the day before the Facebook founder announced 11,000 job cuts. Another Meta employee, seemingly quoting Bosworth, posted on Blind: "Get off Blind.
Patients who get their prescription medications by mail in Oklahoma may soon have better protections for the safety of those drugs than any other state. On Wednesday, Oklahoma regulators proposed the nation’s first detailed rule to control temperatures during shipping, according to pharmacy experts. “This is a huge step,” said Marty Hendrick, executive director of the Oklahoma State Board of Pharmacy, after the board voted to approve the rule Wednesday. The proposed rule would extend that same standard of care to all medications moving through the state, regardless of shipper or medication cost. “The landscape of pharmacy has changed,” he said, with more people getting their medications delivered, especially since the pandemic began.
JERUSALEM, Nov 15 (Reuters) - Israeli digital health firm AEYE Health said on Tuesday it received clearance from the U.S. Food and Drug Administration (FDA) to market its screening system to detect damage to the retina of the eyes in diabetics. Screening diabetics for retinopathy, or damaged retinas, has recently become reimbursable in the United States. The FDA approval follows positive Phase III clinical trial results from last February. It noted that diabetic retinopathy is a leading cause of blindness in the working age and that 90% of such vision loss could be avoided with early detection and treatment. AEYE added it was advancing a follow-on program for the screening of glaucomatous optic neuropathy and expects to initiate FDA pivotal trials soon.
The embattled startup hired against unprofitable growth, Jess Muse, Cerebral's president, said. Cerebral, she said, paid more money on advertising to bring in new patients than it recouped by providing mental-health services and prescriptions. Prioritizing turning a profitCerebral leaders held a series of staff meetings on Monday. During the Monday staff meetings, at least two employees expressed concerns about the increased workload, since remaining staff are taking on patients of those who were laid off. Several employees accused company leaders of blindsiding workers with layoffs after the employees said they were assured the company was performing well.
Critics of Elon Musk’s Twitter takeover say any plan to charge users for identity verification could make information on the site less trustworthy and more vulnerable to manipulation — devaluing the company. The idea of a monthly fee for the blue verification checkmark by users' names was reported Sunday by Casey Newton’s tech-focused newsletter Platformer. Musk hasn't confirmed a charge will be added but on Sunday tweeted, “The whole verification process is being revamped right now,” on his own verified account. Jeff Jarvis, a prolific Twitter user and journalism professor who studies how information travels in the digital age, worries such a plan could backfire. “Twitter has had many, many people working on issues like user interface design and innovation, testing it with user groups, and people who specialize in working with VITs — very important Twitter users,” she said.
Front cameras could help prevent these deaths, safety experts say. On Monday, he announced legislation that would make front blind zone safety features mandatory for motor vehicles. After Congress passed a law to improve rear blind zone safety nearly 15 years ago, it took a decade — rulemaking, regulatory delays and a multiyear rollout — before it fully went into effect. Blumenthal’s bill directs regulators to determine what technology, such as cameras or sensors, to require to make front blind zones safer, much like the rear blind zone law did. But she believes the best way to prevent future tragedies is widespread use of blind zone cameras.
Vinay Trivedi, a vice president at General Atlantic focusing on the technology sector. I don't think we necessarily transitioned fast enough to how people learn if we're only doing audio from home. - David Israel, 27, vice president at Credit SuisseAngel Pu Shum is a principal within Warburg Pincus's technology group. -Allison Boxer, 29, senior vice president and economist at PIMCONoah Zerance, a vice president with Bank of America's global sustainable-finance group. and the response would be, 'Well, we don't know how we do it yet.
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