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The Food and Drug Administration on Tuesday approved a drug from Merck designed to treat a progressive and life-threatening lung condition in a win for both the drugmaker and for patients suffering from the rare disease. The condition refers to when the small blood vessels in the lungs narrow. He noted that the drug will be a "paradigm shift" for patients living with PAH. That includes reducing the risk of death or worsening of the condition by 84% compared to an existing drug alone. Those trials include late-stage studies on patients with more advanced PAH disease, and those who are within the first year after diagnosis.
Persons: Chris Schott, Eliav Barr, PAH, Barr, Merck Organizations: Merck, Drug Administration, JPMorgan, CNBC, Acceleron Pharma Locations: Rahway , New Jersey, U.S, Winrevair
The decision is an early win for the Biden administration as it grapples with a flurry of other legal challenges that drugmakers have filed against the Medicare drug price negotiations. The judge's ruling won't end the legal battle over the policy, which could end up at the Supreme Court. A slate of major companies with drugs selected for negotiations, including J&J, Merck , and Bristol Myers Squibb , have filed separate lawsuits challenging the constitutionality of the price talks. The suit also argued that the price talks violate the Eighth Amendment because they include a "crippling" excise tax aimed at forcing drugmakers to accept the government-dictated price of medicines. The groups also argued that the price talks violate due process by denying pharmaceutical companies and the public input on how Medicare negotiations will be implemented.
Persons: Biden, drugmakers, Judge David Ezra of, Ezra, NICA's, Nicole Longo, PhRMA, Eli Lilly, Johnson, NICA Organizations: U.S . Department of Health, Human Services, Supreme, Medicare, Western, Western District of Texas, Pharmaceutical Research, Manufacturers of America, Global Colon Cancer Association, National, Center Association, CNBC, Pfizer, Johnson, Merck, Bristol Myers Squibb, Chamber of Commerce, Department of Health, Department of Justice Locations: Washington ,, Western District, PhRMA, Ohio
The United States will work with other governments to speed up efforts to make nuclear fusion a new source of carbon-free energy, U.S. Kerry spoke at the Atlantic Council Global Energy Forum. In southern France, 35 nations are collaborating on an experimental machine to harness fusion energy, the International Thermonuclear Experimental Reactor, to prove the feasibility of fusion as a large-scale, carbon-free source of energy. The global nuclear industry launched an initiative at COP28 for nations to pledge to triple this kind of nuclear energy by 2050. Commonwealth Fusion was founded in 2018 by researchers and students from the Massachusetts Institute of Technology Plasma Science and Fusion Center.
Persons: John Kerry, ” Kerry, Kerry, Andrew Holland, Dennis Whyte, Whyte, Edwin Lyman, Lyman, Bob Mumgaard, Mumgaard, it's Organizations: Climate, Atlantic Council Global Energy Forum, United Kingdom, United States, International, Reactor, Fusion Industry Association, Dubai, Commonwealth Fusion Systems, United, United Arab Emirates, Fusion, Lawrence Livermore National Laboratory, Commonwealth Fusion, Massachusetts Institute of Technology Plasma Science, MIT, Commonwealth, Plasma Science, Fusion Center, Union of, Scientists, Washington, ARC, SPARC, AP Locations: States, U.S, Dubai, U.N, United States, France, Japan, Europe, China, Russia, Devens , Massachusetts, COP28, United Arab, Commonwealth, California
The American Red Cross has long been recognized as the universal symbol of humanitarian services —and it's an expensive operation. "When the White House starts raising money, when the big corporations, the NFL, Hollywood A-listers are raising money for the aftermath of a disaster, it's most likely targeted toward the American Red Cross." When CNBC inquired about the pricing of these products, the American Red Cross responded that "prices for a unit of red blood cells is proprietary information. A majority of the American Red Cross' operating expenses, just over $2 billion, is also spent on collecting blood, according to its financial statements. Watch the video above to see how the American Red Cross makes and spends its billions.
Persons: Jake Johnston, Laurie Styron, Michael Thatcher Organizations: Center for Economic, White House, NFL, Hollywood, CNBC, Cross, Navigator
[1/2] Nurse Agnes Besancon check on Gabriel Delabays during a blood donation on the first day gay men in the country could give blood after Switzerland lifted long-standing restrictions, at the transfusion center CRS in Epalinges near Lausanne, Switzerland, November 1, 2023. Switzerland amended blood donation criteria for men who have sexual relations with other men, making ineligibility criteria the same for homosexuals and heterosexuals. Until 2017, gay men were systematically barred from giving blood in Switzerland, a policy dating to the start of the HIV/AIDS epidemic in the 1980s. Some other European countries, including Spain and Italy, have no restrictions preventing men who have sexual relations with men from giving blood. France removed additional restrictions on gay blood donors last year.
Persons: Agnes Besancon, Gabriel Delabays, Denis Balibouse, I'm, Gaé, SwissMedic, Donor Delabays, Gabrielle Tétrault, Farber, Alison Williams Organizations: REUTERS, Swiss Liberal Free Democratic Party, Swiss Transfusion SRC, Thomson Locations: Switzerland, Epalinges, Lausanne, EPALINGES, Swiss, Ecublens, Pink, Spain, Italy, France
The search for Robert Card, 40, of Bowdoin, involved both old-fashioned footwork and advanced technology, but for almost two days after the shooting there was still no sign of Card by air, water or land. Maine's wildlife game wardens were among the officers taking part in the water search. “That AI technology can be used to search the video faster," Carter said. SEARCHING BY AIRColder temperatures expected this weekend would have made it easier to use thermal search equipment, Sauschuck said during the afternoon press conference. “Helicopters and drones, given how wooded it is there, using infrared technology can help you look through the canopy,” Carter said.
Persons: outdoorsman, Robert Card, Bowdoin, Mike Sauschuck, Sauschuck, Ryan Smith, David Carter, ‘ I’ve, , ’ ”, Carter, “ It’s, ” Carter, “ It's, , , Michael Balsamo Organizations: Maine Public, U.S . Coast Guard, Maine's Department of Public, Michigan State University, FBI, “ Helicopters, Maine Department of Inland Fisheries, Wildlife, Canada Border Services Agency, Lewiston Police Department, Analysis, Associated Press Locations: Maine, Androscoggin, Lisbon Falls , Maine, Kennebec, U.S, State, New York
Eisai on Wednesday said an injectable version of the Alzheimer's drug Leqembi showed promising initial results in a clinical trial, potentially paving the way for a new and more convenient option for administering the antibody treatment. Eisai and Biogen said in a release that they plan to apply for U.S. approval of subcutaneous Leqembi by the end of March. Eisai presented the preliminary results, from an extension to a late-stage trial that supported the approval of intravenous Leqembi, at the Clinical Trials on Alzheimer's Disease conference in Boston. The study specifically showed that the injectable form of Leqembi removed 14% more plaque than the approved intravenous formulation. Blood concentration levels of the drug were 11% higher with subcutaneous Leqembi than the other version.
Persons: Eisai, Leqembi, Biogen, Organizations: Eisai, ARIA, Alzheimer's Association Locations: U.S, Boston
The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai/Handout via REUTERS/File Photo Acquire Licensing RightsBOSTON, Oct 25 (Reuters) - An injected version of Eisai (4523.T) and Biogen's (BIIB.O) Alzheimer's drug Leqembi works as well as the current intravenous version at removing toxic brain plaques, according to an analysis presented by Eisai on Wednesday. The Japanese drugmaker's review compared data for 72 patients with early Alzheimer's given Leqembi by subcutaneous injection to prior pivotal trial results from 898 patients who received the drug by infusion. Blood concentration levels of the drug were 11% higher with subcutaneous Leqembi than the IV version. Roll-out of IV Leqembi, which has an annual list price of $26,500, has been slow.
Persons: Eisai, Leqembi, , Eric Reiman, Priya Singhal, Biogen, Michael Irizarry, Alzheimer's, Julie Steenhuysen, Deena Beasley, Bill Berkrot, Leslie Adler Organizations: Reuters, REUTERS, Rights, Banner Alzheimer's Institute, ARIA, Thomson Locations: Handout, Boston, Los Angeles
Nuclear fusion is a breakthrough technology that could help the US achieve pollution-free power. Calling nuclear fusion a pioneering technology, Granholm said President Joe Biden wants to harness fusion as a carbon-free energy source that can power homes and businesses. A successful nuclear fusion was first achieved by researchers at the Lawrence Livermore National Laboratory in California last December in a major breakthrough after decades of work. Nuclear energy is an essential component of the Biden administration's goal of achieving a carbon pollution-free power sector by 2035 and net zero emissions economy by 2050. "We want to see everybody moving forward as quickly as possible (on the clean energy transition), including ourselves," she said.
Persons: it's, , Biden, Jennifer Granholm, Granholm, Joe Biden, It's, Dennis Whyte, Rishi Sunak, Sunak Organizations: Service, US, Associated Press, Lawrence Livermore National Laboratory, Control, Plasma Science, Fusion Center, Massachusetts Institute of Technology, Energy, UK Locations: VIENNA, Vienna, California, France, Washington
The internet went wild over claims scientists discovered a room-temperature superconductor. Here's how a room-temperature superconductor could change everything:Revolutionize the medical industryMRI machines currently depend on liquid helium coolant to keep cool enough to operate. A room-temperature superconductor would go a step further in helping create these fields under normal conditions. With room-temperature superconductors, EV makers might be able to take a closer step towards delivering cheap battery-run cars. This is where room-temperature superconductors could one day step in.
Persons: It's, gloriously, Dr Niladri Banerjee, Banerjee, Michael Fuhrer, Massoud Pedram, Eugene Hoshiko, they'd, Jason Laurea, Lawrence, Robert Knopes, Getty Images Elon, Tesla Organizations: Imperial College London, Theory, School of Physics, Monash University, University of Southern, Airport, Lawrence Livermore National Laboratory, MIT's, Science, Fusion Center, Fusion Systems, Getty Images, TechCrunch Locations: South Korea, Australia, University of Southern California, Shanghai, China, Pudong, levitating, Lawrence Livermore
New York State to Debut First Cybersecurity Strategy
  + stars: | 2023-08-09 | by ( James Rundle | ) www.wsj.com   time to read: +6 min
The state of New York will debut its first cybersecurity strategy, including plans to modernize government networks, provide digital defenses at the county level and regulate critical infrastructure. In addition, the state plans to focus on developing its cybersecurity workforce and educating New York residents and companies about cybersecurity. In March, the White House published the National Cybersecurity Strategy, which touches on several of the themes in New York’s own document. The U.S. Office of the National Cyber Director coordinated with the New York state government during the drafting process, said acting National Cyber Director Kemba Walden. Kemba Walden, acting National Cyber Director Photo: U.S. OFFICE OF THE NATIONAL CYBER DIRECTOR“Certainly we appreciate points of alignment, where appropriate, between state cyber strategies and the National Cybersecurity Strategy.
Persons: Kathy Hochul, Kathryn Garcia, Lev Radin, , Garcia, Colin Ahern, Kemba Walden, ” Walden, ” Garcia, James Rundle Organizations: state’s, of Homeland Security, Emergency Services, New York, cybersecurity, Aging, U.S . Office, National Cyber, New, New York State Department of Financial Services, New York State Intelligence Center, Joint Security Operations Center Locations: New York, Suffolk County, Iowa, Michigan, West Virginia, New York’s Suffolk County, New, New York City, Albany, Telecommuting, Brooklyn, Albany , Rochester, Syracuse, Albany , New York City, Yonkers, james.rundle
New York State Debuts First Cybersecurity Strategy
  + stars: | 2023-08-09 | by ( James Rundle | ) www.wsj.com   time to read: +6 min
The state of New York debuted its first cybersecurity strategy, including plans to modernize government networks, provide digital defenses at the county level and regulate critical infrastructure. In addition, the state plans to focus on developing its cybersecurity workforce and educating New York residents and companies about cybersecurity. In March, the White House published the National Cybersecurity Strategy, which touches on several of the themes in New York’s own document. The U.S. Office of the National Cyber Director coordinated with the New York state government during the drafting process, said acting National Cyber Director Kemba Walden. Photo: U.S. OFFICE OF THE NATIONAL CYBER DIRECTOR“Certainly we appreciate points of alignment, where appropriate, between state cyber strategies and the National Cybersecurity Strategy.
Persons: Kathy Hochul, Kathryn Garcia, Lev Radin, , Garcia, Colin Ahern, Kemba Walden, ” Walden, ” Garcia, James Rundle Organizations: New York, state’s, of Homeland Security, Emergency Services, cybersecurity, Aging, U.S . Office, National Cyber, New, New York State Department of Financial Services, New York State Intelligence Center, Joint Security Operations Center Locations: New, New York, Suffolk County, Iowa, Michigan, West Virginia, New York’s Suffolk County, New York City, Albany, Telecommuting, Brooklyn, Albany , Rochester, Syracuse, Albany , New York City, Yonkers, james.rundle
CNN —Explosions hit critical road bridges linking occupied Crimea with parts of Kherson region under Russian control, Russian authorities say, as Ukraine escalates its targeting of Russian infrastructure and territory. The Russian-appointed acting head of Kherson region, Vladimir Saldo, says the missiles that hit two bridges in Crimea Sunday were all Storm Shadows, an air-launched long-range missile supplied to Ukraine by the UK. Earlier, Ukrainian President Volodymyr Zelensky said a Russian guided aerial bomb struck a blood transfusion center in the Kharkiv region Saturday. MapboxA new wave of Russian missiles also struck sites across Ukraine overnight, most of which were shot down. Any explosions that happen to Russian ships or the Crimean bridge are “an absolutely logical and effective step.
Persons: Vladimir Saldo, Saldo, can’t, It’s, , Volodymyr Zelensky, , Vasyl Maliuk, Maliuk Organizations: CNN, Crimea Sunday, CNN Ukraine, Saturday, Ukrainian Security Service Locations: Crimea, Kherson, Ukraine, Moscow, Russian, Kherson region, Henichesk, Kharkiv, Russia, Ukrainian
"On the size of the opportunity, I think, it's a little too early to say," said GE Healthcare CEO Peter Arduini. GEHC YTD mountain GE Healthcare shares are up 31% year to date. So what's the takeaway for GE Healthcare, Quest and others in the diagnostics space? Zimmerman reiterated a neutral rating on GE Healthcare on Wednesday, saying it was fairly valued relative to its peers. Both stocks have had a down week, but GE Healthcare shares are up 31% in 2023.
Persons: Peter Arduini, it's, Gordon Haskett, Don Bilson, Bilson, Eli Lilly, Ryan Zimmerman, Zimmerman, FactSet Organizations: GE Healthcare, Quest Diagnostics, Drug Administration, Biogen, FDA, ARIA, Quest Locations: U.S
CNN —The US Food and Drug Administration is expected to decide on Thursday whether to grant traditional approval to the Alzheimer’s drug Leqembi, the first medicine proven to slow the course of the memory-robbing disease. Leqembi, from drugmakers Eisai and Biogen, received accelerated approval in January based on evidence that it clears amyloid plaque buildups in the brain that are associated with Alzheimer’s disease. But because of an earlier coverage decision by CMS, which provides insurance coverage for many elderly patients with Alzheimer’s through Medicare, the drug hasn’t been widely used. People with more advanced forms of the disease may not benefit from the drug, he said, and may face increased safety risks. Broad Medicare coverage of Leqembi and similar types of medications to slow the progression of Alzheimer’s disease would probably have a big impact on the program’s spending.
Persons: drugmakers, hasn’t, , ’ ”, Joe Montminy, Lawrence Honig, “ It’s, , Honig, it’s, Leqembi, ” Honig, Georges Naasan, Sue Rottura, ” Drugmaker Eisai, “ You’re, Ivan Cheung, Eisai, ” Montminy, Dr, Sanjay Gupta Organizations: CNN, Food and Drug Administration, Medicare, Services, CMS, Columbia University Irving Medical Center, Alzheimer’s, Behavioral, CNN Health, Kaiser Family Foundation Locations: Mount, Florida
The pharmaceutical industry's largest lobbying group and two other organizations Wednesday sued the Biden administration over Medicare's new powers to slash drug prices for seniors under the Inflation Reduction Act. Pharmaceutical Research and Manufacturers of America, along with the National Infusion Center Association and the Global Colon Cancer Association, argue that the Medicare negotiations with drugmakers violate the U.S. Constitution, in a complaint filed in federal district court in Texas. The groups asked the court to declare the program unconstitutional and prevent the Department of Health and Human Services from implementing Medicare negotiations without "adequate procedural protections" for drug manufacturers. It marks the fourth lawsuit challenging the controversial provision of the Inflation Reduction Act, which became law last summer in a major victory for President Joe Biden and Democratic lawmakers. The lawsuit also argues the policy violates due process by denying pharmaceutical companies and the public input on how Medicare negotiations will be implemented.
Persons: Eli Lilly, Johnson, Joe Biden, PhRMA —, drugmakers, Stephen Ubl, Ubl Organizations: New York Stock Exchange, Biden, Pharmaceutical Research, Manufacturers of America, National, Center Association, Global Colon Cancer Association, drugmakers, Constitution, Pfizer, Johnson, of Health, Human Services, HHS, Democratic, Merck, Bristol Myers Squibb —, U.S . Chamber of Commerce, PhRMA Locations: U.S, Texas
But time spent waiting robs early patients of their memory and ability to live independently. This condition is often, though not always, a sign of early Alzheimer's disease. PET scans cumbersomeTwo types of tests can diagnosis Alzheimer's disease: PET scans and spinal taps. Early Alzheimer's disease can also be diagnosed with a spinal tap, in which fluid around the spinal cord is extracted with a catheter and tested. He believes big players like CVS will provide infusions for Alzheimer's disease on a major scale if they see there's a large and stable market.
The top regulatory agency for nuclear materials safety in the U.S. voted unanimously to regulate the burgeoning fusion industry differently than the nuclear fission industry, and fusion startups are celebrating that as a major win. As a result, some provisions specific to fission reactors, like requiring funding to cover claims from nuclear meltdowns, won't apply to fusion plants. Other differences include looser requirements around foreign ownership of nuclear fusion plants, and the dispensing of mandatory hearings at the federal level during the licensing process, Holland said. The electricity generated by nuclear fission is considered clean energy by the U.S. Department of Energy because it generates no greenhouse gas emissions. And these reactors deliver massive quantities of power: Half of the carbon-free energy generated in the U.S. comes from nuclear fission reactors.
Amazon -owned autonomous vehicle venture Zoox said on Monday that it is now testing its self-driving robotaxis on public roads in California with passengers on board. Zoox executives said the company began the tests after it received approval from the California Department of Motor Vehicles last week. Zoox said one of its vehicles completed a test run with employees on board over the weekend. Zoox unveiled its custom-built, electric robotaxi in 2020, with an eye on offering on-demand autonomous transportation in urban settings. It will continue to test the vehicle with employees and expects to launch a shuttle service for staffers this spring.
A provision in the Inflation Reduction Act that allows Medicare to negotiate prices on the costliest prescription drugs each year will likely save the U.S. billions of dollars — as long as the drug industry doesn't interfere, according to a study published Friday in JAMA Health Forum. They identified 40 drugs that would have been selected by Medicare for drug pricing negotiation under the Inflation Reduction Act's provision. The researchers simulated negotiated prices by using a so-called ceiling price, which is at least 25% off the average price drug manufacturers charge to nongovernment entities, like private health insurance providers. The researchers found that the Medicare drug negotiation provision would have saved the U.S. $26.5 billion, or 5% of all drug spending, during those three years. It plans to release a list of the first 10 drugs it will target for drug pricing negotiation by September.
The Centers for Disease Control and Prevention estimates 5.8 million Americans were living with the disease in 2020 . BIIB 6M mountain Biogen's stock is trading well above its lows Leqembi treats Alzheimer's disease by targeting amyloid-beta plaques in the brain. Attention shifts to Eli Lilly Shares of other Alzheimer's drug developers have often mirrored Biogen's moves. Small drug developers Smaller Alzheimer's drug developers have also been boosted by research developments. Still in an early stage of its research, Prothena has traded as a proxy for developments in Alzheimer's treatment.
But doctors often recommended the monoclonal antibody for people taking certain immunosuppressive medications, such as cancer patients or transplant recipients, since Paxlovid can interact negatively with several of those drugs. Casadevall said convalescent plasma is an effective alternative to monoclonal antibodies, but it's more complicated to administer and oversee. Pharma companies haven't given up on the promise of new monoclonal antibody drugs, however. A spokesperson for Eli Lilly said the company is searching for and evaluating monoclonal antibody candidates. Casadevall said new monoclonal antibody drugs are still worth pursuing, since they have proven safe and effective against Covid.
If successful, Merck could begin marketing the new formulation within a few years, a top Merck executive told Reuters. "The clock for that patent would start ticking from the time we would get that patent approved." Drug patents have a guaranteed term of exclusivity for 20 years after receiving a patent under U.S. law, but sometimes the companies are able to add additional patents that extend their exclusivity. Merck's patents on the subcutaneous version of Keytruda could protect that formulation until at least 2040, according to Tahir Amin, co-founder of drug patents watchdog group Initiative for Medicines, Access & Knowledge (I-MAK). Northwell's Mulloy said moving patients to subcutaneous versions of drugs also opens up spots in infusion centers for additional patients.
Dataminr has a contract for surveilling social media and providing news alerts for the White House. Dataminr is in Twitter's official partner program, which gives it more access to Twitter data. Dataminr, one of Twitter's official partners, will soon get a new social-media-surveillance contract for the White House, according to a newly published government document. A contract justification document mentions that Dataminr would be used on a "Watch Floor," which refers to the watch floor of the White House Situation Room, Dataminr said. The DISA contract is the latest contract in Dataminr's controversial history.
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