2024-07-26 19:12

BRUSSELS, July 26 (Reuters) - The Netherlands on Friday secured EU approval for 2 billion euros ($2.2 billion) of state aid to build a nuclear reactor to produce medical isotopes for cancer treatment. The European Commission, which acts as the EU competition enforcer said the support helps ensure the security of supply of essential and live-saving medicines, confirming a Reuters story on Thursday. The Netherlands, a leading producer of medical isotopes, proposed a new nuclear reactor for medical isotopes following concerns that shortages would arise after 2030. The aid consists of loans and equity for a total amount of about 2 billion euros to a newly established company (NewCo) that will build and operate the reactor that produces the medical isotopes and the nuclear health centre. "The Dutch authorities have committed to ensuring that NewCo, when operating PALLAS, will price its products at a level overing all costs associated with their production and commercialisation," the EU competition watchdog said. "This 2 billion euro measure enables the Netherlands to support a strategic project contributing to the securing of supply of essential medicines and to the development of breakthrough innovation in the field of nuclear technology to the benefit of European citizens," EU antitrust chief Margrethe Vestager said. Sign up here. https://www.reuters.com/business/healthcare-pharmaceuticals/eu-clears-22-bln-dutch-state-aid-medical-isotopes-cancer-treatment-2024-07-26/

2024-07-26 18:59

July 26 (Reuters) - A federal appeals court said on Friday it rejected the Environmental Protection Agency’s decision in 2022 to deny small oil refineries temporary waivers from the nation’s biofuels blending program, and sent the matter back to the agency for review. The decision by the U.S. Court of Appeals for the District of Columbia is a win for the refining industry, which has long opposed federal requirements under the Renewable Fuel Standard that they add biofuels such as corn-based ethanol into the nation’s fuel. The court’s opinion, and details of the decision, were sealed. The RFS was designed to help farmers and to reduce U.S. petroleum imports, but oil refiners – particularly smaller independent ones – say the program imposes costs that put their businesses at risk. The EPA can award exemptions to small refiners if they prove the obligations cause them undue harm. In 2022, the agency rejected a slew of such requests, triggering the legal battle that was spearheaded by refiner Sinclair Wyoming Refining Company and joined by others. The biofuel industry, including producers of corn-based ethanol, have long fought the small refinery waiver program, arguing that it has been overused in a way that helps the oil industry but hurts American farmers. Sinclair did not immediately respond to a request for comment. Biofuels groups said they were "extremely disappointed." "We will evaluate our next steps, which may include seeking further review of today’s decision. Our coalition remains resolute and committed to protecting and defending the proper implementation of the RFS," the Renewable Fuels Association, Growth Energy and the American Coalition for Ethanol said in a statement on Friday. The EPA said it was reviewing the decision. In a separate but related case last year, a U.S. appeals court struck down the EPA’s 2023 blanket denials of small refinery exemptions. Sign up here. https://www.reuters.com/business/energy/us-court-vacates-epa-denials-2022-small-refinery-biofuel-waivers-2024-07-26/

2024-07-26 18:50

EU regulator cites safety concerns, small benefit Eisai, Biogen to seek re-examination of decision The drug's launch in the U.S. has been slow Biogen shares fall 7%, rival Lilly slips 1% July 26 (Reuters) - The European Union's drugs regulator has rejected Eisai (4523.T) , opens new tab and Biogen's (BIIB.O) , opens new tab Leqembi treatment for early Alzheimer's disease, saying the risk of serious brain swelling did not outweigh its small impact on slowing cognitive decline. The decision is a blow to the companies as the drug faces slow take-up in the U.S. and underscores the complexities tied to a new class of drugs that have benefited early-stage patients, but could cause rare and serious side effects. Following the rejection, Biogen's shares fell about 7% in U.S. trading, while rival Eli Lilly (LLY.N) , opens new tab, which makes a similar drug, slipped 1%. Eisai and Biogen said they will seek re-examination of the recommendation, but did not disclose what information they would provide the regulator. The therapy, also known as lecanemab, is approved in the U.S., China, Hong Kong, Israel, Japan and South Korea, and would have been Europe's first drug to treat the neurodegenerative condition rather than its symptoms. The infusion, given twice a month, removes sticky clumps of protein amyloid beta from the brain, believed to be a hallmark of Alzheimer's disease. In clinical trials, the drug slowed cognitive decline by 27% in early Alzheimer's patients, compared with a placebo. In Europe, seven million people live with the disease, according to non-profit Alzheimer's Europe, which was disappointed with the decision. The EU regulator said it relied on the analysis by the agency's Committee for Medicinal Products for Human Use, and cited three primary concerns. An 18-point scale used in the trial to measure functions such as memory and problem-solving showed only a small absolute difference in patients who received lecanemab versus a placebo, it said. It also pointed to cases of ARIA, a type of brain swelling and bleeding, seen in its clinical trials that led to hospitalizations of some patients. The committee noted elevated risk of brain swelling and bleeding in people who have two copies of the APOE4 gene, which is also associated with a higher risk of Alzheimer's. SCRUTINY IN EUROPE Reuters reported last year, citing researchers, that the drug was unlikely to be used widely even if approved in Europe, where cost-conscious countries rigorously scrutinize new drugs. Leqembi's U.S. launch has been lackluster, with bottlenecks due to its requirements such as additional diagnostic tests, twice-monthly infusions and regular brain scans. One Alzheimer's expert said the decision reflected the complex considerations around the drug, which costs roughly $26,500 per year in the U.S. The requirements "lead to the question if limited resources (not just money but also trained staff) could produce better results for patients if used elsewhere," said Sebastian Walsh, NIHR Doctoral Fellow, University of Cambridge. The decision puts pressure on European regulators to create clear guidance on what is the clinically meaningful benefit for treating Alzheimer's disease, said Ivan Koychev, principal clinical investigator at the United Kingdom Dementia Platform. The recommendation must be backed by the European Commission, which usually follows the regulator's decision. The drug has been under review in the region since January 2023. The U.S. approved it last year and requires a warning against brain-related side effects. Lilly's amyloid-lowering drug Kisunla, also known as donanemab, gained U.S. approval this year and is being reviewed by European regulators. Given the Leqembi rejection, "we are hard-pressed to see the EU approving Lilly's donanemab," Piper Sandler analyst Christopher Raymond said in a research note on Friday. Officials at Lilly declined to comment on the EU decision, but John Sims, Lilly's senior medical director, told Reuters that the company believes in the favorable benefit-risk profile for amyloid-targeting therapies. Sign up here. https://www.reuters.com/business/healthcare-pharmaceuticals/eu-medicines-regulator-rejects-eisai-biogen-alzheimers-drug-2024-07-26/

2024-07-26 18:48

July 26 (Reuters) - Winds and lightning strikes have sparked and fanned wildfires across the Pacific Northwest this week, including the largest fire currently burning in the U.S., which was rapidly expanding near the Oregon-Idaho border on Friday. The Durkee Fire near Huntington, Oregon, has scorched 600 square miles (1,600 square km), an area more than half the size of Rhode Island's land mass, authorities said. It is threatening several towns. The blaze was set off by lightning on July 17, and wind gusts up to 60 mph (100 kph) drove the flames across brush, timberland and ranches, killing hundreds of cattle. The fire was only 20% contained on Friday, officials said. While there is zero chance of rain through next week, winds have dropped and cooler air is in store, said meteorologist Marc Chenard of the National Weather Service. "Hopefully it gives firefighters a break," he said. As of Thursday, wildfires this year have burned almost 1 million acres (400,000 hectares) in Oregon and 125,900 acres in Washington, according to the Northwest Interagency Coordination Center in Portland, Oregon. In 2020, the worst year in recent memory, Oregon wildfires scorched more than 1.14 million acres, according to a tally by CBS TV affiliate KOIN. In California, the Park Fire, believed to have been started by an arsonist, has forced the evacuation of more than 4,000 residents in Butte County, about 100 miles northeast of Sacramento. A suspect was arrested on Thursday, accused of pushing a burning car down a bone-dry gully. The fire grew uncontrolled overnight from 125,000 acres on Thursday to 178,090 acres on Friday afternoon, according to the California Department of Forestry and Fire Protection. More than a hundred buildings had been damaged or destroyed. "The biggest challenge with this fire is getting to it," said Fire Captain Dan Collins. "It's steep land with almost no roads. It's hard to get our people and equipment to the fire lines." More than 1,600 firefighters were deployed to contain the blaze, CalFire said. Forecasters warned that winds would reach 30 miles mph (50 kph) on Friday and through the weekend. Combined with low humidity, it is a recipe for rapid growth, officials said. Smoke from fires in western Canada and the Pacific Northwest have brought hazy skies and unhealthy air from the Rocky Mountains to Minneapolis and as far east as Detroit, weather reports said. Denver had the worst air quality in the U.S. on Friday and ranked the 30th worst in the world, according to IQAir, a group that tracks air pollution across the globe. Much of the smoke coming into the Central and Eastern U.S. comes from a raging wildfire in the mountainous Jasper National Park in the Canadian province of Alberta. The park and the town of Jasper, which draws more than 2 million tourists a year, were evacuated on Monday, displacing 10,000 residents and 15,000 park visitors. As much as half of the structures in the town could be damaged or destroyed, officials said, as the blaze burned more than 89,000 acres as of late Thursday. Videos posted on social media show entire streets leveled by the blazes in the Alberta province, with scorched trees, charred metal skeletons of cars, and nothing but rubble where homes and businesses had stood. Sign up here. https://www.reuters.com/world/us/oregon-wildfire-explodes-half-size-rhode-island-2024-07-26/

2024-07-26 18:47

WASHINGTON, July 26 (Reuters) - Boeing (BA.N) , opens new tab is asking suppliers to disclose records on Chinese titanium since 2014, according to a letter seen by Reuters, as the U.S. planemaker widens checks for false paperwork used to authenticate the metal used in commercial jets. Regulators said in June they were investigating whether false or incorrect documents were used to identify the authenticity of titanium used for parts in some Boeing and Airbus (AIR.PA) , opens new tab jets. Airbus said it is collaborating with authorities and investigating the lack of proper traceability affecting a small number of titanium parts from suppliers to programs like the A220, A320 and A350. Reports of forged documentation initially raised concerns about the structural integrity of some aircraft, but planemakers and suppliers say the correct titanium alloy was used and their products are safe. Paper trails are critical in aviation, where regulators insist on clear documentation for even minor production changes to assure planes are safe. "In the interest of full compliance, we are now broadening the scope of our request," Boeing wrote in the letter sent in mid-July to suppliers that asks for details by Aug. 9. It's not clear why Boeing is asking suppliers to provide records for Chinese titanium purchases dating back a decade. While the impact of the industry-wide issue is extremely limited for Boeing, the company said it is "continuing to work with our suppliers to ensure that every titanium part is properly documented." Aerospace-grade titanium's strength and light weight make it ideal for components that take the heaviest punishment, like engine parts and landing gear for big jets. Titanium supply has been tight due to demand for planes and as Western nations seek alternatives to metal from Russia and China. Boeing has been under scrutiny all year following the Jan. 5 mid-air blowout of a door panel on a new 737 MAX 9. The required documents detailing the removal of that key part for repairs have not been located and Boeing believes they were never created. Last year, jet engine manufacturer CFM International disclosed that thousands of its engine components might have been sold with falsified documentation by a British distributor. Joe Buccino, spokesperson for Boeing supplier Spirit AeroSystems (SPR.N) , opens new tab, said the company will comply with the planemaker's letter, which Boeing confirmed. "Documentation compliance is critical in the aviation industry," Buccino said. The Federal Aviation Administration (FAA) said the investigation is ongoing. The European Union Aviation Safety Agency (EASA) was not immediately available for comment. Boeing asked suppliers in February to disclose whether they had procured the metal through distributor Titanium International Group (TIG) since January 2019. In June, the New York Times reported that TIG noticed that the material looked different from previous supplies and determined that paperwork accompanying the titanium seemed inauthentic. The planemaker has since asked its supply chain to confirm their paperwork is legitimate after the company reviewed certificates of conformance from China not recognized as authentic by the original Chinese manufacturer. Sign up here. https://www.reuters.com/business/aerospace-defense/boeing-asks-suppliers-decade-long-titanium-paper-trail-check-forgeries-widens-2024-07-26/

2024-07-26 17:06

July 26 (Reuters) - LinkedIn agreed to pay $6.625 million to settle a proposed class action accusing the Microsoft (MSFT.O) , opens new tab unit of overcharging advertisers by inflating how many people watched video ads on its platform. A preliminary settlement was filed late on Thursday in San Jose, California federal court, and requires approval by U.S. Magistrate Judge Susan van Keulen in San Jose, California. LinkedIn denied wrongdoing. It also agreed to use reasonable efforts for two years to hire an outside auditor to review its ad metrics. Advertisers led by TopDevz of Sacramento, California and Noirefy of Chicago accused LinkedIn of inflating ad metrics by counting video ad "views" from users' LinkedIn apps, even when videos played only off-screen because users scrolled past them. The lawsuit began two weeks after LinkedIn disclosed in November 2020 , opens new tab that its engineers fixed software bugs on the business-focused social media platform that may have led to more than 418,000 overcharges, most under $25. LinkedIn provided credits to nearly all affected advertisers. Thursday's settlement covers U.S. advertisers who bought ads on LinkedIn between January 2015 and May 2023. In a statement, LinkedIn said the settlement "underscores our commitment to the integrity of our ads products and providing a trusted platform for our members and customers." LinkedIn is based in Sunnyvale, California, and Microsoft is based in Redmond, Washington. Microsoft's profit , opens new tab totaled $66.1 billion in the nine months ending March 31. Judge van Keulen had dismissed the lawsuit in December 2021. Advertisers appealed, but put the appeal on hold so both sides could mediate the dispute. The advertisers' lawyers may seek up to $1,656,250, or 25% of the settlement amount, for legal fees. The case is In re LinkedIn Advertising Metrics Litigation, U.S. District Court, Northern District of California, No. 20-08324. Sign up here. https://www.reuters.com/legal/microsofts-linkedin-settles-lawsuit-claiming-it-overcharged-advertisers-2024-07-26/