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Top related persons:
Eisai - 1 Leqembi - 1 Eli Lilly - 1 Kisunla - 1 Aduhelm - 1 Stellantis - 1 Chris Rondeau - 1 Rondeau - 1
Top related locs:
Biogen U.S Japan South Korea China Israel Europe Alzheimer's Europe
Top related orgs:
U.S - 1 European Commission - 1 U.S . Food - 1 Drug Administration - 1 Medicines - 1 European Medicines Agency - 1 Alzheimer's - 1 UAW - 1

Search resuls for: "Medicines Agency's"


4 mentions found


☆ European drug regulator rejects Alzheimer's treatment Leqembi from Biogen, Eisai
  + stars: | 2024-07-26 | by ( Annika Kim Constantino | ) www.cnbc.com   time to read: +2 min
European drug regulators on Friday rejected the Alzheimer's treatment Leqembi from Biogen and Eisai , creating another hurdle for the companies as they scramble to boost uptake of the therapy in the U.S. But it almost always follows the drug regulator's recommendations. The European Medicines Agency's human medicines committee recommended against granting marketing authorization for Leqembi. Leqembi and Kisunla are milestones in the treatment of Alzheimer's after three decades of failed efforts to develop medicines that can fight the fatal disease. In 2021, the European Medicines Agency rejected Aduhelm.
Persons: Eisai, Leqembi, Eli Lilly, Kisunla, Aduhelm Organizations: U.S, European Commission, U.S . Food, Drug Administration, Medicines, European Medicines Agency, Alzheimer's Locations: Biogen, U.S, Japan, South Korea, China, Israel, Europe, Alzheimer's Europe
☆ Stocks making the biggest moves midday: General Motors, Stellantis, Planet Fitness, Adobe and more
  + stars: | 2023-09-15 | by ( Alex Harring | ) www.cnbc.com   time to read: +4 min
Nucor — The steelmaker fell 6.1% after offering worse-than-expected guidance for third-quarter earnings, with the company pointing to pricing and volume challenges. Core & Main — The infrastructure stock retreated 4.1% a day after it announced a secondary stock offering. The bank said Apellis has a favorable risk/reward ahead of third-quarter earnings. The Wall Street firm said the resumption of loan repayments introduce bookings risk to food delivery. The Wall Street firm said its pessimistic outlook was changing despite recent underperformance in the reinsurance space.
Persons: Stellantis, Chris Rondeau, Rondeau, Craig Benson, Nucor, Raymond James, Needham, Charles Shi, Lam, Goldman Sachs, Apellis, MoffettNathanson, Estée Lauder, Goldman, Yun Li, Jesse Pound, Samantha Subin, Pia Singh, Brian Evans, Lisa Kailai Han Organizations: UAW, General Motors Wentzville, General Motors, Ford, United Auto Workers began, Workers, CNBC, LSEG, PTC Therapeutics, Medicines Agency's, Medicinal Products, Arm, Investment, Bloomberg News, Apple, Dexcom, ASML Holding, Lam Research, Taiwan Semiconductor, Adobe, Bank of America, JPMorgan, Apellis Pharmaceuticals, Waste Systems Locations: Wentzville , Missouri, New Hampshire, Wells, underperform
☆ U.S. FDA advisers to weigh on updating initial COVID vaccine doses
  + stars: | 2022-12-16 | by ( ) www.reuters.com   time to read: +1 min
Dec 16 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Friday it planned to hold a meeting of outside experts next month to discuss whether initial doses of COVID-19 vaccines need to be updated to combat circulating variants. While updated booster doses from Pfizer (PFE.N) and Moderna (MRNA.O) are already approved for adults as well as children as young as five years, the FDA said it was important to weigh in on the composition of both initial and booster doses as new variants spread. The independent advisers, who are scheduled to meet on Jan. 26, are also expected to weigh in on whether the timing or composition of booster doses need to be adjusted. In June, advisers to the FDA had recommended a change in the composition of COVID-19 booster shots before fall to combat more recently circulating variants of the coronavirus. Reporting by Bhanvi Satija and Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila and Sherry Jacob-PhillipsOur Standards: The Thomson Reuters Trust Principles.
☆ EU regulator warns of 'disappointing' vaccine booster uptake
  + stars: | 2022-11-24 | by ( Ludwig Burger Maggie Fick | Ludwig Burger | Maggie Fick | ) www.reuters.com   time to read: +4 min
Nov 24 (Reuters) - Recent uptake of COVID-19 vaccine booster doses in the European Union has been "rather disappointing," an official said on Thursday, amid concerns that protection against severe cases of the disease could weaken during the winter. WHO data released late on Wednesday showed that 724,000 new COVID-19 cases were reported in the EU over the past week, down 11% from the previous week. In early October, when experts were warning of a new COVID-19 wave, the number of weekly cases reached 1.5 million. The EMA intends to issue new guidelines for health care providers on the issue of such treatments, he said. But prompt access to Paxlovid remains an issue in the EU, and the EMA is working with governments to change this, he said.
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