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Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Heightened diligence standards and longer decision timelines for early-stage startups slowed venture activity last year, J.P. Morgan found in a report published ahead of the bank’s annual healthcare conference in San Francisco.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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As part of cost-cutting efforts, Alector is letting go of about 25 people as it focuses on advancing its preclinical and research pipeline. Alector is also continuing clinical-stage work on programs for frontotemporal dementia and Alzheimer’s disease.
The British pharmaceutical giant is working with the U.K. Dementia Research Institute to exploit a “natural randomization” experiment to determine whether 65- and 66-year-olds who received GSK’s shingles vaccine Shingrix have reduced dementia risk.
The 9% average salary increase from 2023 to 2024 was the largest for life sciences professionals since 2021. Several factors could be behind the spike, including companies providing higher pay because bonuses and stock compensation went down.
Led by alums from Takeda and Boston Pharmaceuticals, Hillstar Bio is working on treatments that remove harmful immune cells to relieve disease.
Merck joins a growing list of companies targeting lipoprotein(a), high levels of which are associated with an elevated risk of adverse cardiovascular outcomes.
President Donald Trump’s tariffs on pharmaceuticals “to come at some point,” per CNBC, as companies promise to build infrastructure in the U.S.
The Eylea franchise was in need of a win after an appellate court last week denied the pharma’s bid to block Amgen’s biosimilar from the U.S.
If confirmed, Susan Monarez will have her work cut out for her, facing a measles outbreak that has already killed two people—the first measles-related deaths in the U.S. since 2015.
The company, launched with help from ex-Novartis executives, is targeting glutamate signaling in the brain to help treat alcohol- and cocaine-use disorders, among other indications.