| | By Angus Liu An investigation into the national security implications of pharma imports has been underway for two weeks, the Trump administration disclosed Monday. |
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By Nick Paul Taylor Pfizer has axed its oral GLP-1 asset danuglipron after one patient had potential drug-induced liver injury in a phase 1 trial. The setback blows a hole in the Big Pharma’s plans to challenge for the obesity market. |
By Fraiser Kansteiner As tariff threats and FDA staff cuts thrust the biopharma world into uncharted waters, President Donald Trump is offering the industry some reprieve by ordering the elimination of the so-called "pill penalty" baked into 2022’s Inflation Reduction Act. |
By Darren Incorvaia The FDA announced on April 10 that the agency plans to end the requirement for new monoclonal antibodies and some other drugs to be tested in animals. Animal testing will be replaced with a suite of techniques, including computational models and human cell lines and organoids, the agency said. |
By Zoey Becker In a Friday speech to FDA employees, the HHS secretary laid bare his belief that the agency hasn't acted in the best interest of Americans—going many steps further in his own colorful language. |
By Gabrielle Masson The U.S. government continues to end contracts related to the $5 billion Project NextGen initiative, this time terminating funding for an Atlanta biotech’s lead program that’s currently being tested in a mid-stage trial. |
By Nick Paul Taylor GSK has been found guilty of bringing discredit on the pharma industry after a complainant flagged “a shocking error” in the prescribing information for the JAK inhibitor Omjjara. |
By Conor Hale During its quarterly earnings report, executives at Johnson & Johnson said they expect escalating worldwide tariffs to put a $400 million dent in the company’s financial forecasts—largely from its exports of medical devices from the U.S. into China. |
By Darren Incorvaia The White House has ordered the National Institutes of Health to study regret and detransition in people who have transitioned genders, according to multiple reports. |
By Joseph Keenan Aurobindo's Aurolife Pharma has received a Form 483 from the FDA outlining 11 observations at the company's North Carolina inhaler plant, the drugmaker said in a filing. |
Fierce podcasts Don’t miss an episode |
| This week on "Podnosis," Fierce Healthcare Senior Writer Anastassia Gliadkovskaya talks with Equip’s Jessie Menzel, Ph.D., about gaps in eating disorder care. |
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