Policy
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
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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.
Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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In March, the FDA issued a Complete Response Letter for Zynquista as a treatment for type 1 diabetes.
In a filing with the court, Seattle Genetics claimed the right to arbitration to resolve the dispute with Daiichi Sankyo, as is required by the 2008 collaboration agreement.
Promore Pharma AB announces that the new share issue with preferential rights for existing shareholders has been completed.
Eisai Co., Ltd. has announced that LENVIMA, the orally available kinase inhibitor discovered by Eisai, has been accepted by the National Medical Products Administration of China for an application for the additional indication of differentiated thyroid cancer.
The Institute of Cancer Research, London, welcomes the approval by NICE of the innovative targeted cancer treatment palbociclib for women with advanced breast cancer who have already received hormone therapy.
Cardiovascular disease is currently the leading cause of death globally.
Submission follows completion of a Clinical Endpoint study
The companies are facing questions in a criminal probe regarding their marketing distribution practices related to the sale of opioids.
The government said Petit and former Chief Operating Officer William Taylor engaged in a scheme to “fraudulently inflate” the revenue of MiMedx.
Previously, Toujeo was approved only for adults aged 18 years and older.