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Home » Topics » Regulatory » Policy

Policy
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Digital rendering of molecular structures

Open-source AI model can predict small-molecule binding affinity

June 9, 2025
By Anette Breindl
No Comments
Researchers at the Massachusetts Institute of Technology and Recursion Pharmaceuticals Inc. have released an open-source AI model that can predict the binding strength of small molecules as well as structures of proteins and biomolecular complexes. The model, which is called Boltz-2 and was released by the research team on the developer platform Github on June 6, addresses a major bottleneck in drug discovery with its improved ability to predict binding strengths.
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US flag, stock market chart, White House

White House budget proposal would cut FDA, slash NIH budgets

June 2, 2025
By Mark McCarty
The Trump administration released its budget proposal for fiscal year 2026, which would chop roughly 40% from the NIH budget over the current fiscal year — a proposal that might not find much support on Capitol Hill.
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FDA Orange Book

Trump DOJ proposes less intrusive corporate prosecution

May 30, 2025
By Mark McCarty
The U.S. Department of Justice is reshuffling its enforcement focus for the coming three years per a May 12 memo attributed to Matthew Galeotti, director of the department’s criminal division. Galeotti said federal attorneys should avoid prosecutorial adventurism in an effort to strike what he described as “an appropriate balance” between enforcement and “unnecessary burdens on American enterprise.”
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New EOs impacting biopharma, med tech

May 30, 2025
No Comments
A dynamic chart of the latest executive orders (EOs) from the Trump administration that have been published in the Federal Register and that directly impact the biopharmaceutical and medical technology sectors.
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U.S. Capitol building

FDA agrees to addition of policy experts at Q-sub meetings

May 29, 2025
By Mark McCarty
The U.S. FDA’s device guidance drought ended with the issuance of one draft and one final guidance, the latter of which deals with the Q-sub program for early interaction with sponsors of device applications. Per a request by industry, the agency indicated it is amenable to including FDA policy staff during these meetings, which may help to avoid surprises in premarket applications.
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HHS terminating Moderna’s $590M grant for flu vaccines

May 29, 2025
By Jennifer Boggs
No Comments
The funding boost Moderna Inc. had expected via a roughly $590 million Biomedical Advanced Research and Development Authority award now looks to be off the table. The company disclosed May 28 that the U.S. Department of Health and Human Services (HHS) said it will terminate the award for late-stage development and right to purchase pre-pandemic influenza vaccines.
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US trade court blocks emergency tariffs, but threat remains

May 29, 2025
By Mari Serebrov
No Comments
A court decision blocking President Donald Trump’s reciprocal and trafficking tariffs was hardly a day old before the U.S. Court of Appeals for the Federal Circuit stepped in late May 29 to grant a temporary stay while it considers the administration’s appeal. The stay adds further uncertainty to the path ahead for drug and device companies.
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USTR begins search for biopharma R&D ‘freeloaders’

May 28, 2025
No Comments
The U.S. Trade Representative (USTR) is asking for help in its search for “freeloaders” that refuse to shoulder their share of the cost of biopharma R&D.
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U.S. Capitol building, Washington D.C.

US House takes on CBO health panel controversy

May 27, 2025
By Mark McCarty
The controversy over budget scoring by the Congressional Budget Office (CBO) once again prompted legislation that would overhaul the membership of a health advisory panel that may affect legislation dealing with the Medicare program. The Health Panel Act of 2025 requires the panel be composed of six members each appointed by Republicans and Democrats. The bill's sponsor said this is crucial to ensure diversity of political views, which is said to be lacking as the panel is currently constituted.
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U.S. White House

White House eyes 11% cut in FDA budget authority for 2026

May 22, 2025
By Mark McCarty
U.S. FDA commissioner Marty Makary appeared at the May 22 Senate Appropriations Committee with the news the White House proposed an FDA budget for fiscal 2026 of $6.8 billion including user fees. This is a cut of 11.5% that will not likely go over well on Capitol Hill as the FY 2026 budget process unwinds.
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