Three Months In - Biopharma & Regulation in 2025
- Param Malik
- Mar 10
- 5 min read
Updated: Mar 21
WASHINGTON, D.C. - Washington's grip on the biopharma and healthcare sectors tightens in 2025, as a volatile mix of unprecedented regulatory upheaval and political maneuvering collides with innovation and progress. This transformation is being driven by a confluence of factors: rapid technological advancements, evolving public health priorities, and an increasingly complex regulatory landscape. Here we delve into the key shifts and trends shaping biopharma in 2025, and explore the implications of these shifting sands on the industry, future policy, and access to medical care.
Three months into the year, the sector has seen a rapid acceleration of AI integration amidst debates over drug pricing, shifting NIH funding priorities, escalating cybersecurity concerns, and a pervasive wave of federal staffing layoffs that has found its way to agencies like the Department of Health & Human Services (D.H.S.S). These include a cut of roughly one-tenth of the workforce of the Centers for Disease Control & Prevention (C.D.C.), and similarly significant cuts at both the National Institutes of Health (N.I.H.) and the Food & Drug Administration (F.D.A.).
Coupled with the controversial appointment of Robert F. Kennedy Jr. to Secretary of Health & Human Services in February, and the abrupt resignation of N.I.H. Director Francis R. Collins, with a warning that major federal research programs are “at severe risk”, the department and the biopharma sector, more broadly, are facing a period of unprecedented uncertainty. Vacated leadership positions across federal regulatory agencies and the stability of federal research initiatives have ignited widespread concerns about the direction of national health policy, and the overall confidence in the nation’s public health infrastructure.
Novel Drug Approvals
Amidst this turbulent backdrop, the FDA's novel drug approvals in 2025 stand as a testament to the biopharma sector's continued innovation. As of early March 2025, several notable therapies have received the green light, signaling advancements across various therapeutic areas. These approvals also highlight key regulatory trends: the growing focus on targeted therapies for specific patient populations, and the continued push for novel approaches to address unmet medical needs
List of Approved Medicines
(Source: United States Food & Drug Administration (F.D.A.) Center for Drug Evaluation & Research)
Drug Name | Approval Date | FDA Approved Use |
|---|---|---|
Romvimza (vimseltinib) | 2/14/2025 | To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity |
Gomekli (mirdametinib) | 2/11/2025 | To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection |
Journavxi (suzetrigine) | 1/30/2025 | To treat moderate to severe acute pain |
Grafapex (treosulfan) | 1/21/2025 | For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome |
Datroway (datopotamab deruxtecan-dlnk) | 1/17/2025 | To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease |
Drug Pricing & Accessibility
The issue of drug pricing and accessibility has reached a critical juncture in 2025. The approval of groundbreaking gene therapies, like those targeting rare genetic disorders, has reignited the debate over the affordability of potentially curative treatments.
In 2022, President Biden’s Inflation Reduction Act (I.R.A.) included significant reforms to Medicare’s drug pricing reimbursement model, giving the Center for Medicare & Medicaid Services (C.M.S.) the authority to negotiate prices for a select number of high-cost drugs each year and redesigning the Medicare Part D benefit to provide newer financial protections for beneficiaries. In 2025, C.M.S. announced 15 additional Part D drugs selected for price negotiations, including Ozempic, Wegovy, Linzess, Ibrance, and others, leading to potentially reduced revenue for the manufacturers of these drugs while simultaneously lowering the out-of-pocket costs for Medicare beneficiaries, improving accessibility to these medicines.
Then again, the pharmaceutical sector has made clear its intentions to increase the prices of more than 250 branded drugs in the United States, with a median price increase of 4.5% in January. Pfizer, for instance, has raised the prices of more than 60 drugs this year, including Paxlovid, Nurtex, and Ibrance. With drug prices in the U.S. being the highest globally, the IRA’s Medicare drug inflation rebate program requires manufacturers to pay a rebate for raising the price of drugs higher than the rate of inflation and discourages companies from this practice.
From controversial leadership appointments and the ensuing uncertainty surrounding federal research programs to the dynamic interplay of drug pricing negotiations, novel therapeutic approvals, and the rapid evolution of digital health, the events of this year have underscored the critical need for a regulatory framework that can adapt to the accelerating pace of innovation while ensuring patient safety, equitable access, and fiscal responsibility. As the sector grapples with the complex balance between progress, affordability, and equitable access, a shared commitment to addressing the pressing needs of patients and the future of healthcare will be essential.
Read more about the impact of federal research funding cuts on the future of medicine and learn about the most anticipated drug launches of 2025.
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