Zachary Zubulake

EMA CHMP February Meeting | Created with Canva

The February 2026 meeting of the EMA's Committee for Medicinal Products for Human Use (CHMP) resulted in recommendations for twelve new medicines.¹ These outcomes, which included recommendations for three orphan medicines and six biosimilars, reflect the EMAs focus on addressing unmet medical needs through diverse regulatory pathways.

What Novel Treatment Modalities and Regulatory Pathways Reached Milestones?

One of the most notable advancements is the positive opinion for 

mCombriax, an influenza and COVID-19 mRNA vaccine developed by Moderna Biotech Spain SL

.² As the first combined messenger RNA vaccine designed to protect individuals aged 50 and older against both seasonal influenza and COVID-19, its recommendation underscores the increasing maturity of the mRNA platform. The scalability of such combined vaccines is a critical development in managing significant disease burden in the European economic area, where up to 50 million symptomatic cases of seasonal influenza occur annually.

Regulatory flexibility for high-unmet-need areas was further evidenced by the recommendation of a conditional marketing authorization for Ojemda (tovorafenib) from Ipsen Pharma.¹ Intended for pediatric low-grade glioma in patients as young as 6 months, this once-weekly oral therapy addresses a population for whom existing chemotherapy benefits are often modest and associated with substantial side effects. Similarly, X4 Pharmaceuticals received a positive opinion under exceptional circumstances for Xolremdi (mavorixafor). This treatment is intended for WHIM syndrome, an ultra-rare hereditary condition in which the immune system does not work properly. The CHMP noted that WHIM stands for warts, hypogammaglobulinemia, infections, and myelokathexis. These approvals illustrate how the EMA utilizes specific regulatory frameworks to accelerate access for life-threatening conditions when traditional clinical data sets may be difficult to complete.

Other positive opinions for new chemical entities included Onerji (levodopa / carbidopa) from Tanabe Pharma GmbH for Parkinson's disease, Palsonify (paltusotine) from Crinetics Pharmaceuticals Europe GmbH for acromegaly, and Rhapsido (remibrutinib) from Novartis Europharm Limited for chronic spontaneous urticaria.¹

How Does the Current Pipeline Reflect Shifts in Biosimilar Competition and Therapeutic Extensions?

The continued expansion of the biosimilar market remains a focal point for manufacturing strategy, with the CHMP adopting positive opinions for six biosimilar medicines this month.¹ These include insulin lispro (Bysumlog) and insulin aspart (Dazparda) from Gan & Lee Pharmaceuticals Europe GmbH for the treatment of diabetes. Additional biosimilar recommendations were issued for etanercept (Fubelv) by Biosimilar Collaborations Ireland Limited, pertuzumab (Poherdy) by Organon N.V., tocilizumab (Tuyory) by Chemical Works of Gedeon Richter Plc., and teriparatide (Zandoriah) by Cinnagen Co Unipessoal Lda. The likely entry of these products into the market for conditions ranging from rheumatoid arthritis to breast cancer and osteoporosis indicates a highly competitive landscape for biological manufacturing and development.

Lifecycle management also played a prominent role in the committee's decisions, with six therapeutic extensions recommended.¹ Sanofi Winthrop Industrie received a positive opinion for Dupixent (dupilumab) to treat chronic spontaneous urticaria in children aged 2 to 11 years, making it the first biologic treatment for this specific pediatric population. Furthermore, Dr. Falk Pharma GmbH’s Jorveza was recommended for a pediatric-specific formulation to treat eosinophilic esophagitis. This formulation addresses a critical gap in care, as the current treatment often relies on off-label use of adult formulations.

While many applications succeeded, the committee also issued negative opinions for Daybu by Acadia Pharmaceuticals and iloperidone by Vanda Pharmaceuticals.¹ Additionally, Pfizer Europe MA EEIG withdrew its initial application for sasanlimab, or Zumrad, which was being developed for bladder cancer. These outcomes serve as a reminder of the rigorous clinical evidence requirements maintained by the EMA for securing marketing authorization. Finally, the CHMP issued a positive opinion for Sanofi 

Winthrop Industrie’s Acoziborole Winthrop under the EU-M4All procedure, a regulatory mechanism that allows the Agency to support public health and regulatory capacity outside the European Union for diseases such as sleeping sickness.³

European Medicines Agency (EMA). Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23–26 February 2026. Published February 27, 2026. Accessed February 27, 2026. 

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-february-2026

​European Medicines Agency (EMA). First combined COVID-19 and influenza vaccine for people 50 years and older. Published February 27, 2026. Accessed February 27, 2026. 

https://www.ema.europa.eu/en/news/first-combined-covid-19-influenza-vaccine-people-50-years-older

​European Medicines Agency (EMA). New single‑dose oral treatment for human African trypanosomiasis (sleeping sickness). Published February 27, 2026. Accessed February 27, 2026. 

https://www.ema.europa.eu/en/news/new-single-dose-oral-treatment-human-african-trypanosomiasis-sleeping-sickness

Articles

CHMP issued positive opinions for 12 new medicines, including three orphan products and six biosimilars, signaling continued use of differentiated pathways to address unmet need. A first-in-class combined influenza/COVID-19 mRNA vaccine for adults ≥50 years advanced, alongside a conditional recommendation for once-weekly oral tovorafenib in pediatric low-grade glioma and an exceptional-circumstances opinion for mavorixafor in WHIM syndrome. Additional novel approvals, multiple label extensions, several negative opinions, and an EU-M4All recommendation for acoziborole highlighted evidentiary rigor and global-health support.

EMA's Feb 2026 meeting resulted in the recommendation of 12 medicines, including a combined flu/COVID vaccine among the six biosimilars and six therapeutic extensions.

Key Regulatory Trends from EMA’s February 2026 CHMP Meeting 

Asahi Kasei Acquires Aicuris | Created with Canva

In a definitive agreement announced on February 26, 2026, Asahi Kasei will acquire the German-based biopharmaceutical firm Aicuris Anti-infective Cures AG for approximately €780 million ($920 Million).¹ The move represents a calculated effort to strengthen a global pharmaceutical platform by pivoting further into the treatment of severe infectious diseases. This signal suggests a continued industry focus on therapeutic areas where infection-related complications significantly impact patient outcomes in core specialties like transplantation and nephrology.

How Does This Strategic Acquisition Align with Current Development Priorities in Specialty Therapeutics?

This acquisition is a component of a broader strategy to transition toward a more capital-efficient structure by prioritizing high-growth pharmaceutical sectors.¹ By integrating these new assets, Asahi Kasei aims to build a sustainable platform serving immunocompromised patients. Ken Shinomiya, head of healthcare sector, Asahi Kasei, noted the significance of this alignment, in a press release,¹ “This acquisition strengthens our position across interconnected therapeutic areas, including autoimmune diseases, transplantation, kidney disease, and severe infectious diseases. It enhances our pipeline and reinforces our strategy to build a leading global specialty pharmaceutical company.” This consolidation of resources across adjacent clinical areas is intended to drive operating efficiency and accelerate the development of a pipeline that targets significant clinical gaps.

What Impact Will the Integration of These Anti-Infective Assets Have on Long-Term Clinical and Commercial Roadmaps?

The technical focus of the acquired assets highlights emerging modalities and novel mechanisms of action that are of high interest to manufacturing and development professionals.¹ Specifically, pritelivir, a helicase-primase inhibitor for herpes simplex virus (HSV), has completed Phase III trials with a target for FDA approval in 2026. The clinical importance of treating HSV infection in immunocompromised patients aligns with established infrastructure in specialized hospital settings. Additionally, the development of AIC468, an antisense oligonucleotide (ASO) targeting BK virus (BKV) in kidney transplant patients, demonstrates an expansion into genetic-based therapeutics for post-transplant complications. These assets, combined with existing royalty income from the marketed cytomegalovirus (CMV) inhibitor prevymis, provide a layered growth profile. Managing the prevention of CMV infection alongside new treatments for HSV and BKV allows for a more robust infectious disease portfolio.

Shinomiya further explained the rationale behind the timing of the deal,¹ “Given the strategic alignment of this asset and the opportunity to expand within an area where we already have an established presence, we acted in a nimble and disciplined manner to advance our long-term growth objectives. This transaction accords with our capital allocation framework and supports our objective of achieving net sales of ¥300 billion in Pharmaceuticals with an operating margin of 15% or higher by fiscal 2030.” The transaction is expected to close in the first quarter of fiscal 2026, with a positive contribution to operating income anticipated starting in fiscal 2028. The expansion into specialized anti-infectives necessitates a focus on diverse modalities—from small molecule oral drugs to more complex ASO technologies—while leveraging existing clinical and regulatory infrastructure to meet long-term earnings targets.

How Do Strategic Alliances Reshape Global Commercialization for Established Therapies?

Beyond direct acquisitions, the pharmaceutical industry increasingly utilizes targeted partnerships to optimize product lifecycles across diverse regulatory environments.² On February 19

, Asahi Kasei announced a collaboration with MAIA Pharmaceuticals to bring the osteoporosis treatment teribone to the US, which exemplifies this trend. This highlights a strategy where proprietary assets are out-licensed to partners with specific regional expertise in clinical and regulatory navigation. This approach allows organizations to maximize the global value of proven therapies while focusing internal resources on priority sectors like anti-infectives. By leveraging external infrastructure for established products, developers can maintain a lean operational profile while expanding their international footprint.

What Does This Shift Toward Specialized Partnerships Mean for the Broader Pharmaceutical Landscape?

These moves are part of a broader management plan called Trailblaze Together, which prioritizes healthcare as a core growth driver.² By selecting partners for their specialized commercialization capabilities, companies can more efficiently address unmet medical needs in large patient populations, such as the millions of individuals at risk for osteoporotic fractures. The industry is placing newfound importance on developing flexible, high-quality production pipelines that can support varied international markets through collaborative frameworks rather than traditional, isolated expansion models. This evolution suggests that the future of the industry lies in a hybrid approach: acquiring innovative early-stage assets while strategically out-licensing mature products to regional experts.

Asahi Kasei Corp. Asahi Kasei strengthens global pharmaceutical platform with the acquisition of Aicuris [news release]. Tokyo, Japan: Asahi Kasei Corp; February 26, 2026. Accessed February 26, 2026. 

https://www.asahi-kasei.com/news/2025/ae6kh3000000004c-att/e260226.pdf

Asahi Kasei Pharma Corp. Asahi Kasei Pharma selects MAIA Pharmaceuticals to advance Teribone™ for U.S. osteoporosis patients [news release]. Tokyo, Japan: Asahi Kasei Pharma Corp; February 19, 2026. Accessed February 26, 2026. 

https://www.asahi-kasei.com/news/2025/e260219.html

Asahi Kasei will acquire Aicuris for ~€780 million to deepen its specialty pharma footprint in severe infectious diseases affecting immunocompromised populations. The deal adds late-stage and novel anti-infective assets—pritelivir for HSV with a 2026 FDA target and AIC468, an antisense oligonucleotide for BK virus in kidney transplant recipients—while complementing royalty income from letermovir (Prevymis). Financially, the transaction supports a capital-efficient growth model targeting ¥300 billion pharma sales and ≥15% operating margin by FY2030, with operating income contribution expected from FY2028.

Asahi Kasei acquires Aicuris for €780M ($920M), adding anti-infective assets to its transplant and nephrology specialty pharmaceutical platform.

Impacts of Asahi Kasei’s Acquisition of Aicuris on Specialty Pharmaceutical Manufacturing

GSK Acquires 35Pharma | Created with Canva

On February 25, 2026, GSK announced an agreement to acquire 35Pharma Inc. for $950 million, signaling a strategic expansion into the specialized cardiopulmonary market, specifically targeting conditions with high mortality and limited therapeutic options.¹ The focus of this transaction is HS235, a protein-based therapeutic designed as an activin signaling inhibitor. This molecule targets the activin receptor signaling pathway, a validated therapeutic target for pulmonary hypertension (PH), a condition affecting approximately 82 million people globally with a five-year survival rate of only 50%. The global market for these therapies is projected to reach $18 billion by 2032, with activin signaling inhibitors expected to represent half of that value.

How Does the Design of HS235 Address Existing Clinical and Manufacturing Challenges?

A primary challenge in developing treatments for PH is managing the risk of adverse events, such as bleeding and telangiectasia, often caused by off-target binding to bone morphogenetic protein 9 (BMP9) and bone morphogenetic protein 10 (BMP10).¹ HS235 is engineered with enhanced selectivity to reduce binding to BMP9 and BMP10, which is particularly relevant for the significant patient population requiring concurrent anticoagulant or antiplatelet therapies. By improving the safety profile through molecular engineering, developers can potentially address a broader patient base while mitigating risks associated with existing ligands. Tony Wood, chief scientific officer, GSK, said in a press release,¹ “Pulmonary hypertension affects millions of people worldwide, yet patients are underserved. We're delighted to add HS235 to our pipeline, a potential best-in-class medicine with a differentiated profile to reduce risk of bleeding and provide potential metabolic benefits clinically relevant to PH patients. HS235's potential protective effects on vascular function, alongside potential benefits on fat-derived markers of metabolism and inflammation, also offer new development opportunities within our RI&I portfolio to achieve broader coverage across the metabolic, inflammatory, vascular and fibrotic drivers of multiple chronic diseases that affect the lung, liver and kidney.”

What Are the Developmental Prospects for HS235 Beyond Vascular Function?

The clinical development of HS235 has progressed through phase I trials in healthy volunteers, with upcoming studies planned for pulmonary arterial hypertension and PH due to heart failure with preserved ejection fraction.¹ These trials will take place in specialized academic centers in which PH programs are integrated into larger respiratory and critical care units. Beyond its vascular benefits, the underlying mechanism of the drug offers unique metabolic advantages, including fat-selective weight loss and improved insulin sensitivity. These secondary benefits are significant for the PH population, in which obesity and insulin resistance are prevalent comorbidities. Ilia Tikhomirov, CEO, 35Pharma, said in a press release,¹ “In recent years, we witnessed a revolution in our understanding of pulmonary hypertension and how this life-threatening disease could be reversed. We are pleased to be joining forces with GSK, a leader in respiratory and inflammatory drivers of disease, who shares our vision of HS235's potential to transform the treatment of this debilitating condition.” The integration of this asset into the respiratory, immunology, and inflammation portfolio provides scalable opportunities to treat chronic diseases affecting the lung, liver, and kidney by addressing metabolic and inflammatory drivers. Completion of the acquisition is subject to standard regulatory clearances in the US and Canada.

How Else Is GSK Advancing Its Drug Portfolio?

GSK recently announced the results of a study involving over 2.5 million adults that indicated Arexvy

, a recombinant respiratory syncytial virus (RSV) vaccine, was 75.6% effective in preventing related hospitalizations involving severe COPD and asthma flare-ups.² The data showed a 63.1% reduction in major adverse cardiovascular events during hospitalization. Significant reductions in severe flare-ups were also observed for patients with chronic obstructive pulmonary disease and asthma. On these findings. Christian Felter, global medical lead, RSV, GSK, said in a press release,² “These data underscore the value of our RSV vaccine in its observed association with helping to prevent RSV-related hospitalization and reducing the risk of acute events of certain chronic conditions associated with this potentially serious disease.” Ultimately, integrating these advancements into a single portfolio allows for broader clinical coverage across the vascular, metabolic, and inflammatory drivers that define modern pharmaceutical strategy.

GSK. GSK enters agreement to acquire 35Pharma Inc. London (UK): GSK plc; 2026. Available at: 

https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-to-acquire-35pharma-inc/

GSK. GSK’s Arexvy associated with reductions in certain RSV-related risks including heart attack, stroke and severe flare-ups of COPD and asthma, real world study shows. London (UK): GSK plc; 2026. Available at: 

https://www.gsk.com/en-gb/media/press-releases/gsk-s-arexvy-associated-with-reductions-in-certain-rsv-related-risks-including-heart-attack-stroke-and-severe-flare-ups-of-copd-and-asthma-real-world-study-shows/

GSK agreed to acquire 35Pharma for $950 million to expand into cardiopulmonary diseases with high mortality and limited options, centered on HS235, a selective activin signaling inhibitor for pulmonary hypertension. HS235 is engineered to minimize BMP9/BMP10 binding to reduce bleeding/telangiectasia risk, important for patients on anticoagulants or antiplatelets, while potentially improving vascular function and metabolic-inflammatory biomarkers. Phase I is complete, with planned studies in PAH and PH-HFpEF. Separately, real-world data linked Arexvy to fewer RSV-related hospitalizations and in-hospital MACE.

GSK acquires 35Pharma for $950M. The primary focus is HS235, a selective PH drug reducing bleeding risk with metabolic benefits for 82 million patients.

GSK in Agreement to Acquire 35Pharma for Nearly $1B

FDA's Plausible Mechanism Framework | Created with Canva

The FDA has introduced a significant regulatory shift with the release of draft guidance aimed at accelerating the development of individualized therapies for ultra-rare diseases.¹ The Plausible Mechanism Framework provides a structured pathway for obtaining approval for targeted therapies when traditional randomized controlled trials are impractical due to extremely limited patient populations. This initiative, primarily managed by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), addresses the unique challenges of ribonucleic acid (RNA)-based treatments like antisense oligonucleotides and genome-editing technologies. Health and human services Secretary, Robert F. Kennedy, Jr., emphasized in a press release,¹ “President Trump promised to accelerate cures for American families — and we are delivering, especially for children with ultra-rare diseases who cannot afford to wait. We are cutting unnecessary red tape, aligning regulation with modern biology, and clearing a path for breakthrough treatments to reach the patients who need them most.”

What Technical Requirements Define the New Plausible Mechanism Framework?

The draft guidance outlines a shift toward utilizing biological evidence as a cornerstone for effectiveness.¹ To meet the criteria for this framework, sponsors must precisely identify the disease-causing abnormality and demonstrate that their therapy targets the root cause or the proximate biological pathway. Success in pharmaceutical development under this model requires confirming the successful drugging or editing of the target. Furthermore, FDA expects developers to rely on high-quality, well-characterized natural history data from untreated patients to provide a baseline for comparison. Chief medical and scientific Officer and CBER Director Vinay Prasad, MD, MPH, noted the historical significance of this development, stating in a press release,¹ “Designing treatments unique to individual patients has always been the promised goal of personalized medicine. After 25 years the FDA has, for the first time, outlined a framework to facilitate these approvals. The Plausible Mechanism Framework is a revolutionary advance in regulatory science.” For traditional approval under this framework, treatments are still expected to show improved clinical outcomes or changes in biomarkers that are established to predict clinical benefit.

How Will This Framework Impact Manufacturing and Clinical Trial Design?

The shift in regulatory science permits more streamlined approaches to clinical investigations, such as the use of master protocols.¹ This is particularly relevant for manufacturers of technologies that target unique DNA sequences; if a product targets different mutations in a single gene, these variations could be evaluated within a single application. Once a plausible mechanism of action is highly supported, it may serve as the basis for adding further product variants to treat patients with mutations not included in the initial clinical trial. FDA Commissioner Marty Makary, MD, MPH, highlighted this new flexibility, saying,¹ “This guidance is a critical step the FDA is taking to tailor our regulatory approach to patients with ultra-rare conditions. It is our priority to remove barriers and exercise regulatory flexibility to encourage scientific advances and deliver more cures and meaningful treatments for patients suffering from rare diseases.” While the agency acknowledges the necessity of small sample sizes in these contexts, it requires results to be robust enough to rule out chance findings. CDER acting director Tracy Beth Høeg, MD, Ph.D., explained the broader implications for the industry, in a press release,¹saying, “The Plausible Mechanism draft guidance creates a novel framework through which cutting-edge treatments tailor-made for patients with ultra-rare diseases can be used as a basis for FDA approval. We anticipate our Plausible Mechanism draft guidance will inspire industry to place increased focus on individualized therapies, thereby driving innovation, improving safety, lowering costs and offering more patients with ultra-rare diseases a unique shot at a life-saving treatment.” Professionals in the field have 60 days to submit comments on these proposed guidelines, which may influence future developments in RNA and DNA based therapeutics.

How Else is the FDA Prioritizing Fast Approvals?

To further support the domestic supply chain, 

FDA has launched the PreCheck pilot program to increase regulatory predictability for manufacturers

.² This initiative streamlines facility assessments before specific product applications are submitted, facilitating the construction of sites in the US. Makary, stated in a press release,² “After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back. The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive.”

What Are the Procedural Phases for Participating Manufacturers?

The program utilizes two phases to provide early technical advice and facility-specific drug master files, resolving manufacturing issues before drug application submissions.² This engagement allows FDA to expedite assessments and strengthen the pharmaceutical sector. Selection favors facilities that align with national priorities, such as those producing critical medications for the US market or employing innovative facility development. Participants in the pharmaceutical industry can leverage these phases to enhance the efficiency of their manufacturing assessments.

U.S. Food and Drug Administration. FDA launches framework for accelerating development of individualized therapies for ultra-rare diseases. FDA. Published 2026. Accessed February 24, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-launches-framework-accelerating-development-individualized-therapies-ultra-rare-diseases

U.S. Food and Drug Administration. FDA launches PreCheck pilot program to strengthen domestic pharmaceutical manufacturing. FDA. Published 2026. Accessed February 24, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-launches-precheck-pilot-program-strengthen-domestic-pharmaceutical-manufacturing

The FDA issued draft guidance establishing a Plausible Mechanism Framework to enable approvals of individualized therapies for ultra-rare diseases when randomized trials are infeasible. The approach elevates mechanistic and biological evidence, requiring clear definition of the causal abnormality, confirmation of target engagement/editing, and robust natural history comparators. Master protocols may support multiple mutation variants within one gene and allow additions after initial validation. Separately, the PreCheck pilot aims to de-risk and accelerate U.S. manufacturing through pre-application facility assessments and early technical alignment.

FDA's Plausible Mechanism Framework streamlines individualized therapy approvals for ultra-rare diseases.

Impacts of FDA's Plausible Mechanism Framework for Ultra-Rare Disease Therapies

Supreme Court Blocks Trump Tariffs | Created with Canva

The Supreme Court's 6-3 decision to strike down duties imposed under the International Emergency Economic Powers Act (IEEPA)

 represents a pivotal moment for professionals in pharmaceutical development and manufacturing who manage international supply chains.¹ Chief Justice John Roberts observed that,¹ "The president asserts the extraordinary power to unilaterally impose tariffs of unlimited amount, duration and scope," yet the administration points to no statute in which Congress authorized such expansive power under the 1977 law. While this ruling invalidates broad reciprocal tariffs, such as the 34% levy on goods from China, its direct impact on the pharmaceutical sector requires a nuanced understanding of the different legal authorities that govern trade.²

Why Does the Distinction Between Legal Authorities Matter for Drug Manufacturing?

It is critical for industry leaders to recognize that most high-profile pharmaceutical tariffs discussed in 2025 were intended to be imposed under Section 232 of the Trade Expansion Act, rather than the International Emergency Economic Powers Act, often referred to as IEEPA.² In spring 2025, the Department of Commerce launched a Section 232 investigation into pharmaceutical imports and ingredients to assess potential national-security risks. President Trump subsequently announced plans for a 100% tariff on branded or patented pharmaceutical products specifically linked to that investigation.

Consequently, the Supreme Court's ruling against IEEPA primarily affects mega-tariffs and global reciprocal actions, while pharmaceutical-specific measures grounded in national-security authority remain potentially in force.² For example, Section 232 tariffs on steel and aluminum are separate and remain in place even after this decision. Furthermore, negotiated exceptions and trade agreements with the UK and EU were designed to shape how Section 232 duties on drugs would be applied, distinct from the broader emergency powers recently curtailed. This means that while some broad import taxes are gone, the targeted investigations into the pharmaceutical supply chain have not been directly invalidated.

How Have the Tariffs Been Affecting the Pharma Industry?

On the tariff developments, Kristin Ciriello Pothier, Americas Life Sciences Leader, KPMG, comments, "Today's ruling and subsequent developments are only part of the story for the life sciences industry, leaving key questions around tariff exposure and trade uncertainties. Now is the time to pressure-test sourcing models and accelerate AI-driven forecasting. Resilience and disciplined scenario planning will be essential as trade dynamics continue to shift."

The tariffs have caused the industry pivot toward domestic manufacturing, which has accelerated global trade tensions.³ Major developers have already committed billions to reshoring to mitigate potential duties and ensure supply chain resilience. For example, 

Eli Lilly and Company initiated plans for four new manufacturing sites

, bringing its total US capital commitments to over $50 billion.⁴ More recently, 

Johnson & Johnson announced a $1 billion investment in a Pennsylvania manufacturing site

What Are the Long-Term Operational Implications of Shifting Trade Policies?

This massive reallocation of capital responds to an invest-or-tariff ultimatum, where high taxes could be avoided by beginning US facility construction.³ This is a vital shift, as 90% of biotech firms rely on imported components for at least half of their approved products. High costs have already squeezed profit margins, forcing some companies to delay R&D. While the court decision limits broad emergency taxes, onshoring continues to provide benefits like improved quality control and reduced miscommunication. Manufacturers are now prioritizing trade compliance and supplier diversification to balance domestic capacity with flexibility. The industry continues to advocate for stable policies to protect critical inputs like APIs and excipients. By investing in domestic R&D and localized APIs, firms aim to strengthen medicine supply security for the future.

​Supreme Court strikes down most of Trump’s tariffs in a major blow to the president. NBC News. Published February 20, 2026. Accessed February 20, 2026. 

https://www.nbcnews.com/politics/supreme-court/supreme-court-strikes-trumps-tariffs-major-blow-president-rcna244827

Sagonowsky E. Supreme Court steps in as Trump’s tariffs are thrown out. FiercePharma. Published February 20, 2026. Accessed February 20, 2026. 

https://www.fiercepharma.com/pharma/supreme-court-steps-trumps-tariffs-thrown-out

Cole C. The year of the tariff: pharmaceutical supply chain reimagined in 2025. Pharmaceutical Technology. Published Year. Accessed February 20, 2026. 

https://www.pharmtech.com/view/the-year-of-the-tariff-pharmaceutical-supply-chain-reimagined-in-2025

Cole C. Lilly invests $3.5B in Pennsylvania injectable medicine facility. Pharmaceutical Technology. Published February 13, 2025. Accessed February 20, 2026. 

https://www.pharmtech.com/view/lilly-invests-35b-in-pennsylvania-injectable-medicine-facility

Zubulake Z. Johnson & Johnson Announces $1B Investment in Pennsylvania Manufacturing Site. Pharmaceutical Technology. Published February 19, 2026. Accessed February 20, 2026. 

https://www.pharmtech.com/view/johnson-johnson-announces-1b-investment-in-pennsylvania-manufacturing-site

The Supreme Court’s 6–3 ruling curtails use of IEEPA to impose sweeping, open-ended tariffs, eliminating broad reciprocal levies such as the 34% duty on China. However, pharma exposure depends on the governing authority: proposed drug and ingredient tariffs were largely tied to Section 232 national-security powers, including a Commerce investigation into pharmaceutical imports and a floated 100% tariff on branded products. Meanwhile, tariff uncertainty has accelerated onshoring, reshaping capital allocation, compliance priorities, and supply-chain risk management amid heavy reliance on imported inputs.

SCOTUS struck down IEEPA tariffs. Pharma duties under Section 232 persist as they fall outside the ruling's scope.

Supreme Court Rejection of Trump Tariffs Has Nuanced Implications for Pharma Importers

FDA Commissioner Says US is Falling Behind China | Created with Canva

The United States risks ceding leadership in early-stage drug development to China because of avoidable regulatory and operational delays in initiating clinical trials, according to recent comments by FDA Commissioner Marty Makary.¹ In a televised interview, Makary identified hospital contracting, institutional review board (IRB) processes, and Investigational New Drug (IND) application review timelines as key bottlenecks that may be slowing first-in-human and early-phase studies in the US.

How Do US and China Early Development Pipelines Compare?

Currently, China is ahead of the US in clinical trials,

 accounting for around one-third of emerging, global drug approvals.¹ Makary is citing structural constraints that could influence sponsors to conduct phase I and early phase II trials in China over the US. Early development geography can shape subsequent regulatory strategy, patient access, and the global evidence base.

In the interview, Makary called for reforms to streamline trial initiation.¹ He cited three specific areas of concern: protracted hospital contracting negotiations, duplicative or slow-moving ethical review processes, and the time required for IND submission and clearance.

Under current US law, sponsors must submit an IND application to the FDA before initiating clinical trials in humans.² The agency has 30 days to review the application and may impose a clinical hold if safety or protocol concerns arise. While the statutory timeline is fixed, pre-IND preparation, sponsor–FDA interactions, and post-submission queries can extend development timelines. Additionally, multicenter trials often require negotiation of site-specific clinical trial agreements and budget terms, as well as IRB approval, processes that may vary widely across institutions.

China, by contrast, has implemented regulatory reforms in recent years aimed at accelerating drug development.³ In 2017, China’s National Medical Products Administration joined the International Council for Harmonization, committing to align technical requirements with global standards. Subsequent reforms have included implied approval mechanisms for INDs if no objection is raised within a specified period and prioritization pathways for innovative therapies.

Although direct, head-to-head comparisons of median IND review times between the US and China are limited in the peer-reviewed literature, several analyses have documented a substantial increase in China-originated first-in-human trials and oncology innovation programs over the past decade.⁴

These comparisons along with Makary’s comments suggest that future reforms for US drug development will induce additional pressure on producers to shorten tech‑transfer timelines as well as implement more modular or single-use capacity.⁵ US partners will be expected to match the increased speed of China developers while still maintaining the high standards of compliance and quality, as standards are unlikely to be adjusted.

What Do Makary’s Comments Imply About the Future of Clinical Development?

FDA has previously emphasized its commitment to expediting innovative therapies through mechanisms such as Fast Track, Breakthrough Therapy, Accelerated Approval, and 

.² However, these programs primarily affect later-stage development and review. Makary’s comments focus on the pre–proof-of-concept period, where operational inefficiencies rather than formal regulatory timelines may predominate.¹

Adjustments will need to be made to portfolio and trial-location strategy in order for assets to reach first‑in‑human and proof‑of‑concept in competition with China.¹ US and EU developers are under pressure to innovate news ways to streamline early‑phase IND processes and adopt more adaptive or decentralized trial designs to match China’s speed of output.

The US continues to lead globally in total biopharmaceutical R&D spending and in the number of new molecular entities approved annually.⁶ Additionally, the FDA’s 30-day IND review window is relatively short compared with some international counterparts.²

The more salient issue may be system-level fragmentation rather than statutory review times.⁴ A 2020 analysis of global clinical trial trends demonstrated significant expansion of early-phase oncology trials in China, accompanied by regulatory reforms and domestic investment. Still, the quality, reproducibility, and global generalizability of early-phase data require careful evaluation regardless of geography.

What Are the Next Steps for US and EU Manufacturers?

Makary’s statements should be interpreted as policy signaling rather than evidence of imminent regulatory change, as they were presented with no new trial data or FDA guidance.¹ Comparative metrics on median trial startup times, IND clearance intervals, and contract negotiation durations would be necessary to quantify the scope of the issue.

Future reforms could include expanded use of centralized IRBs, harmonized contract templates across federally funded institutions, and enhanced pre-IND consultation programs.³ Policymakers may also look to international models for implied approval or parallel review mechanisms. Any regulatory adjustments that reduce early-phase startup timelines could influence site selection strategies, patient recruitment, and competitive positioning in global drug development.

Along with likely future reforms to accelerate early‑stage approvals, US authorities be more vigilant with the sharing of data and re-investment in regional development.⁵ The sharing of sensitive biological and clinical data with Chinese developers and other countries of concern are likely to be more restrictive. Development teams will have to balance the leveraging of speed and capacity of China’s developers with US scrutiny on clinical data provenance, trial diversity, and biosecurity.

CNBC. FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals. February 18, 2026. 

https://www.cnbc.com/amp/2026/02/18/fda-chief-warns-us-is-losing-ground-to-china-in-early-drug-trials.html

US Food and Drug Administration. Investigational New Drug (IND) Application. Updated 2023. 

https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application

National Medical Products Administration. China joins ICH and advances regulatory reform. Published 2017. 

Hwang TJ, Carpenter D, Lauffenburger JC, Wang B, Franklin JM, Kesselheim AS. Failure of investigational drugs in late-stage clinical development and publication of trial results. JAMA Intern Med. 2016;176(12):1826-1833. 

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2565715

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FDA Commissioner Marty Makary warned that avoidable US startup frictions—hospital contracting, IRB workflows, and IND-related back-and-forth—are eroding competitiveness in first-in-human and early phase II development, potentially shifting sponsors toward China. China’s post-2017 reforms, including ICH alignment and implied IND approvals, have coincided with growth in China-originated early oncology trials and a rising share of global approvals. The core vulnerability is operational fragmentation more than statutory FDA timelines. Policy signals point toward centralized IRBs, harmonized contracting, expanded pre-IND engagement, and tighter scrutiny of cross-border data.

FDA commissioner warns US trial startup delays may cede early drug development to China, urging IND and IRB process reforms amid global competitions.