PharmTech’s Top 10 Articles of 2025

Our top 10 articles for the year track seismic shifts across the pharmaceutical landscape, from high-level trade policy and drug pricing to fundamental regulatory stability and quality control. They highlight policy upheaval, regulatory complexity and quality control, and market disruption in both economics and therapy development. The industry faced intense pressure this year to adjust its global supply chains due to unprecedented tariffs, while simultaneously navigating new government efforts to mandate lower drug prices through most-favored-nation (MFN) deals. Regulatory bodies were defined by internal instability, such as abrupt leadership changes at the FDA, and renewed scrutiny on manufacturing quality (Figure), exemplified by recurring Form 483 citations. Finally, therapeutic innovation continues to accelerate, with massive market growth projected for emerging areas like Metabolic Dysfunction-Associated Steatohepatitis (MASH).

Following is a closer look at each of the top 10 articles.

1. Competition in MASH Is Heating Up as GLP-1s Gate-Crash the Party

The market for treating MASH, a condition affecting more than 250 million people globally, is experiencing a surge in competition. The MASH market was projected as of Sept 15, 2025 to grow significantly, from $7.9 billion in 2024 to $31.8 billion by 2033. Recent regulatory approvals include Madrigal Pharmaceuticals’ orally active thyroid hormone receptor (THR)-β agonist, Rezdiffra, approved by the FDA in March 2024, and Novo Nordisk’s injectable weight-loss drug, Wegovy (semaglutide, a GLP-1RA), approved by the FDA in August 2025 for MASH patients with moderate to advanced liver fibrosis.

2. AstraZeneca Is Next to Reach MFN Deal with White House

AstraZeneca became the second of 17 major pharmaceutical companies, following Pfizer, to agree to the most-favored-nation (MFN) pricing protocols put forth by President Donald Trump. Through this agreement, AstraZeneca will offer drugs at reduced, MFN prices to US patients, including Medicaid recipients, via the forthcoming federal platform, TrumpRx.gov, which is expected to launch in 2026. Separately, AstraZeneca announced a $4.5 billion investment in a new US manufacturing facility near Charlottesville, Virginia, which will support enhanced manufacturing capability for a wider range of medicines, including cancer treatments.

3. FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight

Vinay Prasad, MD, MPH, abruptly departed his role as director of the Center for Biologics Evaluation and Research (CBER) in July 2025, less than three months after his appointment. His brief tenure was characterized by a push for stricter regulatory standards for vaccines and cell and gene therapies, marking a shift from the previous emphasis on regulatory flexibility. Prasad's conservative regulatory decisions, including increased scrutiny of gene therapies for rare diseases and a clash with Sarepta Therapeutics over its product Elevidys, drew significant criticism from industry stakeholders and political commentators. Following his exit, George Tidmarsh, MD, PhD, the new head of the Center for Drug Evaluation and Research (CDER), was appointed as the acting director of CBER. Then, a little over a week later, Prasad returned to his role as CBER head.

4. EMA Looks to Include Patient Perspectives in Drug Regulation

The European Medicines Agency, or EMA, published a draft reflection paper in September 2025, which is open for public consultation, encouraging drug developers to collect and use patient experience data throughout a drug’s lifecycle. The paper emphasizes that patient perspectives—such as prioritizing quality of life over certain clinical endpoints—offer "great value" and play a "complementary role" to scientific data in regulatory reviews. The reflection paper provides principles for generating, collecting, and analyzing this data, derived from sources like clinical trials and post-market real-world evidence.

5. FDA 483 Cites Contamination and Safety Issues at Novo Plant

An FDA inspection conducted between late June and mid-July 2025 resulted in a Form 483 citation for a Novo Nordisk pharmaceutical manufacturing plant in Bloomington, Indiana. The facility, acquired by Novo Nordisk through its purchase of Catalent operations in late 2024, was cited for significant quality concerns, including contamination and unresolved equipment problems. Inspectors documented the presence of “atypical extrinsic particles,” such as human and cat hair in vial stoppers, along with pest infestations in classified areas. Reports indicated recurring complaints of contamination dating back several years, with investigation failures to determine root causes or assess potential impact on upstream batches.

6. The Impact of Europe’s Decision on the Use of Titanium Dioxide

In August 2025, the European Commission (EC) announced it would continue to allow the use of titanium dioxide (TiO2) in medicinal products. This decision followed a 2021 finding by the European Food Safety Authority that TiO2 was unsafe as a food additive due to genotoxicity concerns. The EC concluded that fully replacing TiO2 in all 91,000 affected drug products is not technically feasible without potentially disrupting global supply chains or slowing investment in new treatments.

7. Pharma Implications of Paul Offit’s Removal from Vaccine Advisory Committee

Changes in federal vaccine policy under HHS Secretary Robert F. Kennedy Jr. resulted in the abrupt removal of key advisory figures, including pediatrician Paul Offit, from the FDA’s Vaccines and Related Biological Products Advisory Committee in early September 2025. This removal, alongside the firing of all 17 members of the CDC’s Advisory Committee on Immunization Practices, signaled a potential erosion of scientific oversight and created ambiguity around future vaccine candidate assessment, raising concerns among industry stakeholders about regulatory predictability and the potential restriction of vaccine availability.

8. New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

Pharmaceutical and medical device companies serving the US market frequently receive FDA Form 483s—inspectional observations—or warning letters following FDA inspections. These inspections, which can be surveillance, for-cause, application-based, or follow-up, often occur overseas due to the extended global supply chain. When inspections result in a Voluntary Action Indicated (VAI) or Official Action Indicated (OAI) classification, the issuance of a 483 or warning letter can cause reputation damage, delay new drug approvals (NDAs), and disrupt business operations until the identified systemic issues are fully resolved.

9. How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains

A significant trade policy, announced in September 2025, mandates a 100% tariff on all imported branded or patented pharmaceutical products, effective October 1, 2025. The stated goal is to incentivize domestic production. Crucially, the policy includes a provision: the tariff can be avoided if the company has initiated the construction of a manufacturing facility within the US. This ultimatum has accelerated a trend of major pharmaceutical companies committing vast capital to US infrastructure; for example, AstraZeneca announced a $50 billion commitment, while Johnson & Johnson and Roche committed $55 billion and $50 billion, respectively. This pressure point directly intersects with supply chain security efforts and necessitates strategic re-evaluation of global manufacturing footprints.

10. FDA Releases Draft Guidance on Sampling and Testing of In-Process Materials and Drug Products

The FDA published draft guidance in January 2025 providing recommendations for complying with 21 Code of Federal Regulations (CFR ) 211.110, which governs the sampling and testing of in-process materials and drug products for human drugs and biologics. The guidance stresses that robust product and process development are essential for establishing and maintaining control strategies to ensure quality attributes are obtained. Manufacturers must employ a scientific- and risk-based approach to control processes, identify critical quality attributes, and monitor performance throughout the product lifecycle. The document also addresses quality considerations for drugs utilizing advanced manufacturing technologies (AMTs) and references the new Advanced Manufacturing Technologies Designation Program, designed to encourage AMT adoption.

The pharmaceutical industry, as evidenced by these top articles, operates like a complex ecosystem: shifts in the political climate (tariffs and MFN deals) immediately change the manufacturing topography (onshoring investments), while changes in regulatory leadership (FDA exits) ripple through the innovation pipeline (gene therapy oversight). Concurrently, focused competition in disease areas like MASH demonstrates that therapeutic breakthroughs constantly redefine the economic priorities of the industry.