United States

SHERIDAN, WYOMING - December 2, 2025 - After years of volatility in Alzheimer's R&D, Roche's re-emergence with positive early data for trontinemab is reshaping expectations for the next competitive cycle in disease-modifying therapies, signaling that big pharma is not done pushing for better outcomes in this high-risk, high-need market.

From Aduhelm's fallout to a more mature Alzheimer's market

The modern Alzheimer's era was defined-some would say scarred-by the 2021 approval of Biogen and Eisai's Aduhelm, a controversial and costly monoclonal antibody that ultimately failed to deliver convincing clinical benefit and was later withdrawn. The backlash damaged Biogen's reputation and, for a time, cast doubt on the entire amyloid-directed approach, raising questions about regulatory standards and payer willingness to back expensive, marginally effective therapies.

SHERIDAN, WYOMING - December 2, 2025 - A series of FDA findings at Novo Nordisk's Bloomington, Indiana, fill/finish facility is forcing biotechs to rethink their commercial manufacturing strategies, with Regeneron and Scholar Rock now accelerating alternative capacity plans to break regulatory logjams linked to the ex-Catalent site.

FDA scrutiny at Novo's Bloomington site triggers CRLs

The Bloomington plant, one of three former Catalent sites Novo acquired for $11 billion to support surging GLP-1 demand, has become a bottleneck rather than a release valve for some of its biopharma customers. As a CDMO hub, the facility provided fill/finish services for a range of partners, but repeated quality issues have resulted in an Official Action Indicated (OAI) classification and multiple complete response letters (CRLs) from the FDA.

SHERIDAN, WYOMING - December 2, 2025 - As several large pharmas pull back from cell therapy, a core group of biopharma players is doubling down on CAR T and next-generation approaches, positioning themselves to capture long-term value in oncology and autoimmune disease even as near-term sentiment cools.

Big pharma exits reshape expectations, not potential

Over the past year, the cell therapy field has seen a string of high-profile retreats. Takeda halted new investments in the modality and is offloading its pipeline and platforms after more than eight years of heavy spending. Novo Nordisk followed by terminating all cell therapy work, including a type 1 diabetes program, with nearly 250 roles cut. Belgian biotech Galapagos also shut down its cell therapy business after failing to find a buyer.

SHERIDAN, WYOMING - December 2, 2025 - A wave of first-in-class hereditary angioedema (HAE) therapies is reshaping the U.S. Biotech & Research landscape, but questions remain over how quickly clinicians and patients will adopt these options in an already well-served rare disease market.

New approvals expand hereditary angioedema treatment choices

The HAE pipeline has accelerated dramatically, moving from basic C1 esterase inhibitors to sophisticated RNA-targeting and gene-editing approaches. The disease's life-threatening swelling attacks, including airway involvement, have long justified investment in both acute and prophylactic care, with the first FDA-approved preventive and on-demand therapies arriving in 2008 and 2009.

SHERIDAN, WYOMING - December 2, 2025 - As the United States grapples with record-setting government shutdowns and budget fights, the country's biotech and research ecosystem is confronting a deeper structural problem: federal science funding is increasingly unstable, putting early-stage innovation, talent pipelines and long-term competitiveness at risk. For an industry built on long horizons and high-risk discovery, interruptions to programs such as NIH grants and Small Business Innovation Research (SBIR) contracts are more than a temporary setback-they threaten the foundations of America's leadership in biopharma innovation.

Federal science funding as the backbone of U.S. biopharma

SHERIDAN, WYOMING - November 25, 2025 - Philips has received U.S. FDA 510(k) clearance for the latest release of its Cardiovascular Workspace (IntelliSpace Cardiovascular, ISCV), enabling U.S. health systems to deploy the cardiovascular imaging and information management platform as a cloud-hosted, SaaS solution on Philips HealthSuite. The move positions hospitals and cardiology networks to modernize IT, scale integrated diagnostics, and accelerate real-world adoption of AI-enabled cardiovascular workflows.

Cloud-based cardiovascular informatics for U.S. health systems

SHERIDAN, WYOMING - November 25, 2025 - Nestlé Health Science is deepening its open innovation strategy in nutrition and health through a series of academic and startup collaborations focused on women's health, healthy longevity and weight management, positioning itself at the center of fast-growing therapeutic nutrition markets. By linking university-based science, entrepreneurial talent and its own R&D capabilities, the company aims to accelerate the translation of emerging technologies into differentiated nutritional solutions for consumers and patients.

SHERIDAN, WYOMING - November 13, 2025 - Dentsply Sirona is strengthening its long-term commitment to increasing oral-health access for U.S. veterans, deepening its partnership with Dental Lifeline Network (DLN) and activating employee-driven support initiatives across the country. The renewed collaboration aligns with the company's global sustainability strategy and reflects a growing corporate focus on social-impact programs that directly address care gaps in underserved populations.

Strengthening a Decades-Long Collaboration

Dentsply Sirona and DLN have worked together since 1999, forming one of the dental industry's most enduring corporate-nonprofit collaborations. Entering its 26th year, the partnership includes direct financial support, in-kind product donations and professional-volunteer mobilization through Dentsply Sirona's VETERANS@DS employee resource group.

SHERIDAN, WYOMING - November 13, 2025 - Pfizer has completed its $7 billion acquisition of Metsera, securing a set of differentiated obesity and cardiometabolic candidates as regulatory momentum accelerates around metabolic disease innovation in the United States. The deal positions Pfizer at the center of one of the most politically scrutinized and fastest-growing therapeutic markets, as federal leaders push for expanded access and a stronger domestic pipeline in obesity care.

SHERIDAN, WYOMING - November 13, 2025 - As the TrumpRx platform approaches launch in early 2026, U.S. drugmakers are rolling out targeted direct-to-consumer pricing for a carefully chosen mix of dermatology, respiratory, cardiovascular, immunology, and metabolic products. While the discounts generate attention, analysts say their commercial impact varies sharply by drug class, revenue cycle, and therapeutic demand-revealing a strategic pattern rather than a broad affordability shift.

Discounting Patterns Reveal Manufacturers' Portfolio Priorities
Pfizer, AstraZeneca, Amgen, Bristol Myers Squibb, Novo Nordisk, and Lilly have each chosen different subsets of products for deep DTC price cuts. Across these offerings, a clear pattern emerges: brands with declining growth, approaching patent expirations, or limited payer friction are overrepresented.