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Regeneron and Scholar Rock Reroute Fill/Finish as Novo's Indiana Plant Faces FDA Heat

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Regeneron and Scholar Rock Reroute Fill/Finish as Novo’s Indiana Plant Faces FDA Heat

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.

Building the Next Generation of Biologics: How Protein Engineering Platforms Are Catching Up with Complexity

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Building the Next Generation of Biologics: How Protein Engineering Platforms Are Catching Up with Complexity

SHERIDAN, WYOMING - December 2, 2025 - As bispecifics, antibody-drug conjugates (ADCs), protein degraders and AI-designed mini-proteins move rapidly into clinical development, discovery teams are confronting a new bottleneck: not target ideas, but the practical engineering and scalable production of molecules that strain conventional biologics workflows.

From monoclonals to a radically more complex biologics toolbox

Monoclonal antibodies still anchor the biologics market, with more than 160 FDA approvals and a dominant share of global drug revenues. But the modality mix is shifting fast. More than 200 ADCs are now in clinical stages, bispecific approvals have climbed to 19 with sales above $12 billion in 2024, and regulators are increasingly supportive of novel protein formats.

AGC Biologics Tackles Speed, Scale and Yield in Next-Generation Microbial Manufacturing

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AGC Biologics Tackles Speed, Scale and Yield in Next-Generation Microbial Manufacturing

SHERIDAN, WYOMING - December 2, 2025 - Microbial fermentation is moving back to the center of biologics manufacturing strategy, and contract development and manufacturing organizations (CDMOs) like AGC Biologics are under pressure to turn the platform's greatest strength-speed-into a reproducible, industrial-scale advantage.

Microbial fermentation's resurgence - and its speed problem

Microbial systems have long been valued for fast, efficient production of biologics, and they are now seeing renewed interest for a new generation of therapies. Yet the same speed that makes microbial fermentation attractive also makes it unforgiving. Typical production runs last around 48 hours, leaving very little time to diagnose and correct process deviations once a run is underway.

Six Cell Therapy Holdouts Double Down on CAR T and Autoimmune Plays as Big Pharma Retreats

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Six Cell Therapy Holdouts Double Down on CAR T and Autoimmune Plays as Big Pharma Retreats

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.

HAE Market Pivots to RNA and Gene Therapies as Patient 'Stickiness' Slows Uptake

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HAE Market Pivots to RNA and Gene Therapies as Patient ‘Stickiness’ Slows Uptake

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.

U.S. Biotech at Risk: How Federal Budget Cuts Undermine Innovation Leadership

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U.S. Biotech at Risk: How Federal Budget Cuts Undermine Innovation Leadership

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

Tech-Powered CPG: How AI, Analytics and Sustainable Innovation Will Shape 2026

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Tech-Powered CPG: How AI, Analytics and Sustainable Innovation Will Shape 2026

SHERIDAN, WYOMING - December 2, 2025 - As consumer packaged goods companies head into 2026, Kellanova sees technology not as a back-office enabler but as a growth catalyst connecting insight to action, purpose to performance, and innovation to impact. From agentic AI to connected commerce and smart, sustainable supply chains, the company's leadership argues that digital transformation in CPG is now about reinvention, not just modernization.

Agentic AI moves from pilots to real business impact

Agentic AI is emerging as a force multiplier across the CPG value chain, capable of analyzing real-time data, making recommendations and executing actions without constant human intervention. In practice, that means automating repetitive tasks, streamlining cross-functional workflows and reacting to market shifts with new speed and precision.

Ambient Textile Lighting from molo Brings Soft, Acoustic Comfort to Modern Workspaces

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Ambient Textile Lighting from molo Brings Soft, Acoustic Comfort to Modern Workspaces

SHERIDAN, WYOMING - November 28, 2025 - Design studio molo is reimagining ambient lighting as both a material and a wellbeing tool, using paper-like textile lamps and sculptural luminaires to soften workspaces, public interiors and homes while improving acoustics and visual comfort.

Light as a Material for Architecture and Wellbeing

At molo, light is treated as a material in its own right, on par with wood or paper. With its ability to influence how people experience space, both natural and artificial light are central to the studio's approach. Textile lamps become architectural elements that modulate shadow, texture and colour, turning illumination into an emotional component of interior design rather than a purely functional afterthought.

Global Automotive Alloy Wheel Market Gains Momentum as OEMs Double Down on Lightweight Design

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Global Automotive Alloy Wheel Market Gains Momentum as OEMs Double Down on Lightweight Design

SHERIDAN, WYOMING - November 28, 2025 - Growing demand for lightweight, design-driven and performance-oriented components is steadily expanding the global automotive alloy wheel market, with new research from Valuates Reports projecting revenues to rise from USD 11.4 billion in 2022 to USD 14.17 billion by 2029, a compound annual growth rate (CAGR) of 3.1% driven by OEM integration and aftermarket upgrades worldwide.

OEM Shift to Lightweight Wheels Reshapes Automotive & Mobility Strategies

In the global Automotive & Mobility industry, alloy wheels have moved from optional upgrade to core specification as manufacturers seek every opportunity to reduce vehicle weight and improve driving dynamics. Lower unsprung mass translates into smoother acceleration, more responsive steering and more efficient braking - all critical attributes as automakers balance efficiency, comfort and safety.

DEKRA Road Safety Report 2025 Highlights Persistent High-Risk Crash Scenarios Despite Technology Gains

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DEKRA Road Safety Report 2025 Highlights Persistent High-Risk Crash Scenarios Despite Technology Gains

SHERIDAN, WYOMING - November 28, 2025 - Modern vehicles and infrastructure have made roads significantly safer in recent decades, but new findings from the DEKRA Road Safety Report 2025 show that certain "classic" crash scenarios remain stubbornly dangerous and will require a combination of smarter assistance systems, better infrastructure and targeted awareness campaigns to reduce fatalities and serious injuries further.

Persistent high-risk crash scenarios despite overall progress