Navigating key news stories in pharma

Featured Stories

Featured
Predicting Accurately to De-Risk Early Development
Strategy
Predicting Accurately to De-Risk Early Development
Strategy

An exposure-driven, translational approach, linking early ADME with biomarker discovery, can help teams define the therapeutic window long before lead candidate nomination, according to Hong Wan from BioDuro.

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Strategy
News
Rilzabrutinib Gains Regulatory Nods in the U.S. and Japan
Regulatory
Rilzabrutinib Gains Regulatory Nods in the U.S. and Japan
Regulatory

The U.S. FDA has granted breakthrough therapy designation and Japan’s MHLW has designated orphan drug status to Sanofi’s BTK inhibitor, rilzabrutinib (Wayrilz), as a treatment for wAIHA.

Regulatory
Predicting Accurately to De-Risk Early Development
Strategy
Predicting Accurately to De-Risk Early Development
Strategy

An exposure-driven, translational approach, linking early ADME with biomarker discovery, can help teams define the therapeutic window long before lead candidate nomination, according to Hong Wan from BioDuro.

Strategy
CBER Issues RTF for Moderna’s Investigational Flu Shot
Regulatory
CBER Issues RTF for Moderna’s Investigational Flu Shot
Regulatory

According to Moderna, the reasoning for the refusal to review the BLA by the regulatory authority is inconsistent with previous feedback, leading the company to request a Type A meeting.

Regulatory

R&D

Featured
Novo Nordisk Reveals Headline Phase III Trial Results Evaluating Combination Obesity Treatment
Novo Nordisk Reveals Headline Phase III Trial Results Evaluating Combination Obesity Treatment

The company’s fixed-dose combination treatment demonstrated superior efficacy to its individual components and was shown to be safe and well-tolerated, consisted with other incretin and amylin-based therapies.

Vetter Advances Next-Generation Tamper-Evident Syringe Closure Towards Launch
Vetter Advances Next-Generation Tamper-Evident Syringe Closure Towards Launch

The company has advanced its next‑generation tamper‑evident syringe closure from design finalization to industrialization ahead of a planned 2027 launch to strengthen its position in prefilled drug‑delivery solutions.

SGS Strengthens RSV Vaccine Research with Launch of Challenge Agent
SGS Strengthens RSV Vaccine Research with Launch of Challenge Agent

A new RSV A-strain challenge agent has been introduced by SGS to enhance CHIM studies and accelerate vaccine development. The breakthrough aims to generate more accurate, data-driven insights into RSV infection and immune response.

GSK, LTZ Therapeutics Collaborate on Next-Gen Immunotherapies
GSK, LTZ Therapeutics Collaborate on Next-Gen Immunotherapies

The companies will leverage GSK’s scientific expertise with LTZ’s immune engager platform to develop new first-in-class MCE therapies for the treatment of hematologic cancers and solid tumors.

Expansion

Featured
Eli Lilly Expands U.S. Manufacturing with New Pennsylvania Facility
Eli Lilly Expands U.S. Manufacturing with New Pennsylvania Facility

The USD 3.5 billion site reflects Lilly’s strategy to expand domestic capacity for glucagon-like peptide-1 (GLP‑1) drugs amid soaring demand and supply‑chain scrutiny.

Vetter Commits to New Production Facility in Germany
Vetter Commits to New Production Facility in Germany

The CDMO commits EUR 480 million to a new production facility on its Saarlouis site as it puts into action its long-term growth strategy to meet rising global biopharma demand.

Novartis Invests in End-to-End Manufacturing in U.S.
Novartis Invests in End-to-End Manufacturing in U.S.

The company is creating a new flagship manufacturing hub in North Carolina that will enable end-to-end manufacturing of its key medicines in one geographic location.

Spinout Ensorcell Launches with Three Flagship Life Science Tools
Spinout Ensorcell Launches with Three Flagship Life Science Tools

Backed by the expert team and cutting-edge resources of Re:Build Manufacturing, Ensorcell will offer innovative, high-quality scientific tools designed to accelerate discoveries and improve patient outcomes.

Dealmaking

Featured
Bio/Pharma M&A in the Year of Execution Certainty
Bio/Pharma M&A in the Year of Execution Certainty

With a looming patent cliff, continuing geopolitical pressures, and regionalized supply chains, there is a need for new creative deal structures and alternative financing to ensure successful M&A momentum.

Partnership Set Up to Address Growing Demand for Self-Administered Therapies
Partnership Set Up to Address Growing Demand for Self-Administered Therapies

A manufacturing collaboration between ten23 health and BD will support the commercialization of a wearable injector platform that offers a ready-to-use option for subcutaneous administration of high-dose biologics.

AbbVie, RemeGen Sign Exclusive Licensing Agreement for Novel Bispecific Antibody
AbbVie, RemeGen Sign Exclusive Licensing Agreement for Novel Bispecific Antibody

The agreement will allow AbbVie to develop, manufacture, and commercialize RemeGen’s novel PD-1/VEGF bispecific antibody in combination with its ADCs across multiple solid tumors.

Servier Taps Insilico's Pharma.AI in Multi-Billion Oncology Deal
Servier Taps Insilico's Pharma.AI in Multi-Billion Oncology Deal

Insilico Medicine has entered a multi‑year R&D collaboration with Servier to discover and develop novel AI‑designed oncology therapies. The deal will combine Insilico’s Pharma.AI platform with Servier’s global oncology development and commercialization capabilities.

Strategy

Featured
Predicting Accurately to De-Risk Early Development
Predicting Accurately to De-Risk Early Development

An exposure-driven, translational approach, linking early ADME with biomarker discovery, can help teams define the therapeutic window long before lead candidate nomination, according to Hong Wan from BioDuro.

The Need for Collaboration to Ensure Excipient Availability and Innovation
The Need for Collaboration to Ensure Excipient Availability and Innovation

In this deep-dive panel discussion moderated by The Pharma Navigator, several experts map out the future of excipients, addressing everything from climate-driven disruption to the need for greater industry collaboration.

Delivering Success — The Importance of Considering Drug Delivery Early
Delivering Success — The Importance of Considering Drug Delivery Early

As chronic diseases rise globally, the bio/pharma industry is pivoting toward increasingly complex molecules that demand more sophisticated delivery strategies, which must be considered early on in development.

Cellular Origins Completes Series A Financing Round
Cellular Origins Completes Series A Financing Round

The raised funds, totaling USD 40 million, will be used to accelerate the company’s growth and to advance its robotic platform, Constellation, which enables flexible, scalable cell therapy manufacturing.

Future Biopharma

Featured
The Role of Artificial Intelligence in Antibody Drug Discovery
The Role of Artificial Intelligence in Antibody Drug Discovery

Traditional antibody discovery is notoriously slow and resource-intensive, but a new wave of AI tools is enabling optimization of candidates prior to them reaching the clinic, accelerating development timelines. 

Weathering Headwinds: Bio/Pharma’s Roadmap for Success in 2026
Weathering Headwinds: Bio/Pharma’s Roadmap for Success in 2026

Despite geopolitical uncertainties, regulatory reforms, and fluctuating capital expenditure, the bio/pharma industry is entering 2026 with renewed focus and confidence.

The Outsourcing Pivot for Bio/Pharma Innovation
The Outsourcing Pivot for Bio/Pharma Innovation

Facing a world of political risk and scientific hurdles, pharma companies are downsizing internal footprints to focus on portfolio management while leaning on CDMOs for specialized execution, explains Owen Murray from Bend Bioscience.

Pharmapack 2026: Moving Toward a Large-Volume Future
Pharmapack 2026: Moving Toward a Large-Volume Future

From managing high viscosity to preventing agglomeration, the industry is shifting toward larger-volume, device-compatible solutions that prioritize both drug stability and healthcare efficiency, points out Dr. Robert Lindner from SCHOTT Pharma.

Regulatory

Featured
Rilzabrutinib Gains Regulatory Nods in the U.S. and Japan
Rilzabrutinib Gains Regulatory Nods in the U.S. and Japan

The U.S. FDA has granted breakthrough therapy designation and Japan’s MHLW has designated orphan drug status to Sanofi’s BTK inhibitor, rilzabrutinib (Wayrilz), as a treatment for wAIHA.

CBER Issues RTF for Moderna’s Investigational Flu Shot
CBER Issues RTF for Moderna’s Investigational Flu Shot

According to Moderna, the reasoning for the refusal to review the BLA by the regulatory authority is inconsistent with previous feedback, leading the company to request a Type A meeting.

FDA Grants Priority Review of sBLA for Datopotamab Deruxtecan
FDA Grants Priority Review of sBLA for Datopotamab Deruxtecan

If the application is successful, the therapy will become the first-line treatment for patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

Xenon Presents Clinical and Regulatory Milestones at J.P. Morgan Healthcare Conference
Xenon Presents Clinical and Regulatory Milestones at J.P. Morgan Healthcare Conference

The company is advancing its lead KV7 potassium channel modulator azetukalner through multiple Phase III trials in epilepsy and mood disorders, and planning its transition to commercial-stage growth.

Upcoming Events

Featured
Advanced Therapies Week 2026

Advanced Therapies Week 2026 is the leading cell and gene therapy conference in the United States, bringing 2,000+ biotech, pharma, CDMO, and investment leaders to San Diego for four days of networking, innovation, and deal-making.

Glioblastoma Drug Development Summit 2026

The 7th Glioblastoma Drug Development Summit is your opportunity to accelerate innovation and bring life-changing therapies closer to those who need them most.

SmartLab Europe 2026

Across pharma, biotech, F&B, chemicals, and FMCG, R&D leaders are modernising complex lab environments, integrating new LIMS with legacy systems, ensuring seamless data flow, and inspiring teams to embrace change. At SmartLab Exchange Europe, they go beyond vision to implementation.