Navigating key news stories in pharma

Featured Stories

Featured
Transforming Modern Drug Development with RWE
Strategy
Transforming Modern Drug Development with RWE
Strategy

No longer relegated to post-market safety monitoring, RWE is emerging as a critical strategic tool in early drug development, helping to de-risk pipelines, refine target product profiles, and optimize trial design.

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Strategy
News
Measuring More of What Matters
Strategy
Measuring More of What Matters
Strategy

Technological innovations are allowing for improvements in the clinical trial sector and providing greater volumes of data; however, companies should be mindful to ensure they are measuring meaningful data.

Strategy
Transforming Modern Drug Development with RWE
Strategy
Transforming Modern Drug Development with RWE
Strategy

No longer relegated to post-market safety monitoring, RWE is emerging as a critical strategic tool in early drug development, helping to de-risk pipelines, refine target product profiles, and optimize trial design.

Strategy
Lonza Strengthens Advanced Synthesis Offering
Strategy
Lonza Strengthens Advanced Synthesis Offering
Strategy

By fully integrating support for ADC technologies into its Advanced Synthesis portfolio, Lonza is now able to offer phase-appropriate CDMO support for bioconjugates from discovery through clinical supply.

Strategy

R&D

Featured
Preclinical Study Finds Nanotrastuzumab to be Comparable with Herceptin HYLECTA
Preclinical Study Finds Nanotrastuzumab to be Comparable with Herceptin HYLECTA

The nanoparticle suspension formulation was found to mirror the reference product closely in terms of AUC, Cmax, and Tmax across a 21-day Göttingen minipig study performed by Charles River Laboratories.

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.

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
Company Launches to Accelerate Development of a Novel CGT for Pediatric CP
Company Launches to Accelerate Development of a Novel CGT for Pediatric CP

Kidswell Bio and Treehill Partners have joined forces to create a new company aimed at accelerating the clinical development of a novel SHED stem cell therapy showing early efficacy signals for pediatric cerebral palsy (CP).

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.

Strategy

Featured
Measuring More of What Matters
Measuring More of What Matters

Technological innovations are allowing for improvements in the clinical trial sector and providing greater volumes of data; however, companies should be mindful to ensure they are measuring meaningful data.

Transforming Modern Drug Development with RWE
Transforming Modern Drug Development with RWE

No longer relegated to post-market safety monitoring, RWE is emerging as a critical strategic tool in early drug development, helping to de-risk pipelines, refine target product profiles, and optimize trial design.

Lonza Strengthens Advanced Synthesis Offering
Lonza Strengthens Advanced Synthesis Offering

By fully integrating support for ADC technologies into its Advanced Synthesis portfolio, Lonza is now able to offer phase-appropriate CDMO support for bioconjugates from discovery through clinical supply.

The Delicate Balance Between Innovation and Execution
The Delicate Balance Between Innovation and Execution

When approaching their clinical trials, sponsors need to balance the program’s needs with the tools and approaches they want to implement to ensure success, explains György Barta from Research Professionals.

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
Roche's pMN Therapy Meets Primary Endpoint in Phase III Trial
Roche's pMN Therapy Meets Primary Endpoint in Phase III Trial

The company has revealed that its humanized, glycoengineered Type II anti-CD20 mAb has achieved superior complete remission rates versus tacrolimus in the MAJESTY study.

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.

Upcoming Events

Featured
BIO Investment & Growth Summit 2026

BIO, the Biotechnology Innovation Organization, is the premier biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the United States and more than 35 countries around the globe.

10th Impurities: Genotoxic, Nitrosamine, & Beyond Summit 2026

The 10th Impurities: Genotoxic, Nitrosamine & Beyond Summit I #Egenotoxic 2026 is one of the most respected and widely attended gatherings in the field of pharmaceutical impurity control.

PHARM Connect Congress 2026

PHARM Connect Congress is the largest and most important pharmaceutical manufacturing and biotechnology business summit in the Central Eastern European region, taking place annually in spring. With its 400+ participants from over 25 countries in the region and beyond, the Congress is a great platform in Europe to benchmark and network.