Navigating key news stories in pharma

Featured Stories

Featured
From Complex APIs to Patient-Centricity: The Power of Oral Dosage Innovation
Strategy
From Complex APIs to Patient-Centricity: The Power of Oral Dosage Innovation
Strategy

The oral dosage market is being shaped by a variety of innovations aimed at improving bioavailability, enhancing patient-centricity, and supporting complex molecules with sophisticated formulation solutions.

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Strategy
News
SCHOTT Pharma Expands Pharmaversity with Launch of Knowledge Hub
Misc.
SCHOTT Pharma Expands Pharmaversity with Launch of Knowledge Hub
Misc.

The company’s pharmaceutical educational initiative will now include an extensive collection of assets as well as an extensive library of research, industry insights, and case studies for packaging professionals.

Misc.
Thermo to Acquire Sanofi’s Sterile Manufacturing Site, Expanding Strategic Partnership
Dealmaking
Thermo to Acquire Sanofi’s Sterile Manufacturing Site, Expanding Strategic Partnership
Dealmaking

The site in Ridgefield, N.J., will provide Thermo with additional U.S. drug product manufacturing capacity and will allow the company to meet the growing demand from pharma and biotech customers for U.S. drug product manufacturing.

Dealmaking
Roche Weighs Next Steps for Astegolimab After Mixed COPD Trial Results
Regulatory
Roche Weighs Next Steps for Astegolimab After Mixed COPD Trial Results
Regulatory

Contrasting outcomes for Roche’s investigational anti-ST2 monoclonal antibody treatment for COPD, mean the company needs to discuss the outcomes with regulatory authorities and evaluate next steps.

Regulatory

Dealmaking

Featured
Thermo to Acquire Sanofi’s Sterile Manufacturing Site, Expanding Strategic Partnership
Thermo to Acquire Sanofi’s Sterile Manufacturing Site, Expanding Strategic Partnership

The site in Ridgefield, N.J., will provide Thermo with additional U.S. drug product manufacturing capacity and will allow the company to meet the growing demand from pharma and biotech customers for U.S. drug product manufacturing.

Brenntag, Budenheim Cooperate to Offer Phosphate-Based Excipients in Parts of Europe
Brenntag, Budenheim Cooperate to Offer Phosphate-Based Excipients in Parts of Europe

Customers in Germany, France, Benelux, Poland, and the Nordics will be able to purchase the higher bulk density excipients, which are useful for those seeking to reduce tablet size, from Brenntag.

New Strategic Investment Set to Speed Up Growth for PCI
New Strategic Investment Set to Speed Up Growth for PCI

With this latest private transaction, Bain Capital, a private investment firm, joins PCI’s investor base of Kohlberg, Mubadala, and Partners Group, which are focused on supporting the company in its growth plans.

Univercells and Repligen Collaborate to Bring Real-Time PAT to Bioreactors
Univercells and Repligen Collaborate to Bring Real-Time PAT to Bioreactors

The partnership will see the integration of a real time glucose monitoring platform into a bioreactor range, eliminating the need for manual testing of nutrients and improving data resolution.

Future Biopharma

Featured
Meeting Modern Needs: Top Insights from Drug Development and Delivery Insights for 2025 Day
Meeting Modern Needs: Top Insights from Drug Development and Delivery Insights for 2025 Day

As the complexity of drug molecules evolve and patient expectations grow, industry leaders reveal why the next generation of drug delivery must balance cutting-edge science, flexible manufacturing, and patient-centric design.

Consortium Forms to Develop Fully Automated Robotics CGT Manufacturing Platform
Consortium Forms to Develop Fully Automated Robotics CGT Manufacturing Platform

With a grant of £1 million from Innovate UK, Cellular Origins, the CGT Catapult, and Resolution Therapeutics will work together to create a fully automated, scalable cell therapy manufacturing platform.

BIO 2025: Understanding the Nuances of Cell Therapy Projects
BIO 2025: Understanding the Nuances of Cell Therapy Projects

Cell therapies are distinct from other therapies, meaning that CDMOs shouldn’t take a cookie-cutter approach to these unique projects, notes Nirupama Pike from Catalent in this post-BIO 2025 interview.

Terumo Launches New Intradermal Injection System
Terumo Launches New Intradermal Injection System

The new system has been designed to deliver vaccines and other drug products intradermally, which offers advantages over other forms of injectable administration.
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R&D

Featured
Preclinical Data Demonstrates Therapeutic Efficacy of Enveric’s Lead Candidate
Preclinical Data Demonstrates Therapeutic Efficacy of Enveric’s Lead Candidate

The company’s research in a well-established rodent model has shown that EB-003 has potential as an effective treatment for post-traumatic stress disorder, representing an opportunity in an underserved market.

Nanoform Receives Funding to Advance Clinical Development of Nanoapalutamide
Nanoform Receives Funding to Advance Clinical Development of Nanoapalutamide

Business Finland is providing Nanoform with a EUR 5 million R&D loan to be used to accelerate the clinical development of the nanoformulated version of apalutamide through to the pivotal bioequivalence study.

Dicot Pharma Unveils MoA Findings for Potency Therapy
Dicot Pharma Unveils MoA Findings for Potency Therapy

The latest studies on the mechanism of action for LIB-01 have demonstrated that the drug targets the underlying nerves and vascular structures that are involved in penile erections.

New Data Demonstrates Unique Expression Profile of RNA Platform
New Data Demonstrates Unique Expression Profile of RNA Platform

Circio presented the enhanced in vivo data for its circVec platform in viral and non-viral vectors at ASGCT 2025.

Expansion

Featured
Circio Expands into Novel Lab Facilities in Stockholm
Circio Expands into Novel Lab Facilities in Stockholm

Marking a strategic move for the company, the expansion will enable acceleration of pre-clinical development of the circVec circular RNA expression data platform.

Vetter Breaks Ground on New U.S. Clinical Manufacturing Site
Vetter Breaks Ground on New U.S. Clinical Manufacturing Site

An official groundbreaking ceremony marked the start of construction on the service provider’s new site in Des Plaines, Ill., which will house a clinical production facility for aseptic manufacturing, new process areas for material preparation and compounding, in addition to other buildings.

Enzene Expands New Jersey Facility to Boost Next-Gen Biomanufacturing
Enzene Expands New Jersey Facility to Boost Next-Gen Biomanufacturing

To meet growing demand for advanced, domestic biomanufacturing capabilities, Enzene Biosciences is scaling up its soon-to-launch New Jersey facility to 80,000 square feet and integrating its proprietary continuous manufacturing platform.

Bend Adds Particle Engineering and Spray-Drying Capabilities with New Suites
Bend Adds Particle Engineering and Spray-Drying Capabilities with New Suites

Located within Bend’s Oregon facility, the four new process development and manufacturing suites will support spray drying and unit operations, helping the company to meet the growing needs of clients in these areas.

Strategy

Featured
Putting a Spotlight on Formulation Services
Putting a Spotlight on Formulation Services

The CDMO model is evolving to incorporate more innovative approaches and specialist capacity as a result of the increasingly complex development pipeline. In this article, The Pharma Navigator editors provide a snapshot of some of the news from CDMOs helping innovators with their formulation requirements.

Meeting New Needs: The Key Trends Shaping Oral Dosage Formulation
Meeting New Needs: The Key Trends Shaping Oral Dosage Formulation

Increasingly complex and diverse molecules in the development pipeline and greater demand for patient-centricity are leading to a need for developers to employ advanced formulation approaches and strategies.

From Complex APIs to Patient-Centricity: The Power of Oral Dosage Innovation
From Complex APIs to Patient-Centricity: The Power of Oral Dosage Innovation

The oral dosage market is being shaped by a variety of innovations aimed at improving bioavailability, enhancing patient-centricity, and supporting complex molecules with sophisticated formulation solutions.

Adapting to an Expedited Review Process
Adapting to an Expedited Review Process

A new priority review program, unveiled by the FDA with the potential to dramatically reduce the regulatory review process for drug applications, will require increased agility, responsiveness, and readiness from CDMOs with less room for error.

Regulatory

Featured
Roche Weighs Next Steps for Astegolimab After Mixed COPD Trial Results
Roche Weighs Next Steps for Astegolimab After Mixed COPD Trial Results

Contrasting outcomes for Roche’s investigational anti-ST2 monoclonal antibody treatment for COPD, mean the company needs to discuss the outcomes with regulatory authorities and evaluate next steps.

FDA Considers Broader Use of GSK’s RSV Vaccine for At-Risk Adults
FDA Considers Broader Use of GSK’s RSV Vaccine for At-Risk Adults

While the final regulatory decision is expected in the first half of 2026, the expanded use of Arexvy, to include younger at-risk adults, could help protect more than 21 million Americans vulnerable to RSV.

Mitigating Potential Contamination Through Risk-Based Formulation
Mitigating Potential Contamination Through Risk-Based Formulation

Oral solid dosage formulation strategies are being reshaped to align with the evolving regulatory landscape and to enhance patient safety by mitigating potential contamination risks.

AstraZeneca Gains European Approval for Perioperative Immunotherapy for MIBC
AstraZeneca Gains European Approval for Perioperative Immunotherapy for MIBC

With the durvalumab-based perioperative regimen, MIBC patients have a new treatment option that has been proven to provide statistically significant and clinically meaningful improvement in survival rates.

Upcoming Events

Featured
Next Generation Gene Therapy Vectors Summit 2025

The 5th Next Generation Gene Therapy Vectors Summit returns as the only vector therapy-specific platform for experts to join forces, share technical insights, transform viral and non-viral vector design and selection, and streamline translation to the clinic.

Fc-mediated Function Summit 2025

The 5th Fc-Mediated Function Summit is the essential destination for experts driving innovation in Fc-receptor targeting and antibody domain modification.

Targeted Radiopharmaceuticals Summit US 2025

The 4th Targeted Radiopharmaceuticals Summit US returns to San Diego as the largest end-to-end, industry focused platform. Gathering 275+ global stakeholders, sharing exclusive scientific and strategic insights from players including Novartis, AstraZeneca, BMS, Ratio Therapeutics, Alpha-9 Oncology, AdvanCell, Mariana Oncology, Abdera Therapeutics and many more!