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
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.

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.

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

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.

Strategy

Dealmaking

Featured
Partnership Forms to Develop Broad-Spectrum NTM Clinical Candidate
Partnership Forms to Develop Broad-Spectrum NTM Clinical Candidate

BioVersys and Shionogi are joining forces to progress the development of non-tuberculous mycobacteria clinical candidates with the potential for a selected number of molecules to be licensed for global commercialization.

Bend and Starton Collaborate on Oral Sustained Release Form of STAR-LLD
Bend and Starton Collaborate on Oral Sustained Release Form of STAR-LLD

The collaboration will leverage Bend’s expertise in controlled release formulation, manufacturing process, and analytical method development, and Starton’s deep understanding of continuous delivery of lenalidomide.

BioDuro and SGX Partner Up to Improve Efficiencies in Complex Drug Development
BioDuro and SGX Partner Up to Improve Efficiencies in Complex Drug Development

The companies will combine a drug discovery platform and a novel framework to reduce the cost and time it takes to develop complex therapies.

Sanofi Enters into Agreement to Acquire Blueprint Medicines
Sanofi Enters into Agreement to Acquire Blueprint Medicines

The proposed acquisition will expand Sanofi’s immunological portfolio with a precision medicine already approved for the treatment of ASM and ISM, a next-gen highly selective kinase inhibitor, and an investigational oral drug.

Future Biopharma

Featured
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.

A Rapid Evolution: Highlights and Insights from Advancing Complex Biologics Day 2025
A Rapid Evolution: Highlights and Insights from Advancing Complex Biologics Day 2025

The biologics sector is rapidly evolving thanks to scientific innovation and investment. In this article, insights and perspectives from a selection of senior leaders shaping the future of biologics are reviewed.

BIO 2025: Getting to the Root of Cardiopulmonary Diseases with Epigenetic Modulation
BIO 2025: Getting to the Root of Cardiopulmonary Diseases with Epigenetic Modulation

Epigenetic modulation has been important in the development of oncology therapies, but its use in cardiovascular diseases is just beginning. In this pre-BIO interview, Sten Sörensen from Cereno Scientific provides some insights into developments in this field.
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R&D

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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.

Accure Therapeutics Granted USD 1.6 Million to Advance Parkinson’s Drug Candidate
Accure Therapeutics Granted USD 1.6 Million to Advance Parkinson’s Drug Candidate

The Michael J. Fox Foundation for Parkinson’s Research and the Luxembourg National Research Fund have provided funding for two separate projects assessing Accure Therapeutics’ ACT-02 for the treatment of Parkinson’s disease.

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
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.

Navigating Industry Challenges with Renewed Optimism
Navigating Industry Challenges with Renewed Optimism

Despite current hurdles facing biopharma and biotech companies, the recent BIO International Convention event saw innovation take center stage and provided a sentiment of optimism for the future, so long as industry does not rest on its laurels.

BIO 2025: Investment Limiting Effect of the Capability Gap
BIO 2025: Investment Limiting Effect of the Capability Gap

Drug development companies are struggling to gain financial support because management capabilities are lacking. In this BIO 2025 interview, Ali Pashazadeh from Treehill Partners discusses the investment landscape in more detail.

Regulatory

Featured
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.

Dizal Gains FDA Nod for Oral Therapy to Treat NSCLC with EGFR Exon 20 Insertion Mutations
Dizal Gains FDA Nod for Oral Therapy to Treat NSCLC with EGFR Exon 20 Insertion Mutations

This regulatory decision, which has been accepted under an accelerated basis, makes sunvozertinib the only approved targeted oral treatment for NSCLC with EGFR exon20ins.

CSL Gains FDA Approval for its Preventative HAE Treatment
CSL Gains FDA Approval for its Preventative HAE Treatment

The once-monthly injection, which is the first FDA-approved HAE treatment, was proven to significantly reduce HAE attacks in a Phase III trial and strengthens CSL’s presence in the competitive rare disease market.

Upcoming Events

Featured
CRS Annual Meeting 2025

The CRS 2025 Annual Meeting & Exposition will take place in the vibrant city of Philadelphia, PA, USA, from July 14-18, 2025. This year, under the exciting theme "Next-Generation Delivery Innovations," they will explore groundbreaking advancements and transformative ideas in controlled release science and technology.

AAPS Summer Scientific Forum 2025

AAPS brings scientists working in pharmaceutical analysis and bioanalysis together in the Summer Scientific Forum. Dive deep into the latest research in these areas, then cross-connect with other scientists in shared high-level sessions focused on regulatory issues that impact both disciplines.

Process Development for Cell Therapies Summit 2025

Join the 4th Process Development for Cell Therapies Summit to hear from 24+ industry leaders from biopharma and service providers as they share best practices for driving process robustness, scalability, speed, and affordability. Gain insights into how to develop consistent, scalable, and cost-effective solutions for both autologous and allogeneic cell therapies.