Navigating key news stories in pharma

Featured Stories

Featured
Navigating Industry Challenges with Renewed Optimism
Strategy
Navigating Industry Challenges with Renewed Optimism
Strategy

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.

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Strategy
News
Navigating Industry Challenges with Renewed Optimism
Strategy
Navigating Industry Challenges with Renewed Optimism
Strategy

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.

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

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.

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

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.

Expansion

Dealmaking

Featured
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.

CDMO Forms Strategic Collaborations for Cell-Based Therapies in Eye Disease and Solid Tumors
CDMO Forms Strategic Collaborations for Cell-Based Therapies in Eye Disease and Solid Tumors

Porton Advanced has announced separate partnerships with TongEYE and Hualong Biological, as it moves into regenerative therapies for vision loss and innovative immunotherapies for solid tumors.

Regeneron to Buy Bankrupt DNA Testing Firm
Regeneron to Buy Bankrupt DNA Testing Firm

The court supervised purchase, which is still subject to relevant conditions, will see Regeneron acquire the assets of 23andMe, except for its Lemonaid Health business.

Future Biopharma

Featured
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.

BIO 2025: Making Biologics Manufacturing Accessible
BIO 2025: Making Biologics Manufacturing Accessible

Prior to BIO 2025, Russell Miller from Enzene Biosciences highlights how a fully connected continuous manufacturing platform is enhancing biologics production and, hence, improving patient access.

BIO 2025: Targeting the Microenvironment to Treat Solid Tumors
BIO 2025: Targeting the Microenvironment to Treat Solid Tumors

Solid tumors are difficult to treat as a result of numerous factors, in this interview, Oury Chetboun from Seekyo Therapeutics, details how targeting functional proteins in the tumor microenvironment can help.

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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
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.

Bora Adds Small-Scale Isolator Line to Baltimore Facility
Bora Adds Small-Scale Isolator Line to Baltimore Facility

The company has added the further sterile fill/finish capacity to the site in response to continued growth in demand for its drug product services.

Ecolab Opens New Bioprocessing Lab in Eastern U.S.
Ecolab Opens New Bioprocessing Lab in Eastern U.S.

The new facility adds to the company’s existing infrastructure and is set to provide comprehensive technical support for bioprocessing to biopharmaceutical companies and contract manufacturers.

Strategy

Featured
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.

Serving as a Gateway to the Americas’ Pharma Market
Serving as a Gateway to the Americas’ Pharma Market

In this interview, Sarah Griffin from Informa Markets provides a review of CPHI Americas 2025 and teases some potential exciting innovations being planned for the 2026 edition of the conference.

Rising Rates of Measles are Highlighting Level of Vaccine Misinformation
Rising Rates of Measles are Highlighting Level of Vaccine Misinformation

While the spread of misinformation about vaccines is contributing to greater vaccine hesitancy, global rates of measles outbreaks are rising at alarming rates, leading to warnings being issued to international travelers.

Regulatory

Featured
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.

Sarepta Gains Recognition from FDA for its Viral Vector Technology
Sarepta Gains Recognition from FDA for its Viral Vector Technology

As a result of the capability to be used across multiple therapeutic programs, the U.S. regulatory body has granted Sarepta’s AAVrh74 platform with platform technology designation.

Moderna Gains FDA Approval for New Coronavirus Vaccine
Moderna Gains FDA Approval for New Coronavirus Vaccine

This approval, which was based on the results of a Phase III trial demonstrating a higher relative efficiency of the new vaccine compared with the old version, marks the third for the company from the FDA.

Novavax’s COVID-19 Jab Gets FDA Approval
Novavax’s COVID-19 Jab Gets FDA Approval

The recombinant protein-based, non mRNA vaccine has been granted full marketing approval to prevent COVID-19 in adults aged 65 years and older and patients aged 12–64 years who are at risk of severe infection due to underlying conditions.

Upcoming Events

Featured
ADC Toxicity Summit 2025

The 3rd ADC Toxicity Summit is the only industry-led event bringing together toxicology, pharmacology, translational science, and clinical development experts to accelerate bench-to-bedside-to-bench innovation by preventing, predicting, and mitigating toxicities to enhance ADC safety and clinical translation.

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.