The funding, which is part of a larger investment commitment from the European Commission, will be used to progress Ethris’ differentiated mRNA vaccine technology as a treatment for pandemic flu.

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.

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.

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

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).

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.

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.

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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.

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.

Claims that the use of acetaminophen/paracetamol while pregnant is linked to autism have been effectively disproved through a rigorous review and meta-analysis of current evidence.