Phase I trial results for the company’s novel long-acting amylin analog, have demonstrated significant potential for patients to lose up to 9.79% of body weight in 12–13 weeks with no serious adverse events.

Under this new arrangement, the companies will work together to further develop Indomo’s DT-001 candidate, which will be combined with the ClearPen device to allow self-treatment of inflammatory acne lesions.

As emerging therapies target increasingly niche genetic pathways, the adoption of AI modeling, organoids, and advanced AAV delivery is becoming essential to ensure successful clinical progression and patient access.

With support from LSIMF, Codis is expanding its UK facility with the addition of a GEA PSD-4 commercial-scale spray dryer, making it the only CDMO in the UK to offer such capacity.

The major USD 15.5 million upgrade at ESTEVE CDMO’s Morton Grove, Illinois plant, is expected to supercharge small-molecule API production for pharmaceutical and biotech clients across North America.

In efforts to streamline its portfolio and prioritize core capabilities, the company has agreed two separate transactions to divest its CDMO and Cell Solutions as well as select European Discovery Services sites.

Patient outcomes are transforming, thanks to innovative, curative, tailored therapies; however, industry needs to address a few pressing issues to ensure the huge promise of these drugs can be achieved.

The companies will integrate their strengths from early-stage development and commercial-scale GMP API manufacturing to offer clients an end-to-end API solution.

While advancements are unlocking new possibilities in inhaled drug delivery and the pipeline is strong, the regulatory landscape is still challenging, highlighting the need for specialized partners to unlock future success.

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.