Navigating key news stories in pharma
Featured Stories
As global volatility exposes the fragility of lean supply models, the industry is pivoting toward regionalized manufacturing and agile optionality to safeguard patient access.
Automation and living contamination control strategies are helping to answer some of industry’s most pressing sterile manufacturing challenges, explains Dr. Laura Moody from Syntegon.
While the benefits of continuous manufacturing have been well-documented, regulatory alignment and complex control systems remain barriers to universal adoption, notes Mike Fazio from L.B. Bohle.
The push for regionalized supply chains is having an impact on the CDMO landscape, with responsiveness and flexibility now considered equally important as efficiency and scale, notes Andrea Oro from ESTEVE CDMO.
R&D
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.
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.
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 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.
Expansion
The new service, which is available at Lonza’s Singapore site, aims to help bioprocessing customers improve scalability, reduce manufacturing risk, and accelerate development timelines.
Plans for a further 3,000-square-metre spray drying and high-potency containment unit at Celrà facility in Girona, Spain, have been announced by the CDMO.
The company will add new reactor suites to its Delaware campus, increasing its API reactor capacity by more than double and enabling the company to meet new demand for high-quality domestic manufacturing.
The German contract manufacturer is expanding its lyophilization capacity with a complete production line from equipment supplier Syntegon, as demand for sterile freeze-dried pharmaceuticals continues to grow across the sector.
Dealmaking
Aptar Pharma has entered into a technical collaboration with COVIRIX Medical to evaluate its handheld dry powder inhaler device with broad‑spectrum antiviral compounds for high‑risk respiratory viruses.
San Diego-based Trenchant BioSystems has partnered with engineering firm Invetech to develop a fully automated manufacturing platform it claims could cut production costs by up to 80%.
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.
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.
Strategy
Automation and living contamination control strategies are helping to answer some of industry’s most pressing sterile manufacturing challenges, explains Dr. Laura Moody from Syntegon.
While the benefits of continuous manufacturing have been well-documented, regulatory alignment and complex control systems remain barriers to universal adoption, notes Mike Fazio from L.B. Bohle.
The push for regionalized supply chains is having an impact on the CDMO landscape, with responsiveness and flexibility now considered equally important as efficiency and scale, notes Andrea Oro from ESTEVE CDMO.
As global volatility exposes the fragility of lean supply models, the industry is pivoting toward regionalized manufacturing and agile optionality to safeguard patient access.
Future Biopharma
As cost pressures for drug developers persist, there is an inevitability that the industry will transition to continuous processes to overcome the limitations of traditional batch fed manufacturing.
Driven by regulatory evolution and a commitment to sustainability, the excipients’ sector is reinforcing its position as a sophisticated and credible stakeholder in the modern pharmaceutical supply chain.
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.
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.
Regulatory
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.
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.
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.
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.
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