Navigating key news stories in pharma
Featured Stories
As the industry pivots toward eco-design and green procurement, the whole value chain must align to bridge the gap between environmental targets and manufacturing reality.
Following the global launch of the Synchrony S1 PFS system, ten23 health has completed robustness testing to ensure the platform is ready for clients navigating the complexities of drug-device regulations.
By securing the rights to a Phase II dissolvable implant for glaucoma and diabetic retinopathy, targeting the underlying vascular causes of vision loss, Bayer is positioning itself at the forefront of long-acting ocular drug delivery.
With industry reaching the limits of traditional formulation techniques, to overcome solubility and bioavailability challenges, spray-drying is increasingly emerging as a primary development pillar.
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
Philadelphia-based CDMO, PCI Pharma Services, has committed to substantial investments in sterile fill/finish and drug-device combination assembly across its global operations.
SPONSORED CONTENT: As CDMOs face increasing demand for agility and resilience, Azam Razzaq from FUJIFILM Biotechnologies reveals how the expanded Borealis facility is helping to bridge the gap between clinical supply and commercial reality for sponsors.
The expansion of the Swiss CDMO’s activities into the Asia Pacific area marks a significant milestone in its global growth and means it will be able to better serve pharma and biotech companies across the region.
In response to the growing demand for in-human trial material, German CDMO Vetter is expanding its clinical manufacturing network with new infrastructure in the U.S. and Austria.
Dealmaking
By securing the rights to a Phase II dissolvable implant for glaucoma and diabetic retinopathy, targeting the underlying vascular causes of vision loss, Bayer is positioning itself at the forefront of long-acting ocular drug delivery.
The acquisition is expected to create a global powerhouse in women’s health, biosimilars and branded generics with operations in 150 countries, and is set to close in early 2027 pending approvals.
With this definitive acquisition agreement, the CDMO will expand its presence on the global market with its first European location and will enable greater customer support.
The companies have entered into the evaluation agreement to investigate whether circVec circular RNA technology can be delivered to T cells using Acuitas’ targeted lipid nanoparticles.
Strategy
Following the global launch of the Synchrony S1 PFS system, ten23 health has completed robustness testing to ensure the platform is ready for clients navigating the complexities of drug-device regulations.
With industry reaching the limits of traditional formulation techniques, to overcome solubility and bioavailability challenges, spray-drying is increasingly emerging as a primary development pillar.
As the industry pivots toward eco-design and green procurement, the whole value chain must align to bridge the gap between environmental targets and manufacturing reality.
As smaller batch products become more prominent within drug development, companies are being required to adopt more agile, modular approaches to ensure commercial viability is achievable.
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 European Commission has approved dupilumab (Dupixent) as the first targeted therapy for chronic spontaneous urticaria (CSU) in children in the EU, broadening its use in type‑2‑driven inflammatory diseases.
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.
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