Navigating key news stories in pharma
Featured Stories
Macroeconomic headwinds, compressed regulatory pathways, and an influx of asset-light virtual innovators are leading to an evolution in outsourcing service delivery models.
Macroeconomic headwinds, compressed regulatory pathways, and an influx of asset-light virtual innovators are leading to an evolution in outsourcing service delivery models.
Backed by USD 101 million in cumulative financing, Ethyreal Bio is targeting the shared pathogenic driver of Graves' disease and thyroid eye disease with a differentiated, long-acting subcutaneous antibody.
A novel pan-sarbecovirus vaccine candidate developed by the University of Cambridge and DIOSynVax has demonstrated safety in a Phase I, needle-free clinical trial.
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
Ahead of its exhibition at CPHI Americas, Curia announced the completion of its Spanish aseptic upgrades alongside concurrent sterile vial filling and lyophilization expansions underway in Glasgow.
The company’s expanded stability storage hub now delivers a wide spectrum of ICH-compliant and ultra-low-temperature solutions, addressing growing needs for stability data and GMP analytical support across complex drug programs.
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.
Dealmaking
The objective of the joint research collaboration between Circio and GenAssist is to evaluate potential synergy between the companies’ complementary technologies for the development of next-gen AAVs.
A newly signed USD 1.9 billion global research collaboration and licensing agreement is set to combine Ascidian Therapeutics’ exon editing platform with Eli Lilly’s expertise in genetic medicines.
The acquisitions of Curevo, LimmaTech Biologics, and Vaccine Company will enable the pharma giant to build a pipeline targeting viral and bacterial pathogens linked to long-term neurological and oncological risks.
An exclusive, strategic deal between GSK and Sino Biopharmaceutical's CTTQ unit in China has been struck with the aim of accelerating the rollout of bepirovirsen for Chinese patients.
Strategy
Backed by USD 101 million in cumulative financing, Ethyreal Bio is targeting the shared pathogenic driver of Graves' disease and thyroid eye disease with a differentiated, long-acting subcutaneous antibody.
As the pharmaceutical supply chain digitizes, the unique human element of face-to-face networking remains fundamental, according to Sherma Ellis-Daal, Brand Director for CPHI Americas.
Ahead of CPHI Americas, Kent Payne from Wilmington PharmaTech reveals how shifting geopolitical regulations, private equity capital, and specialized technical expertise are driving domestic pharmaceutical manufacturing.
As the generic and biosimilar market enters a period of growth, developers are moving away from costly empirical testing and leveraging advanced technologies to overcome technical hurdles to formulation.
Future Biopharma
Macroeconomic headwinds, compressed regulatory pathways, and an influx of asset-light virtual innovators are leading to an evolution in outsourcing service delivery models.
A novel pan-sarbecovirus vaccine candidate developed by the University of Cambridge and DIOSynVax has demonstrated safety in a Phase I, needle-free clinical trial.
SPONSORED CONTENT: Pedro Fernandes Botas and Mark Macdonald from Codis break down how advanced spray drying capabilities, mathematical modeling, and commercial operations experience are helping sponsors navigate the modern formulation landscape.
As specialized modalities push classical manufacturing models to their limits, organizations must treat internal talent development with the same level of process excellence they apply to biological pipelines.
Regulatory
AstraZeneca’s camizestrant has faced a regulatory setback in the U.S., with the FDA extending its review, seeking clearer evidence that early intervention improves long-term outcomes for patients with advanced breast cancer.
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.
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