Navigating key news stories in pharma
Featured Stories
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.
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.
R&D
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.
The company has advanced its next‑generation tamper‑evident syringe closure from design finalization to industrialization ahead of a planned 2027 launch to strengthen its position in prefilled drug‑delivery solutions.
Expansion
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.
The company is creating a new flagship manufacturing hub in North Carolina that will enable end-to-end manufacturing of its key medicines in one geographic location.
Backed by the expert team and cutting-edge resources of Re:Build Manufacturing, Ensorcell will offer innovative, high-quality scientific tools designed to accelerate discoveries and improve patient outcomes.
Dealmaking
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.
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).
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.
Strategy
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.
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.
Future Biopharma
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.
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.
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.
Despite geopolitical uncertainties, regulatory reforms, and fluctuating capital expenditure, the bio/pharma industry is entering 2026 with renewed focus and confidence.
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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