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.

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.

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. 

In this deep-dive panel discussion moderated by The Pharma Navigator, several experts map out the future of excipients, addressing everything from climate-driven disruption to the need for greater industry collaboration.

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.

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.

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.

Claims that the use of acetaminophen/paracetamol while pregnant is linked to autism have been effectively disproved through a rigorous review and meta-analysis of current evidence.

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.

Despite geopolitical uncertainties, regulatory reforms, and fluctuating capital expenditure, the bio/pharma industry is entering 2026 with renewed focus and confidence.

Facing a world of political risk and scientific hurdles, pharma companies are downsizing internal footprints to focus on portfolio management while leaning on CDMOs for specialized execution, explains Owen Murray from Bend Bioscience.

The company is advancing its lead KV7 potassium channel modulator azetukalner through multiple Phase III trials in epilepsy and mood disorders, and planning its transition to commercial-stage growth.

From managing high viscosity to preventing agglomeration, the industry is shifting toward larger-volume, device-compatible solutions that prioritize both drug stability and healthcare efficiency, points out Dr. Robert Lindner from SCHOTT Pharma.

Changes to sustainability reporting requirements are leading to renewed focus on supplier tools and packaging tenders, and driving a greater need for industry to adapt to ESG standards, reveals Morten Munk from FUJIFILM Biotechnologies.

The agreement will allow AbbVie to develop, manufacture, and commercialize RemeGen’s novel PD-1/VEGF bispecific antibody in combination with its ADCs across multiple solid tumors.