Early Phase Development

Findings from a real-world data analysis have been released from the Bristol-Myers Squibb-Pfizer Alliance, demonstrating that Eliquis is associated with lower rate of major bleeding compared with vitamin K antagonist, dabigatran or rivaroxaban.

AbbVie has closed the Phase III trial that was evaluating Rova-T as no survival benefit for patients receiving treatment for advanced small-cell lung cancer (SCLC) was found during the interim analysis.

AstraZeneca has confirmed that its triple combination therapy, Breztri Aerosphere, has met its primary endpoint in a Phase III clinical trial (ETHOS).

AstraZeneca announced that its therapy for the treatment of patients with heart failure, Farxiga (dapagliflozin), has met the DAPA-HF trial primary endpoint.

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.

Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.

New CDMO facility supports early-stage API manufacturing and scale up.

In this collaboration, AbCellera will apply its expertise to generate panels of antibody candidates for Gilead to evaluate.

Eli Lilly is set to acquire exclusive worldwide rights for potential non-opioid treatment CNTX-0290 from Centrexion Therapeutics in a deal potentially worth $997.5 million.

The companies will join forces to use artificial intelligence (AI) and machine learning to discover and develop new treatments for two chronic diseases.

University of Southern California scientists have made an advancement in chimeric antigen receptor (CAR) T-cell therapy that seems to eliminate its severe side effects, making the treatment safer and potentially available in outpatient settings.

Catalent invests $5 million in hot melt extrusion capabilities at Somerset, NJ facility.

Worth up to $605 million, the collaboration will focus on studying a preclinical novel target that could lead to potential new treatments for autoimmune diseases.

Think ahead to production requirements when planning strategies in early development of gene and cell therapies.

Findings from the Los Angeles Biomedical Research Institute could enable a new generation of anti-infectives.

The companies announced a collaboration to jointly discover and develop treatments to address unmet medical needs in a specific neurological disease.

Process optimization improves process mass intensity, reduces environmental impact, and improves cycle time for bio/pharmaceutical processes.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.

The partners will collaborate on the development and commercialization of a B-cell maturation antigen-targeting immunotherapeutic for treating multiple myeloma.

The multi-year agreement will give Novartis access to AbCellera’s expertise and state-of-the-art antibody discovery technology for up to ten clinically-relevant disease targets.

A study funded by the National Institutes of Health has created a virtual library expected to expand the availability of “make-on-demand” molecules for drug discovery.

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.

Researchers at the University of Delaware have made a step forward in gene therapy by engineering microparticles that deliver gene-regulating material to hematopoietic stem and progenitor cells, which live deep in bone marrow and direct the formation of blood cells.

A new plasma B cell antibody discovery workflow launched by Berkeley Lights enables the shortening of antibody drug discovery from month to a day.

The new reagents are designed to support clinical-phase and commercialization stages of cell and gene therapy production and to enhance DNA transfection.

The companies aim to advance research into inflammatory bowel disease.

The acquisition will give Genentech full rights to Jecure’s preclinical portfolio of NLRP3 inhibitors.

The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.