Eurofins Viracor ExPeCT CAR-T qPCR assay is a tool designed for monitoring and optimizating CAR-T therapies.

Moderna will leverage Life Edit’s suite of gene editing technologies to advance development of in vivo gene editing therapies.

Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.

AbbVie and Capsida have expanded their existing collaboration to advance three new gene therapy programs.

The goal of this collaboration is to develop an approach to personalized radiotherapy and drug discovery that is based in genomics and artificial intelligence.

GAO calls for more oversight of institutional review boards in clinical trials.

This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.

Agilent’s therapeutic nucleic acids facility gains architectural design support from CRB.

Pfizer reports that the combination of talazoparib and enzalutamide demonstrated statistically significant improvement in patient survival in a Phase III trial.

Quotient Sciences’ facility expansion is designed to increase support for fully integrated drug development programs.

LIfT and Minaris will work together to develop a manufacturing process for LIfT’s allogeneic neutrophil progenitor cell therapy.

Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.

The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.

Takeda’s acquisition of Nimbus Lakshmi will grant them rights to NDI-034858, an oral, selective allosteric TYK2 inhibitor being evaluated for the treatment of multiple autoimmune diseases.

Bill Anderson, former CEO of Roche’s pharmaceutical division, will take over as CEO of Bayer on June 1, 2023.

GenScript PrioBio and Bio Immunitas will work together to develop and fast track manufacturing of a novel therapeutic platform.

The kit is meant for use for the detection and quantitation of residual host cell protein.

Growth in outsourcing has been the result of COVID-19 projects taking precedence, which has pushed some contract manufacturing to second-tier CDMOs.

After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.

Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy.

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.

The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.

Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.

Pharmapack Europe has announced the winners of the 2023 Pharmapack Awards spanning five categories across two dedicated awards.

Roche’s Phase III global program, centered around the biologic crovalimab as a treatment for paroxysmal nocturnal haemoglobinuria, showed the drug was non-inferior to current standards of care.

Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.

The change would impact every package and hundreds of systems.

Thermo Fisher and Celltrio are introducing a new automation platform to address critical scale-up challenges in biotherapeutics.