The strategic investments by the CRDMO, which are aligned with its long-term strategy, will strengthen its integrated oligonucleotide platform and capabilities to delivery ADC solutions.

The location of the facility has been purposefully chosen to be as central as possible to cell and gene therapy companies located across the U.S. and will allow the company to meet growing demand for pDNA development and manufacturing services.

FDA has granted approval to Viatris for its generic intravenous iron replacement product as a treatment of iron deficiency anemia in adult and pediatric patients with chronic kidney disease.

If the oral antibiotic gains regulatory approval, patients who are 12 years of age and older in the U.S. suffering from urogenital gonorrhea will have an alternative, non-invasive treatment option.

This latest FDA leadership appointment comes as the agency focuses on balancing regulatory challenges with opportunities for accelerated patient access.

This partnership will leverage BioDuro’s expertise and Atombeat’s in silico modeling know-how to launch an AI-powered platform that allows for accelerated development of next-generation peptides.

D’Herve has succeeded Dr. Singh, bringing a wealth of industry experience to the position, having previously served in senior positions at Evonik.

Strategic early planning, optimal CDMO selection, careful scale management, and stringent quality, along with greater industry collaboration, will ensure future biomanufacturing success.

Recent fatalities in clinical trials for gene therapies have led to greater regulatory scrutiny and concerns over safety, particularly in relation to the use of viral vectors, leading industry to question whether a potential therapeutic reinvention is needed.

The companies will work together, leveraging Syntekabio’s AI prediction platform for virtual screening to uncover new, high-potential indications for MetaVia’s DA-1241 oral therapy.

Through this acquisition, ESTEVE will expand its contract development and manufacturing services for small-molecule APIs from pre-clinical through to commercial manufacturing within the U.S.

The strategic collaboration will also provide GSK with an exclusive worldwide license for Hengrui’s potential best-in-class PDE3/4 inhibitor, which is in clinical development as an add-on maintenance treatment for COPD.

Pegcetacoplan (EMPAVELI), which was shown to be safe and effective in a Phase III clinical trial, is now approved for the treatment of U.S. patients 12 years and older with C3G and primary IC-MPGN.

The strategic collaboration and license agreement is potentially worth more than USD 1 billion and offer patients less burdensome treatment regimens through sustained ocular delivery of therapies.

In efforts to position itself for long-term growth, Rocket is reducing its company headcount, undergoing a structural reorganization, and prioritizing late-stage AAV cardiovascular programs.

Through the exclusive option and license agreement, Novartis will fund Matchpoint’s research into oral covalent inhibitors and will have the option to exclusively develop and commercialize all products resulting from the collaboration.

The company’s pharmaceutical educational initiative will now include an extensive collection of assets as well as an extensive library of research, industry insights, and case studies for packaging professionals.

The site in Ridgefield, N.J., will provide Thermo with additional U.S. drug product manufacturing capacity and will allow the company to meet the growing demand from pharma and biotech customers for U.S. drug product manufacturing.

Contrasting outcomes for Roche’s investigational anti-ST2 monoclonal antibody treatment for COPD, mean the company needs to discuss the outcomes with regulatory authorities and evaluate next steps.

The CDMO model is evolving to incorporate more innovative approaches and specialist capacity as a result of the increasingly complex development pipeline. In this article, The Pharma Navigator editors provide a snapshot of some of the news from CDMOs helping innovators with their formulation requirements.