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Eurofins Genomics Blue Heron’s novel mRNA synthesis service is designed for customizable applications.

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

Donaldson Company’s €136 million (US$148 million) acquisition of Univercells is designed to broaden its portfolio of biomanufacturing solutions.

Tower Cold Chain will soon open its new headquarters in Philadelphia.

This arrangement was approved by the shareholders at BELLUS on June 16, 2023, according to a company press release.

FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.

The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.

The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.

The prestigious award, worth €20,000 (US$22,000), goes to Maurice Michel of the Science for Life Laboratory at Karolinska Institutet, Stockholm, Sweden.

The companies hope address the need for efficient collection, cryopreservation, quality control, and logistics capabilities of leukapheresis materials to support various aspects of the cell therapy workflow.

This collaboration is the first commercialization into the United States and Canadian markets for Rio Biopharmaceuticals.

Sanofi’s Open Innovation Portal is designed to promote community feedback and propose novel solutions to various problems in the healthcare landscape.

Sandbox AQ’s molecular simulation division is collaborating with companies like AstraZeneca and Sanofi to develop novel treatments for various disorders.

The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.

The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

PIF has established Lifera, a new manufacturing entity that will manufacture, stockpile, and supply bio/pharmaceuticals both locally and through partnerships.

India’s Enzene Biosciences is investing $50 Million into a new biopharma manufacturing plant in Hopewell, NJ.

The transaction is expected to close in the third quarter of 2023.

Eli Lilly & Company will pay Verve Therapeutics up to $525 million to advance a lipoprotein gene editing research program.

The new facility also provides a plan for scalable product production processes that can potentially be replicated by Vaxxas domestically and globally.

There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.

Advanco’s acquisition of Vantage Consulting Group boosts its position as a provider of independent pharmaceutical serialization solutions.

The collaboration between the Pistoia Alliance and Matador Japan will work to accelerate research and promote access to a global pharmaceutical ecosystem.

The bioreactor scaler tool helps scaling between development and manufacturing and to de-risk scaling activities and ensure product quality.

The integration of the binders into a routine lateral flow test will support the clinical and commercial development of rapid diagnostics for Alzheimer’s disease through nasal sampling.

Mendus and NorthX Biologics will work to develop and commercialize Mendus’ lead asset, vididencel, an allogeneic dendritic cell vaccine.