Syngene has acquired a multi-modal biologics drug substance manufacturing facility in Bangalore, India, from Stelis Biopharma.

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

The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.

If we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal.

The debate surrounding drug pricing changes rages on.

A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.

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

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

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

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.

Sobi has officially acquired CTI, a biopharma company focused on blood related cancers and rare diseases, in a merger valued at approximately $1.7 billion.

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.

The Segmentation by Exogenous Perfusion system uses a cell’s location in the tumor to find differences in gene activity.

FDA’s new draft guidance outlines key considerations for psychedelic drug development programs.

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

Aenova has opened a new building for the production of highly potent APIs in Germany.

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.