Wednesday, November 23, 2022 Daily Archives

Biosimilars: Senate Bill aims to change interchangeability requirement

A Republican Senator has introduced the Biosimilar Red Tape Elimination Act in an effort to remove the need for switching studies and increase biologics competition. The arrival of biosimilars in the US came almost a decade after Europe first embraced the competitive biologic modality. And even then, biosimilars have been distinguished in the US due to the need to prove interchangeability with the reference product through switching studies if they are to be substituted without the intervention of a health…

RVAC and A*STAR partner to build mRNA capabilities in Singapore

RVAC Medicines and the Agency for Science, Technology and Research (A*STAR) will develop solutions to construct mRNA manufacturing and analytics capabilities in Singapore. RVAC, a messenger RNA (mRNA) technology platform firm headquartered in Singapore, will work with research and development (R&D) agency A*STAR to jointly establish a laboratory. The joint laboratory will be located at A*STAR’S Bioprocessing Technology Institute (BTI) in Singapore and will be used to advance a preclinical production platform, which will enable the generation of raw materials…

CSL Behring up as FDA approves hemophilia B gene therapy

With a list price of $3.5 million, Hemgenix (etranacogene dezaparvovec) becomes the most expensive single-dose drug and the first gene therapy approved for hemophilia B. The US Food and Drug Administration (FDA) gave CSL Behring’s one-time gene therapy the thumbs up yesterday to treat adults with hemophilia B, a rare bleeding disorder caused by a gene defect that results in insufficient production of blood clotting protein factor IX. “We are thrilled to witness this milestone in hemophilia B treatment,” said…

Fujifilm to build $188m NC cell culture media plant

The Research Triangle Park facility will significantly expand Fujifilm Irvine Scientific’s cell culture media capacity to feed the projected double-digit growth in demand from industry. The planned 250,000 square-foot facility – construction of which is scheduled to start in spring 2023– will produce animal component-free, dry powder, and liquid media for biomanufacturing customers. The site in Research Triangle Park (RTP), North Carolina will be the latest in Fujifilm Irvine Scientific’s cell culture media network, joining production sites in Santa Ana…