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ATMP Elena Resko Europe

In Depth 15 Dec 2022

To avoid stagnation, the EU must refine its ATMP regulation

Over the decades, the EU has spearheaded the adoption of advanced therapy medicinal products (ATMPs) such as cell and gene therapies. However, changes are needed to ATMP regulations to keep Europe competitive with the rest of the world. The EU has a rich resource base in terms of biotech innovation. Over the last decades, this […]

December 15, 2022 - 8 minutesmins - By Jonathan Smith

gene therapy

News and Trends 15 Dec 2022

EMA gives Myrtelle’s Canavan disease gene therapy candidate OD designation

Myrtelle Inc., a clinical stage gene therapy company, has announced that the European Medicines Agency (EMA) has granted orphan drug (OD) designation for rAAV-Olig001-ASPA, the company’s lead gene therapy product candidate for the treatment of Canavan disease (CD). EMA OD designation’s aim is to encourage the development of treatments for life-threatening rare conditions by providing […]

December 15, 2022 - 3 minutesmins - By Jim Cornall

gene therapy

News and Trends 14 Dec 2022

Replay targets genetic brain disorders with new gene therapy company, Kaleibe

Replay, a genome writing company, today announced the launch of Kaleibe, an HSV gene therapy company targeting genetic brain disorders. It is the third of Replay’s product companies to launch since the company’s formation in July and will leverage Replay’s high payload capacity herpes simplex virus (HSV) delivery vector, synHSV, to target genetic brain disorders. […]

December 14, 2022 - 4 minutesmins - By Jim Cornall

cell culture

News and Trends 8 Dec 2022

MicrofluidX raises £3.3M to develop advanced therapy manufacturing platform

MicrofluidX (MFX), a U.K. based provider of next-generation bioreactors for cell research and manufacturing, has announced £3.3 million ($4 million) of secured investments. This brings the company’s total funding to date to £7 million ($8.5 million). MicrofluidX’s next generation platform, the Cyto Engine, addresses the need for an affordable, scalable cell culture platform to revolutionize […]

December 8, 2022 - 2 minutesmins - By Jim Cornall

DNA genetics

News and Trends 8 Dec 2022

Polyplus announces completion of acquisition of Xpress Biologics to expand plasmid DNA

Polyplus has announced the completion of an acquisition of Belgian Xpress Biologics to expand plasmid DNA technology. Xpress Biologics specializes in the production of plasmid DNA and protein using microbial expression systems. Polypus concentrates on the manufacturing of advanced therapeutic medicinal products from research to commercial grade. The acquisition will strategically expand the Polyplus plasmid […]

December 8, 2022 - 2 minutesmins - By Liza Laws

gene therapy

News and Trends 5 Dec 2022

MaxCyte and Curamys sign cell and gene therapies agreement

MaxCyte, Inc. and Curamys have announced the signing of a strategic platform license. MaxCyte is a cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support cell-based research. Curamys is a South Korean biotechnology company developing cell and gene therapy using cell fusion technology […]

December 5, 2022 - 2 minutesmins - By Jim Cornall

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retinal eye disease

News and Trends 1 Dec 2022

FDA clears SparingVision’s investigational new drug application to treat ocular diseases

SparingVision today announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) for SPVN06. The genomic medicine company has had its developing vision-saving treatments for ocular diseases, lead gene independent therapy for the treatment of retinitis pigmentosa (RP), a form of rod-cone dystrophy (RCD) and the most prevalent […]

December 1, 2022 - 4 minutesmins - By Liza Laws

hearing loss sensorion ear cell

More News! 30 Nov 2022

FDA grants Sensorion Orphan Drug Designation for hearing loss drug

Sensorion a clinical-stage biotechnology company has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to OTOF-GT, its lead gene therapy program for hearing loss. The drug is intended for the treatment of otoferlin gene mediated hearing loss. Sensorion is on track to file a clinical trial application (CTA) […]

November 30, 2022 - 3 minutesmins - By Liza Laws

Shutterstock cell and gene therapy

News and Trends 29 Nov 2022

BioPharma Dynamics expands to provide more solutions for cell and gene therapy industry

BioPharma Dynamics have expanded their portfolio for the cell and gene therapy market to offer a range of chemically defined T-Cell media, DMSO-free cryopreservation solutions, and recombinant growth factors. Suitable for cell therapy applications at any stage, the portfolio of cell media products include immune cell media, stem cell media, and cell cryopreservation solutions. Supporting applications which […]

November 29, 2022 - 2 minutesmins - By Liza Laws

Miquel Vila Perelló gene therapy SpliceBio

Interview 28 Nov 2022

Breaking barriers to gene therapies for childhood rare diseases

The majority of known rare genetic diseases affect children, and gene therapies could help them live normal lives. Miquel Vila-Perelló, CEO and co-founder of the Spanish biotech SpliceBio, outlines how its technology could widen the range of genetic diseases treatable with gene therapies. Last week, World Children’s Day was celebrated as a means to improve […]

November 28, 2022 - 5 minutesmins - By Jonathan Smith

hemophilia b treatment gene therapy

News and Trends 24 Nov 2022

Gene therapy approval “game changer” in hemophilia B treatment

The approval of CSL’s gene therapy Hemgenix has ushered in a new era for hemophilia B treatment. With the addition of other approvals like Rocktavian and Upstaza, 2022 could be a turning point for the broader gene therapy field. Earlier this week, etranacogene dezaparvovec (Hemgenix) made history as the first gene therapy approved by the […]

November 24, 2022 - 7 minutesmins - By Jonathan Smith

shutterstock business collaboration 1

News and Trends 23 Nov 2022

BIA and Exopharm sign joint research agreement to develop integrated technology

Slovenian-based Sartorius BIA Separations (BIA), a bio-chromatography company, and Australia’s Exopharm Ltd., a company working with transformative medicines using exosomes, or extracellular vesicles (EVs), have entered into a formal collaboration. A material transfer agreement has been signed by both companies and an associated collaborative program has been implemented which aims to exploit the synergy of […]

November 23, 2022 - 4 minutesmins - By Liza Laws

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