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Krystal Biotech receives FDA approval for DEB topical gene therapy

Pharmaceutical Technology

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. Topic sponsors are not involved in the creation of editorial content. It prevents epidermis adhesion to the dermis.

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Moderna to set up new mRNA manufacturing facility in Kenya

Pharmaceutical Technology

Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company is also committed to establishing mRNA manufacturing facilities in Australia, Canada, the US and the UK. Topic sponsors are not involved in the creation of editorial content.

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New facility boosts UK’s cell and gene therapy manufacturing capacity

Pharmaceutical Technology

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. This is important due to the UK’s currently limited short-scale manufacturing capacity.

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Genenta Science signs manufacturing service deal with AGC Biologics

Pharmaceutical Technology

Genenta Science and AGC Biologics have signed a development and manufacturing service agreement (MSA). Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science.

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Marker to offload cell manufacturing assets to CellReady

Pharmaceutical Technology

Marker Therapeutics has reached a non-dilutive agreement to sell cell manufacturing assets to CellReady for $19m in cash. CellReady is a newly created contract development and manufacturing organisation (CDMO) founded by Marker board member and co-founder John Wilson. Both firms expect to complete the deal on 26 June 2023.

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Medical Device Innovation Summit: India is poised to be a manufacturing hub for medical equipments and devices

Pharma Mirror

The first digital session of Medical Device Innovation Summit concludes on a positive note with industry leaders addressing burning topics to promote innovation in the medical equipment industry.

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Mendus and NorthX to establish cell therapy manufacturing unit

Pharmaceutical Technology

Mendus has entered an alliance with NorthX Biologics to co-establish a cell therapy manufacturing unit for its lead asset, vididencel, in Sweden. Mendus has partnered with NorthX and Swedish investment firm Flerie Invest, which will make an initial investment of Skr90m ($8.25m) in the manufacturing unit.