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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.

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With global expansion planned, Krystal lays out blockbuster ambitions for topical gene therapy

Fierce Pharma

Not even one year after becoming a commercial biotech, Krystal Biotech has blockbuster dreams for its flagship product. | In its first six months of commercial availability, Krystal's topical gene therapy Vyjuvek raked in more than $50 million.

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Krystal's topical gene therapy gains steam, prompting analyst group to boost sales projection

Fierce Pharma

At the start of its first-ever conference call to present its quarterly numbers, Krystal Biotech CEO Krish Krishnan was quick to point out that the company’s positive earnings for the third quarter | Krystal Biotech's launch of Vyjuvek, the world's first topical gene therapy, has been so promising that analysts with Evercore ISI increased (..)

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ISPE QC/Analytical Community of Practice Established

ISPE

The Steering Committee meets monthly to discuss QC-specific topics and to update progress towards knowledge sharing projects ( ISPE Guides , Pharmaceutical Engineering ® Magazine articles, ISPE Training , etc.). This new CoP is led by a recently formed Steering Committee comprised of seasoned subject matter experts.

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STAT+: FDA approves first treatment for skin condition that causes persistent wounds, a redosable gene therapy

STAT

The therapy, known as Vyjuvek and made by Krystal Biotech, will soon be available for patients with dystrophic epidermolysis bullosa, a genetic disease that causes painful blisters and persistent wounds. Patients with the condition live covered in bandages to try to stop new blisters from forming and to dress their wounds.

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First redosable gene therapy approved

European Pharmaceutical Review

The gene therapy is a topical gel that restores functional copies of the COL7A1 gene to provide wound healing and sustained functional COL7 protein expression with redosing. DEB affects the skin and mucosal tissues caused by one or more mutations in the COL7A1 gene, according to Krystal Biotech.

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NKGen Biotech signs agreement to merge with Graf Acquisition

Pharmaceutical Technology

NKGen Biotech, a clinical-stage natural killer (NK) cell therapy firm, has signed a definitive agreement to combine its business operations with Graf Acquisition. NKGen Biotech will become a publicly traded company, while Graf will be rebranded as NKGen Biotech.

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