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EMA PRIME status granted to Janssen’s inherited retinal disease gene therapy pharmatimes
March 06, 2020
Janssen has announced that the European Medicines Agency (EMA) has granted both PRIME (PRIority MEdicines) and Advanced Therapy Medicinal Product (ATMP) designations to its adeno-associated virus (AAV)-RPGR gene therapy product ...
Amicus Opens Philly CoE contractpharma
March 06, 2020
Amicus Therapeutics has opened the company’s Global Research and Gene Therapy Center of Excellence in uCity Square in Philadelphia, PA, to advance its portfolio of rare disease gene therapy programs.
FUJIFILM Diosynth Expands Gene Therapy Mfg. Capacity contractpharma
March 03, 2020
The $35 million capacity expansion at College Station, TX will add cell culture and high throughput manufacturing suites.
BioMarin to Begin Clinical Trial with BMN 307 Gene Therapy americanpharmaceuticalreview
January 17, 2020
BioMarin announced both the U.S. Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. have granted the Company Investigational New Drug (IND) status and approved its Clinical Trial Application (
Gene Therapy May Be Long-Term Cure for Type of Hemophilia drugs
January 03, 2020
A new gene therapy appears to serve as a functional cure for the most common type of hemophilia, early clinical trial results indicate.
Syncona invests $80m in Freeline’s systemic disease gene therapies pharmaceutical-technology
December 23, 2019
Syncona has committed to investing $80m in gene therapy-focused Freeline’s Series C financing round.
Roche concludes acquisition of Spark Therapeutics, Inc. to strengthen presence in gene therapy worldpharmanews
December 20, 2019
Roche and Spark Therapeutics, Inc. announced the completion of the acquisition following the receipt of regulatory approval from all government authorities required by the merger agreement.
High-tech method for uniquely targeted gene therapy developed worldpharmanews
December 17, 2019
Neuroscientists at Lund University in Sweden have developed a new technology that engineers the shell of a virus to deliver gene therapy to the exact cell type in the body that ...
Limelight Bio emerges with $75m to develop next generation gene therapies to overcome limitations of current treatments pharmaceutical-business-review
December 11, 2019
Limelight Bio, a privately held, multi-platform, multi-disease biopharmaceutical company developing novel gene therapies ...
Pfizer amps up gene therapy manufacturing with another North Carolina facility fiercepharma
September 26, 2019
Pfizer has several programs for possible genetic cures it is shepherding through its pipeline, including one with partner Sangamo Therapeutics for treating hemophilia A and another for Duchenne muscular dystrophy.

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