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706,449 Results for "paragon gene therapy a unit of catalent biologics".
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Business
Siren Biotechnology and Catalent Enter Partnership for Manufacturing of AAV Gene Therapies for Cancer
Siren Biotechnology, pioneers of Universal AAV Immuno-Gene Therapy for Cancer, and Catalent Inc., the leader in enabling the development and supply of better treatments for patients worldwide, entered a strategic partnership to support the development and manufacturing of Siren Biotechnology’s AAV immuno-gene therapies.
May 8, 2024
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2 min read
Press Releases
Paragon Therapeutics Appoints Susanna High as Chief Executive Officer
November 21, 2024
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3 min read
Pipeline
Neurogene Drops Batten Gene Therapy Program
After failing to receive the RMAT designation from the FDA for its early-stage Batten disease gene therapy, Neurogene tells investors that it’s evaluating options for the program.
November 19, 2024
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2 min read
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Kate Goodwin
Deals
Amid Novo Buy, Catalent Offloads New Jersey Facility to Ardena
European CDMO Ardena will buy Catalent’s oral solids manufacturing facility in Somerset, N.J.
October 14, 2024
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1 min read
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Annalee Armstrong
Duchenne muscular dystrophy
Regenxbio Gears Up to Challenge Sarepta in DMD as Gene Therapy Advances to Pivotal Studies
Regenxbio is pushing its Duchenne muscular dystrophy gene therapy into pivotal development, with a BLA planned for 2026—potentially posing a threat to Sarepta’s Elevidys.
November 19, 2024
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2 min read
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Tristan Manalac
Approvals
PTC Wins First FDA Nod for Direct-to-Brain Gene Therapy, Targets Ultrarare Disease
The FDA has followed in the footsteps of its European counterparts and granted accelerated approval to PTC Therapeutics’ gene therapy Kebilidi for AADC deficiency. It is the first approved gene therapy to be delivered directly to the brain.
November 14, 2024
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2 min read
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Tristan Manalac
Gene therapy
Neurogene Details Gene Therapy Complication, Sending Shares Plummeting Again
Neurogene’s shares fell by 36% as the market opened Monday morning following news that a patient experienced systemic hyperinflammatory syndrome in a Phase I/II clinical trial of Rett syndrome gene therapy NGN-401.
November 18, 2024
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2 min read
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Annalee Armstrong
Editorial
Why It’s OK to Talk About Catalent’s Pending Buyout by ‘Novo’
The group of like-named companies that include Novo Holdings and Novo Nordisk—the two tied to a multibillion-dollar buyout of Catalent currently under FTC review—ultimately send proceeds to the Novo Nordisk Foundation, one of the world’s largest charitable foundations.
October 24, 2024
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6 min read
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Jef Akst
Editorial
Lilly vs. Novo: The ‘He Said, She Said’ Row About Catalent’s GLP-1 Work
With Novo Holdings’ $16.5 billion buyout of Catalent being reviewed by regulators, what work the contract drug manufacturer may or may not be performing for Eli Lilly remains a point of contention.
November 8, 2024
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4 min read
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Greg Slabodkin
Podcast
Q3 Earnings Kick Off With J&J, Bluebird in Tough Spot, Novo-Catalent Deal Under Fire, More
J&J beat expectations this week to launch the Q3 earnings season; a study about children treated with bluebird bio’s Skysona comes at a bad time for the company; Sen. Warren calls for scrutiny of Novo’s purchase of Catalent; and other news.
October 16, 2024
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1 min read
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Heather McKenzie
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