Andelyn Biosciences manufacturing facility ready for clients as company seeks CEO
The 250,000-square-foot commercial-scale manufacturing facility for the genetic material and delivery viruses needed for gene therapy is "ready for client production," the spinoff from Nationwide Children's Hospital announced in a LinkedIn post last week. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 27, 2022 Category: Pharmaceuticals Authors: Carrie Ghose Source Type: news

Google-backed gene therapy firm launches Morrisville manufacturing facility
A California-based gene therapy company has opened a manufacturing site in Morrisville with the potential for major growth. (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - September 22, 2022 Category: Health Management Authors: Zac Ezzone Source Type: news

Google-backed gene therapy firm launches Morrisville manufacturing facility
A California-based gene therapy company has opened a manufacturing site in Morrisville with the potential for major growth. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - September 21, 2022 Category: American Health Authors: Zac Ezzone Source Type: news

Cambridge biotech acquired for $53M following move from Philadelphia
Renovacor Inc., a Cambridge-based gene therapy company that relocated from Philadelphia earlier this year, is set to be acquired by New Jersey firm Rocket Pharmaceuticals Inc. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - September 20, 2022 Category: American Health Authors: Rowan Walrath Source Type: news

Gene Therapy for Degenerative Brain Disorder Wins FDA Nod
(MedPage Today) -- The FDA granted accelerated approval to elivaldogene autotemcel (eli-cel; Skysona), a gene therapy to treat early, active cerebral adrenoleukodystrophy (CALD) in boys ages 4 to 17 years, drugmaker bluebird bio announced Friday... (Source: MedPage Today Pediatrics)
Source: MedPage Today Pediatrics - September 19, 2022 Category: Pediatrics Source Type: news

FDA Fast Tracks Approval of Therapy for Rare Neurologic Disorder FDA Fast Tracks Approval of Therapy for Rare Neurologic Disorder
The US Food and Drug Administration has granted accelerated approval to the gene therapy elivaldogene autotemcel (Skysona) for the treatment of cerebral adrenoleukodystrophy in boys.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - September 19, 2022 Category: Neurology Tags: Neurology & Neurosurgery News Alert Source Type: news

European Commission approves Roche ’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
Phase III data that showed people with nAMD and DME treated with Vabysmo up to every four months achieved similar outcomes compared to receiving treatment every two months with afliberceptIn addition, patients treated with Vabysmo received up to 33% fewer median number of injections compared to afliberceptReducing the number of eye injections over time could offer a less burdensome treatment schedule for individuals, their caregivers and healthcare systemsVabysmo simultaneously targets and inhibits two disease pathways involving Ang-2 and VEGF-A linked to a number of vision-threatening retinal conditionsBasel, 19 September...
Source: Roche Investor Update - September 19, 2022 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
Phase III data that showed people with nAMD and DME treated with Vabysmo up to every four months achieved similar outcomes compared to receiving treatment every two months with afliberceptIn addition, patients treated with Vabysmo received up to 33% fewer median number of injections compared to afliberceptReducing the number of eye injections over time could offer a less burdensome treatment schedule for individuals, their caregivers and healthcare systemsVabysmo simultaneously targets and inhibits two disease pathways involving Ang-2 and VEGF-A linked to a number of vision-threatening retinal conditionsBasel, 19 September...
Source: Roche Media News - September 19, 2022 Category: Pharmaceuticals Source Type: news

FDA Approves Skysona (elivaldogene autotemcel) Gene Therapy for Early, Active Cerebral Adrenoleukodystrophy (CALD)
Skysona is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys with this devastating and fatal neurodegenerative disease SOMERVILLE, Mass.--(BUSINESS WIRE)--Sep. 16, 2022-- bluebird bio, Inc. (Nasdaq:... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 18, 2022 Category: Drugs & Pharmacology Source Type: news

FDA approves second gene therapy from bluebird bio
Somerville gene therapy firm bluebird bio Inc. has netted a second key win from the U.S. Food and Drug Administration. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 17, 2022 Category: Biotechnology Authors: Rowan Walrath Source Type: news

The Petri Dish: bluebird loses another CFO; Imara sells drug to local startup
Gene therapy firm bluebird bio Inc. is losing its second chief financial officer this year. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 15, 2022 Category: Pharmaceuticals Authors: Rowan Walrath Source Type: news

SparingVision raises $75.2M as it eyes Philadelphia expansion
The French gene therapy company established its U.S. headquarters in Philadelphia earlier this year (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 14, 2022 Category: Pharmaceuticals Authors: John George Source Type: news

The Relentless Momentum of the Status Quo in Healthcare
(MedPage Today) -- When it comes to understanding the why behind structural stalemate in healthcare, look no further than this "framework" on market access for gene therapies, developed by a working group convened by Blue Cross Blue Shield Association... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - September 14, 2022 Category: American Health Source Type: news

Gene therapy startup Forge Biologics raises $90M on biotech manufacturing strength
The startup is readying the gene therapy industry's largest equipment – vats that could easily fit two full-grown humans in frames 16 feet tall – to ease a manufacturing bottleneck for the extremely tiny viruses and gene snippets. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 13, 2022 Category: Biotechnology Authors: Carrie Ghose Source Type: news

Krystal Biotech talks the company's strategy, pipeline as it awaits word from FDA
Krishnan said that Krystal's pipeline is not only gene therapies for rare skin diseases but also using the same platform for respiratory and pulmonary diseases. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 13, 2022 Category: Biotechnology Authors: Paul J. Gough Source Type: news