The Cell and Gene Therapy Catapult (CGT Catapult) has confirmed its involvement in the development of a new £900m ($1,097m) life science campus in Stevenage, UK: which is set to become one of the largest in Europe.
Pfizer currently has an unprecedented number of anticipated launches, says its CEO: with the company expecting to have up to 19 new products or indications in the market in the next 18 months.
Vector BioMed, a CDMO specializing in the manufacture of lentiviral vectors, launched this week; its first financing round was led by Viking Global Investors and Casdin Capital.
Charles River Laboratories International, Inc and Rznomics Inc, a South Korea-based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, have established a viral vector contract development and manufacturing organization...
The European Medicines Agency (EMA) is planning to alert healthcare professions about liver failure cases linked to Zolgensma, a gene therapy against spinal muscular atrophy (SMA), which is developed by Novartis.
Last week saw Opus Genetics announce it had acquired the rights to two preclinical-stage adeno-associated virus (AAV)-based gene therapy product candidates for inherited retinal diseases (IRDs) from Iveric Bio.
Replay, the genome writing company formed in July, has launched its third product company, Kaleibe, which will use HSV gene therapy to target genetic brain disorders.
France’s Polyplus has made two acquisitions of late, one to expand its plasmid DNA engineering technology and services portfolio, and another to enhance its GMP fill and finish capacities.
Annogen has begun a research project with Pfizer to functionally test tens of thousands of disease-related non-coding sequence variants for their effect on gene regulation.
Emmes has announced the creation of a dedicated center for cell and gene therapy research: which will focus on supporting clinical trials for the Clinical Research Organization’s (CRO) clients.
Gene therapy company Kriya Therapeutics is acquiring Redpin Therapeutics, a privately held biotech developing regulatable gene therapies for intractable diseases of the nervous system.
Chameleon Biosciences, a Berkeley-based biotech aiming to enable safer and more effective gene therapies, has won the Immunomodulatory Solution of the Year in the Biotech Breakthrough Awards, run by the Tech Breakthrough organization.
Sensorion, a biotech specializing in therapies for hearing loss disorders, has been granted Rare Pediatric Disease Designation from the US Food and Drug Administration (FDA) for its lead gene therapy candidate, OTOF-GT.
ReiThera has received operational authorization from the Italian Medicines Agency (AIFA) to open a new production area at its facility near Rome for the large-scale production of viral vectors for vaccines and gene therapy.
London investment fund Syncona will acquire retinal gene therapy company Applied Genetic Technologies Corporation (AGTC): with AGTC noting it had been facing ‘significant challenges’ in funding operations beyond 2022.
Yapan Bio, a contract development and manufacturing organization (CDMO) based in India, says it can now support end-to-end development and manufacturing of RNA, DNA and gene therapy products starting from plasmids.
US gene therapy CDMO, Andelyn Biosciences, has opened a new GMP clinical and commercial manufacturing facility to support cell and gene therapy (CGT) development and manufacturing.
Eli Lilly and Company will acquire Akouos, a precision genetic medicine company developing a portfolio of adeno-associated viral gene therapies for the treatment of inner ear conditions, including sensorineural hearing loss.
The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.
Fujifilm Diosynth Biotechnologies (FDB) said the expansion of its large-scale microbial manufacturing facility at the Billingham campus in the north-east of England, has got underway.
The US Food and Drug Administration (FDA) has granted Accelerated Approval for bluebird bio’s Skysona (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral...
BrainVectis, a subsidiary of AskBio, has received clearance from the French authorities to start a Phase 1-2 clinical trial for its novel Huntington’s Disease gene therapy, BV-101.
The U.S. Food and Drug Administration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel), also known as beti-cel: a one-time gene therapy custom-designed to treat the underlying genetic cause of beta thalassemia in adult and pediatric...
Avista Therapeutics, a University of Pittsburgh Medical Center (UPMC) spinout, is teaming up with Roche to develop novel AAV gene therapy vectors for eye diseases.
VIVEbiotech has completed the latest expansion phase of its lentiviral vector manufacturing capabilities; the development is aimed at alleviating the viral vector bottleneck for advanced therapies.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) made several recommendations for approval of drugs and therapies at its June 2022 meeting.
BIO, the world’s largest trade association for the biotech industry, has responded to the US Food and Drug Administration's draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells.
The developer says it is harnessing parvovirus vectors that can deliver larger gene therapy payloads with enhanced tissue specificity and with minimal neutralizing immunity.
The Cell and Gene Therapy Catapult (CGT Catapult) and the UK Dementia Research Institute (UK DRI) have announced a collaboration to accelerate clinical development of adeno-associated virus (AAV) based gene therapies for dementia.
Charles River Laboratories International and ASC Therapeutics have announced plans to manufacture ASC618, a second-generation gene therapy for hemophilia A.
AGC Biologics will add viral vector suspension technology and capacity for the development and manufacturing of gene therapies at its commercial-grade campus in Longmont, Colorado.
Regenxbio says it is to delay dosing of patients in its DMD gene therapy clinical trial following a quality issue at an unnamed third-party contract manufacturer.
The US Food and Drug Administration (FDA) has granted commercial licensure approval for Novartis’ Durham, N.C. site, a multi-product gene therapy manufacturing facility, which will start producing Zolgensma immediately.
The first patient has been dosed in the Phase 1/2 clinical trial of OCU400, a modifier gene therapy candidate for the treatment of retinitis pigmentosa (RP) resulting from mutations in the nuclear receptor subfamily 2 group E member 3 (NR2E3) and Rhodopsin...
While skills shortages present one of the main challenges to the biopharma industry, North Carolina believes its investments in the life science ecosystem have given it a ‘multiple decade jumpstart’ in building a successful biopharma hub for both manufacturing...
There were 168 Advanced Therapy Medicinal Product (ATMP) trials ongoing in the UK in 2021, compared to the 154 studies reported the previous year, a 9% increase, finds a new report.
