The messenger RNA (mRNA) specialist Moderna has teamed up with ElevateBio-owned Life Edit Therapeutics to develop gene editing therapies that are delivered into patients in vivo.
After voluntarily pausing a phase 1/2 trial due to safety concerns in January 2023, the gene edited cell therapy firm Graphite Bio has discontinued the development of nulabeglogene autogedtemcel (nula-cel), its lead candidate cell therapy for sickle cell...
New company Syena says it has the potential to create the next generation of cell therapy: combining the safety, potency and scalability of natural killer (NK) cells with the ability of T cell receptors (TCR) to target intracellular tumor antigens.
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.
The European Medicines Agency (EMA) has validated the marketing authorization application of Vertex Pharmaceuticals and CRISPR Therapeutics for exa-cel.
Despite an uncertain macroeconomic environment, Lonza says its ‘resilient’ business model and sustained market demand delivered a strong financial performance in 2022, in line with the Swizterland based CDMO’s outlook.
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 unprecedented rise in approvals for new cell and gene therapies, and the increasing industry need for cell lines to support the production of therapeutics, has spurred US CDMO, the Center for Breakthrough Medicines (CBM), to act
In 2022, the UK continued to have a signficant footprint in ATMP clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022, according to a new report.
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 year was a slow one in terms of dealmaking in the life sciences sector but the final quarter saw a major uptick, finds the EY annual M&A Firepower report.
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.
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.
Merck has signed a Memorandum of Understanding (MoU) with Synplogen, a startup spun out of Kobe University's Graduate School of Science, Technology and Innovation.
Curamys, a South Korean biotech developing cell and gene therapy using cell fusion technology to treat rare intractable diseases, has signed a strategic platform licensing agreement with US tech developer, MaxCyte.
Enhancing the skills of employees working in the UK’s advanced therapy medicinal products (ATMP) sector and the broader cell and gene therapy industry is mission critical for the CGT Catapult.
BioNTech will create an mRNA facility in Singapore through the acquisition of a Novartis site: which will become its Regional Headquarters and production center for the Asia Pacific region.
Orgenesis, the biotech specializing in cell and gene therapy (CGT) at the point of care, and private equity firm, Metalmark, have signed a major investment partnership.
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.
Lonza is to increase the size of the cell and gene therapy (CGT) development space at its Houston facility; the expansion will include viral vector-based process development and analytical development laboratories.
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.
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.
BioNTech will establish an mRNA research and innovation center in Victoria, alongside clinical scale manufacturing capabilities. Meanwhile, it has also pledged to step up clinical development of oncology therapies in the country.
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.
Rocket Pharmaceuticals, a late-stage, clinical biotech advancing a pipeline of genetic therapies for rare childhood disorders, will acquire Renovacor: helping it strengthen its position in AAV-based cardiac gene therapy.
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...
Orca Bio, a biotech developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, will expand its current manufacturing capabilities with the construction of a new 100,000-square-foot commercial...
Ori Biotech, a company aiming to bring automated manufacturing to the CGT industry, has been executing its strategic plan following the US$100m it raised in its Series B funding round earlier this year.
ElevateBio and the University of Pittsburgh have entered into a long-term strategic partnership to accelerate the development of innovative cell and gene therapies: with ElevateBio to locate its next BaseCamp process development and GMP manufacturing...
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...
Biomanufacturing company National Resilience has announced a strategic collaboration with Mayo Clinic in biomanufacturing to deliver novel biotherapeutics for rare and complex conditions.
