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.
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...
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...
Vertex Pharmaceuticals will acquire ViaCyte, a privately held biotech focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320m.
The European Commission (EC) has approved Kite’s CAR T-cell therapy, Yescarta, (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
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.
The BIO International Convention in San Diego this week heard the US-based Center for Breakthrough Medicines (CBM) is to speed up plans to build what it calls the largest cell therapy manufacturing operation worldwide.
Umoja Biopharma and TreeFrog Therapeutics have formed an alliance to address challenges facing ex vivo allogeneic therapies in immuno-oncology, including issues scaling up production to reach all patients.
CDMO Matica Bio has opened a new 45,000-square-foot facility dedicated to the production of viral vectors and cell-based products used in cell and gene therapies, vaccines, oncolytic therapies and other genetic medicines.