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.
Edinburgh CDMO RoslinCT and Massachusetts CDMO Lykan Bioscience will combine to create a global advanced therapies CDMO: offering significantly expanded manufacturing capacity.
A $76m investment in the facility in Grand Island, New York, will increase capacity to produce raw materials used in manufacture of vaccines and biologic therapies.
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.
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 industry had over 50 new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in both 2020 and 2021, up from an annual total of 29 a decade ago.
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 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.
Measuring potency for gene and cell therapies is not so clear-cut, and some companies have hit roadblocks in their submissions to regulatory agencies as a result.
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.
Charles River Laboratories International and ASC Therapeutics have announced plans to manufacture ASC618, a second-generation gene therapy for hemophilia A.
Evonik will build a production facility for pharmaceutical lipids in Indiana: with the new site ‘positioning the group for future growth in novel mRNA-based therapies beyond COVID-19 vaccines’.
As part of a wider expansion project, Merck commits to expanding an existing facility and building an entirely new one, as part of its strategy to focus on investment in Ireland.
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.
Capital investments in Swiss biotech companies reached CHF 3.33bn ($3.53bn) in 2021; while R&D investments increased to a record-high CHF 2.56bn ($2.71bn).
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.
