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.
Catalent has announced a multi-year $350m investment at its facility in Bloomington, Indiana, to expand biologics drug substance and drug product manufacturing capabilities.
Kite, a Gilead company, says the US Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland.
Lonza has added new integrated capabilities in cell binding, cell separation, and bead removal to its closed, automated, and scalable platform for personalized therapy manufacturing.
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...
The US FDA has approved Yescarta, Kite's CAR-T cell therapy, for initial treatment in adults with large B-cell lymphoma (LBCL) that is refractory to one prior therapy or that relapses within 12 months of first-line chemoimmunotherapy.
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...
Janssen’s Carvykti, a therapy for multiple myeloma, has been approved for conditional marketing authorization (CMA) by the European Medicines Agency (EMA).
Exothera, a CDMO specializing in the industrialization of vaccine and gene therapy processes, reports that it has achieved GMP certification for its facilities in Jumet, Belgium.
The Cell and Gene Therapy Catapult (CGT Catapult) has today published the ‘National Cell and Gene Therapy Vision for the UK’, a document outlining recommendations for a national strategy for the adoption of cell and gene therapies.
Fujifilm Irvine Scientific, Inc, has announced the acquisition of Shenandoah Biotechnology, a company supplying recombinant proteins to the drug discovery, life science research, and cell and gene therapy markets.
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.
