Solid Biosciences announces that its gene therapy for DMD has been placed under clinical hold again, after a patient experienced a serious adverse event.
Gilead’s continued investment in cell therapy manufacturing capabilities, at a time when sales at the nascent business unit are flatlining, was called into question by investors.
US FDA places a hold on a clinical study testing Novartis’ Zolgensma in patients with SMA Type 2, after information provided to the authorities by AveXis.
The pace of development in the industry sees greater demand for a trained workforce, which is leading away from ‘classroom’ to technology-assisted working environments, says training lead at Zenith.
NIH and the Gates Foundation have set themselves the goal of bringing curative gene therapies to clinical trials in the US and Africa in the next seven to 10 years.
Early dialogue with patients is ‘critical’ to design efficient clinical development programs for ATMPs and avoid ‘data gaps’, an executive from ARM says.
Novartis announces its third quarter results that show Zolgensma is outperforming sales expectations, but company notes approval in EU and Japan pushed back over manufacturing queries.
Alkermes to work collaboratively with the Fred Hutchinson Cancer Research Center on the clinical development of a drug candidate as a combination treatment alongside Keytruda.
An expansion to BIA Separations' Cornerstone set of processing services for viral vector development adds the use of kryptonase and CIMmultus chromatography device.
Novo Nordisk partners with bluebird on a three-year research arrangement looking to discover gene therapy candidates for the treatment of genetic diseases, including hemophilia.
GSK taps Lyell’s technology to delay ‘exhaustion’ of T cells and will explore creating a new platform to develop cell and gene therapies for rare cancers.
The gene therapy space is a rapidly developing areas in the industry, as a result those with expertise are finding their knowledge is invaluable to companies looking to advance in the space.
Cellectis chooses Lonza to take on the clinical manufacturing of its UCART blood cancer immunotherapy candidates, intended to be marketed as industrialized, readily available CAR-T cells.
GSK’s biopharmaceutical manufacturing facility will be focused on the company’s pipeline of biologic medicines, including gene therapies, and vaccines.
CGT Catapult adds six additional clean room spaces to its Stevenage manufacturing center, to aid companies readying themselves for clinical and commercial manufacture.
McKesson partners with TrakCel aiming to address the supply chain challenges of cell and gene therapy developers in late stages of development or approaching commercialization.
BIA Separations introduces technology able to remove host-cell DNA and proteins from AAV products, aiming to accelerate clinical development of gene therapies.
GE Healthcare teams up with Germfree to create a fully integrated, expandable manufacturing solution that is geared towards the development of ‘emerging biotherapeutics’.
Four pharma companies are providing half of the investment required for ‘world’s largest genetics project’, in return for access to the genomic data generated.
The seventh #NLSDays event saw the latest trends in fields including ATMP, clinical evolution, and R&D technologies, find their audience in Scandinavia.
Noile-Immune signs its second high profile agreement, the latest with Adaptimmune to combine the companies’ technology in pre-clinical studies for the treatment of cancer.
Already in 2019, there have been a number of deals to pick up vector and plasmid manufacturers, such acquisitions are a sign of a rapidly developing market, one report suggests.
Vertex is set to acquire Semma, which is developing a stem cell curative treatment for type 1 diabetes and expects the deal to ‘rapidly advance’ its potential therapy.
As MilliporeSigma expands its patent portfolio for its genome editing technology, the company’s head of strategy discusses how CRISPR is changing the bioproduction landscape.
908 Devices launches Rebel, a bioprocess analyzer, enabling researchers to conduct their own cell culture media analysis to accelerate process development ‘by weeks’.
Atelerix to work on the development of gel stabilisation technologies enabling room temperature storage of Rexgenero’s cell therapy candidate, under an Innovate UK grant.
The Alliance for Regenerative Medicine released a ‘Statement of Principles’ on gene editing, as controversy over the technology’s potential rumbles on.
UK government invests further in businesses manufacturing advanced therapies, opening a fund for companies working on technology to improve commercial production.
Pfizer invests half a billion dollars to expand its gene therapy manufacturing facility in North Carolina and enhance its position to compete in the booming market.
Contract packaging provider Reed-Lane adds dedicated room for vial and ampule kitting to its cold chain capabilities to limit intra-facility travel and product excursion as a means of security.
Merck enters a clinical collaboration agreement with Oncologie to evaluate the combination of investigational drug Bavituximab and Keytruda in cancer patients.
The increasing number of cell and gene therapies in clinical development is evolving the supply chain into a ‘supply cycle,’ says TrakCel CEO, with service providers being called to maintain control under pressure.
The FDA approves targeted biologic, Dupixent, for the treatment of atopic dermatitis in patients 12 to 17 years old, the first treatment of its kind for adolescents.
