Search Results: "bluebird bio lentiglobin"
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Bluebird analysis finds gene therapy ‘very unlikely’ to be cause of patient’s cancer
Bluebird bio said independent analyses found that the gene therapy inserted its payload at a site not known to cause cancer. Based on the results, CEO Nick Leschly said the company has asked the FDA for permission to resume the three clinical trials that were placed on hold in February during the inquiry.
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Bluebird scrambles to find out if its gene therapy caused cancer in clinical trial
Cancer is a known risk of lentiviral-based gene therapies. Though bluebird says its gene therapy is engineered to avoid that risk, the company is suspending two clinical trials pending the outcome of its inquiry.
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Biopharma companies face regulatory, deal delays due to Covid-19
Intercept Pharmaceuticals and bluebird bio said they had encountered regulatory snags at the FDA for their investigational drugs, while Pfizer is pausing most of its clinical trials and delaying completion of a deal with Mylan to create a new company.
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By year end, bluebird bio eyes clinical updates on blood cancer, blood disorder programs
An analyst wrote that it is unlikely bluebird would provide full data from its registration-directed study of the CAR-T bb2121 by year end, which is more likely to come early next year.
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bluebird bio picks five-year installment plan for gene therapy in blood disorder
The biotech company said it would price Zynteglo for beta-thalassemia at about $1.8 million for the European market. Data for the therapy in that disease and also sickle cell disease are being presented at EHA.
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bluebird’s gene therapy gets nod from EMA panel – for real this time
The EMA’s Committee for Human Medicinal Products recommended a conditional approval for Zynteglo in beta-thalassemia. A third-party press release erroneously stated the agency had approved the product earlier this week.
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Erroneous announcement about bluebird’s LentiGlobin prompts correction from company
Two beta-thalassemia advocacy organizations – one British and one Italian – issued a press release Monday that claimed the EMA had approved the gene therapy under the brand name Zynteglo.
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Artificial Intelligence, BioPharma
Microsoft, Oxford Biomedica to apply cloud, machine learning to improving gene therapy
The partnership between the US software giant and UK-based biotech company is designed to increase the yield and improve the purity of lentiviral vectors in gene therapy.
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Industry execs forecast the year ahead for gene therapy at Biotech Showcase
Hospitals – especially in Europe – anticipate growing interest from international patients. But a wave of industry consolidation is debatable.
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bluebird bio’s stock tanks after report of serious toxicity in sickle cell patient
A company analysis deemed the patient’s myelodysplastic syndrome was unrelated to LentiGlobin, but a news report indicated it may have stemmed from the conditioning regimen used in the trial.
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Just a cool #JPM15 Bluebird Bio slide that shows its impressive scope
Bluebird Bio‘s work has been at the epicenter of gene therapy, working on a litany of fields […]
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Vertex to pay CRISPR Therapeutics $900M for bigger share of gene-editing alliance
Vertex Pharmaceuticals is amending its collaboration with CRISPR Therapeutics, paying $900 million now for chance to grab a bigger share of a gene-editing therapy’s profits later—if the treatment is approved. Clinical trials evaluating the CRISPR-based therapy are underway in sickle cell disease and beta thalassemia.
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Presentations at EHA highlight gene therapy approaches to beta-thalassemia, sickle cell disease
Phase III data on bluebird bio’s Zynteglo, as well as Vertex and CRISPR Therapeutics’ CTX001, showed patients achieving transfusion independence via two gene therapy approaches.
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MD Anderson oncologist Stephen Hahn confirmed as FDA commissioner
The Senate voted 72-18 Thursday to confirm Hahn, a radiation oncologist and chief medical executive at The University of Texas MD Anderson Cancer Center.
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NIH, Gates Foundation invest $200M to develop gene therapies for developing countries
The partnership will have a particular focus on therapies to treat sickle cell disease and HIV, with each party committing $100 million to the effort.
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Bristol Myers Squibb SVP Ho Sung Cho highlights pioneering work with protein degradation in support of drug development
In a podcast with MedCity News, Cho talked about the company’s profile in the San Diego life science ecosystem, the need to fail fast and frequently in the early stages of drug development and the work BMS is doing to combat Covid-19.
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MedCity Spotlight Video: Fruit Street Health on diabetes and telemedicine
Although it has focused on diabetes management, Founder and CEO Laurence Girard says that the company is growing its telemedicine services to include virtual primary care support for other chronic conditions such as hypertension, mental health and smoking cessation that pair community and clinical components.
