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Bluebird said on Tuesday (April 20) that after solving the setbacks related to the manufacturing industry and overcoming the delays caused by the COVID-19 pandemic, Zynteglo failed to reach an agreement with the German authorities, the first listed country.
Compensation agreement
.
Due to the frustration of Zynteglo's listing on the first European market, Bluebird Bio is currently laying off employees and plans to "reduce and reshape" its workforce in parts of Germany
.
A spokesperson for the company declined to disclose the details, saying only that the plan involves dismissal of an unknown number of employees
The setback in Germany is not the only driver of layoffs
.
"We have faced many challenges in the past year, which led us to make a difficult decision to reduce the company's workforce and to say goodbye to some valuable employees
Bluebird Biologics has targeted Zynteglo's first indication for the treatment of beta-thalassemia for commercial promotion in Germany, and many other companies' drugs follow this strategy when they are launched in Europe
.
Now, the company says that the compensation price proposed by the German health authorities does not reflect the potential lifelong benefits of Zynteglo as a one-time treatment for a serious genetic disease
.
Therefore, it decided to withdraw the drug from the German market
Bluebird said that although the company continues to have "fruitful negotiations" with other European countries, it has decided to lay off employees to "focus on European priority markets
.
" The company will also use some resources for research and development to advance its late-stage gene therapy plan
Zynteglo (betibeglogene autotemcel, beti-cel) is a one-time gene therapy that adds a functional copy of a modified form of β-globin gene (βA-T87Q-globin gene) to the patient’s own hematopoietic (blood) stem cells (HSCs) In
.
The drug is currently being evaluated in Phase 3 clinical studies Northstar-2 (HGB-207) and Northstar-3 (HGB-212)
The European Commission approved the conditional marketing authorization (CMA) of beti-cel, the trade name is Zynteglo? Gene therapy, which is suitable for transfusion-dependent β-thalassemia (TDT) patients who are 12 years old and older without β0/β0 genotype, hematopoietic Stem cell (HSC) transplantation is suitable, but there is no relevant HSC donor that matches human leukocyte antigen (HLA)
.
Zynteglo won EU approval in early 2019
.
On April 28, 2020, the European Medicines Agency (EMA) updated the drug's CMA, which is valid in the 27 member states of the European Union, as well as the United Kingdom, Iceland, Liechtenstein and Norway
Just as the drug's marketing finally kicked off earlier this year, Bluebird Bio suffered another setback in February
.
Two cases of blood cancer were reported in the phase 1/2 clinical trial of LentiGlobin (bb1111) gene therapy for sickle cell disease.
Bluebird Bio launched an investigation last month and received positive news
.
The company found that AML cases are unlikely to be caused by lentiviral vectors carrying gene therapy
On Tuesday, Bluebird Bio pointed out that the diagnosis of MDS cases has been revised to transfusion-dependent anemia
.
These mysteries seem to have been solved, and Bluebird now believes that it has enough information to persuade regulatory agencies to lift the clinical hold on sickle cell disease research, including phase 3 trials
.
These restrictions are expected to be lifted in mid-2021
.
Reference source:
1.
bluebird bio Provides Update on Severe Genetic Disease Programs and Business Operations
2.
Bluebird bio lays off staffers in Europe as Zynteglo rollout hits an early reimbursement snag
