COMMERCIAL AND OTHERS
Cytosen Therapeutics and KBI Biopharma pair up to manufacture NK cells and Nanoparticles
CytoSen Therapeutics and KBI Biopharma paired up to manufacture therapeutic Natural Killer Cell by using a closed system manufacturing process. According to the initial collaboration, KBI will be subjected to manufacture the NK cell product for Cytosen’s upcoming Phase II trial evaluating company’s CSTD002-NK in acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients undergoing haploidentical hematopoietic stem cell transplantation (HSCT), expected to begin the first half of 2019. KBI will also manufacture CytoSen’s proprietary nanoparticles used in the expansion of the NK cell product.
New-generation drugs undergo testing to treat people with Alzheimer’s
Cognition Health has come up with a Generation Study that is recruiting thousands of people at risk of the condition for preventive treatment of Alzheimer’s in the Europe, United States, and Canada. The people at risk of developing the neurodegenerative disorder will have access to a new-generation drug to stop the disease from erupting in the first place.
In the first phase of the trial, healthy volunteers with no sign of cognitive decline and aged 60-75 will be recruited and have a cheek swab taken in order to check if they carry any genetic markers that put them at risk of Alzheimer’s. The design of the trial will further include those with two copies if the APOE4 gene associated with Alzheimer’s and those with one copy of the gene. The recruited participants will be eligible for the treatment and follow ups for five to eight years.
The new drug therapy is designed to target abnormalities in certain brain proteins. The scientists have identified that beta amyloid is over produced by patients with Alzheimer’s. This is due to the over-activity of BACE enzyme. As stated by the company, the upcoming product has been proven effective and is designed to reduce the activity of BACE enzyme and to further reduce the accumulation of the toxic protein in the brain.
Valsartan manufacturing process issues drew imports from Chinese Drugmaker to stand still
On September 30, 2018, the FDA halted imports of drug ingredients manufactured by China’s Zhejiang Huahai Pharmaceuticals after the presence of N-nitrosodimethylamine (NDMA) was found in one of its manufactured products, Valsartan. The company has sold USD 50 million worth of valsartan in 2017 and the latest update can prove to be a huge loss for the company as a significant number of valsartan products have been recalled across the globe due to the impurity.
The halt was led by major manufacturing process issues observed during an inspection of company’s manufacturing plant. The inspector pointed out a range of serious problems regarding Huahai’s quality management system in FDA’s heavily-redacted inspection report. The inspection report further stated that the Chinese firm did not carry out a risk assessment for a change in their drug-making process.
This update raises the question whether other products manufactured in China is as per the global standards.
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