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 overproduced by patients with Alzheimer’s. This is due to the over-activity of the 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 standstill
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 the 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 of whether other products manufactured in China is as per the global standards.
