Leukemia new drug SGN-CD33A explosion major safety hazard January 04, 2017 Source: Bio Valley For Seattle Genetics, it’s a little difficult to bring up the spirit to face the upcoming 2017. The reason is that the company's leukemia drug vadastuximab talirine (SGN-CD33A), which is in the early stages of development, has a major safety hazard in early clinical studies. Four patients died unexpectedly in clinical studies. This result also caused the company's share price to suffer a setback, down 15%. To this end, the FDA has announced the suspension of two clinical 1/2 studies on the treatment of acute myeloid leukemia. In addition, two other clinical Phase I studies have been partially suspended (no new subjects may be recruited and existing subjects may continue to study). The company said that six patients had severe liver damage in clinical studies, and four of them had died. Seattle Genetics is currently actively working with the FDA to investigate whether SGN-CD33A therapy causes liver toxicity and actively modifies existing treatments to ensure patient safety. Antibody Drug Coupling Technology (ADC) is the core technology of Seattle Genetics. The problematic vadastuximab talirine was also developed based on this technology. In fact, ADC technology has long been considered one of the best choices for targeted therapy. Including Aibowei, Astellas, Bayer, Genentech, GlaxoSmithKline and Pfizer have established extensive cooperation with Seattle Genetics in this field. Earlier, the company's antibody-conjugated drug SGN-LIV1A achieved good results in the clinical phase I study of triple-negative breast cancer, a type of breast cancer that is difficult to treat. The company's most well-known product is Adcetris (brentuximab vedotin), which was approved five years ago as a second-line treatment for typical Hodgkin's lymphoma. Whether 2017 Seattle Genetics will be able to come, we still need to wait and see. (Bio Valley Bioon.com) Diagnostic reagents can be divided into two categories: in vivo diagnostic reagents and in vitro diagnostic reagents. It is mostly a reagent for detection by the reaction between antigen and antibody. Urine Rapid Test Kit,Rapid Test Kit 6-Panel,Toxoplasma rapid test kits,Fecal Occult Blood Test Jilin Sinoscience Technology Co. LTD , https://www.jilinsinoscience.com
A: Classification of in vitro diagnostic reagents:
1. In vitro biodiagnostic reagents managed as drugs include:
1. Blood type and tissue type reagents;
2. Microbial antigen, antibody and nucleic acid detection reagents;
3. Tumor marker reagents;
4. Immunohistochemistry and human tissue cell reagents;
5. Human genetic testing reagents;
6. Biochips;
7. Allergy diagnostic reagents.
2. In vitro reagents managed as medical devices include:
1. Clinical basic test reagents;
2. Clinical chemistry reagents;
3. Blood gas and electrolyte determination reagents;
4. Vitamin determination reagents;
5. Cell histochemical stains;
6. Autoimmune diagnostic reagents;
7. Microbiological test reagents.
B: According to medical test items, clinical diagnostic reagents can be roughly divided into clinical chemical test reagents, immunology and
Serological testing reagents, hematological and cytogenetic testing reagents, microbiological testing reagents, body fluid excretion
Detection reagents, genetic diagnosis reagents, etc. Among them, the market share of clinical chemistry
The largest, close to 34%; followed by the immunology market, accounting for about 29%. Novel immunodiagnostic reagents and genetic diagnostic tests
The reagent was developed in the late 1980s, and it is the most common diagnostic reagent for all current diagnostic reagents, regardless of technology or market.
The fastest growing product.