EASY GLOBAL TRAINING Entered an Agreement to Provide Medical Affairs Consulting Services for SBLA Filing of KEYTRUDA® (PEMBROLIZUMAB) with FDA.
As of Jan 1, 2016, Easy Global Training entered an agreement with Merck, a leading global biopharmaceutical company, for regulatory writing process of accelerated sBLA filing of Keytruda® (Pembolizumab) oncology drug, a breakthrough organ agnostic cancer treatment drug, with FDA.
KEYTRUDA® (pembrolizumab) is a prescription medication that is used to treat Advanced Melanoma, Non-Small Cell Lung Cancer (NSCLC), and Head & Neck Squamous Cell Cancer (HNSCC) through activating body’s immune system. However, this drug can potentially cause your immune system to attack normal body tissue and organs, which can at times become serious or even life-threatening. If this self-attack happens, certain symptoms may appear, including:
- Lung problems specifically pneumonia;intestinal problems specifically colitis;
- Liver problems specifically hepatitis;
- Hormone gland issues specifically in the thyroid, pituitary, adrenal glands, and pancreas;
- Kidney problems specifically nephritis or kidney failure; or
- Problems in other organs (eyesight changes, severe muscle or joint pains, severe muscle weakness, anemia, and rash)
You need to immediately call your doctor in case of any of these symptoms. The clinical trials are still ongoing. For more information and to get updates about this drug, please follow the manufacturer’e news at https://www.keytruda.com/information-about-keytruda/https://www.keytruda.com/information-about-keytruda/
REFERENCES
- Important Risk Information About KEYTRUDA® (pembrolizumab): https://www.keytruda.com/
- Receive more information about KEYTRUDA or sign up for support: https://www.keytruda.com/information-about-keytruda/
OUR COMPANY
Easy Global Training is based in Potomac, MD in the United States. It is a leading, up-to-date information network in the fields of Regulatory Affairs, quality compliance, and medical affairs for life sciences (drugs, excipients, devices, and combination products), food & food ingredients, dietary supplements, and complementary / alternative medicine. Our portfolio of products includes webinars (live and on-demand), e-learning self-paced modules, in-class training, white papers, e-books, guidelines, best practices, reports, job aids, and e-newsletters. We also provide social media channels with webcasts and interviews from the industry experts, as well as academic and regulatory body experts on regulatory training and quality compliance hot topics, best practices (GMP, GDP. GCP. GLP. GVP, …), guidelines, and regulations at a global level. For your convenience, we also provide a variety of forms and templates across these fields. Easy Global Training strives to provide a wide network of high-quality resources that are up-to-date and to communicate new updates as well as new insights and competitive points of view. This is a collaborative platform, designed for professionals across a variety of fields to learn and share valuable information related to the latest laws, policies and regulations, while ensuring continuous improvement in global operations, regulatory training, quality compliance, and safety.
