CDSCO has organised the workshop on hands on training/demonstration on POST APPROVAL SUBMISSION at CDSCO (HQ) on 17/11/2017. In the workshop DCGI officials has given the live demonstration of filing the following applications for Global Clinical Trials (GCT) 1. Major…
With INR 1,272,391 treatment for 100 days FDA approves Merck drug to prevent post-transplant infections
The FDA has approved a new Merck & Co drug to prevent infections in patients who have had stem cell transplants. Cytomegalovirus (CMV) infection can cause major complications after stem cell transplants, and while there are already antiviral treatments available,…
Shire CEO backs outcomes-based deals in rare diseases
Rare disease firms will increasingly use payment schemes where health systems are only charged when drugs work, the CEO of specialist pharma Shire has said. Under the leadership of CEO Flemming Ornskov, Shire has transformed itself into the leader in rare…
Wearable Tech Emerging For Chronic Pain Relief
The opioid crisis has revealed another real ongoing problem: a lot of people have chronic pain. For example, Lady Gaga recently revealed that she suffers from fibromyalgia, a chronic pain condition that the Centers for Disease Control and Prevention…
2018 Pipeline Report
Amid the constant battle with biology and new complexities in fighting disease, persistence seems to be paying off for drug developers. Major driving forces include the rise of CAR -T and other gene therapy, newly discovered cancer targets, better patient…
Cellectis gets FDA go-ahead to restart fatal CAR-T trial
The FDA has said Cellectis can restart trials of its ‘off-the-shelf’ CAR-T cancer immunotherapy, after revising protocols in a trial that killed one patient and left another with life-threatening complications. UCART123 is a CAR-T therapy produced independently of the patient,…
Speedy review for Jazz’ high-risk AML chemo
Dublin, Ireland-based Jazz Pharmaceuticals’ Vyxeos is being given a speedy review in Europe as a treatment for certain types of high-risk acute myeloid leukemia (AML). The European Medicines Agency’s Committee for Medicinal Products for Human Use is considering the chemotherapy’s…
