The FDA has given Fast Track Designation to an Alzheimer’s disease (AD) clinical drug that targets an underlying—and often untreated—pathology of the disease. Biopharmaceutical company Alzheon Inc.’s lead clinical investigational drug ALZ-801, a novel, oral anti-amyloid optimized prodrug of tramiprosate,…
CDSCO making Clinical Trial Application Easy and Online – SUGAM Update
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…
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…
Global Clinical Research NEWS From OCT-2017
October 31, 2017 | October was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Clinerion, Novaseek, goBalto, and more. Clinerion expands the global coverage of its services in the Americas, adding 60…
Factory CRO acquires MileStone Research Organization
Factory CRO, a leading global CRO focused on medical devices and IVDs, has announced the acquisition of MileStone Research Organization. MileStone, located in San Diego, specializes in clinical research and reimbursement solutions for the medical device and biologics industries. “The…
OCT expands presence in U.S.
OCT, an Eastern European CRO, expands its presence in North America. In October 2017, OCT’s representative office in the U.S. has been strengthened by additional employees. In particular, the U.S. team was complemented by Anna Yanaeva, Business Development Director. “We…
