Zafgen Inc (NASDAQ:ZFGN)
Zafgen, Inc. (ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today issued the following statement:
“Zafgen recently learned of a patient death which occurred in the Company’s ongoing double-blind, randomized, placebo-controlled Phase 3 bestPWS study of beloranib in Prader-Willi Syndrome, a rare genetic disorder with a high rate of mortality linked to obesity and its co-morbidities. The cause of death remains unknown at this time. According to normal practice, the event was reported to the U.S. Food and Drug Administration, at which point the Agency initiated a discussion with the Company. The Company is working with the Agency to expedite a review and understanding of this event, and to determine implications of the event on the conduct of the trial, and anticipates providing an update as its discussions with the Agency progress. The thoughts of the Company are with the family of the patient at this time. Zafgen remains committed to ensuring the safety of all patients enrolled in its studies.
Tocca Life Holdings Inc (OTCMKTS:TLIF)
TOCCA Life Holdings, Inc. (OTC PINK: TLIF) announced today that it is filing an application for FDA approval for the first of its products, “TOCCA Screen.” TOCCA Screen is expected to be the most comprehensive home drug test kit currently available.
With 1 out of 4 families in America affected by the disease of addiction, TOCCA’s bio technology focus on clinical laboratory toxicology and home based sobriety products used for early detection, is a key component of in its objective of creating accountability in the home and in the workplace.
Estimates of the total overall costs of substance abuse in the United States, including productivity and health-and crime-related costs, exceed $600 billion annually. This includes approximately $193 billion for illicit drugs, $193 billion for tobacco, and $235 billion for alcohol. Fortunately, treatment is available to help people counter addiction’s powerful disruptive effects. Early detection, as with any disease, is a critical component in treating the disease of addiction, along with treatment itself and appropriate after care. Clinical toxicology and in home drug testing addresses two of the critical steps in arresting the disease of addiction. First they allow for early detection and second they form part of an effective after care program, keeping the patients and those around them safe.
Radius Health Inc (NASDAQ:RDUS)
Radius Health, Inc. (RDUS) announced positive top-line data from the first six months of the ACTIVExtend trial that showed women who were previously treated with 18 months of abaloparatide (ABL) subcutaneous (SC) injection experienced no new vertebral fractures and an increased bone mineral density (BMD) during the first six months of treatment on alendronate (ALN). These data were presented today at a plenary oral session during the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting.
The first six months of the Phase 3 ACTIVExtend trial were conducted in 1,139 subjects enrolled in the ACTIVE trial, who completed 18 months of treatment with either ABL-SC or placebo. Patients in the ACTIVE study were offered up to 24 additional months of treatment with ALN at a dose of 70 mg per week.
The post Biotech News: Zafgen Inc (NASDAQ:ZFGN), Radius Health Inc (NASDAQ:RDUS), Tocca Life Holdings Inc (OTCMKTS:TLIF) appeared first on Live Trading News.