Pharma News

Merck, known as MSD outside the United States and Canada, announced top-line results from the company’s Phase 3 pivotal trial, ONCEMRK. ONCEMRK is evaluating an investigational once-daily formulation of ISENTRESS® (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg once-daily), for previously untreated HIV-1 infected adults.

Vericel Corporation , a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, announced that the U.S. Food and Drug Administration has approved the Company's Humanitarian Device Exemption (HDE) supplement for Epicel® (cultured epidermal autografts) to revise the labeled indications of use to specifically include pediatric patients and to add pediatric labeling.  The revised product label also specifies that the probable benefit of Epicel, mainly related to survival, was demonstrated in two Epicel clinical experience databases and a randomized, controlled, independent physician-sponsored study comparing outcomes in patients with severe burns treated with Epicel and standard care compared to standard care alone.

The World Health Organisation (WHO) has sought concrete measures against diminishing efficacy of antibiotics which, if it continues, will make bacterial infections such as skin sores and diarrhoea untreatable and fatal.

Swedish researchers have developed a new magnetic imaging technique that utilises sugar to assess the malignancy of tumours in cancer patients.

An anti-retroviral (ARV) drug sometimes included in treatments to prevent mother-to-child HIV transmission during pregnancy may have adverse effects on infant development, new research has found.

Working hard to shed those extra kilos? Take heart as according to a new study, losing as little as five percent of your body weight is enough to reap significant health benefits.

Researchers have developed a low-cost and portable diagnostic device that can be used to detect Ebola infection and many other diseases.

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Higher body weight and taller stature during adolescence increase the risk of developing a rare type of cancer of the lymphatic system, shows new research.

Aeolus Pharmaceutical inc.  announced that it has received notice that the U.S. Food & Drug Administration ("FDA") has removed the clinical hold on the Company's Investigational New Drug application for AEOL 10150 ("10150") as a treatment for the lung and delayed effects of acute radiation exposure ("Lung-ARS"). The lifting of the clinical hold allows the Company to initiate its planned human safety study in healthy normal volunteers.

Amgen and UCB announced top-line results from the Phase 3 placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME). These data showed FRAME met the co-primary endpoints by reducing the incidence of new vertebral fracture through months 12 and 24 in postmenopausal women with osteoporosis treated with romosozumab. The study also met the secondary endpoint of reducing the incidence of clinical fractures (composite of vertebral and non-vertebral fractures) in postmenopausal women with osteoporosis through 12 months. However, the secondary endpoint of reducing the incidence of non-vertebral fractures through months 12 and 24 was not met.