Pharma News

formulation approved dose, tolerability and immunologic efficacy, investigational new formulation Astellas Pharma Inc. and Medivation, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI® (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC.

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.