Pharma News

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.

Bellicum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for BPX-501, the Company’s lead product candidate.

Nivalis Therapeutics, Inc. announced the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation for the Company’s lead investigational drug, N91115, a novel stabilizer of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Zydus Cadila has received approval from the USFDA to market Doxycycline Capsules USP, 50 mg, 75 mg, and 100 mg.  The drug falls in the anti-bacterials segment.

AstraZeneca announced that the European Commission (EC) has granted marketing authorisation for ZurampicTM (lesinurad) 200mg in combination with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid (sUA) levels with an adequate dose of an XOI alone.