Pharma News

Cranberry extracts can help fighting urinary tract infections (UTIs) or bladder infection in breast-fed babies less than one year of age, new research says

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Greater intake of dietary nitrate and green leafy vegetables is associated with a 20-30 percent lower risk of primary open-angle glaucoma (POAG), according to a study.

The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for BENEPALI® , an etanercept biosimilar referencing Enbrel®. BENEPALI has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. Biogen intends to make BENEPALI available for patients in the coming weeks.

BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter to the Company's New Drug Application (NDA) for KyndrisaTM (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to exon 51 skipping.
amenable to exon

Five Prime Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for FPA008 for the treatment of Pigmented Villonodular Synovitis (PVNS), a locally aggressive tumor of the synovium.

Impax Laboratories, Inc. announced that the United States Food and Drug Administration (FDA) has approved the Company's supplemental new drug application (sNDA) for EMVERM (mebendazole) 100 mg chewable tablets

The US Food and Drug Administration cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model currently being used in health care facilities and make the needed repair as quickly as possible.

Heron Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL® (granisetron) Injection,extended release and would not be taking action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016 and anticipates taking action in late February 2016.

Nivalis Therapeutics, Inc., a clinical stage pharmaceutical company focused on developing innovative solutions for people with cystic fibrosis (“CF”),  announced the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to the Company's lead investigational drug, N91115, a novel stabilizer of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.