Pharma News

The US Food and Drug Administration (FDA) issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health.

Titan Pharmaceuticals, Inc.  and partner Braeburn Pharmaceuticals announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted 12 to 5 in favor of approving Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine. The Committee’s vote followed presentation and discussion of data regarding Probuphine’s efficacy, safety, and risk-benefit profile. The New Drug Application (NDA) for Probuphine was resubmitted to the FDA in August 2015, and accepted by the FDA in September 2015. A target agency action date has been set for February 27, 2016.

A team of neurosurgeons and engineers has developed wireless brain sensors that monitor pressure and temperature inside the brain and then are absorbed by the body so that there is no need for surgery to remove the devices.

Two consecutive nights of “catch up” sleep on the weekend may reverse the increased risk of diabetes associated with short-term sleep deficit during the work week, suggests new research.

A novel light-activated nanotherapy developed by researchers at the University of Colorado- Boulder may be an effective weapon against the drug-resistant bacteria, say researchers including one of Indian-origin.

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

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.