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  • Calif. Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis® (ranibizumab injection) 0.5 mg prefilled syringe (PFS) as a new method of administering the medicine. Like the Lucentis 0.5 mg vial, the 0.5 mg PFS is approved to treat people with wet age-related macular degeneration (AMD) and macular edema after retinal vein occlusion (RVO). The Lucentis PFS is the first syringe prefilled with an anti-VEGF medicine FDA-approved to treat two eye conditions.

  • Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation announced that data from a randomized, double-blind, multicenter, exploratory phase 1b study evaluating the effects of investigational oral GED-0301 (mongersen) 160 mg on both endoscopic response and clinical remission in patients with active Crohn’s disease will be presented in Vienna, Austria at the United European Gastroenterology Week (UEGW)

  • Ferring Pharmaceuticals announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for REKOVELLE® (follitropin delta), recommending that the European Commission grants marketing authorisation for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.The European Commission has authority to grant marketing authorisation for medicines in the 28 countries of the European Union (EU). Following a European Commission decision, authorisation can also be granted by national authorities in Norway and Iceland.

  • Move over aspirin, a new formulation of ibuprofen might prove to be a "wonder drug." In a research report published online in The FASEB Journal, scientists used mice and rats to show that ibuprofen arginate may allow people to take higher doses without the cardiovascular side effects that are associated with current formulations found in over the counter products. In addition to being better tolerated, ibuprofen arginate also is released into the bloodstream more rapidly than the current formulations, likely providing faster pain relief.

  • High cholesterol might harm more than our cardiovascular systems. New research using animal models, published online in The FASEB Journal, suggests that high cholesterol levels trigger mitochondrial oxidative stress on cartilage cells, causing them to die, and ultimately leading to the development of osteoarthritis. This research tested the potential therapeutic role of mitochondria targeting antioxidants in high-cholesterol-induced osteoarthritis and provided proof-of-concept for the use of mitochondrial targeting antioxidants to treat osteoarthritis.

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  • Researchers at The University of Texas at Dallas are sweating the small stuff in their efforts to develop a wearable device that can monitor an individual's glucose level via perspiration on the skin.

  • The US Food and Drug Administration (FDA) has accepted for filing Allergan's supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam), seeking the addition of new phase 3 clinical trial data evaluating Avycaz in patients with complicated urinary tract infections (cUTI), including pyelonephritis, due to designated susceptible pathogens to the current product label.

  • SkylineDx,a commercial-stage biotech company, has received a notice of allowance for a Japanese patent related to its prognostic SKY92 gene signature for multiple myeloma. The announcement comes as SkylineDx prepares to attend the 78th Annual Meeting of the Japanese Society of Hematology (JSH2016) in Pacifico Yokohama, October 13 -15, 2016.

  • Viamet Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to VT-1161, a novel oral agent for the treatment of recurrent vulvovaginal candidiasis (RVVC), or recurrent vaginal yeast infection, a common and difficult to treat condition in women. There are no approved therapies in the United States for RVVC.

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