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  • Addex Therapeutics announced that the company will conduct a phase IIa Proof of Concept Study of dipraglurant in focal cervical dystonia (CD). Addex expects to initiate the trial in the fourth quarter of 2016. The study was developed with support from the Dystonia Medical Research Foundation and in collaboration with investigators from the Dystonia Coalition, an international network of experts devoted to advancing research in dystonia. Buz Jinnah, Director of the Dystonia Coalition and Professor of Neurology at Emory University, will serve as the lead investigator.

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  • 19 October 2016
    Pfizer Announces The U.S. Availability Of Biosimilar INFLECTRA

    INFLECTRA will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be available in the U.S. It is approved for the treatment of:
    -adult patients and pediatric patients (ages six years and older) with moderate to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
    -adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to conventional therapy; and
    -moderate to severely active rheumatoid arthritis in combination with methotrexate; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis.

  • Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) approved TECENTRIQ® (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. This approval is based on results from the randomized Phase III OAK and Phase II POPLAR studies. The largest study, OAK, showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.74, 95% CI: 0.63, 0.87). The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.

  • Vedanta Biosciences, pioneering the development of a novel class of therapies for immune and infectious diseases based on rationally designed consortia of bacteria derived from the human microbiome, announced that the European Patent Office (EPO) has issued European Patent EP2575835. The patent broadly covers pharmaceutical compositions of Clostridium live bacterial strains and further expands Vedanta Biosciences’ patent portfolio after the issuances of three U.S. patents in the previous months and earlier issuances in Japan. The patents are exclusively licensed to Vedanta Biosciences under an agreement with the University of Tokyo and provide coverage through at least 2031.

  • AiMeD, the apex body of Indian medical device manufacturers, has urged the Ministry of Health and Family Welfare for speedy implementation of the decision taken three months ago by the Prime Minister’s Office to initiate wide ranging regulatory reforms for medical device sector in order to boost domestic manufacturing and investment in the sector as well as to ensure enhanced healthcare security for common Indian citizens.

  • 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.

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