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  • The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Novartis' Cosentyx (secukinumab) in Europe to treat ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients. Cosentyx is the first of a new class of medicines called interleukin-17A (IL-17A) inhibitors to be recommended for AS and PsA - conditions that affect around five million people in Europe.

  • U.S. Food and Drug Administration approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.

  • Ambry Genetics (Ambry), a leader in clinical genetic diagnostics and genetics software solutions, announced that it is launching a new suite of seven genetic testing panels for epilepsy.
    Tests can be ordered from November 6 with the first samples expected to be tested on November 9.

  • In consultation with the U.S. Food and Drug Administration (FDA), the U.S. Product Inserts (USPI) for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) have been updated from 'not recommended in Child Pugh B patients' to a contraindication in patients with Child-Pugh B cirrhosis. The updated USPI for VIEKIRA PAK also includes a recommendation for physicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients.

  • Allergan plc, a leading global pharmaceutical company, announced the launch of the over-the-counter artificial tear Refresh Optive gel drops, a new aqueous gel expertly designed for patients to relieve their dry eye symptoms. New Refresh Optive Gel Drops are formulated with Glycerin and a unique blend of the active ingredient CMC which binds to the eye surface to provide long-lasting relief from dry eye discomfort.

  • US Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 4 to recommend the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). All 10 who backed the drug, lesinurad, qualified their vote by urging the FDA to ask AstraZeneca for studies after the drug's launch to gauge its long-term effectiveness and safety.

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