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Zercepac (trastuzumab biosimilar) / Fosun Pharma, IntasAccord Healthcare Launches Zercepac (trastuzumab) biosimilar in the UK (PRNewswire) - Sep 24, 2020 - "Accord Healthcare (Accord) today announced the launch of Zercepac® (trastuzumab) as a biosimilar of the reference product Herceptin®, in the UK, following approval by the European Commission in July 2020....Zercepac is indicated for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer...will be available in a 150mg single-dose vial."DKN-01 / Eli Lilly, Leap TherapLeap Therapeutics Announces FDA Fast Track Designation Granted to DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer (PRNewswire) - Sep 24, 2020 - “Leap Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express high Dickkopf-1 protein (DKK1), following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.”Orkambi (lumacaftor/ivacaftor) / Vertex; Trikafta (elexacaftor/tezacaftor/ivacaftor) / Vertex; Kalydeco (ivacaftor) / VertexVertex to Present New Data at European and North American Virtual Cystic Fibrosis Conferences Highlighting Long-Term Use of CFTR Modulators (Businesswire) - Sep 24, 2020 - "An oral presentation at the ECFS Digital Conference will highlight, for the first time, interim results from the TRIKAFTA open-label extension study, which showed safety and efficacy consistent with the results of the Phase 3 pivotal studies in patients with CF ages 12 and older...Four additional scientific abstracts for ORKAMBI® and TRIKAFTA® were published in the Journal of Cystic Fibrosis as part of the ECFS conference. In addition, six scientific presentations will occur at NACFC regarding KALYDECO,® ORKAMBI and TRIKAFTA, including new data from KALYDECO in infants ages 4 to less than 6 months old."meloxicam/rizatriptan (AXS-07) / Axsome TherapAxsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Demonstrating Rapid Onset of Action and Reduced Symptom Recurrence in the Acute Treatment of Migraine (GlobeNewswire) - Sep 24, 2020 - P3, N=1,594; MOMENTUM (NCT03896009); Sponsor: Axsome Therapeutics, Inc.; "Axsome Therapeutics, Inc....today announced that AXS-07...rapidly relieved and substantially reduced relapse of migraine pain, as compared to the potent active comparator rizatriptan, in the MOMENTUM Phase 3 trial. These findings were presented at the live sessions of the 2020 American Academy of Neurology (AAN) Science Highlights platform held virtually September 23-24....AXS-07 demonstrated faster and more durable relief of migraine pain as compared to rizatriptan. The probability of achieving pain relief with AXS-07 was greater than with rizatriptan within 30 minutes after dosing and at every time point thereafter, with a median time to migraine pain relief that was nearly 3x faster for AXS-07 compared to rizatriptan (1.5 vs. 4.0 hours, p
