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llllllllll imatinib / Generic mfg.; Qinlock (ripretinib) / DecipheraZai Lab Announces NDA for Ripretinib Granted Priority Review by China’s NMPA (GlobeNewswire) - Aug 4, 2020 - "Zai Lab Limited...announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for ripretinib for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib."llllllllll Avelas Announces Top-Line Data Showing Pegloprastide (AVB-620) Can Significantly Improve Cancer Detection in Real Time During Breast Cancer Surgery (Businesswire) - Aug 4, 2020 - P2/3, N=92; NCT03113825; Sponsor: Avelas Biosciences, Inc; "Avelas Biosciences, Inc...announced...positive top-line data demonstrating that the company’s recently completed Phase 2/3 registration study of the use of pegloprastide (AVB-620) during surgery met its primary endpoint of detecting cancer in margin specimens in real time (pKymriah (tisagenlecleucel-T) / NovartisNovartis announces Kymriah meets primary endpoint at interim analysis of pivotal study in follicular lymphoma (GlobeNewswire) - Aug 4, 2020 - P2, N=97; ELARA (NCT03568461); Sponsor: Novartis Pharmaceuticals; "ELARA trial findings will be included in regulatory submissions, with filing in the US anticipated in 2021, and the EU following....Novartis today announced positive results from the Phase II ELARA trial of Kymriah® (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL). At the interim analysis, the global study met its primary endpoint of complete response rate (CRR), as assessed by independent review committee."llllllllll ELX-02 / Eloxx PharmaEloxx Pharmaceuticals Receives U.S. Orphan Drug Designation for ELX-02 for the Treatment of Cystic Fibrosis (GlobeNewswire) - Aug 4, 2020 - "Eloxx Pharmaceuticals...today announced that the U.S. Food and Drug Administration (FDA) has granted the Company orphan drug designation for ELX-02 for the treatment of Cystic Fibrosis...in our Phase 2...We look forward to reporting top line results as soon as feasible, and believe that this will be a major value inflection point for our Company."llllllllll Darzalex Faspro (daratumumab/hyaluronidase) / J&JJanssen Announces Health Canada Approval of DARZALEX SC, a New Subcutaneous Formulation for the Treatment of Patients with Multiple Myeloma (Canada Newswire) - Aug 4, 2020 - "The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved DARZALEX® SC (daratumumab), a new subcutaneous formulation of daratumumab.1 DARZALEX® SC is approved in four regimens across five indications in patients with multiple myeloma, most notably newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients…The approval is based on data from the Phase 3 COLUMBA and Phase 2 PLEIADES studies."
