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llllllllll Opdivo (nivolumab) / Ono Pharma, BMSHealth Canada Approves OPDIVO (nivolumab) plus YERVOY (ipilimumab) Combined with Limited Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer (Canada Newswire) - Aug 11, 2020 - "Today, Bristol Myers Squibb Canada (BMS) announces Health Canada's approval of OPDIVO (nivolumab) in combination with YERVOY (ipilimumab) with two cycles of platinum-double chemotherapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC), with no Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) tumour aberrations and no prior systemic therapy for metastatic NSCLC...The Health Canada approval was based on results from the randomised phase III clinical trial CheckMate -9LA."llllllllll emtricitabine/tenofovir disoproxil fumarate / Generic mfg.China National Medical Products Administration Approves Truvada for HIV Pre-Exposure Prophylaxis (PrEP) (Businesswire) - Aug 11, 2020 - "Gilead Sciences, Inc....today announced that the China National Medical Products Administration (NMPA) has approved a pre-exposure prophylaxis indication for Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg,FTC/TDF). In China, Truvada for PrEP® is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg....Truvada is the first medicine approved for HIV prevention in China....The approval of Truvada for PrEP was supported by data from two randomized, double-blind, placebo-controlled trials known as the Pre-Exposure Prophylaxis Initiative (iPrEx) and Partners PrEP."llllllllll NiCord (omidubicel) / Gamida CellGamida Cell Reports Second Quarter 2020 Financial Results and Provides Company Update (Businesswire) - Aug 11, 2020 - "Next month, Gamida Cell will report initial data from an observational study that includes data contemporaneous to the Phase 3 study of omidubicel; Gamida Cell today announced that it has initiated an open-label, single-arm study to provide access to omidubicel for patients with high-risk hematologic malignancies; Gamida Cell expects to present the full data set, including secondary endpoint data, at a medical meeting in the fourth quarter of 2020. The company also expects to begin submitting the biologics license application for omidubicel to the FDA on a rolling basis in the fourth quarter of 2020."llllllllll XMT-1536 / Mersana, AdimabMersana Therapeutics Receives FDA Fast Track Designation for XMT-1536 for the Treatment of Patients with Platinum-resistant Ovarian Cancer (GlobeNewswire) - Aug 11, 2020 - "Mersana Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for XMT-1536, for the treatment of patients with platinum-resistant high-grade serous ovarian cancer who have received up to three prior lines of systemic therapy or patients who have received four prior lines of systemic therapy regardless of platinum status."llllllllll Pedmark (sodium thiosulfate) / Fennec PharmaFennec Pharmaceuticals receives complete response letter from the FDA for its New Drug Application for Pedmark to prevent ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic, solid tumors (GlobeNewswire) - Aug 11, 2020 - "Fennec Pharmaceuticals...announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for PEDMARK™ (a unique formulation of sodium thiosulfate), for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients ≥1 month to 18 years of age with localized, non-metastatic, solid tumors. According to the CRL, after recent completion of a pre-approval inspection of the manufacturing facility of our drug product manufacturer, the FDA identified deficiencies resulting in a Form 483, which is a list of conditions or practices that are required to be resolved prior to the approval of PEDMARK™."
