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[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZenecaTrastuzumab deruxtecan granted FDA Priority Review for treatment of patients with HER2-positive metastatic breast cancer (AstraZeneca Press Release) - Oct 16, 2019 - "AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) date for trastuzumab deruxtecan, a HER2-targeting antibody drug conjugate (ADC) and potential new medicine for the treatment of HER2-positive metastatic breast cancer, is set for the second quarter of 2020."Lynparza (olaparib) / Merck (MSD), AstraZeneca; Keytruda (pembrolizumab) / Merck (MSD)Olaparib Plus Pembrolizumab as Post-Induction Therapy in Triple Negative Breast Cancer Olaparib plusz pembrolizumab posztindukciós terápiaként tripla negatív emlőrákban (clinicaltrialsregister.eu) - Oct 17, 2019 - P2/3; N=317; Ongoing; Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,IncTecentriq (atezolizumab) / RocheTecentriq: Regulatory submissions in US/EU for neoadjuvant HER2+ breast cancer in 2022 or later (Roche) - Oct 16, 2019 - Q3 2019 Results: Regulatory submissions in US/EU in combination with capecitabine or carboplatin/gemicitabine for TNBC in 2022 or later [Screenshot]Piqray (alpelisib) / NovartisPiqray: Regulatory approval in EU for HR+/HER2- advanced breast cancer in 2020 (Novartis) - Oct 14, 2019 - Kisqali MONALEESA-3 ESMO Data Investor Call [Screenshot]Kisqali (ribociclib) / NovartisKisqali: “The P value of 0.00455 crossed the prespecified boundary to claim superior efficacy (P < 0.01129)”; Advanced breast cancer (Novartis) - Oct 14, 2019 - Kisqali MONALEESA-3 ESMO Data Investor Call [Screenshot]Zejula (niraparib) / GSK, J&J, TakedaClovis’ Rubraca approved for Cancer Drugs Fund (PharmaTimes) - Oct 14, 2019 - "NICE has also recently recommended niraparib as a treatment for this patient group and olaparib tablets for the BRCA-positive subgroup, both for use in the CDF."Keytruda (pembrolizumab) / Merck (MSD)Keytruda regulatory estimate: Approval for TNBC in 2020 (J.P. Morgan) - Oct 19, 2019 - A subscription to Thomson ONE is required to gain full access to report 68079155; Page no: 5; REPORT TITLE: "Merck & Co., Inc.: Does Keytruda concentration cap MRK's multiple? We see shares as cheap on sotp basis”; AUTHOR: Schott, Christopher, et al; DATE: 10/10/2019Perjeta (pertuzumab) / Roche; Tecentriq (atezolizumab) / Roche; Rozlytrek (entrectinib) / RocheRoche reports very strong sales growth in the first nine months of 2019 – outlook raised (GlobeNewswire) - Oct 16, 2019 - "Pharmaceuticals Division sales up 12%, driven by high demand for recently launched medicines, mainly Ocrevus, Hemlibra, Tecentriq and Perjeta...New treatment options and diagnostic test approved in the third quarter....in the US Rozlytrek for lung cancer with a specific gene mutation and solid tumours carrying a certain gene fusion; in the EU three new indications for Tecentriq: for a certain type of breast cancer; for the initial treatment of non-small cell as well as small cell lung cancer"Keytruda (pembrolizumab) / Merck (MSD); AE 37 / GenerexGenerex Biotechnology announces merger with public vehicle for public trading of NuGenerex Immuno-Oncology (GlobeNewswire) - Oct 15, 2019 - "Generex has positioned its wholly-owned cancer subsidiary NuGenerex Immuno-Oncology to be merged with the public company, thereby completing the company’s go-public strategy to realize the value of the Ii-Key technology and AE37 immunotherapeutic vaccine program. NGIO is currently enrolling a Phase II trial to establish the recommended biologic dose for AE37 Peptide Vaccine in combination with Keytruda® (Pembrolizumab) that will enhance the tumor-specific immune response and demonstrate efficacy in patients with advanced triple-negative breast cancer (NSABP FB-14); the trial is currently screening and enrolling patients at multiple clinical research sites."Opdivo (nivolumab) / Ono Pharma, BMS; Keytruda (pembrolizumab) / Merck (MSD)Uruguay to request inclusion of Opdivo, Keytruda into PAHO’s Strategic Fund (GBI Health) - Oct 14, 2019 - "According to Alicia Ferreira, head of Uruguay’s National Resources Fund (FNR), the country will call for the Pan American Health Organization (PAHO) to include Bristol-Myers Squibb (BMS)’s Opdivo (nivolumab) and Merck, Sharp & Dohme (MSD)’s Keytruda (pembrolizumab) into the Strategic Fund. The petition will be made at the next meeting of member countries, to which Janssen and MSD, the main manufacturers of Opdivo and Keytruda respectively, will be invited...The drugs, which have a monthly cost of about USD 13,000, will initially be used to treat melanoma, although their coverage will later be extended to include breast cancer and other tumors."
