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abiraterone (DST-2970) / DisperSol Tech; Lynparza (olaparib) / Merck (MSD), AstraZenecaLynparza recommended for approval in the EU by CHMP for BRCA-mutated metastatic castration-resistant prostate cancer (AstraZeneca Press Release) - Sep 21, 2020 - "AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations...based its positive opinion on a subgroup analysis of patients with BRCA1/2 mutations from the PROfound Phase III trial....AstraZeneca and MSD are exploring additional trials in metastatic prostate cancer including the ongoing PROpel Phase III trial...in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021."Mononine (human plasma derived coagulation factor IX) / CSL BehringMononine Soon Will No Longer Be Available to Treat Hemophilia B (Hemophilia News Today) - Sep 21, 2020 - "Mononine, a long-standing treatment to prevent and control bleeding in hemophilia B, will be discontinued due to declining demand in recent years. CSL Behring, the therapy’s manufacturer, said the decision was based on the emergence of next-generation hemophilia B treatments now in greater use....'Accordingly, we are discontinuing MONONINE....The medication is expected be available through mid-2021, based on current supply, giving patients time to move to another therapy."AB201 / ARCA BiopharmaARCA biopharma Announces Submission of IND Application to U.S. FDA for AB201 as a Potential Treatment for COVID-19 (GlobeNewswire) - Sep 21, 2020 - "ARCA biopharma, Inc....today announced it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of patients hospitalized with COVID-19. Pending FDA feedback, ARCA anticipates initiating the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 as early as the fourth quarter of this year."Avastin (bevacizumab) / Roche; Lynparza (olaparib) / Merck (MSD), AstraZenecaLYNPARZA (olaparib) Recommended for Approval in EU by CHMP as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer (Businesswire) - Sep 21, 2020 - “AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending LYNPARZA for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a BRCA1/2 mutation and/or genomic instability. The positive opinion was based on a biomarker subgroup analysis of the Phase 3 PAOLA-1 trial…”ArmonAir Digihaler (fluticasone propionate) / Teva; AirDuo Digihaler (salmeterol/fluticasone proprionate) / TevaTeva Launches Two Digital Inhalers in the U.S., AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder and ArmonAir Digihaler (fluticasone propionate) Inhalation Powder (Businesswire) - Sep 21, 2020 - "Teva... today announced the launch of AirDuo® Digihaler® (fluticasone propionate and salmeterol) inhalation powder and ArmonAir® Digihaler® (fluticasone propionate) inhalation powder, two digital maintenance inhalers for patients with asthma. AirDuo® Digihaler® is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older. ArmonAir® Digihaler® is a prescription medicine for the long-term treatment of asthma in patients 12 years and older. "
