Daily Top News – July 7, 2020

July 7, 2020

Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Novartis receives EC approval for Enerzair Breezhaler, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU (GlobeNewswire) – Jul 7, 2020 – “European Commission approves once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS1….Approval based on robust efficacy and safety data from the Phase III IRIDIUM study, in which once-daily Enerzair Breezhaler was superior to once-daily Atectura® Breezhaler® (IND/MF) in improving the lung function of patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment.”


decitabine/cedazuridine (ASTX727) / Otsuka
FDA Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home (PRNewswire) – Jul 7, 2020 – “Today, the U.S. Food and Drug Administration approved Inqovi (decitabine and cedazuridine) tablets for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). This represents an important advance in treatment options for patients with MDS, a type of blood cancer, who previously needed to visit a health care facility to receive intravenous therapy….The approval was based on clinical trial results which showed similar drug concentrations between intravenous decitabine and Inqovi. Additionally, about half of the patients who were formerly dependent on transfusions were able to no longer require transfusions during an 8-week period. The safety profile of Inqovi was also similar to intravenous decitabine.”


Bineuta (benegrastim) / Yifan Pharma
Evive Biotech meets primary and secondary endpoints in global Phase III clinical trial for their novel chemotherapy-induced neutropenia treatment (PRNewswire) – Jul 7, 2020 – P3, N=393; NCT03252431; Sponsor: Generon (Shanghai) Corporation Ltd; “Evive Biotech…is delighted to announce that its pivotal Phase III study (NCT03252431) for F-627 (efbemalenograstim alpha) to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients has met its primary and secondary endpoints, demonstrating strong and lasting benefit….This trial was conducted under a Special Protocol Assessment (SPA) in agreement with the Food and Drug Administration (FDA) of the United States Federal Government and will be submitted as part of the Biologic License Application (BLA) filing to the FDA, and the Market Authorization Application (MAA) filing to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).”


silmitasertib (CX-4945) / Senhwa Biosci, University of California
Senhwa Biosciences’s Silmitasertib Receives Rare Pediatric Disease Designation from U.S. FDA for Treatment of Recurrent Sonic Hedgehog Medulloblastoma (PRNewswire) – Jul 7, 2020 – “Senhwa Biosciences, Inc….announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for its drug Silmitasertib, a Casein Kinase 2 (CK2) inhibitor, being developed as a treatment for recurrent sonic hedgehog (SHH) medulloblastoma.”


Posiphen (R-phenserine) / Annovis Bio
Annovis Bio Receives Institutional Review Board Approval to Initiate 15 Site Phase 2 Study in 68 Parkinson’s and Alzheimer’s Patients (GlobeNewswire) – Jul 7, 2020 – “Annovis Bio Inc….reported that it has received Central Institutional Review Board (IRB) approval to begin its Phase 2 clinical study in early PD and early AD patients at 15 sites across the US….The two-part study is designed to treat a combined total of 68 PD and AD patients for 4 weeks with Annovis’ lead compound, ANVS401. The study compares in both patient populations how nerve cells die by measuring all the steps…and how ANVS401 might reverse the toxic cascade and recover normal brain function….’We believe we remain on track to complete the study by the first quarter of 2021.'”

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