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Hemlibra (emicizumab-kxwh) / RocheNew data from phase IIIb study reinforces safety profile of Roche’s Hemlibra in people with haemophilia A (Roche Press Release) - Jul 13, 2020 - P3b, N=195; STASEY (NCT03191799); Sponsor: Hoffmann-La Roche; "Roche...today announced results from the second interim analysis of the phase IIIb STASEY study, which reinforce the safety profile of Hemlibra® (emicizumab)...Further new interim data suggest that people on Hemlibra may be able to undergo certain minor surgeries without additional preventative (prophylactic) coagulation factor. These data were presented at the International Society on Thrombosis and Hemostasis (ISTH) 2020 Virtual Congress, 12-14 July 2020....A separate analysis described management and outcomes of minor and unplanned major surgeries in patients...suggest people with haemophilia A with factor VIII inhibitors who undergo certain minor surgeries whilst receiving Hemlibra may not need additional preventative coagulation factor."2X-121 / Oncology Venture; glutathione PEGylated liposomal doxorubicin (2X-111) / Oncology VenturePress release Oncology Venture acquires full ownership of its PARP inhibitor (2X-121) program (GlobeNewswire) - Jul 13, 2020 - "Oncology Venture...announced...that it has secured the remaining ownership in its priority PARP inhibitor (2X-121) program along with its 2X-111 program, by acquiring all outstanding shares in Oncology Venture US Inc. (formerly 2X Oncology, Inc.) from its external shareholders and warrantholders. As a result of the transaction, the Company now has 100 % ownership of 2X-121, which is being clinically developed as an anti-cancer therapeutic..."bupropion/dextromethorphan (AXS-05) / Axsome Therap[/13/2061104/0/en/Axsome-Therapeutics-Completes-Successful-FDA-Pre-NDA-Meeting-for-AXS-05-for-the-Treatment-of-Major-Depressive-Disorder.html]Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-05 for the Treatment of Major Depressive Disorder (GlobeNewswire) - Jul 13, 2020 - "Axsome Therapeutics, Inc....today announced that it has completed a successful pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for AXS-05 for the treatment of major depressive disorder (MDD)....The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company’s planned NDA submission including the clinical and nonclinical requirements....Company believes its regulatory data package will be sufficient to support an NDA for AXS-05 in MDD, and Axsome remains on track to submit the planned NDA in the fourth quarter of 2020."BNT162c2 / BioNTech, Fosun Pharma, Pfizer; BNT162b1 / Fosun Pharma, BioNTech, Pfizer; BNT162b2 / Pfizer, Fosun Pharma, BioNTech; BNT162a1 / Pfizer, BioNTechPFIZER AND BIONTECH GRANTED FDA FAST TRACK DESIGNATION FOR TWO INVESTIGATIONAL MRNA-BASED VACCINE CANDIDATES AGAINST SARS-COV-2 (Pfizer Press Release) - Jul 13, 2020 - "Pfizer Inc. (NYSE: PFE) and BioNTech...today announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program...received Fast Track designation from the U.S. Food and Drug Administration (FDA)....The Project Lightspeed vaccine development program is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities....Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial as soon as later this month and are anticipating enrolling up to 30,000 subjects"Avastin (bevacizumab) / Roche; paclitaxel / Generic mfg.; carboplatin / Generic mfg.; Tecentriq (atezolizumab) / RocheRoche provides update on Phase III study of Tecentriq in women with advanced stage ovarian cancer (Roche Press Release) - Jul 13, 2020 - P3, N=1300; IMagyn050 (NCT03038100); Sponsor: Hoffmann-La Roche; "Roche...today announced that the Phase III IMagyn050 study showed that the addition of Tecentriq® (atezolizumab) to Avastin® (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival (PFS) for the front-line treatment of women with newly diagnosed advanced stage ovarian cancer....Data for the overall survival (OS) co-primary endpoint are currently immature and follow-up will continue until the next planned analysis. Results from IMagyn050 will be further evaluated in order to inform the Tecentriq gynaecologic development programme..."
