Daily Top News – September 15, 2020

September 15, 2020

Ajovy (fremanezumab) / Otsuka, Teva
First Long-Term Data on the use of AJOVY (fremanezumab-vfrm) Injection in Patients with Migraine Published in Neurology (Teva Press Release) – Sep 15, 2020 – P3, N=1,890; HALO (NCT02638103); Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; “No clinically significant patterns of AEs or serious AEs were seen in the current study. No treatment-emergent, clinically significant laboratory findings were observed….In patients with CM or EM, the monthly number of migraine days decreased from baseline to month 12 (CM quarterly, –7.2 days; CM monthly, – 8.0 days; EM quarterly, –5.2 days; EM monthly, –5.1 days). Reductions in monthly number of headache days of at least moderate severity from baseline to month 12 were observed.”


mavrilimumab (KPL-301) / Kiniksa; Arcalyst (rilonacept) / Regeneron, Kiniksa
Kiniksa Announces U.S. Orphan Drug Designation for Mavrilimumab for the Treatment of Giant Cell Arteritis (GlobeNewswire) – Sep 15, 2020 – “Kiniksa Pharmaceuticals, Ltd….today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to mavrilimumab for the treatment of giant cell arteritis (GCA)….There will be a live webcast of Kiniksa’s presentation at the Morgan Stanley 18th Annual Global Healthcare Conference on Wednesday, September 16th at 2:00 p.m. Eastern Daylight Time. The company will provide an update on key activities relating to rilonacept, mavrilimumab…”


magrolimab (Hu5F9-G4) / Ono Pharma, Gilead
Gilead’s Magrolimab, an Investigational Anti-CD47 Monoclonal Antibody, Receives FDA Breakthrough Therapy Designation for Treatment of Myelodysplastic Syndrome (Businesswire) – Sep 15, 2020 – “Gilead Sciences, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS)…The FDA granted Breakthrough Therapy designation for magrolimab based on positive results of an ongoing Phase 1b study…”


Yervoy (ipilimumab) / Ono Pharma, BMS; Opdivo (nivolumab) / Ono Pharma, BMS
European Medicines Agency Validates Bristol Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma (Businesswire) – Sep 15, 2020 – “Bristol Myers Squibb…announced that the European Medicines Agency (EMA) validated a type II variation application for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the treatment of patients with previously untreated, unresectable malignant pleural mesothelioma (MPM). Validation of the application confirms the submission is complete and begins the EMA’s centralized review process…The type II variation application is supported by data from the pivotal Phase 3 CheckMate -743 trial…”

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