Daily Top News – June 11, 2020

June 11, 2020

tralokinumab (CAT 354) / LEO Pharma, AstraZeneca
LEO Pharma announces European Medicines Agency acceptance of Marketing Authorization Application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (Businesswire) – Jun 11, 2020 – “LEO Pharma A/S…today announced that the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for tralokinumab….The acceptance of this MAA marks the beginning of the formal review procedure for this potential new treatment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).”


Tecentriq (atezolizumab) / Roche; Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Exelixis announces initiation of CONTACT-01 phase 3 pivotal trial of cabozantinib in combination with atezolizumab in previously treated metastatic non-small cell lung cancer (Businesswire) – Jun 11, 2020 – “Exelixis, Inc…announced the initiation of CONTACT-01, a global phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with metastatic non-small cell lung cancer (NSCLC) who have been previously treated with an immune checkpoint inhibitor (ICI) and platinum-containing chemotherapy. Two additional phase 3 pivotal trials in metastatic castration-resistant prostate cancer (CRPC; CONTACT-02) and renal cell carcinoma (RCC; CONTACT-03) are planned as part of the clinical trial collaboration between Exelixis and Roche.”


mRNA-1273 / Moderna
Moderna advances late-stage development of its vaccine (mRNA-1273) against Covid-19 (Businesswire) – Jun 11, 2020 – “Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants enrolled in the U.S….The Company expects dosing in the Phase 3 study to begin in July….The first cohort of healthy adults ages 18-54 years (n=300) in the Phase 2 study of mRNA-1273 is fully enrolled….Funding from the Biomedical Advanced Research and Development Authority (BARDA)…partially supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273…”


berubicin (RTA 744) / CNS Pharma, WPD Pharma
CNS announces the FDA has granted Orphan Drug Designation for brain cancer drug berubicin (PRNewswire) – Jun 11, 2020 – “CNS Pharmaceuticals, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its lead product Berubicin for the treatment of malignant gliomas…We look forward to continuing to execute on our strategic plan and initiating a Phase II trial evaluating the effect of Berubicin on patients with glioblastoma later this year. ‘”


Nyvepria (pegfilgrastim-apgf) / Pfizer
FDA approves Pfizer’s oncology supportive care biosimilar, Nyvepria (pegfilgrastim-apgf) (Businesswire) – Jun 11, 2020 – “Pfizer…announced the United States (U.S.) Food and Drug Administration (FDA) has approved NYVEPRIA™ (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim). NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.”

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