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FarmaKology Newsletter - Issue #63
IDEAYA is a precision medicine oncology company developing targeted therapeutics and translational biomarkers to guide patient treatment. IDEAYA’s pipeline is directed to tumor cell and immune oncology targets approached using synthetic lethality and direct targeting of oncogenic pathways. Headquartered in South San Francisco, California, IDEAYA has assembled leading scientists, professionals and advisors with extensive knowledge and expertise in cancer biology, immunology, small molecule chemistry, biomarker discovery, and clinical development.
Novartis provides update on CAN-COVID trial in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS)
Novartis today announced new data from an interim analysis for the randomized, double-blind, placebo-controlled CAN-COVID trial evaluating the efficacy and safety of canakinumab in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome. The ongoing trial failed to meet its primary endpoint showing that treatment with canakinumab plus standard of care (SoC) did not demonstrate a significantly greater chance of survival for patients without the need for invasive mechanical ventilation, compared with placebo plus SoC up to Day 291. The trial did not meet its key secondary endpoint of reducing the COVID-19-related death rate during the 4-week period after treatment. The safety profiles of canakinumab plus SoC and placebo plus SoC were comparable.
PFIZER ANNOUNCES POSITIVE PHASE 3 STUDY RESULTS FOR XELJANZ ® (TOFACITINIB) IN ANKYLOSING SPONDYLITIS (AS)
Pfizer Inc. announced today positive results from a Phase 3 investigational study evaluating the safety and efficacy of tofacitinib in adults with active ankylosing spondylitis (AS). Tofacitinib is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of AS.The study met its primary and key secondary endpoint of Assessment in SpondyloArthritis International Society 20 and 40 response, respectively, compared to placebo at week 16.The AS study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that included 270 adult patients with active AS. The study evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo.
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with Two Cycles of Chemotherapy for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer
Bristol Myers Squibb today announced that the European Commission has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The combination of Opdivo plus Yervoy with two cycles of chemotherapy is the first dual immunotherapy-based treatment option approved for patients in the European Union (EU) with this disease.
Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With Cystic Fibrosis as Early as Four Months of Age
Vertex Pharmaceuticals Incorporated today announced that the European Commission has granted approval of the label extension for KALYDECO® (ivacaftor) granules to include the treatment of infants with cystic fibrosis ages 4 months and older and weighing at least 5 kg who have the R117H mutation or one of the following gating (class III) mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
Research & Study
Listen to 121 - But Wait, There’s More! Unusual Warfarin Interactions and 134 more episodes by HelixTalk - Rosalind Franklin University's College Of Pharmacy Podcast, free! No signup or install needed. 121 - But Wait, There’s More! Unusual Warfarin Interactions. 120 - When it Rains it Pours: A Succinct Clinical Review of Hyponatremia due to SIADH.