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BIOPHARMA INDUSTRY UPDATES | MARCH 2021

Biomarkers

Protein implicated in the progression of cardiac disease is a novel biomarker associated with inflammatory status and disease severity in patients with COVID-19

Vertebrate homolog of lin-4 is reported as a novel diagnostic biomarker for cervical cancer, whose expression is significantly lower in cervical cancer patients than those in the healthy controls

Member of the WAP family and encoded by WFDC2 gene is reported as a novel inflammatory biomarker correlated with overall disease severity and the degree of pulmonary dysfunction in patients with cystic fibrosis

Novel biomarker for the diagnosis and monitoring of myasthenia gravis

Bifunctional enzyme with methylene dehydrogenase and cyclohydrolase activity is reported as a novel biomarker for predicting prognosis and pathological stages in patients with esophageal carcinoma

Diagnostics (510K)

Roche Molecular Systems, Inc.

Siemens Healthcare Diagnostics Products Ltd.

DiaSorin Inc.

Euroimmun US, Inc.

Fujirebio Diagnostics, Inc.

Clinical Practice Guidelines

Guidelines on the diagnosis and treatment by European Society for Medical Oncology (ESMO)

Guidelines by the European Head and Neck Society (EHNS), European Society for Medical Oncology (ESMO), and European Society for Radiotherapy and Oncology (ESTRO)

Guidelines on the diagnosis and treatment by the European Association of Neuro-Oncology (EANO)

Guidelines on the diagnosis and management by National Comprehensive Cancer Network (NCCN)

Guidelines for the management by American College of Cardiology (ACC) and American Heart Association (AHA)

Drugs

Tepotinib for Non-Small Cell Lung Cancer; EMD Serono; FDA

Voclosporin for Lupus Nephritis; Aurinia Pharmaceuticals Inc.; FDA

Cabotegravir for HIV Infection; ViiV Healthcare; FDA

Myovant Sciences; FDA

BioCryst Pharmaceuticals, Inc.; FDA