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BIOPHARMA INDUSTRY UPDATES | JULY 2021

Biomarkers

Apelin-13, a 13 amino acid oligopeptide which is the ligand for the
apelin receptor is reported as a diagnostic biomarker whose levels are
higher in both dry-type age-related macular degeneration (AMD) patients
and neovascular AMD patients compared to the control group.

Transfer RNA-derived fragment tRF-28-QSZ34KRQ590K in plasma exosomes is reported as a potential diagnostic biomarker in pediatric patients with atopic dermatitis.

Spliceosome-associated protein 130, a novel danger-associated molecular pattern is reported as a novel noninvasive biomarker that correlates with disease severity in patients with idiopathic pulmonary fibrosis.

Neuron-specific enolase (NSE), a cell specific isoenzyme of the glycolytic enzyme enolase is reported as a biomarker that correlates with extent of disease and distinguishes responders from non-responders during immunotherapy in patients with Merkel cell carcinoma.

Krebs von den Lungen-6 (KL-6), a type of transmembrane mucoprotein is reported as a novel prognostic biomarker in COVID-19 patients with severe pulmonary involvement.

Diagnostics (510K)

Horiba ABX SAS

Ventana Medical Systems, Inc.

Roche Diagnostics

Roche Diagnostics

Guardant Health, Inc.

Clinical Practice Guidelines

Guidelines on the emergency management of Inflammatory bowel disease from the World Society of Emergency Surgery/The American Association for the Surgery of Trauma (WSES/AAST)

Guidelines on the management of actinic keratosis from the American Academy of Dermatology (AAD)

Guidelines on the management of thymic epithelial tumors from the Oncological Group for the Study of Lung Cancer/Spanish Society of Radiation Oncology (OECP/SEOR)

Guidelines for the diagnosis of asthma in children aged 5–16 years from the European Respiratory Society (ERS)

Guidelines for management of patients with anaplastic thyroid cancer from the American Thyroid Association (ATA)

Drugs

Aducanumab for Alzheimer’s disease; Biogen; FDA

Sotorasib for Non-small cell lung cancer; Amgen Inc.; FDA

Infigratinib for Cholangiocarcinoma; BridgeBio Pharma, Inc.; FDA

Pegcetacoplan for Paroxysmal nocturnal hemoglobinuria; Apellis Pharmaceuticals, Inc.; FDA