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July 26, 2021

Biopharma Industry Updates | July 2021


  • Apelin-13
    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.
  • tRF-28-QSZ34KRQ590K
    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
    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)
    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)
    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)

Clinical Practice Guidelines

  • Inflammatory Bowel Disease
    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)
  • Actinic Keratosis
    Guidelines on the management of actinic keratosis from the American Academy of Dermatology (AAD)
  • Thymic Epithelial Tumor
    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)
  • Asthma
    Guidelines for the diagnosis of asthma in children aged 5–16 years from the European Respiratory Society (ERS)
  • Anaplastic Thyroid Cancer
    Guidelines for management of patients with anaplastic thyroid cancer from the American Thyroid Association (ATA)


  • Aducanumab
    Aducanumab for Alzheimer’s disease; Biogen; FDA
  • Sotorasib
    Sotorasib for Non-small cell lung cancer; Amgen Inc.; FDA
  • Ibrexafungerp
    Ibrexafungerp for Vulvovaginal candidiasis; Scynexis, Inc.; FDA
  • Infigratinib
    Infigratinib for Cholangiocarcinoma; BridgeBio Pharma, Inc.; FDA
  • Pegcetacoplan
    Pegcetacoplan for Paroxysmal nocturnal hemoglobinuria; Apellis Pharmaceuticals, Inc.; FDA

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