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4 days ago
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Tristan Manalac, 18 Nov 2020
The substitution of isoleucine to leucine at amino acid 97 (I97L) in the core region of the hepatitis B virus (HBV) seems to reduce its potency, decreasing the efficiency of both infection and the synthesis of the virus’ covalently closed circular (ccc) DNA, reports a new study presented at The Liver Meeting Digital Experience by the American Association for the Study of Liver Diseases (AASLD 2020).

Original New Drug Application Approvals by US FDA (01 - 15 June 2019)

15 Jun 2019
New drug applications approved by US FDA as of 01 - 15 June 2019 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

NUCALA
  • Active Ingredient(s): Mepolizumab
  • Strength: 100 mg/mL
  • Dosage Form(s) / Route(s): Injectable; subcutaneous
  • Company: GlaxoSmithKline
  • Approval Date: 06 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
    • The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 
  • Approved Label06 June 2019 (PDF)

POLIVY
  • Active Ingredient(s): Polatuzumab vedotin-piiq
  • Strength: 140 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Genentech
  • Approval Date: 10 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. 
  • Approved Label10 June 2019 (PDF)

KANJINTI
  • Active Ingredient(s): Trastuzumab-anns
  • Strength: 420 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Amgen, Inc.
  • Approval Date: 13 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • The treatment of HER2 overexpressing breast cancer.
    • The treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Approved Label13 June 2019 (PDF)
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Most Read Articles
4 days ago
Ivermectin confers benefits in the treatment of COVID-19, with a recent study showing that its use helps reduce the risk of death especially in patients with severe pulmonary involvement.
3 days ago
Mental health comorbidities are common among patients with type 2 diabetes mellitus and may lead to worse outcomes, a recent study has found.
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

Tristan Manalac, 18 Nov 2020
The substitution of isoleucine to leucine at amino acid 97 (I97L) in the core region of the hepatitis B virus (HBV) seems to reduce its potency, decreasing the efficiency of both infection and the synthesis of the virus’ covalently closed circular (ccc) DNA, reports a new study presented at The Liver Meeting Digital Experience by the American Association for the Study of Liver Diseases (AASLD 2020).