Most Read Articles
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Dr. Hsu Li Yang, Dr. Tan Thuan Tong, Dr. Andrea Kwa, 08 Jan 2021
Antimicrobial resistance has become increasingly dire as the rapid emergence of drug resistance, especially gram-negative pathogens, has outpaced the development of new antibiotics. At a recent virtual symposium, Dr Hsu Li Yang, Vice Dean (Global Health) and Programme Leader (Infectious Diseases), NUS Saw Swee Hock School of Public Health, presented epidemiological data on multidrug-resistant (MDR) gram-negative bacteria (GNB) in Asia, while Dr Tan Thuan Tong, Head and Senior Consultant, Department of Infectious Diseases, Singapore General Hospital (SGH), focused on the role of ceftazidime-avibactam in MDR GNB infections. Dr Andrea Kwa, Assistant Director of Research, Department of Pharmacy, SGH, joined the panel in an interactive fireside chat, to discuss challenges, practical considerations, and solutions in MDR gram-negative infections. This Pfizer-sponsored symposium was chaired by Dr Ng Shin Yi, Head and Senior Consultant of Surgical Intensive Care, SGH.
Pearl Toh, 26 Nov 2020
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.
Yesterday
Daily intake of cow’s milk formula in early life helps prevent the development of cow’s milk allergy later on without competing with breastfeeding, a recent study has found.

Original New Drug Application Approvals by US FDA (16 - 31 December 2020)

05 Jan 2021
New drug applications approved by US FDA as of 16 - 31 December 2020 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.

MARGENZA
  • Active Ingredient(s): Margetuximab-CMKB
  • Strength: 250mg/10mL (25mg/mL)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Macrogenics, Inc.
  • Approval Date: 16 Dec 2020
  • Submission Classification: Not Available
  • Indication(s): Not Available
  • Approved Label: Not Available

RIABNI
  • Active Ingredient(s): Rituximab-ARRX
  • Strength: 100mg/10mL (10mg/mL)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Amgen, Inc.
  • Approval Date: 17 Dec 2020
  • Submission Classification: Not Available
  • Indication(s): Indicated for:
    • Adult patients with non-Hodgkin’s Lymphoma
    • Adult patients with Chronic Lymphocytic Leukemia (CLL)
    • Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids 
  • Approved Label: 17 Dec 2020 (PDF) 

ORGOVYX
  • Active Ingredient(s): Relugolix
  • Strength: 120 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Myovant Sciences
  • Approval Date: 18 Dec 2020 
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with advanced prostate cancer
  • Approved Label: 18 Dec 2020 (PDF)

GEMTESA
  • Active Ingredient(s): Vibegron
  • Strength: 75 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Urovant Sciences GMBH
  • Approval Date: 23 Dec 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults
  • Approved Label: 23 Dec 2020 (PDF)
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Most Read Articles
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Dr. Hsu Li Yang, Dr. Tan Thuan Tong, Dr. Andrea Kwa, 08 Jan 2021
Antimicrobial resistance has become increasingly dire as the rapid emergence of drug resistance, especially gram-negative pathogens, has outpaced the development of new antibiotics. At a recent virtual symposium, Dr Hsu Li Yang, Vice Dean (Global Health) and Programme Leader (Infectious Diseases), NUS Saw Swee Hock School of Public Health, presented epidemiological data on multidrug-resistant (MDR) gram-negative bacteria (GNB) in Asia, while Dr Tan Thuan Tong, Head and Senior Consultant, Department of Infectious Diseases, Singapore General Hospital (SGH), focused on the role of ceftazidime-avibactam in MDR GNB infections. Dr Andrea Kwa, Assistant Director of Research, Department of Pharmacy, SGH, joined the panel in an interactive fireside chat, to discuss challenges, practical considerations, and solutions in MDR gram-negative infections. This Pfizer-sponsored symposium was chaired by Dr Ng Shin Yi, Head and Senior Consultant of Surgical Intensive Care, SGH.
Pearl Toh, 26 Nov 2020
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.
Yesterday
Daily intake of cow’s milk formula in early life helps prevent the development of cow’s milk allergy later on without competing with breastfeeding, a recent study has found.