News & Updates

Original New Drug Application Approvals by US FDA (01 - 15 October 2022)

15 Oct 2022

New drug applications approved by US FDA as of 01 - 15 October 2022 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.

Original New Drug Application Approvals by US FDA (01 - 15 October 2022)

15 Oct 2022

Pre-DAA IL-1β can predict HBV reactivation in HCV

14 Oct 2022

Among hepatitis C virus (HCV) patients with resolved hepatitis B virus (HBV) infections, levels of interleukin (IL)-1β before the initiation of direct-acting antiviral (DAA) treatment may help predict HBV reactivation, reports a recent study.

Pre-DAA IL-1β can predict HBV reactivation in HCV

14 Oct 2022

Kidney transplant recipients see lower IgG production after COVID-19 jab

14 Oct 2022 by

Vaccination against COVID-19 seems to be less effective among kidney transplant recipients, according to a recent study. Cessation or reduction of immunosuppressive treatments may help increase the production of immunoglobulin (Ig)G in these patients.

Kidney transplant recipients see lower IgG production after COVID-19 jab

14 Oct 2022

AZD7442 (tixagevimab–cilgavimab) prevents COVID-19 in high-risk populations

12 Oct 2022 by

Though most COVID-19 safe management measures have been lifted in Singapore, the pandemic continues to adversely impact the lives of immunocompromised patients at high risk of severe infection.

“It has been an absolute misery for these patients and their families,” said Dr Leong Hoe Nam, Infectious Disease Specialist at Mount Elizabeth Novena Hospital, Singapore. “The virus is an unseen enemy that may strike unexpectedly. The strike may kill, or if not, maim the individual. Patients isolate themselves for fear of getting infected while their family members fear bringing the illness back home.”

Immunocompromised patients are those with suppressed immunity resulting from health conditions, including solid organ and haematological cancers, end-stage kidney and liver disease, organ or bone marrow transplants, and immune-mediated inflammatory diseases such as rheumatoid arthritis, or those on active treatment with immunosuppressive medications. [Expert Rev Vaccines 2022;1-17; BMJ 2021;374:n2098]

AZD7442 (tixagevimab–cilgavimab) prevents COVID-19 in high-risk populations

12 Oct 2022

Metformin, ivermectin, fluvoxamine OUT for severe COVID-19 prevention?

11 Oct 2022 by

The use of metformin, fluvoxamine, or ivermectin in an outpatient setting did not appear to prevent progression to severe COVID-19, according to results of the phase III COVID-OUT trial.

Metformin, ivermectin, fluvoxamine OUT for severe COVID-19 prevention?

11 Oct 2022

Cefepime/enmetazobactam effective for suspected gram-negative complicated UTI

11 Oct 2022 by

Patients with complicated urinary tract infection (UTI) or acute pyelonephritis caused by gram-negative pathogens may fare better with cefepime/enmetazobactam than with piperacillin/tazobactam, as the former is associated with a greater likelihood of achieving treatment success, according to the results of a phase III trial.