Tags : Older

Biotech

GSK Presents Results of Maternal & Older Adults RSV Vaccines

Shots: GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults […]Read More

Regulatory

Amgen’s Nplate (Romiplostim) Receives FDA’s Approval for Immune Thrombocytopenia Aged

Shots: The approval is based on P-III & P-I/II study results assessing Nplate vs PBO in pediatric patients with Immune Thrombocytopenia (ITP) for at least six months who had no response to corticosteroids, immunoglobulins or splenectomy The  P-III & P-I/II study demonstrated increase in overall platelet response (71% vs 20%) with durable platelet response (52% vs 10%) Nplate is a thrombopoietin […]Read More

Regulatory

GW Pharmaceuticals’ Epidiolex (cannabidiol) Receives FDA Approval for Epilepsy for

Shots: The approval is based on three P-III studies results assessing Epidiolex (cannabidiol, PO) vs PBO in 516 patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome aged ≥ 2yrs. The study demonstrated in reduction in frequency of seizures Epidiolex (cannabidiol, PO) is an oral anti-epileptic drug and has received FDA’s PR, FT, & OD designation on 27 […]Read More