Month: June 2018

Uncategorized

Achaogen’s Zemdri (plazomicin) Receives FDA Approval for Complicated Urinary Tract

Shots: The approval is based on P-III EPIC (Evaluating Plazomicin in cUTI) study results assessing Zemdri (plazomicin, IV) vs Meropenem in 388 patients with cUTI including pyelonephritis aged ≥18 yrs. P-IIIEPIC study results: composite cure rate (CCR) @5 day (88.0% vs 91.4%); CCR at test-of-cure (TOC) (81.7% vs 70.1%) Zemdri (plazomicin, qd) is an aminoglycoside […]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

Regulatory Uncategorized

Medicines Development for Global Health’s (MDGH) Moxidectin Receives FDA Approval

Shots: The approval is based on two clinical studies results assessing Moxidectin vs SoC Ivermectin in patients with river blindness aged ≥ 12 yrs. The study resulted in meeting 1EPswith superiority of Moxidectin vs SoC Ivermectin and resulted in suppression of microfilariae in the skin Moxidectin (8mg, PO) is macrocyclic lactone anthelmintic medication active against […]Read More

Regulatory

Eli Lilly’s Olumiant (baricitinib) Receives FDA Approval for Moderately-to-Severely Active

Shots: The approval is based on P-III RA-BEACON study results assessing Olumiant vs PBO in 527 patients with inadequate response or intolerance to one or more TNF inhibitor therapies P-III RA-BEACON study results: ACR20 (49% vs 27%) physical function based on the Health Assessment Questionnaire Disability Index (HAQ-DI) before/ after treatment (1.71, 1.78/ 1.31, 1.59) […]Read More