Tags : Infection

Regulatory

Shionogi Receives MHLW’s Approval for Xofluza’s sNDA to Treat Post-Exposure

Shots: The approval is based on P-III BLOCKSTONE study assessing Xofluza (baloxavir marboxil, 10/20mg) vs PBO in patients in household members aged ≥12yrs. who was living with someone with an influenza infection confirmed by a rapid influenza diagnostic test Result: The proportion of household members who developed influenza (1.9% vs 13.6%); well tolerated with no […]Read More

Regulatory

ViiV Healthcare Reports Submission of MAA to EMA for the

Shots: The MAA is based on P-III ATLAS and FLAIR studies results assessing cabotegravir + rilpivirine (monthly injectable) in 1,100+ patients with HIV-1 infection with suppressed viral load who are not resistant to cabotegravir or rilpivirine demonstrated similar efficacy to 3-drug oral regimen The EMA’s MAA follows NDA submission of dual regimen to the US […]Read More

Pharma

ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives European Commission Marketing Authorization for

Shots: The marketing authorization is based on GEMINI 1 & 2 studies result assessing Dovato vs dolutegravir + tenofovir disoproxil fumarate/emtricitabine in 1400+ patients with HIV-1 infection for 48wks. The GEMINI 1 & 2 studies result demonstrated that two drug regimen showed non-inferior efficacy based on plasma HIV-1 RNA <50 copies/ml compared three-drug regimen in […]Read More

Regulatory

ViiV Healthcare Files NDA for Cabotegravir + Edurant (rilpivirine) to

Shots: The submission is based on P-III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies results assessing Cabotegravir + Edurant (rilpivirine) (injected monthly) vs SOC (three-drug regimen) in 1,100+ patients infected with HIV + viral suppression across 16 countries for 48wks. The P-III ATLAS & FLAIR studies resulted in maintaining […]Read More

Regulatory

Merck Reports Acceptance of NDA from FDA for Its (Imipenem/Cilastatin)

Shots: The NDA filing is based on the P-III RESTORE-IMI 1 study results, assessing Imipenem/Cilastatin + Relebactam (IMI/REL) vs imipenem/cilastatin + colistin (IMI+CST) in patients with gram-negative bacterial infections The P-III RESTORE-IMI 1 study were presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Madrid, Spain, in Aprl 2018 […]Read More