Tags : Infection

Janssen Collaborates with Arrowhead for the Initiation of REEF-1 P-IIB

Shots: Janssen to pay ~$25M milestone payments to Arrowhead with the onset of trial and has begun the dosing of patients in REEF-1(NCT03982186) P-IIB study involving assessing of JNJ-3989, JNJ-6379, NA, and/or PBO in 450 patients with chronic hepatitis B virus infection for 48 wks., evaluating its safety and efficacy Additionally, in Oct 2018 Arrowhead […]Read More

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

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

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

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