HIV pre-exposure prophylaxis (PrEP)

Merck Pauses Enrollment for Two Phase 3 Clinical Trials of Investigational, Once-Monthly, Oral Islatravir for Pre-Exposure Prophylaxis of HIV-1 infection

Clinical Trials, HIV, HIV pre-exposure prophylaxis (PrEP), Merck, Patient Enrollment, R&D

Merck announced a pause in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 clinical studies evaluating investigational, once-monthly, oral islatravir (ISL) – a nucleoside reverse transcriptase translocation inhibitor – for pre-exposure prophylaxis (PrEP) in people at high risk of HIV-1 infection.

December 6, 2021/by Business Wire

Fast Track, Breakthrough and Priority Reviews: Sanofi and ViiV

Acid alpha-glucosidase (GAA) enzyme, Biologics License Application (BLA), Breakthrough Therapy Designation, Bruton's Tyrosine Kinase (BTK) Inhibitors, Chronic Immune Thrombocytopenia (ITP), Clinical Trials, Enzyme Replacement Therapy (ERT), Fast Track Designation, FDA, HIV pre-exposure prophylaxis (PrEP), HIV Prevention, Muscle Disease, Orphan Drug Designation, PDUFA, Pompe disease, Priority Review Status, R&D, Sanofi

The U.S. Food and Drug Administration granted various designations for Sanofi’s avalglucosidase alfa for Pompe disease, Sanofi’s rilzabrutinib for immune thrombocytopenia, and ViiV Healthcare’s cabotegravir for HIV prevention.

November 18, 2020/by BioSpace