What Transpire Bio’s Trelegy ANDA reveals about the next wave of inhaler competition
Trelegy is a blockbuster, but complex inhaler generics are closing in. Transpire Bio’s FDA filing could test GSK’s respiratory moat.
Pharma & Biotech
Pharma & Biotech
LGM Pharma’s $15m U.S. manufacturing expansion signals a deeper shift away from import dependence in pharma supply chains
LGM Pharma expands U.S. CDMO capacity with a $15M investment across Texas and Colorado. Explore what this means for domestic drug manufacturing. Read more.
Pharma & Biotech
Bionpharma wins FDA approval for Etravirine as STEERLife’s FragMelt proves regulatory-ready
Bionpharma Inc. has secured Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration for its generic version of Etravirine tablets, a second-line treatment for HIV-1. Developed in partnership with STEERLife, the formulation leverages the proprietary FragMelt continuous manufacturing platform to overcome the heat- and shear-sensitivity of the active pharmaceutical ingredient.