LHP588 is an oral, brain-penetrant lysine-gingipain (Kgp) inhibitor designed to block the key virulence factor of P. gingivalis
The new lineup includes CereTom Elite, OmniTom Elite, OmniTom Elite PCD, and BodyTom 32/64
New manufacturing facility in Mebane to produce at least 40 million laboratory pipette tips per week
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
The first pillar is advanced manufacturing, focused on upgrading existing CDMO
The $700 million project is part of Roche’s $50 billion investment in US manufacturing, infrastructure and R&D
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