NEW JERSEY INSTITUTE OF TECHNOLOGY

Tharimmune's TH104 Advances to Phase 2 for Pruritus in Primary Biliary Cholangitis

5 months ago

• Tharimmune plans to initiate a Phase 2 clinical trial in 2025 to evaluate TH104 for moderate-to-severe pruritus associated with primary biliary cholangitis (PBC). • The Phase 2 trial will be a multicenter, randomized, double-blind, placebo-controlled study enrolling approximately 40 patients across the U.S., Europe, and the UK. • TH104 demonstrated a favorable pharmacokinetic profile and a mild side-effect profile in a Phase 1 clinical trial, with positive regulatory feedback from the FDA and EMA. • The company also reported corporate achievements, including licensing agreements and the appointment of Sanam Parikh to its Board of Directors.

J&J's Continuous Manufacturing Journey: Pioneering Success with HIV Drug Prezista

7 years ago

• Johnson & Johnson achieved a historic FDA approval in 2016 to transition HIV medication Prezista from batch to continuous manufacturing, marking a significant advancement in pharmaceutical production methods. • The continuous manufacturing system demonstrates superior efficiency through real-time quality monitoring, reduced waste, and flexible production capabilities, while maintaining the highest quality standards. • J&J's strategic decision to implement continuous manufacturing with an established product like Prezista, rather than a new drug, has provided valuable insights and lessons for future pharmaceutical manufacturing innovation.