Recovering Patent Life with Patent Term Extension

Merck's Dr Dave Maraldo outlines 3 principles for placing manufacturing capacity and how end-to-end ADC supply chains could shift platform thinking.

Donidalorsen sustained a 95% reduction in hereditary angioedema attacks over 2 years, and patients switching from other prophylaxis saw a 71% drop.

A single 240 mg dose of WVE-007 cut visceral fat while preserving lean mass for 1 year, as Activin E fell by up to 88% across INLIGHT dose groups.

Detalimogene voraplasmid produced a 56% complete response rate in BCG-unresponsive bladder cancer, with an estimated 43% of responses lasting a year.

Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.

Gene-corrected nula-cel freed all 3 RESTORE patients from transfusions, with sickle hemoglobin below 20% in the 2 followed for over 6 months.

Matt Truppo, Richard Jaenisch, and Brian Drapeau examine AI's impact on drug success, human oversight, data governance, and biopharma's future.

This FAQ explains how aseptic processing, contamination control, and validation protect patients amid sterile injectable failures.