Flexible Solutions For Potent Product Handling

FDA has effectively paused its Commissioner’s National Priority Voucher pilot and appears to have halted new complete response letter postings, according to reports. HHS says work on the program is ongoing.

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.

A single dose of Zai Lab’s long-acting bispecific ZL-1503 produced at least 90% inhibition of an atopic dermatitis signaling biomarker through Week 12 in healthy volunteers. Its 40- to 50-day half-life supports a target of dosing every 12 weeks.

In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.

FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.

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

FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.

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.