Feliza Mirasol

This year’s AAPS PharmSci 360 highlighted AI transparency, computer modeling in formulation, oral peptide delivery, and new business models.

Industry experts discuss how reshoring, fill/finish capacity, and cold chain technology are shaping a more resilient biopharma supply chain.

Lonza's Visp expansion adds 3 multiproduct suites at up to 1200 L plus 500-L single-use capacity to scale commercial ADC production from 2028.

HM15421/GC1134A could become the first subcutaneous enzyme replacement therapy for Fabry disease, with BioMarin paying $70 million upfront.

DAX-044 aims to confine IL-12 activity to tumors and avoid the toxicity that has limited IL-12 therapy, with phase 1 testing expected in 2027.

The proposed FDA guidance would let sponsors add patient-specific gene editing variants to approved BLAs via in vitro data, with comments due November 27, 2026.

Catalent Pharma Solutions's Dr Karunakar Sukuru explains how peptide potency, dose, and patient needs guide the choice between softgel and sublingual dosage forms.

All 9 patients treated with BB-301 gene therapy met formal response criteria for improved swallowing in an ongoing OPMD trial.

Etentamig cut the risk of progression or death by 60% vs standard therapies in the phase 3 CERVINO trial of triple-class exposed myeloma.

Speaking at AAPS PharmSci 360, Dr Stephanie Johnson, a principal formulation scientist at Pfizer, details how platform formulations save time before commitment, shift risk downstream, and what AI tools need to earn trust.

Risvutatug rezetecan extended median progression-free survival to 5.5 months vs 1.4 months with chemotherapy in pretreated osteosarcoma.

Izalontamab brengitecan extended median progression-free survival to 11.1 months vs 5.7 months with chemotherapy after EGFR TKI failure.

This year's PharmSci 360 will close with a plenary on fixing drug development economics given by Averin's Dr Berry.

Dr Karunakar Sukuru of Catalent explains how lipid-based softgels address physiological barriers to oral peptide delivery as approvals increase.

A patient with relapsing MS died of septic pneumonia 44 days after zola-cel CAR T infusion, as all 60 dose level 2 patients stayed off DMTs.

FNIH CEO Dr Julie Gerberding will open the October 25-28 meeting with a talk on using AI, adaptive trials, and alternative methods in drug development.

Insilica's Dr Thomas Luechtefeld argues process traceability, not benchmark accuracy alone, determines whether AI toxicology decisions can be trusted.

Phase 1 HCXT-2001, an oral macrocyclic IL-23R peptide, could be paired with emvistegrast as a daily oral IBD treatment, according to Gilead.

Zylidac will test whether optogenetic cell lines that hit 21 g/L in small-scale CHO runs can deliver higher-yield complex biologics at GMP scale.

Revakinagene taroretcel (Encelto), the only FDA-approved MacTel therapy, slowed photoreceptor loss by up to 54.8% vs sham in phase 3 trials.

At PharmSci 360, Insilica CEO Thomas Luechtefeld will present on auditable agentic AI systems and how they are expanding computational toxicology beyond single predictive models.

Dr Julie Gerberding and Dr David Berry will headline the October 25-28 New Orleans meeting, which adds a USP standards workshop and AI, organoid tracks.

Backed by €400 million (US$449 million) in EU-cleared German aid, the new Frankfurt facility is designed to secure insulin supply for people with diabetes from 2032.

EA2251, the 7th registrational trial of ivonescimab, will test it plus chemotherapy vs pembrolizumab or durvalumab regimens in first-line BTC.

Inhaled EXO-CD24 kept 85% of patients with ARDS free of respiratory failure at day 7 vs 33.3% with placebo in a 90-patient phase 2b trial.

Nuravax will test AV-1959R in a 160-adult phase 2 trial to see whether the amyloid vaccine can prevent Alzheimer disease before symptoms begin.

BMS's Dr Nathan Pennell outlines how biomarker testing barriers and trial diversity affect patient access to targeted oncology drugs.

Guselkumab (Tremfya) sustained perianal fistula healing through 1 year in Crohn disease, with remission climbing to 35% in one FUZION dosing arm.

Cemiplimab's proposed EU regimen could cut Libtayo infusion visits from every 3 weeks to every 6 weeks, trimming infusion time by up to half.

EST-201 and EST-101 target the genetic root cause of ADPKD, a disease affecting more than 8 million people worldwide, with trials starting 2027-2028.