Drug Development

The FDA approved the first orexin receptor agonist for narcolepsy type 1, which validates a new mechanism-driven approach shaping CNS drug development and regulatory pathways.

Pathos AI's $2.09 billion license for Alphamab's TNBC drug JSKN016 signals rising cross-border oncology deals and manufacturing coordination demands.

Pharma's 2026 predictions revisited: AI tools have arrived, but organizational readiness, data governance, and regulatory gaps now limit real-world impact.

Content on PharmTech.com this week showed that while AI is being utilized in drug discovery, manufacturing execution still lags behind. However, manufacturers are rethinking where and how they build capacity, transfer technology, and monitor quality in real time.

Across development, manufacturing, quality, and outsourcing, the pharma industry is being asked to scale complexity without sacrificing control.

FDA revises draft guidance for 17 generic peptide products, including semaglutide and tirzepatide, updating testing standards ahead of a September comment deadline.

GSK invests £400M ($455 million) in a new Cambridge Biomedical Campus R&D hub, closing Stevenage by 2029 and expanding Ware's manufacturing scale-up capacity.

Pharma manufacturing and development experts reassess their 2026 predictions for the industry and look ahead to the second half of the year.

European biotechs are utilizing AI to identify novel immunoinflammatory targets in respiratory diseases.

Megha Sinha, Kolter AI explains how Pharma has automated drug discovery and manufacturing AI, but not regulatory execution.

AI is reshaping discovery, manufacturing, and supply chain routing. Manufacturers are investing in capacity and resilience.

FDA advisers vote to allow pharmacy compounding of unapproved peptides BPC-157, KPV, TB-500, MOTs-C despite thin safety data and industry ties.

Campbell Bunce, chief scientific officer at Abzena, provides an update on the momentum in antibody-oligonucleotide conjugates development and the operational pressures shaping CDMO/CRO strategy for the rest of 2026.

Megha Sinha, Kolter AI, discusses how pharma's AI bottleneck shifted from technology to readiness as execution across 60 markets stays manual.

The FDA approval of Jideytro (zidesamtinib) for previously treated ROS1-positive NSCLC has implications for drug developers.

Campbell Bunce, chief scientific officer at Abzena, revisited his 2026 industry predictions on the direction of the biologics and bioconjugate market and gives an update on ADCs.

Megha Sinha, Kolter AI, talks on how orchestrator roles surged in pharma AI, but teams need computed plans, not titles, to close the skills gap.

Novo Nordisk’s complaint contends that Lilly's campaigns leave out information about the most effective injectable doses of Wegovy (semaglutide) and Ozempic (semaglutide) currently on the market.

BMS is scaling AI drug discovery with new NVIDIA infrastructure, cutting research timelines via faster, more efficient computing power.

Megha Sinha, Kolter AI, discusses how digital twins run pharma supply chains but miss the regulatory execution needed to launch changes across markets.

Jeffrey C. Mocny, PhD, of Abzena, and Anna McMahon, MS, of Cellares, discuss how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data for better patient outcomes and safety.

FDA proposes a hub-and-spoke manufacturing registration rule and approves three drugs for multiple myeloma, IgA nephropathy, and bladder cancer.

EMA and EISMEA have formalized their cooperation through a work program aimed at helping small biopharma and medtech innovators engage with EU regulatory requirements earlier in development, potentially reducing late-stage manufacturing and quality problems for complex modalities.

Dostarlimab monotherapy achieves sustained 12-month complete response in dMMR/MSI-H rectal cancer, potentially sparing chemo and surgery.

FDA approves subcutaneous isatuximab-irfc for multiple myeloma, backed by trial data showing efficacy comparable to IV dosing across three regimens.