Genentech’s $2bn Holly Springs bet is taking shape, but the hardest manufacturing work is still ahead
Genentech’s $2 billion Holly Springs plant reaches a key milestone as Roche builds U.S. manufacturing capacity for future metabolic medicines.
Pharma & Biotech
Pharma & Biotech
Can Greenstone’s patient-derived islet organoids reveal why some beta cells fail first in type 1 diabetes?
Greenstone Biosciences will build patient-derived islet organoids to study beta-cell vulnerability and identify potential type 1 diabetes drug targets.
Pharma & Biotech
LEO Pharma’s sales engine is accelerating, but its next growth bet is already squeezing margins
LEO Pharma’s strategic brands are surging as dersimelagon expands its pipeline, but heavier investment is putting 2026 margins under pressure.
Pharma & Biotech
FDA Fast Track designation advances BH-30643 in C797S-positive lung cancer
BH-30643 gets FDA Fast Track status after early responses in C797S-positive lung cancer as BlossomHill expands the Phase 1/2 SOLARA trial.
Pharma & Biotech
Anzu-cel Phase 3 plan changes as slower melanoma events push Immatics to single 2027 analysis
Immatics reshapes anzu-cel’s Phase 3 trial after slower PFS events, targeting one definitive H1 2027 analysis and a larger survival dataset.
Pharma & Biotech
Pelareorep gets clearer FDA path toward accelerated approval in RAS-mutant colorectal cancer
FDA feedback could let pelareorep move directly into a pivotal colorectal cancer expansion if randomized REO 033 data support accelerated approval.
Pharma & Biotech
UK already had dronabinol APIs. What makes Dunbar Pharma’s plant-derived entry different?
Dunbar Pharma brings plant-derived dronabinol API to the UK through IPS Pharma, opening a new pharmaceutical cannabinoid supply route.
Pharma & Biotech
DURAVYU Phase 3 setback leaves EyePoint relying on second pivotal wet AMD trial
DURAVYU misses its Phase 3 wet AMD endpoint despite cutting treatment burden 42%. See why EyePoint’s upcoming LUCIA trial is now critical.
Pharma & Biotech
UroGen takes UGN-103 to FDA as non-surgical bladder cancer strategy expands
UroGen files UGN-103 with the FDA after a 77.8% Phase 3 complete response rate as its bladder cancer franchise gains commercial momentum.
Pharma & Biotech
FDA clears Shanghai Ark Biopharmaceutical’s ziresovir Phase 2 trial in critically ill infants with RSV
Shanghai Ark Biopharmaceutical Co., Ltd. ((ArkBio) has received authorization from the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 trial of ziresovir, an oral antiviral being developed for infants with severe respiratory syncytial virus infection, including patients requiring treatment in a pediatric intensive care unit. The planned multicenter, randomized, double-blind and placebo-controlled