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Acrux (ASX: ACR) secures clearer FDA Phase III pathway for female testosterone treatment
Acrux has received formal FDA feedback defining the Phase III clinical development requirements for Female Testosterone MDTS, potentially supporting a future United States registration application while leaving trial funding, safety evidence and commercial partnerships unresolved.
GSK commits more than $800m to Pennsylvania hub and 300 new jobs
GSK plc is committing more than $800 million to expand its Upper Merion, Pennsylvania operations into an integrated biologics manufacturing and research hub, creating more than 300 jobs over five years while retaining about 4,500 existing positions across the state. The investment follows another $800 million Pennsylvania project announced in 2024 and gives GSK a larger United States manufacturing footprint as its specialty medicines pipeline expands.
Fagron (EBR: FAGR) posts 23% Q3 growth as IV bag recovery becomes the test
Fagron delivered €281.3 million of Q3 revenue and reaffirmed FY2026 guidance, but acquisition contributions widened the gap between headline and organic growth while an industry-wide IV bag recall constrained North American compounding volumes.
VYVGART Sjögren’s setback sends argenx shares lower despite $1.5bn quarterly sales
argenx shares sink after the Phase 3 UNITY failure removes a major VYVGART expansion opportunity despite continued blockbuster sales growth.
Roche’s vamikibart sustains vision gains for 52 weeks as July 2027 FDA decision approaches
Genentech has reported sustained visual improvements and reduced retinal swelling through one year in two Phase III studies of vamikibart for uveitic macular edema. Approximately two-thirds of eligible patients required no retreatment after week 16, strengthening the potential treatment's durability profile. However, mixed statistical results between the pivotal trials and the absence of a direct steroid comparison remain important considerations ahead of the expected July 2027 FDA decision.
Pfizer wants to reduce 330 Catania roles. Can October talks save some of the jobs?
Pfizer Inc.’s employment dispute at its Catania pharmaceutical facility enters a critical phase on October 13 and 14, when unions are expected to negotiate possible alternatives to a redundancy procedure affecting 330 employees.
Why is Cipla’s InvaGen cutting 205 New York jobs while the US pipeline keeps expanding?
InvaGen Pharmaceuticals is preparing 205 permanent layoffs across two New York facilities effective November 27, adding a workforce dimension to Cipla's North American reset after regional revenue fell 21% in its latest reported quarter. The notices cite economic reasons but do not indicate a complete withdrawal from US manufacturing.
Why is Caribou Biosciences ending CAR-T development before a planned phase 3 trial?
Caribou Biosciences is winding down its allogeneic CAR-T programmes and sharply reducing its workforce after financing constraints overtook clinical progress, leaving $113.8 million of mid-year liquidity and its genome-editing assets at the centre of a strategic review.
EUROAPI targets North American compounding market through MEDISCA as peptide strategy expands
EUROAPI has entered a strategic distribution partnership with MEDISCA to expand European-manufactured pharmaceutical ingredient access in North America and explore peptide opportunities. The agreement offers a potential route to new customers as EUROAPI restructures its manufacturing business, but undisclosed contract economics and tightening US compounding regulations leave its financial impact uncertain.
BridgeBio targets achondroplasia market with first potential oral therapy as FDA fast-tracks infigratinib
BridgeBio’s oral infigratinib wins FDA Priority Review, setting up a February decision and potential challenge to injectable achondroplasia drugs.