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NewsInventiva Completes Last Patient Visit in NATiV3 Phase 3 Trial
Inventiva completes last patient visit in NATiV3 Phase 3 trial; topline data expected Q4 2026 ahead of a planned H1 2027 FDA submission.
Pfizer COVID-19 Vaccine EUA Revoked; Comirnaty BLA Takes Effect
Moderna Loses EUA Status as Spikevax Gains Full FDA Approval
FDA Issues Safety Tables & Figures Framework for NDA/BLA Reviews
FDA Signals GCP Shift as Foreign Trial Sites Face Inspections
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11 storiesIndia Glycols Demerges Biopharma Unit Into Ennature Bio Pharma
India Glycols demerges its biopharma division into Ennature Bio Pharma Limited, which posted Rs. 90 crore revenue in Q1 FY2027.
NeuroThera Seeks FDA Orphan Drug Status for SCI-110
NeuroThera Labs pursues FDA Orphan Drug Designation for SCI-110 in adult Tourette Syndrome, engaging RK Strategies to support federal stakeholder outreach.
FDA Updates Guidance on Hepatic Impairment PK Studies
FDA's CDER issues updated guidance on hepatic impairment PK studies, affecting study design, data analysis, and dosing label decisions for sponsors.
Novartis Halts Rap-cel Trials After Three Patient Deaths
Novartis halts rap-cel autoimmune trials after 3 IEC-HS deaths; BMS pauses zola-cel studies citing inflammatory safety signals.
Teva Nears Trump Administration Deal to Cut Medicaid Drug Costs
Teva is negotiating a Medicaid pricing deal with the Trump administration, with implications for generics supply contracts and volume planning across the sector.
AstraZeneca Acquires Dizal, Secures Global Zegfrovy Rights
AstraZeneca closes Dizal acquisition, gaining global control of lung cancer drug Zegfrovy and triggering GMP integration obligations across its manufacturing network.
Teva’s TEV-408 Meets Primary Endpoint in Phase 2a Celiac Study
Teva's TEV '408 met its primary endpoint in a Phase 2a celiac study, preventing gluten-induced intestinal damage after a single subcutaneous dose.
Evotec Partners With Plectonic to Advance T Cell Engager Platform
Evotec and Plectonic combine BiTco and LOGIBODY® platforms in a preclinical collaboration targeting T cell engager limitations in solid tumors.
Nicox Extends Cash Runway to Q1 2028 Ahead of NCX 470 PDUFA Date
Nicox reports €8.4M cash runway through Q1 2028, with NCX 470's April 2027 PDUFA date as the pivotal milestone for extending operations into 2029.
India Glycols Spins Off Biopharma Unit as Ennature Bio Pharma
India Glycols demerges its biopharma operations into Ennature Bio Pharma, which posted Rs. 90 crore revenue in Q1 and plans a stock exchange listing.
FDA CBER Convenes NGS Workshop on Biologics Detection Standards
FDA CBER's September 23 NGS workshop signals advancing regulatory expectations for adventitious agent detection in biologics under ICH Q5A(R2).
Worth your time this week
aTyr Expects FDA Response on Phase 3 Sarcoidosis Study
Telix Completes BiPASS Enrollment, Secures FDA NDA Path
Elevar Presents CARES-310 Age Data at ILCA 2026
