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Pharma overhaul: EMA hails “Once-in-a-Generation” reform
Policy | December 16, 2025

Pharma overhaul: EMA hails “Once-in-a-Generation” reform

The reform is set to modernise how medicines are developed, authorised, and made available across the EU


Sanofi secures two breakthrough nods in China for rare blood disorders
News | December 16, 2025

Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia


Neuren partner Acadia bags FDA go-ahead for new DAYBUE STIX powder for Rett Syndrome
Drug Approval | December 16, 2025

Neuren partner Acadia bags FDA go-ahead for new DAYBUE STIX powder for Rett Syndrome

The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste


Sobi to acquire Arthrosi Therapeutics in $950 million deal, bolstering gout pipeline
Clinical Trials | December 16, 2025

Sobi to acquire Arthrosi Therapeutics in $950 million deal, bolstering gout pipeline

The drug is currently being evaluated in two fully recruited global Phase 3 studies for progressive and tophaceous gout, with results expected in 2026.


Zenas BioPharma and InnoCare hit key milestone in Lupus drug trial, secures China Phase 3 nod
Clinical Trials | December 16, 2025

Zenas BioPharma and InnoCare hit key milestone in Lupus drug trial, secures China Phase 3 nod

The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort


Alphyn Biologics bags $25 million financing to advance breakthrough skin disease therapies
News | December 16, 2025

Alphyn Biologics bags $25 million financing to advance breakthrough skin disease therapies

Alphyn is developing Zabalafin Hydrogel as the first therapy to simultaneously tackle the interconnected drivers of AD


Anova launches AI-powered patient matching platform to speed clinical trial enrollment
News | December 16, 2025

Anova launches AI-powered patient matching platform to speed clinical trial enrollment

Clinical trial enrollment has long been a bottleneck in drug development


Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga
News | December 15, 2025

Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga

Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility