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Apitoria Pharma receives 5 observations from USFDA for API facility
Drug Approval | August 31, 2025

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported


Zydus Therapeutics reports positive phase-3 results in rare liver disease
News | August 29, 2025

Zydus Therapeutics reports positive phase-3 results in rare liver disease

Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients


Lighthouse receives $49.2 million NIA grant to advance phase 2 study of Alzheimer’s disease
News | August 28, 2025

Lighthouse receives $49.2 million NIA grant to advance phase 2 study of Alzheimer’s disease

LHP588 is an oral, brain-penetrant lysine-gingipain (Kgp) inhibitor designed to block the key virulence factor of P. gingivalis


Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra
Policy | August 27, 2025

Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra

The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion


SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services
News | August 27, 2025

SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services

The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations


Terumo India launches Terufusion advanced infusion systems in India
News | August 26, 2025

Terumo India launches Terufusion advanced infusion systems in India

Terufusion Advanced Infusion Systems combine a smart syringe pump, smart infusion pump, and pump monitoring system software for precise and efficient drug administration


Roche’s US subsidiary Genentech breaks ground on $700 million manufacturing facility in North Carolina
News | August 26, 2025

Roche’s US subsidiary Genentech breaks ground on $700 million manufacturing facility in North Carolina

The $700 million project is part of Roche’s $50 billion investment in US manufacturing, infrastructure and R&D


India releases first-ever National Guidelines/SOPs for animal blood transfusion and blood banks
News | August 26, 2025

India releases first-ever National Guidelines/SOPs for animal blood transfusion and blood banks

Guidelines aim to establish state-regulated veterinary blood banks


Nanavati Max Hospital performs 4-hour simultaneous pancreas-kidney transplant on 25-year-old with Type-1 diabetes
Healthcare | August 26, 2025

Nanavati Max Hospital performs 4-hour simultaneous pancreas-kidney transplant on 25-year-old with Type-1 diabetes

The complex four-hour surgery was performed by a multidisciplinary team of doctors


FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy
Drug Approval | August 25, 2025

FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy

KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB