Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA

The audit has been concluded with no major observations

CCI approves merger between Aster DM Healthcare and Quality Care India

The merged entity ‘Aster DM Quality Care’ will be jointly controlled by Aster Promoters and Blackstone

Teva and Sanofi present new outcome from Phase 2b study of duvakitug

Findings to form the basis for a Phase 3 program, anticipated to start in H2 2025

CDSCO, NRAI meets WHO international standards for vaccine regulations

India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI

Zydus receives approval from COFEPRIS to market? Mamitra to treat various cancers

The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2

Zydus receives approval from COFEPRIS of Mexico to market ‘Bhava’ to treat various cancers

Urgent need to redefine pharma companies’ role on several issues of the industry: Dr. K. Nagaiah, Chief Scientist, CSIR - IICT, Hyderabad

The expiry date of almost all strips is rubber stamped vanish in a matter of 3 to 4 months, making the remaining tablets waste for subsequent use before expire date

EMA approves Biocon Biologics’ new mAbs facility in India

Renews GMP certifications for India and Malaysia sites

Briefs: Concord Biotech and Shelter Pharma

Shelter Pharma Limited secured an order from Berlin International Medical Co D3Cure 50 ml x 30000 pcs

Dupixent late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM

Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD