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2570 News Found

Unichem gets 5 observations from USFDA for Goa formulation facility
Drug Approval | July 17, 2024

Unichem gets 5 observations from USFDA for Goa formulation facility

The inspection closed with five observations which were more of procedural changes with none of these related to data integrity


Merck starts commercial production of first GMP-compliant manufacturing line for cell culture media in China
News | July 16, 2024

Merck starts commercial production of first GMP-compliant manufacturing line for cell culture media in China

€ 6.6 million investment at Nantong site expands production capabilities for cell culture media


Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial
Drug Approval | July 14, 2024

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension


Thermo Fisher Scientific completes acquisition of proteomics solutions company ‘Olink’
News | July 14, 2024

Thermo Fisher Scientific completes acquisition of proteomics solutions company ‘Olink’

Protein research is key to advancing our understanding of human biology and delivering on the promise of precision medicine


Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
Drug Approval | July 10, 2024

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product


Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets
Drug Approval | July 10, 2024

Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets

This product will be manufactured at Lupin’s Pithampur facility in India


Merck inks MoU with Afrigen Biologics for development of mRNA vaccine technology platform
News | July 05, 2024

Merck inks MoU with Afrigen Biologics for development of mRNA vaccine technology platform

Aim of the collaboration is to develop mRNA platform technology, scale up and troubleshoot challenges in mRNA process optimization


GSK and CureVac restructure collaboration into new licensing agreement
News | July 05, 2024

GSK and CureVac restructure collaboration into new licensing agreement

CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced


Evonik appoints Yann d’Herve as new head of Health Care business line
People | July 04, 2024

Evonik appoints Yann d’Herve as new head of Health Care business line

Yann d’Hervé takes over responsibility for the Health Care business at Evonik, effective July 1