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4806 News Found

USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations
Drug Approval | September 14, 2024

USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations

The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices


Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable
News | September 14, 2024

Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable

Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus’ injectable portfolio for the US market


DFC commits US $20 mn loan to Panacea Biotec towards capacity expansion for hexavalent vaccine
News | September 13, 2024

DFC commits US $20 mn loan to Panacea Biotec towards capacity expansion for hexavalent vaccine

The wP-IPV-based hexavalent vaccination is an innovative immunization alternative to the current pentavalent and standalone IPV vaccines


Merck launches single-use reactor to accelerate ADC manufacturing
News | September 12, 2024

Merck launches single-use reactor to accelerate ADC manufacturing

Increases efficiency by 70% compared to stainless steel or glass manufacturing methods


AGC and Medinet sign agreement for cell therapy CDMO business
News | September 12, 2024

AGC and Medinet sign agreement for cell therapy CDMO business

A new initiative to contribute to enhancing drug discovery capabilities in the field of gene and cell therapy in Japan


Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast
Clinical Trials | September 11, 2024

Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast

ALS patients experience neuroinflammation and rapid neurodegeneration


Evonik starts operation of new spray drying facility for pharmaceutical oral excipients
News | September 11, 2024

Evonik starts operation of new spray drying facility for pharmaceutical oral excipients

Investment in new plant meets increasing demand for functional excipients for oral drug delivery


Merck announces positive top-line results from Phase 3 trial evaluating efficacy and safety of Gardsil 9
Clinical Trials | September 11, 2024

Merck announces positive top-line results from Phase 3 trial evaluating efficacy and safety of Gardsil 9

The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9


Datopotamab deruxtecan showed median overall survival of 14.6 months in TROPION-Lung01 Phase III trial
Clinical Trials | September 10, 2024

Datopotamab deruxtecan showed median overall survival of 14.6 months in TROPION-Lung01 Phase III trial

TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population


Briefs: Wanbury and Bafna Pharmaceuticals
News | September 10, 2024

Briefs: Wanbury and Bafna Pharmaceuticals

Wanbury receives CEP approval from EDQM for launch of Dextromethorphan API