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Results For "regulatory"

1132 News Found

Strides Pharma's CDMO arm OneSource raises Rs. 801 crore in pre-listing round
News | October 16, 2024

Strides Pharma's CDMO arm OneSource raises Rs. 801 crore in pre-listing round

The share subscription agreements are being executed at a pre-money equity value of US$ 1.65 billion


Akums Drugs enters into license and distribution agreement with Triple Hair, Canada
News | October 16, 2024

Akums Drugs enters into license and distribution agreement with Triple Hair, Canada

Akums Drugs will undertake this development and commercialization in India


Granules India appoints Ramraj Rangarajulu as President and Head - Formulations Operations
People | October 15, 2024

Granules India appoints Ramraj Rangarajulu as President and Head - Formulations Operations

He will join in place of Anil Arora, current President- Formulations Operations who will be superannuating in November, 2024


CDSCO, NRAI meets WHO international standards for vaccine regulations
Policy | October 14, 2024

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


Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3
Drug Approval | October 14, 2024

Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3

Indoco is comprehensively working on the remedial action plan


Alkem enters into licensing agreement with BioTherapeutics
News | October 11, 2024

Alkem enters into licensing agreement with BioTherapeutics

Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings


OneSource unveils new brand identity at CPHI Milan
News | October 11, 2024

OneSource unveils new brand identity at CPHI Milan

Aims to achieve CDMO sales of US$ 400 million by 2028


Biocon Biologics’ sponsored report suggests ways to increase adoption of Biosimilars in poor countries
Policy | October 09, 2024

Biocon Biologics’ sponsored report suggests ways to increase adoption of Biosimilars in poor countries

Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines


Aurigene Oncology gets positive results of Phase 1 study for CAR-T cell therapy for multiple myeloma
Diagnostic Center | October 09, 2024

Aurigene Oncology gets positive results of Phase 1 study for CAR-T cell therapy for multiple myeloma

India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma


Calquence granted priority review in US for patients with untreated mantle cell lymphoma
Drug Approval | October 06, 2024

Calquence granted priority review in US for patients with untreated mantle cell lymphoma

Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy