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Results For "regulatory"

1625 News Found

Carbogen Amcis successfully completed Swissmedic inspection of its Vionnaz facility
News | January 10, 2025

Carbogen Amcis successfully completed Swissmedic inspection of its Vionnaz facility

The site’s GMP Certification has been successfully renewed


Biocon Biologics embarks on a three-stage strategic journey
News | January 08, 2025

Biocon Biologics embarks on a three-stage strategic journey

Successfully transformed the organization from a two-country operation focused on development and manufacturing to a fully integrated company with a strong commercial engine bringing us closer to patients in over 120 countries


Caplin Point receives EIR from FDA with Zero 483 observations
Drug Approval | January 07, 2025

Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.


Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation
Digitisation | January 07, 2025

Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation

NutrifyGenie AI, a leading AI-driven platform, was integral in designing scientifically differentiated formulations for a multinational client


Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara
News | January 07, 2025

Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara

The biosimilar Ustekinumab has been developed and manufactured by the company


Zydus Lifesciences appoints Vikram Shukla as President - Parenteral Operations
People | January 06, 2025

Zydus Lifesciences appoints Vikram Shukla as President - Parenteral Operations

He has 29+ years’ comprehensive experience in world-class Formulations and API (for US and EU requirements) mainly related to injectables


Merck inks agreement with Hansoh Pharma for investigational Oral GLP-1 receptor agonist
News | January 01, 2025

Merck inks agreement with Hansoh Pharma for investigational Oral GLP-1 receptor agonist

Hansoh Pharma has granted Merck an exclusive global license to develop, manufacture and commercialize HS-10535


Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals
News | December 31, 2024

Immedica to acquire biopharmaceutical company Marinus Pharmaceuticals

Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for an enterprise value of approximately US$ 151 million


IDEAYA Biosciences enters license with Hengrui Pharma for a novel phase 1 DLL3 Topo-I-Payload ADC targeting SCLC and NET solid tumors
News | December 31, 2024

IDEAYA Biosciences enters license with Hengrui Pharma for a novel phase 1 DLL3 Topo-I-Payload ADC targeting SCLC and NET solid tumors

Exclusive global license outside of Greater China for SHR-4849, a Phase 1 DLL3-targeting Topo-I-payload antibody drug conjugate (ADC)


Reliance acquires Karkinos Healthcare for Rs. 375 Cr
Healthcare | December 29, 2024

Reliance acquires Karkinos Healthcare for Rs. 375 Cr

Karkinos is in the business of providing technology-driven, innovative solutions for the early detection, diagnosis, and management of cancer.