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4891 News Found

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


Zydus and ICMR initiate a Phase 2 trial of Desidustat in patients with Sickle Cell Disease
News | October 14, 2024

Zydus and ICMR initiate a Phase 2 trial of Desidustat in patients with Sickle Cell Disease

The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease


Natac receives GMP certificate to manufacture for the pharmaceutical sector
News | October 12, 2024

Natac receives GMP certificate to manufacture for the pharmaceutical sector

The GMP certificate will allow the manufacturing site in Hervás, Cáceres to manufacture active ingredients for the pharmaceutical industry that is based on medicinal plants


USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B
Drug Approval | October 12, 2024

USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis


SIBUR to provide raw materials to Russian medical industry
News | October 12, 2024

SIBUR to provide raw materials to Russian medical industry

SIBUR is developing a special grade of polycarbonate compatible with radiation sterilization


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


FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting


Privi Speciality Chemicals gets USFDA certificate for camphor product
News | October 11, 2024

Privi Speciality Chemicals gets USFDA certificate for camphor product

The company can now expand its business horizon into the area of pharmaceutical applications in the USA


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