Briefs: Zydus Lifesciences and Kimia Biosciences
The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.
The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.
Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy
Patritumab deruxtecan is a specifically designed potential first-in-class HER3 directed antibody drug conjugate (ADC) discovered and being developed by Daiichi Sankyo.
Both the plants have a total Capex of Rs. 75 crore and expected production timeline is Q3 FY23
Company will invest approximately ¥16 billion to increase production capacity by approximately 70% to ensure a stable supply
With this expansion, the Grand Island site provides redundant capacity to support global supply of media and further extends the site’s capabilities to produce the high-quality technology and materials needed for the development and commercial manufacturing of vaccines and biologic therapies
The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients
The WAVEsystem with the WAVEcontrol 4.0 embedded
The total budget of Rs. 3119.46 crores has been allocated/ released as a central share to States/UTs since the inception of the scheme and they have reported an expenditure of Rs. 2290.20 crores.
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