Drug Approval | October 16, 2024
Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
Declan brings over 25 years of expertise in the pharmaceutical and biotech sectors
India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI
The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease
SIBUR is developing a special grade of polycarbonate compatible with radiation sterilization
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
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
Aims to achieve CDMO sales of US$ 400 million by 2028
We now rank 3rd in pharmaceutical production by volume and 14th by value
Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic
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