Drug Approval | October 16, 2024
Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
He will join in place of Anil Arora, current President- Formulations Operations who will be superannuating in November, 2024
India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI
Strokes are affecting approximately 1.8 million people annually
The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease
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
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
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
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