Based on data, 1.75 mg/kg dose established as recommended dose for Phase 3 trial of this investigational antibody-drug conjugate
Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems
Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients
First GMP batch released at Lonza’s next-generation mammalian manufacturing facility in Portsmouth (US)
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
The product will be manufactured at Lupin’s Somerset facility in the US
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
Medanta is expected to incur a project capex of ~Rs. 600 crores in next 3-4 years
The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities
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