Drug Approval | January 23, 2024
EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome
GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023
GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023
Projected ~US$100 million cash balance of combined company expected to fund operations through mid-2025 and to clinical data over the next 12 to 24 months
New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS)
In fact, the overall CPHI Pharma Index – a collateralised metric of all major ranking categories – has risen by more than 8%, the largest year-on-year gain in the survey’s six year history
Pluvicto and Scemblix launches are progressing well and we are awaiting data in earlier lines of therapy.
The estimated capex is to the tune of Rs. 140 crore to be funded through debt and internal accrual
‘Infinite Care’ comprises two key pillars - Sparsh Sankalpa and Sparsh Sukshema
Infigratinib is not FDA-, Health Canada- or Therapeutics Goods Association-approved for any other indication
Real-world evidence from more than 850,000 hospitalized patients provides clinical insights on the use of Veklury (remdesivir) as stand of care Covid-19 treatment
The transaction as well as the open offer is expected to be completed by June this year.
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