Shots:
The US FDA has granted a PMA to the IsoPSA in vitro diagnostic (IVD) kit for the diagnosis of high-grade prostate cancer
Approval was based on the clinical evidence from a prospective study of the IsoPSA test conducted at 14 sites across the US, as well as data from supporting analytical validation studies
IsoPSA, a…
Shots:
The US FDA has approved Cabometyx for treatment-experienced, inoperable, LA/M, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts (≥12yrs.)
Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts (2 arms: pNET: n=99; epNET: n=199) that showed improved PFS; data was presented at ESMO 2024 & published…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of March, Samsung Bioepis Initiated P-I Study of SB17…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Cadila expanded its footprints in India with the launch of its two biosimilars Bevaro (bevacizumab, biosimilar) and Ritucad (rituximab, biosimilar)
Our team at PharmaShots has summarized 9 key events of the biosimilar space of July 2020
1. Samsung…

