Ridhi Rastogi
Shots:
Henlius has granted Sandoz exclusive rights of the HLX13, a biosimilar version of Yervoy (ipilimumab), which is being assessed in a Henlius-led P-I/III trial for inoperable HCC, targeting enrollment of 656 pts
As per the deal, Sandoz will register & market HLX13 in Australia, Canada, EU, Japan, & the US in exchange for milestone-based…
Shots:
The US FDA has approved Rinvoq (15mg; QD) to treat adults with giant cell arteritis (GCA) following the EC’s Approval in Apr 2025
Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in 1st study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO +…
Shots:
Eli Lilly has entered into a global licensing & multi-target research collaboration with Creyon Bio to identify, develop & market novel RNA-targeted oligonucleotide therapies for Lilly’s named targets using Creyon’s AI-powered Oligo Engineering Engine
As per the deal, Lilly will get exclusive rights of lead candidates & handle further research, development & marketing upon…
Shots:
The US FDA has approved Zevaskyn (prademagene zamikeracel) for treating wounds in adult & pediatric RDEB pts based on the intra-pts controlled P-III (VIITAL) trial & has also granted RPD PRV to Abeona, which the company intends to monetize; Zevaskyn to be commercially available in Q3’25
The P-III Trial assessed Zevaskyn in RDEB pts,…
Shots:
PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA
The March 2025 report covers designations granted to 37 drugs and 3 medical devices, spanning 11 small molecules, 10 biologics, 10 cell and gene therapies & 3 medical devices among…
Shots:
Personalis has reported interim VICTORI study data assessing its NeXT Personal assay for the detection of early residual or recurrent CRC via ctDNA using blood samples from 71 pts with resectable Stage I-IV CRC
At 15.75mos. mFU, 100% pts with recurrences, incl. distant metastases, were detected via ctDNA before imaging, with 87% detected within…
Shots:
The EC has granted conditional approval to Lynozyfic for the treatment of adults with r/r multiple myeloma based on P-I/II (LINKER-MM1) trial data assessing Lynozyfic in >300 pts; P-II dose expansion portion is ongoing. BLA under the US FDA’s Review (PDUFA: Jul 10, 2025)
In the trial, 117 pts on 200mg had a 71% ORR, with…
Shots:
The CHMP has recommended vutrisiran to treat ATTR-CM adults based on global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts; EC's decision expected in Jun 2025. MAA under PMDA review, with global applications planned in 2025 & beyond
Study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved…