Dipanshu Dixit
Shots:
Formation Bio reported that its subsidiary, Libertas Bio, has licensed gusacitinib, an oral dual JAK/SYK inhibitor, to Sanofi, which will investigate it in a new, previously unstudied indication through a P-I trial
The deal could total up to €545M ($627.64M), including upfront and milestone payments, along with low to mid-teen royalties on future sales…
Shots:
Nitinotes has received the FDA’s IDE approval to begin a pivotal trial of its EndoZip System for endoscopic sleeve gastroplasty; enrollment is set to start by Q3’25
The trial will assess the safety & efficacy of the EndoZip System for obesity pts. (n=184) across up to 10 US and additional international sites. As a…
Shots:
The US FDA has approved Benlysta (belimumab) 200 mg/mL Autoinjector for SC use in pts (age≥5) with active LN receiving standard therapy
Benlysta (belimumab) is a BLyS-specific inhibitor that reduces B cell survival and differentiation by binding to soluble BLyS, targeting autoreactive B cells.
With this approval, GSK offers a first-of-its-kind at-home SC option…
Shots:
PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA
The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others …
Shots:
The UK’s MHRA has approved Hetronifly (serplulimab) to treat previously untreated adults in the UK with extensive-stage small cell lung cancer (ES-SCLC)
Approval were based on the global P-III (ASTRUM-005) study (n=585) across 128 trial sites, which showed a mFU of 42.4 mos. & 4-year OS rate of 21.9% with serplulimab + CT, confirming its long-term…
Shots:
The EC has approved Sephience (sepiapterin) to treat PKU in pts of all ages and disease severities across all 30 EEA states; launch is anticipated in Germany in H1 of July
Approval was based on APHENITY study results and long-term extension data showing durable effects and improved dietary flexibility
Sephience is an oral synthetic…
Shots:
The CHMP has recommended AVT06, a biosimilar version of Eylea (aflibercept 2 mg), across all 30 EEA states
AVT06 is a recombinant fusion protein that inhibits VEGF to reduce neovascularization and vascular permeability. The CHMP recommends MAA for wet AMD, visual impairment from macular oedema due to RVO (branch or central), diabetic macular oedema…
Shots:
The CHMP has recommended Nirogacestat as a monotx. for adults with progressing desmoid tumors needing systemic treatment, the EC’s decision is expected in Q3’25
Opinion was supported by the MAA on P-III (DeFi) global trial (N=142) assessing Nirogacestat (n=700) vs PBO (n=72), which met the 1EP, showing a 71% reduction in PFS vs PBO,…