Shots:
CereVasc completed enrollment in the ETCHES-1 Study evaluating its eShunt System in adults with communicating hydrocephalus resulting from elevated intracranial pressure following post-aneurysmal subarachnoid hemorrhage
Study will assess changes in intracranial pressure, device performance & safety, with pts monitored for safety outcomes for up to 24mos. following the procedure
eShunt System is designed to…
NEWS
The US FDA Accepts Celcuity’s Gedatolisib NDA under Priority Review to Treat HR+/HER2- Breast Cancer
Shots:
The US FDA has accepted NDA under priority review of gedatolisib in HR+/ HER2-, PIK3CA wild-type advanced breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jul 17, 2026)
NDA was supported by data from the PIK3CA wild-type cohort of the P-III (VIKTORIA-1) study assessing gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2-…
Shots:
Zydus Lifesciences has reported Tishtha, biosimilar version of Opdivo (Nivolumab), is now available in the India
Tishtha will be available in 100 mg and 40 mg strengths
Nivolumab is a mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma
Ref: Zydus | Image: Zydus | Press Release
Related News: Shanghai Henlius Receives the US FDA…
Shots:
The US Early Feasibility Study assessed TTVR system in 22 pts with severe to torrential tricuspid regurgitation; enrollment in the trans-jugular cohort is complete, with the study continuing via Trisol’s newly developed trans-femoral access route
Safety outcomes showed <5% permanent pacemaker need at 30 days, with considerable reduction in tricuspid regurgitation following implantation
At 30 days…
Shots:
The EC has approved Aqneursa (levacetylleucine), available as 1g granules for oral suspension, with or without miglustat for treating adults & pediatric pts (≥6yrs.; ≥20kg) with NPC
Approval was backed by P-III (IB1001-301) crossover study assessing Aqneursa vs PBO in NPC pts, which showed improved neurological symptoms & function after 12wks. as measured by…
Shots:
The EC has approved Dawnzera (SC autoinjector; Q4W/Q8W) for the routine prevention of HAE attacks in pts (≥12yrs.)
Approval was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate, with 94% overall mean monthly reduction at 1yr. in the OASISplus OLE study
Approval…
Shots:
Insilico Medicine & Hygtia Therapeutics have entered into a co-development global collaboration agreement for Insilico's ISM8969 program for CNS disorders
As per the deal, Hygtia will receive 50% worldwide rights to research, develop, register, manufacture, & commercialize ISM8969 in exchange for ~$66M, incl. milestone payments & $10M initial upfront payment
Under the agreement, Insilico…
Shots:
LEO Pharma has initiated P-III (DELTA CARE 1) trial assessing Anzupgocream vs cream vehicle for the treatment of adults with mild to sev. lichen sclerosus (LS)
DELTA CARE 1 will enroll ~652 adults with LS, starting with 300 female pts for dose selection, followed by evaluation vs vehicle in ~352 additional female & male pts…
Shots:
The US FDA has granted clearance to ION-C Facet Fixation System, part of SurGenTec’s posterior cervical platform, for the treatment of cervical pseudoarthrosis
Clearance was supported by IRB-approved long-term study data showing bridging bone across facet joints with no reported AEs, implant migration, or revision surgeries, & postoperative imaging confirming preserved cervical alignment &…
Shots:
GSK & Shionogi, together with Pfizer, have agreed to replace Pfizer’s 11.7% economic interest in ViiV Healthcare with an investment by Shionogi, reshaping the ownership structure of ViiV Healthcare
As per the deal, ViiV Healthcare will issue new shares to Shionogi for $2.125B, cancel Pfizer’s stake, pay Pfizer $1.875B, & distribute a $0.25B special…

