Shots:
IDEAYAhas entered into an additional clinical study collaboration and supply agreement with Gilead Sciences to evaluate the efficacy and safety of IDE397 + Trodelvy in MTAP-Deletion NSCLC
IDEAYA is currently enrolling patients in a monotx. expansion study for IDE397 in MTAP-deletion NSCLC and urothelial cancer, alongside the P-I/II study evaluating IDE397 with Trodelvy in…
Shots:
Based on ARCADIA and OLYMPIA studies EU approved Nemluvio for moderate-to-severe AD and PN and is now approved for SC use in pts. aged 12 and older for AD and in adults for PN who are candidates for systemic therapy
ARCADIA 1 & 2 studies assessed Nemluvio (Q4W) + TCS ± TCI vs PBO…
Shots:
Sanofi and J&J have discontinued the P-III (E.mbrace) study of ExPEC9V after IDMC interim analysis due to insufficient efficacy against extraintestinal pathogenic E. coli , leading to a $250M impairment charge before tax
The P-III trial assessed single dose of ExPEC9V (IM) vs PBO in adults (≥60yrs.) with UTI history in past 2yrs. to prevent invasive…
Shots:
Japan’s MHLW received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Regulatory review is ongoing in the US, EU & China, with global filings planned
Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n>15000)…
Shots:
The P-III (TALAPRO-2) trial assessed Talzenna + Xtandi vs PBO + Xtandi in mCRPC ± HRRm pts for >4yr. (mFU: 52.5mos.) that were randomized into 2 Arms (A1: no genetic selection & A2: HRRm pts)
A1 showed reduced death risk by 20% & mOS of 45.8 vs 37mos. while A2 depicted death risk…
Shots:
EC has approved Andembry for HAE pts (≥12yrs) in 30 EEA states (incl. Iceland, Liechtenstein & Norway) following UK’s MHRA & Australia’s TGA approval in Jan 2025. Although, regulatory review is ongoing for the US, Switzerland, Japan & Canada
Approval was based on the P-III (VANGUARD) trial (Data published in The Lancet) assessing Andembry vs PBO & OLE…
Shots:
BI has launched Semintra (4mg/mL) in the EU for the treatment of systemic hypertension in cats
Semintra has shown clinical efficacy in reducing proteinuria & blood pressure, which may help restore kidney balance while also promoting cat’s appetite, activity levels, & QoL
Semintra (QD) is a telmisartan solution administered orally or on top…
Shots:
J&J MedTech has launched the Cereglide 92 Catheter System with the Innerglide 9 delivery aid in the US to ease insertion & guidance of interventional devices in the neurovascular system
Cereglide 92 features a .092” inner diameter with Innerglide 9 delivery aid, Brite-line tech for complete catheter visibility, & TruCourse for flexibility to…
Shots:
Dalan Animal Health has developed shrimp vaccine for white spot syndrome virus (WSSV) & early mortality syndrome (EMS) using its innate immunity platform, extending its validation from honeybee vaccine to aquaculture
Dalan’s shrimp vaccine (administered via the broodstock) will offer non-GMO as well as non-chemical alternative to conventional vaccines & has shown 62% &…
Shots:
The US FDA has approved sBLA for Adcetris + lenalidomide + Rituxan to treat adults with r/r LBCL (incl. DLBCL NOS, indolent lymphoma associated DLBCL, or HGBL), previously treated with ≥2L of therapy & are not eligible for auto-HSCT or CAR-T therapy
Approval was based on P-III (ECHELON-3) trial assessing Adcetris with lenalidomide +…

