Shots:
The US FDA has granted FTD to ADI-001 for treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement
Adicet Bio is advancing ADI-001 in six autoimmune indications, with patient enrollment ongoing in the P-I LN study. Enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff…
NEWS
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The CHMP has recommended Imfinzi for the treatment of LS-SCLC pts whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions
Opinion was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by Imfinzi…
Shots:
The EC has approved Hetronifly + CT (carboplatin & etoposide) as a 1L treatment for extensive-stage small cell lung cancer (ES-SCLC) pts.
Serplulimab, an anti-PD-1 mAb for 1L SCLC therapy, is approved in China and several SEA countries. ESMO rates it 4/5 on the MCBS for ES-SCLC. Its trial results were published in…
Shots:
The US FDA has granted RMAT designation to Vigil (gemogenovatucel-T) as a maintenance therapy for newly diagnosed advanced Stage IIIb/IV HRP ovarian cancer pts with cTMB-H who achieved complete response post-debulking surgery & frontline Pt-based doublet CT
Designation was backed by ongoing P-IIb (VITAL) trial assessing Vigil vs PBO showed improved RFS (1EP) in all…
Shots:
Imagene & Tempus AI have collaborated to advance lung cancer diagnostics by enhancing biomarker prediction, integrating AI tools into clinical workflows, & allowing commercial access to diagnostic solutions
Collaboration will integrate Imagene's AI multi-gene panel for rapid NSCLC biomarker prediction from biopsy images with Tempus' clinical reach & real-world data, creating a unified…
Shots:
Akeso has completed patient enrollment in the global P-III (HARMONi-6/AK112-306) trial (1/6 P-III trials) assessing ivonescimab + Pt-based CT vs Tevimbra + Pt-based CT to treat 1L squamous NSCLC in China
Multiple P-III trials are underway, incl. HARMONi-3 (vs Keytruda + CT) in 1L sq- & non-sq NSCLC (led by Summit Therapeutics), plus trials…
Shots:
Dawn Health & Novartis have launched Cora BC app to offer support to all breast cancer pts & their kin following the development of Ekiva MS & Ekiva PNH. Launch will start in Germany, extending to other markets incl. UK, Canada & Australia
Cora BC tracks pts health with regular check-ins, intuitive graphs, plus personalized reminders…
Shots:
Japan’s MHLW has received NDA for conditional approval of avacincaptad pegol (ACP) to treat geographic atrophy (GA) secondary to AMD
Submission was backed by the P-II/III (GATHER1) & P-III (GATHER2) trials assessing safety & efficacy of ACP (2mg, Q1M, intravitreal) in pts with GA secondary to AMD
Data from both trials showed reduced…
Shots:
Cumberland reported topline data from P-II (FIGHT DMD) trial assessing ifetroban (150/300mg, QD) vs PBO in DMD pts (n=41) for 12mos.; funded via the US FDA orphan products grant
Study showed that ifetroban (300mg) led to 3.3% overall LVEF improvement (1EP), with a 1.8% increase vs 1.5% decline; on comparison with matched natural…
Shots:
Formycon has signed an exclusive license agreement with Lotus Pharmaceutical to commercialize FYB203/Ahzantive in APAC countries, including Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, and Hong Kong. Additionally, Formycon will supply the finished product to Lotus
As per the agreement, Klinge will receive upfront and milestone payments, along with royalties on Lotus’ net…

