Shots:
Labcorp has launched the Elecsys pTau-181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.)
The test delivers a 97.9% negative predictive value to help rule out Alzheimer’s pathology in symptomatic pts & offers a less invasive, more accessible alternative to brain scans or lumbar punctures…
Shots:
Approval was based on the P-III (PANOVA-3) trial assessing Optune Pax, a TTFields device used concomitantly with gemcitabine & nab-paclitaxel (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer
Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In mPP (198 received Optune…
Shots:
The US FDA has approved Keytruda/Keytruda Qlex + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapy
Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W) with CT…
Shots:
The global P-II (VALIANT) trial data assessed Verekitug vs PBO in 478 pts with severe asthma for ~60wks., with a minimum of 24wks. of treatment. Eligible pts could then enroll in the VALOUR LTE trial
Trial met its 1EP, reducing annualized asthma exacerbation rates by 56% (100mg; Q12W) & 39% (400mg, Q24W), with FEV1…
Shots:
Madrigal has entered into an exclusive global license agreement with Suzhou Ribo Life Science & its subsidiary Ribocure Pharmaceuticals for 6 preclinical siRNA programs in metabolic dysfunction-associated steatohepatitis (MASH)
The deal allows Madrigal to pair a targeted gene-silencing siRNA approach with Rezdiffra to assess whether genetically reducing disease drivers can enhance its therapeutic impact,…
Shots:
The Chinese NMPA has approved the initiation of P-II trials of AK139 across seven indications, incl. COPD, severe bronchial asthma, chronic spontaneous urticaria, allergic rhinitis, CRSwNP, mod. to sev. atopic dermatitis, & prurigo nodularis
AK139 is an IL-4Rα/ST2 bispecific antibody that blocks both the IL-4/IL-13 pathway via binding to IL-4Rα subunit & the IL-33/ST2…
Shots:
OrsoBio has reported topline P-IIa PoC trial data assessing TLC-2716 (6 or 12mg, QD, PO) vs PBO in 30 overweight pts with severe hypertriglyceridemia & metabolic dysfunction–associated steatotic liver disease (MASLD)
The study met its 1EP, showing statistically significant reductions in fasting triglycerides & remnant cholesterol, plus improved liver fat by MRI-PDFF, with stronger lipid…
Shots:
THX has granted Biocodex an exclusive global license to develop & commercialize Batten-1 for juvenile Batten disease (CLN3), along with exclusive US & Canada rights to develop & commercialize TX01 for Gaucher & Niemann-Pick type C disease
As per the deal, THX will lead clinical development with financial & scientific support from Biocodex, which will…
Shots:
Insilico Medicine has entered into multiple AI-powered drug discovery collaborations with CMS, focusing on advancing therapeutic programs across CNS & autoimmune disease indications
As per the deal, Insilico will leverage its Pharma.AI platform for target discovery & small-molecule design & optimization, while CMS will lead clinical development, regulatory strategy, trials, & commercialization
Under the…
Shots:
The US FDA has granted RMAT Designation to KB707 for the treatment of advanced or metastatic NSCLC
Designation was supported by the ongoing P-I/II (KYANITE-1) trial assessing KB707 (administered via nebulization) across 7 cohorts: Arms 1-4 as monotx., Arm 5 with Keytruda, Arm 6 with Keytruda & CT & Arm 7 with CT alone…

