Clinical Trial News

Novartis Highlights Scemblix and Kisqali Data at ASH and SABCS

9 months ago

• Scemblix demonstrated favorable safety and tolerability in newly diagnosed chronic myeloid leukemia patients in the ASC4FIRST Phase III study. • Kisqali showed promising distant disease-free survival across key subgroups in HR+/HER2- early breast cancer from the Phase III NATALEE trial. • Novartis is presenting over 65 abstracts at ASH and SABCS, showcasing advancements in hematologic diseases and cancers.

FDA Approves Roche's PATHWAY HER2 Test as Companion Diagnostic for Biliary Tract Cancer

9 months ago

• Roche's PATHWAY HER2 (4B5) test gains FDA approval as the first companion diagnostic for HER2-positive biliary tract cancer (BTC) patients. • The test identifies patients eligible for treatment with ZIIHERA, offering a new option for those with previously treated, unresectable, or metastatic BTC. • This approval expands the clinical utility of the PATHWAY HER2 (4B5) test, which was previously indicated for HER2-targeted breast cancer therapies. • The PATHWAY HER2 (4B5) test standardizes immunohistochemistry processes, reducing variability and potential errors in HER2 status assessment.

FDA Approves Roche's PATHWAY HER2 Test as Companion Diagnostic for HER2-Positive Biliary Tract Cancer

9 months ago

• Roche's PATHWAY HER2 (4B5) test gains FDA approval as a companion diagnostic for identifying biliary tract cancer (BTC) patients eligible for ZIIHERA treatment. • The approval addresses a critical need for standardized HER2 testing in BTC, where treatment options are limited and prognosis is generally poor. • This expansion significantly broadens the clinical utility of the PATHWAY HER2 (4B5) test, offering a new avenue for personalized medicine in BTC. • ZIIHERA is the first FDA-approved treatment for adults with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer.

Advancements in ALS Research, AI-Driven Drug Discovery, and Single-Cell Protein Profiling Highlighted

9 months ago

Answer ALS and Cedars-Sinai have completed a large ALS patient-based stem cell and bio data repository, offering researchers unprecedented access to biological and clinical data.
Healx will use Sanofi compound data with its Healnet AI platform to identify new disease indications, leveraging AI to find connections for novel treatments.
Scale Biosciences and Revvity’s BioLegend have launched TotalSeq Phenocyte, a single-cell protein profiling solution for identifying and characterizing rare cell subtypes.
BioNTech acquired Biotheus, obtaining full rights to BNT327/PM8002, a bispecific antibody targeting PD-L1 and VEGF-A, enhancing its oncology strategy.

FDA Approves Attruby (Acoramidis) for ATTR-CM, Showing Near-Complete TTR Stabilization

9 months ago

• The FDA has approved Attruby (acoramidis) for treating adults with ATTR-CM, aiming to reduce cardiovascular death and related hospitalizations. • Attruby is the first and only approved product with a label specifying near-complete stabilization (≥90%) of Transthyretin (TTR). • Clinical trials demonstrated Attruby's rapid benefit, with a 42% reduction in combined all-cause mortality and recurrent cardiovascular hospitalization events at 30 months. • BridgeBio will provide Attruby free for life to U.S. clinical trial participants and offers patient support services through ForgingBridges™.

Alkannin Shows Promise in Esophageal Cancer Treatment by Targeting GSK3β

9 months ago

Alkannin, a natural compound, significantly inhibits esophageal squamous cell carcinoma (ESCC) cell proliferation in vitro and in vivo.
The compound induces G2/M phase cell cycle arrest and apoptosis in ESCC cells by suppressing GSK3β expression.
Transcriptomic analysis identifies GSK3β as a key target in Alkannin's anti-ESCC effects, suggesting a novel therapeutic strategy.
In vivo studies demonstrate that Alkannin effectively inhibits the growth of ESCC xenograft tumors in mice, supporting its potential as a cancer drug.

Johnson & Johnson Seeks FDA Approval for Tremfya to Treat Pediatric Psoriasis and Arthritis

9 months ago

Johnson & Johnson has submitted sBLAs to the FDA for Tremfya (guselkumab) to treat moderate-to-severe plaque psoriasis in children aged 6 and older.
The submission also seeks approval for Tremfya to treat active juvenile psoriatic arthritis in children aged 5 and older.
The sBLAs are based on data from the Phase 3 PROTOSTAR study and pharmacokinetic data from adult studies VOYAGE 1 and 2, and DISCOVER 1 and 2.
Tremfya, an IL-23 inhibitor, is already approved for adults with plaque psoriasis, psoriatic arthritis, and ulcerative colitis.