FDA Considers Narrowing PD-1 Inhibitor Label for Gastric Cancer Based on PD-L1 Expression
The FDA is considering limiting the use of PD-1 inhibitors like Keytruda and Opdivo in gastric adenocarcinoma based on PD-L1 expression levels.
Diamyd Medical Warrants Expire as Phase 3 Trial Readout Nears
Diamyd Medical's warrants of series TO 3 expired on September 25, 2024, concluding the exercise period that began on September 2, 2024.
Vertex Highlights Vanzacaftor Triple Combination Data and Long-Term TRIKAFTA Impact at NACFC
Vertex Pharmaceuticals presented Phase 3 data on vanzacaftor/tezacaftor/deutivacaftor, showing non-inferiority to TRIKAFTA® in ppFEV1 and improved CFTR function.
pmIL12 Gene Therapy Shows Promise in Preclinical Cancer Study
Intratumoral pmIL12 gene electrotransfer (GET) demonstrated anti-tumor effectiveness in a murine model of cancer, warranting further clinical investigation.
Vutrisiran Shows Promise in ATTR-CM Treatment: Alnylam's HELIOS-B Data Highlights Cardiac Benefits
New data from the HELIOS-B study reveals vutrisiran significantly improves cardiac structure and function in ATTR-CM patients over 30 months compared to placebo.
Combination Therapies Reshape Frontline HCC Treatment Landscape
Combination regimens, including STRIDE (single tremelimumab and regular-interval durvalumab), are transforming first-line HCC treatment, offering personalized options.
Decitabine Plus CHAG Regimen Shows Promise in Relapsed/Refractory AML
A study shows that combining decitabine with the CHAG priming regimen yields a high complete remission rate (74.2%) in relapsed/refractory AML patients.
FDA Approves Ziihera (zanidatamab-hrii) for HER2-Positive Biliary Tract Cancer
The FDA has granted accelerated approval to Ziihera (zanidatamab-hrii) for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC).
Savara's Molgramostim Shows Promise in Autoimmune Pulmonary Alveolar Proteinosis
Savara Inc. presented results from the Phase 3 IMPALA-2 trial of molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (aPAP).
R2-ISS Staging System Validated for Relapsed/Refractory Multiple Myeloma in Novel Agent Era
The Revised International Staging System (R2-ISS) effectively stratifies risk in relapsed/refractory multiple myeloma patients, showing progressive decline in survival with increasing stage.
Imlifidase Shows Promise in Guillain-Barré Syndrome and Expands Gene Therapy Access
Phase 2 data indicates imlifidase, combined with IVIg, significantly improves motor function and accelerates recovery in Guillain-Barré Syndrome (GBS) patients.
MediciNova's Ibudilast Shows Promise in ALS Trial: Interim Analysis Reveals Strong Correlations
MediciNova's COMBAT-ALS Phase 2/3 trial of MN-166 (ibudilast) in ALS shows positive correlations between 6-month and 12-month data for key metrics.
CyanVac's Intranasal COVID-19 Vaccine Candidate, CVXGA, Enters Phase 2b Trial
CyanVac's CVXGA, an intranasal COVID-19 vaccine, has dosed its first participant in a Phase 2b clinical study.
Tabelecleucel Shows Sustained Efficacy in EBV+ PTLD, FDA Decision Expected in January 2025
Tabelecleucel demonstrates a 50.7% objective response rate in patients with relapsed or refractory EBV+ PTLD after transplant, according to Phase 3 ALLELE study results.
AIM Vaccine's Serum-Free Rabies Vaccine Achieves Phase III Goals, Paving Way for Market Launch
AIM Vaccine's iterative serum-free rabies vaccine demonstrated strong immunogenicity and safety in Phase III trials, meeting all pre-set clinical objectives.
EUS-Guided Celiac Plexus Block Shows Promise in Pancreatic Cancer Pain Management
Endoscopic ultrasound-guided celiac plexus block (EUS-CPB) is being investigated for pain palliation in pancreatic cancer patients.
Phase 3 ASCEND Trial Shows Long-Term Safety of STS101 Nasal Powder for Acute Migraine Treatment
Phase 3 ASCEND study demonstrates the long-term safety and tolerability of STS101 (dihydroergotamine nasal powder) over 12-18 months for acute migraine treatment.
IMUNON's IMNN-001 Demonstrates Significant Survival Benefit in Ovarian Cancer Phase 2 Trial
IMUNON's IMNN-001 Phase 2 OVATION 2 study showed an 11.1-month increase in median overall survival compared to standard care for ovarian cancer patients.
LaNova Medicines Initiates Phase 1 Trial of LM-299, Anti-PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors
LaNova Medicines has begun a Phase 1 clinical trial in China for LM-299, a bispecific antibody targeting PD-1 and VEGF, in patients with advanced solid tumors.
Khondrion's Sonlicromanol Receives FDA Clearance for Phase 3 Trial in Primary Mitochondrial Disease
Khondrion received FDA clearance for its IND application to initiate a pivotal Phase 3 trial of sonlicromanol in adult patients with primary mitochondrial disease (PMD).