• The FDA has approved Orlynvah (sulopenem etzadroxil and probenecid) for treating uncomplicated urinary tract infections (uUTIs) in adult women with limited oral antibacterial options. • Orlynvah is the first approved indication for Iterum Therapeutics and the first oral penem antibiotic approved in the U.S., offering a novel treatment option. • The approval targets uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, addressing antimicrobial resistance challenges. • Iterum Therapeutics is seeking a strategic transaction for Orlynvah to maximize stakeholder value following this FDA approval.

A retrospective study of 580 AML patients undergoing allo-HSCT revealed the impact of pre-transplant MRD status on outcomes.

Ascletis Pharma has completed enrollment of 480 patients in a Phase III trial evaluating denifanstat (ASC40), a once-daily oral tablet, for moderate to severe acne.

Ascletis Pharma has completed enrollment of 480 patients in its Phase III clinical trial for ASC40 (denifanstat), an oral tablet for moderate to severe acne.

• Analysis of two randomized trials reveals that Xifaxan monotherapy is more effective than lactulose in reducing overt hepatic encephalopathy (OHE) recurrence and mortality. • New data highlights Xifaxan's impact on reducing rehospitalizations for OHE in both commercially insured and Medicare patient populations. • Plenvu's efficacy as a bowel preparation medication is confirmed in colonoscopy patients with comorbid conditions or those on medications affecting bowel prep quality.

NeuroPace has submitted three-year safety and effectiveness data from its largest prospective neuromodulation trial, involving over 300 patients with drug-resistant focal epilepsy, to the FDA.

Altimmune has reached an agreement with the FDA on the design of its Phase 3 program for pemvidutide in treating obesity, marking a significant regulatory milestone.

Puma Biotechnology has commenced the ALISCA-Breast1 Phase II trial to evaluate alisertib combined with endocrine therapy for HR+/HER2- metastatic breast cancer patients.

IMUNON has secured FDA alignment on its Chemistry, Manufacturing, and Controls (CMC) strategy for IMNN-001, an immunotherapy targeting advanced ovarian cancer.

Luspatercept gains FDA approval as a frontline treatment for anemia in lower-risk myelodysplastic syndrome (MDS) patients without prior erythropoiesis-stimulating agent (ESA) use.

A groundbreaking UK study involving 135 children across ten pediatric intensive care units examines pressure reactivity index monitoring in traumatic brain injuries, aiming to improve treatment outcomes.

Immuneering Corporation announced it will hold a virtual Investor Event in early January 2025 to discuss data from its ongoing Phase 2a trial of IMM-1-104, including additional data from IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer, initial data from IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer, and initial data from IMM-1-104 monotherapy in second-line pancreatic cancer.

A groundbreaking 17-year international clinical trial involving 889 colon cancer patients shows that structured exercise programs reduce cancer recurrence risk by 28% and death risk by 37%.

Ruhr University Bochum researchers successfully produced human DNase1 enzyme in yeast cells for the first time, marking a breakthrough after decades of reliance on expensive hamster cell production methods.

Acelyrin will present Phase 2 data for subcutaneous Lonigutamab, indicating a potentially best-in-class efficacy and safety profile for Thyroid Eye Disease (TED).

A University of Birmingham study reveals digoxin could save the NHS £100m annually compared to beta-blockers in treating elderly patients with heart failure and atrial fibrillation.

Dr. Nusayba Bagegni, a medical oncologist at Washington University, has received the 2024 Early Career Cancer Clinical Investigator Award from the NCI.

Researchers at the University of Cincinnati are trialing personalized mRNA vaccines to prevent lung cancer recurrence after surgery.

Vera Therapeutics has secured an exclusive licensing agreement with Stanford University for a novel fusion protein targeting BAFF and APRIL, enhancing its portfolio for B-cell mediated diseases. The company is progressing with its Phase III ORIGIN 3 study, with topline results expected in Q2 2025, supported by promising Phase II data that highlight the potential for eGFR stabilization and successful market entry of atacicept.

A comprehensive review of literature reveals significant disparities in biologic therapy access for psoriasis patients, including barriers related to race, age, socioeconomic status, and rural residence.