Samsung Bioepis received a positive CHMP opinion for Obodence and Xbryk, biosimilars of Amgen's Prolia and Xgeva, respectively, targeting osteoporosis and skeletal-related conditions.

Roivant Sciences has acquired mosliciguat, an experimental drug, from Bayer to develop as a treatment for pulmonary hypertension.

The Department of Veterans Affairs (VA) has initiated the Prostate Cancer, Genetic Risk, and Equitable Screening Study (ProGRESS) to investigate the potential of genetic testing in refining prostate cancer screening. This study aims to personalize screening recommendations based on individual genetic profiles, potentially improving screening efficacy and reducing unnecessary procedures.

Inmagene Biopharmaceuticals has announced positive results from a phase 2a clinical study of IMG-007, a treatment for moderate-to-severe atopic dermatitis. The study showed a significant reduction in eczema area and severity index (EASI) and a favorable safety profile, suggesting potential for long-term management of the condition.

Dr. Annemarie Shepherd highlights the advantages of proton therapy for thymic cancer patients, particularly in cases where tumors are located near the heart. The treatment offers precise targeting with minimal radiation exposure to surrounding tissues, potentially reducing long-term cardiovascular complications in patients who often have decades of life ahead.

A first-in-human phase 1 trial evaluated BNT221, a personalized neoantigen-specific T cell therapy, in patients with advanced melanoma who progressed after standard treatments. The study demonstrated the feasibility and safety of manufacturing patient-specific T cell products targeting multiple tumor mutations, while providing early evidence of clinical activity.

The FDA's 2024 mandate for boxed warnings on CAR-T cell therapies due to potential risks of secondary T-cell malignancies has sparked debate among clinicians and researchers. While initial concerns were raised, subsequent studies suggest the risk is low and comparable to other treatments, questioning the necessity of the warning.

Alder BioPharmaceuticals announced the presentation of new data from the PROMISE 1 and PROMISE 2 phase 3 clinical trials for eptinezumab, their lead investigational product for migraine prevention, at the American Headache Society annual meeting. The data highlights eptinezumab's efficacy in reducing migraine days and improving quality of life for patients.

The FDA has granted fast track designation to the combination of botensilimab and balstilimab for treating non-MSI-H/dMMR metastatic colorectal cancer patients without active liver involvement. This designation aims to expedite the development and review of the treatment for heavily pretreated patients resistant or intolerant to standard therapies.

Recent discussions and studies highlight the evolving landscape of non-small cell lung cancer (NSCLC) treatment, focusing on antibody-drug conjugates (ADCs) and their potential benefits, sequencing strategies, and management of toxicities. Key trials such as EVOKE-01, HERTHENA-Lung01, and MARIPOSA are examined for their impact on patient care.

The unexpected FDA approval of Sarepta Therapeutics' Vyondys 53 for Duchenne muscular dystrophy has sparked discussions about the potential flexibility the FDA might show towards Biogen's Alzheimer's drug, aducanumab. This comes amidst skepticism over the efficacy and safety of both drugs, with Biogen's application based on a controversial Phase 3 study.

FluoGuide A/S has released its interim report for the first nine months of 2024, highlighting preparations for the FG001 phase II head and neck trial application and progress on clinical and regulatory plans for aggressive brain cancer. The company reported a net loss of DKK 20,218 thousand for the period.

Recent clinical trials, including the groundbreaking PRESTO-1 trial, have highlighted the potential of exercise therapy as a viable anticancer strategy. Findings suggest that specific doses of exercise can significantly impact tumor biology in prostate cancer patients, paving the way for further research into its efficacy across various solid tumors.

Cargo Therapeutics has announced the discontinuation of its Phase II FIRCE-1 clinical trial evaluating firi-cel, an autologous CD22 CAR-T therapy, following safety concerns. The decision came after an ad hoc analysis revealed an unfavorable benefit-risk profile, leading to a downgrade of the company's stock rating by Chardan.

A discrete choice experiment with 205 ALK+ NSCLC patients and 125 caregivers found that both groups overwhelmingly prioritized 3-year progression-free survival when making treatment decisions.

Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor.

The World Health Organization (WHO) has assessed India's Central Drugs Standard Control Organization (CDSCO), the nation's top drug regulator.

Yale School of Medicine surgeon-scientist Sara Pai, MD, PhD, has achieved FDA orphan drug designation for pembrolizumab to treat recurrent respiratory papillomatosis (RRP), a rare condition caused by HPV. This designation, based on a clinical trial showing significant benefits for RRP patients, highlights the innovative role of surgeon-scientists in advancing treatments.

The FDA has granted approval for monthly maintenance dosing of Leqembi (developed by Eisai and Biogen) for early Alzheimer's disease patients. After 18 months of bi-weekly treatment, patients can transition to monthly dosing at half the original dose, based on Phase 2 study results and modeling simulations demonstrating sustained therapeutic benefits.

The European Medicines Agency (EMA) has waived the requirement for pediatric trials of mesdopetam, Irlab Therapeutics' candidate therapy for levodopa-induced dyskinesia in Parkinson's disease. This decision, aligned with a similar FDA ruling, allows Irlab to focus on adult trials as they prepare for Phase 3 studies of the D3 receptor antagonist.