Davy James

A full summary of the acute adverse effects of psilocybin in the treatment of depression and anxiety is vital for health care providers to provide effective patient counseling.

Findings from the Phase I/II KRYSTAL-1 trial of Krazati (adagrasib) plus cetuximab showed promising clinical activity and tolerable safety in patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer.

Findings from MONeT clinical trial show positive safety and efficacy of Abrysvo in individuals aged 18 to 59 years with an increased risk of developing severe respiratory syncytial virus-associated lower respiratory tract disease.

In the EMPACT-MI trial, Jardiance produced a 10% relative risk reduction in the primary composite endpoint of time to first hospitalization for heart failure or all-cause mortality.

Trial to analyze novel therapy MK-1084 plus Keytruda (pembrolizumab) in certain patients with metastatic non-small cell lung cancer whose tumors harbor KRAS G12C mutations and express PD-L1.

In the Phase III BE HEARD I and BE HEARD II trials, a greater proportion of patients with moderate-to-severe hidradenitis suppurativa who were administered Bimzelx achieved the primary endpoint of clinically meaningful improvements in HiSCR50.

Raludotatug deruxtecan is a potential first-in-class CDH6-directed antibody drug conjugate that has shown promise in patients with CDH6-expressing serous-type ovarian cancer and renal cell carcinoma.

The investigational TROP2-directed antibody drug conjugate improved progression-free survival in patients with unresectable or metastatic HR-positive, HER2-negative breast cancer.

Phase III GATHER2 trial data show Izervay reduced the rate of geographic atrophy lesion growth across every month and every-other-month dosing through two years of treatment.

Krazati (adagrasib) was previously granted accelerated approval by the FDA to treat patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer who were previously administered at least one systemic therapy.

LPCN 1148 is an oral treatment that has shown promise preventing recurrence of overt hepatic encephalopathy and treating sarcopenia.

Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.

mRNA-1283 was found to elicit a higher immune response against SARS-CoV-2 than Moderna's licensed COVID-19 vaccine, mRNA-1273.

Odronextamab is being evaluated for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma following two or more prior lines of systemic therapy.

Opdivo plus Yervoy was found to produce a statistically significant and clinically meaningful overall survival improvement compared with sorafenib or lenvatinib in patients with advanced hepatocellular carcinoma.

Pivotal Phase III Study 302 trial data show an objective response rate of 36.2% based on an independent review committee assessment in the treatment of relapsed/refractory cutaneous T-cell lymphoma.

Jemperli plus chemotherapy with or without adding maintenance treatment with Zejula produced a statistically significant overall survival and progression-free survival benefit in patients with primary advanced or recurrent endometrial cancer.

Keytruda plus chemoradiotherapy found to significantly improve overall survival in patients newly diagnosed with high-risk locally advanced cervical cancer.

THARROS trial investigators seek to provide first-of-its-kind evidence supporting a strategy of comprehensive cardiopulmonary risk reduction with a triple therapy in patients with chronic obstructive pulmonary disease.

Clinical trials planned for the fourth quarter of 2024 will evaluate a new multi-valent vaccine to protect against multiple types of human papillomavirus, and to analyze the efficacy and safety of a single-dose of Gardasil 9.

Adcetris (brentuximab vedotin) plus lenalidomide and rituximab produced statistically significant and clinically meaningful improvements in overall survival in patients with relapsed or refractory diffuse large B-cell lymphoma.

Blenrep (belantamab mafodotin) combined with pomalidomide plus dexamethasone showed favorable progression-free survival compared with standard of care in the second-line and later treatment of relapsed or refractory multiple myeloma.

Zilebesiran added to standard of care treatment for mild to moderate hypertension produced a clinically and statistically significant decrease in systolic blood pressure after three months.

The FDA previously halted the IOV-LUN-202 trial following reports of a grade 5 serious adverse event that may have been linked to treatment with Iovance Biotherapeutics’ novel tumor infiltrating lymphocyte cell therapy LN-145, which is being evaluated in patients with advanced non–small cell lung cancer.

Zolgensma (onasemnogene abeparvovec), a one-time gene therapy, showed a clinical benefit for older and heavier patients with spinal muscular atrophy, many of whom were previously treated with another disease-modifying therapy.

Data from a pair of Phase III trials indicated a progression-free survival and complete response advantage in favor of Brukinsa in patients with relapsed or refractory chronic lymphocytic leukemia.

UCB seeks approval of Bimzelx (bimekizumab-bkzx) for psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa.

PL9643 ophthalmic solution is a melanocortin agonist with a novel mechanism of action that produced a clinically meaningful and statistically significant reduction in pain associated with dry eye disease.

Epkinly (epcoritamab-bysp), subcutaneously administered, T-cell engaging, IgG1-bispecific antibody, was previously granted Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory follicular lymphoma.

Survodutide produced a statistically significant improvement in metabolic dysfunction-associated steatohepatitis among 83% of those administered the drug compared to 18.2% of those given a placebo.