Don Tracy, Associate Editor

Results from the Phase Ib Beamion LUNG-1 trial found that zongertinib achieved an objective response rate of 66.7% in previously treated patients with advanced non-small cell lung cancer with HER2 mutations.

Filspari is considered the first non-immunosuppressive treatment to significantly slow kidney function decline in adults with IgA nephropathy.

Results of the FENopta study found that after one year of treatment, 96% of patients experienced no relapses of multiple sclerosis, with an annualized relapse rate of just 0.04.

Results from the MATINEE trial found that Nucala led to a statistically significant and clinically meaningful reduction in moderate/severe exacerbations of chronic obstructive pulmonary disease compared to placebo over 104 weeks.

Boruzu is the first ready-to-use version of bortezomib for subcutaneous and intravenous administration in the treatment of multiple myeloma and mantle cell lymphoma.

Results from the QWINT-1 and QWINT-3 trials found that insulin-naïve patients achieved similar reductions in A1C levels using once-weekly efsitora compared to daily insulin glargine and degludec.

Data from the Phase II/III DEVOTE study demonstrated that Spinraza showed significant motor function improvements at six months in infants with spinal muscular atrophy.

Results from the FINE-HEART pooled analysis of three Phase III clinical trials highlighted the potential of finerenone in treating high-risk cardiovascular patients.

Results of the RESTORE study revealed that 94% of participants preferred Lumryz over twice nightly oxybate treatments for narcolepsy.

Results from the Phase III EXPLORER-LTE study found that Camzyos maintained effectiveness in treating symptomatic obstructive hypertrophic cardiomyopathy after 3.5 years of treatment.

Submission is supported by results from the Phase III Vivacity-MG3 study, which demonstrated that nipocalimab, combined with standard care, significantly improved outcomes for patients with antibody-positive generalized myasthenia gravis.

Submission of a New Drug Application for mirdametinib included data from the Phase IIb ReNeu trial, which evaluated patients with NF1-associated plexiform neurofibromas causing significant morbidity.

Results of the INTEGUMENT-OLE study found that the roflumilast cream not only maintained but improved its efficacy over time treating children from two to five years of age with mild to moderate atopic dermatitis.

A new National Institutes of Health grant will advance research into the role of the serotonin 5-HT2A receptor in mitigating methamphetamine use.

Topline results from the Phase III V-MONO study of Leqvio found that twice-yearly Leqvio achieved clinically LDL-C lowering compared to both placebo and ezetimibe.

The new vials of Zepbound are available through a new self-pay pharmacy channel, priced over 50% lower than other incretin medications for obesity.

Shorespan-007 is expected to enroll approximately 300 patients with essential thrombocythemia and will compare bomedemstat to hydroxyurea, the current standard of care.

Expanded indication makes Omnipod the first automated insulin delivery system to be approved for the management of both type 1 and type 2 diabetes.

Results from the Phase III BOREAS and NOTUS trials found that Dupixent reduced moderate-to-severe COPD exacerbations by 31% over 52 weeks.

The MACI Arthro can be administered through small incisions using custom instruments to repair cartilage defects in the knee.

64Cu-SAR-bisPSMA has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and a longer half-life in PET imaging of PSMA-positive prostate cancer lesions, Clarity says.

In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, MD, chief medical officer, IMF, discusses challenges of access and advancement of myeloma therapies.

Findings from a recent study demonstrated that high-dose psilocybin provided a superior reduction in depressive symptoms compared to both placebo and escitalopram in patients with major depressive disorder.

Findings from a study published in the Journal of the Obesity Society may significantly advance the understanding of GLP-1 analogues and their role in treating obesity.

Acceptance of supplemental Biologics License Application was based on results from the Phase III CheckMate-9DW trial, which demonstrated that the combination of Opdivo and Yervoy significantly improved overall survival in patients with hepatocellular carcinoma.

Breakthrough therapy designation for GSK5764227 based on preliminary data from the ongoing ARTEMIS-001 Phase I trial, which showed the novel therapy’s promise treating patients with relapsed or refractory extensive-stage small-cell lung cancer.

The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech, which could improve the treatment of heart failure with reduced ejection fraction.

Approval marks the first multitargeted regimen to surpass Tagrisso in efficacy in the first-line treatment of advanced non-small cell lung cancer, according to Johnson & Johnson.

In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, chief medical officer, IMF, offers a glimpse at multiple initiatives that the IMF is working towards to improve myeloma treatment globally.

Approval of Niktimvo was based on positive data from the AGAVE-201 study, which demonstrated a 75% response rate in patients with chronic graft-versus-host disease.