Don Tracy, Associate Editor

Accelerated approval is based on results of the ASC4FIRST Phase III trial, which demonstrated Scemblix's superior efficacy in achieving major molecular response compared to standard of care tyrosine kinase inhibitors in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Roxybond is the and only FDA-approved abuse-deterrent immediate-release 10 mg oxycodone formulation designed to reduce abuse of pain medication via intranasal and intravenous routes.

CMG1A46 is currently being developed for B cell-driven autoimmune diseases, primarily systemic lupus erythematosus and lupus nephritis.

Collaboration seeks to advance the treatment of non-small cell lung cancer by combining Keytruda with Moderna’s novel neoantigen therapy, which has shown positive results across cancer types.

Acquisition includes Aliada’s lead asset, ALIA-1758, which is being developed for the treatment of Alzheimer disease.

Under terms of the deal, Richter will receive an upfront cash payment of $25 million, along with potential future development, regulatory, and commercialization milestones.

Growth is expected due to increased instances of chronic diseases such as cancer and Alzheimer disease.

Despite a recent FDA Complete Response Letter issued to Lykos for midomafetamine capsules for the treatment of post-traumatic stress disorder, experts believe that the future is bright for psychedelic drugs that treat mental health conditions.

Najat Khan, chief R&D officer, chief commercial officer, Recursion, and Fred Hassan, director, Warburg Pincus, discuss how artificial intelligence can help reduce healthcare costs at the 20th Annual Young & Partners Pharmaceutical Executive Summit held at the Yale Club of New York.

Under terms of the deal, Merck will provide an upfront payment of $30 million, with potential milestone payments of up to $1.3 billion for the Yale University spinout that develops targeted therapies for cancer.

Peter Marks, director, Center for Biologics Evaluation and Research, FDA, presented the keynote presentation on the future of gene therapy as part of the 20th Annual Young & Partners Pharmaceutical Executive Summit held at the Yale Club of New York.

Under terms of the deal, Sanofi would sell a 50% controlling stake in Opella to CD&R, while remaining a significant shareholder.

The expanded indication of Selarsdi for the treatment of diseases such as psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease is expected to support the official launch early next year.

Regulatory action marks the fourth aesthetic indication and the first beyond facial treatments for Botox.

Vyloy is the first CLDN18.2-targeted therapy for advanced gastric and gastroesophageal junction adenocarcinoma to be approved in the United States.

Priority Review status for GSK’s New Drug Application for gepotidacin was based on promising results from the Phase III EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin in uncomplicated urinary tract infections.

Expanded approval of Lumryz offers a once-nightly treatment option for younger patients, eliminating the need for traditional narcolepsy treatments that often require multiple doses throughout the night.

Partnership is expected to develop radioligand therapies based on lead-212 alpha-emitting isotopes, which offer the opportunity to destroy cancer cells with minimal damage to healthy tissue.

Vyalev is the first and only FDA-approved subcutaneous 24-hour infusion of a levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson disease.

Results from the Phase II/III Vibrance-MG study found that patients with generalized myasthenia gravis who were treated with nipocalimab plus standard-of-care achieved sustained disease control.

Results from the Phase III Vivid-1 trial found that more Crohn disease patients treated with mirikizumab achieved histologic response at week 52 compared to ustekinumab.

As part of the collaboration, Exelixis and Merck will evaluate zanzalintinib in combination with Keytruda for head and neck cancer.

Expanded indication of Bimzelx offers a prefilled syringe with a single 2 mL subcutaneous injection, improving upon the previous regimen of two 1 mL injections.

Acquisition of Longboard grants Lundbeck access to bexicaserin, 5-HT2C receptor agonist that has demonstrated promise in treating seizures associated with rare developmental epileptic encephalopathies.

Hympavzi is the first anti-tissue factor pathway inhibitor therapy to be approved in the United States for routine prophylaxis of bleeding in patients with hemophilia A or B without inhibitors.

JAMA study finds that redispensing oral anticancer drugs reduces approximately two-thirds of medication waste as healthcare stakeholders seek more sustainable practices.

Approval was based on results from the Phase III INAVO120 trial, which found that Itovebi in combination with palbociclib and fulvestrant significantly improved progression-free survival in patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses integrating digital solutions with traceability and drug administration.

Data from the Phase III AReSVi-006 clinical trial found that Arexvy offered a cumulative efficacy of 62.9% against lower respiratory tract disease caused by respiratory syncytial virus.

Healgen’s Rapid Check COVID-19/Flu A&B Antigen Test is the first non-prescription COVID-19/flu combination test to be authorized by the FDA without emergency use authorization.