Don Tracy, Associate Editor

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.

A new study found that among 2,200 patients with irritable bowel diseases, 63% encountered financial barriers that led to missed doses of medication.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses ways that digital passports can help ensure patients receive the correct medication.

Felzartamab granted Breakthrough Designation after a clinical trial showed a significant improvement in late antibody-mediated rejection in kidney transplant recipients compared with placebo.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses innovations in label design that could lead to improved patient outcomes and less medical errors.

Under terms of the deal, Astellas will obtain the license for the global development and commercialization of AVB-101 to treat frontotemporal dementia with progranulin mutations.

Breakthrough Therapy designation for survodutide was based on preliminary clinical data showing potential improvement in patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis over existing therapies.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses scenarios where unclear labeling led to challenges for patient outcomes.

Under the agreement, AstraZeneca will be granted access to CSPC's small molecule candidate, YS2302018, with the goal of treating dyslipidemia and cardiovascular disease.

Approval was based on results from Phase I clinical safety studies, which demonstrated that using three tubes of Ameluz maintained similar safety and systemic exposure levels as one tube in treating actinic keratosis in patients undergoing photodynamic therapy.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses ways to ensure that product labels are easily understood universally.

Approval of Cologuard Plus follows results from the BLUE-C study, which demonstrated a 95% sensitivity for detecting colorectal cancer.

Approval for Opdivo was based on results from the CheckMate-77T trial, which demonstrated that the combination significantly improved event-free survival and pathologic complete response in adults with resectable non-small cell lung cancer without EGFR or ALK rearrangements.

Under terms of the deal, Philogen will complete clinical trials for Fibromun, seek approval, and handle manufacturing, with Sun Pharma leading global commercialization.

Priority Review was based on data from the ECHO Phase III trial, which demonstrated that a combination of Calquence, bendamustine, and rituximab reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.

Marketed as a biosimilar to Stelara, approval of Otulfi was based on clinical data demonstrating comparable efficacy in treating inflammatory conditions such as Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis.

New facilities are expected to focus on manufacturing next-generation medicines and biologic medicines.

Laura Johnson, senior director, sales, life sciences, Loftware, discusses issues faced by the pharmaceutical industry when it comes to proper drug labeling.

CN201 is currently being evaluated in Phase I and Phase Ib/II clinical trials for relapsed or refractory non-Hodgkin lymphoma and B-cell acute lymphocytic leukemia.