Don Tracy, Associate Editor

As a part of National HIV Testing Day, the Centers for Disease and Control Prevention encourages testing as a part of taking charge of individual health and wellness.

Results from three randomized clinical trials show safety and efficacy of a brexpiprazole-sertraline combination in adult patients with post-traumatic stress disorder.

The collaboration with OpenAI is part of Lilly’s strategy to combat drug-resistant pathogens through its Social Impact Venture Capital Portfolio.

Investment is expected to fund a new fill and finish manufacturing facility to enhance production of injectable treatments for obesity and chronic diseases.

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses how AbbVie is advancing the development of bispecific biologic therapies in both solid tumors and blood cancers.

Cordella is the first pulmonary artery pressure-guided platform indicated for home-based comprehensive heart failure patient management.

Approval of Wakix marks the first time a non-scheduled treatment option for excessive daytime sleepiness has been approved for patients ages 6 years and older.

Accelerated approval for Krazati is based on results from the Phase 1/2 KRYSTAL-1 study, which demonstrated a 34% objective response rate in patients with previously treated, locally advanced, or metastatic colorectal cancer.

Results of the PURPOSE 1 trial indicated that a twice-yearly injection of lenacapavir outperformed the once-daily oral Truvada preventing HIV in cisgender women.

Expansion of Elevidys includes patients over the age of four years with Duchenne muscular dystrophy regardless of their ambulatory status.

Data from an early phase trial published in Nature found that Parkinson disease patients treated with UB-312 experienced significant improvements in motor functions and daily living.

Approval of Sofdra marks the first chemical entity to be approved by the FDA to treat primary axillary hyperhidrosis.

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer.

Approval of Skyrizi marks the first IL-23 specific inhibitor approved for both ulcerative colitis and Crohn disease of similar severity, according to AbbVie.

Approval of Keytruda combination for patients with primary advanced or recurrent endometrial carcinoma is based on results from the NRG-GY018/KEYNOTE-868 clinical trial, which was Phase III trial to evaluate an anti-PD-1 immunotherapy plus chemotherapy combination in patients with two distinct tumor types.

Approval for Capvaxive was based on results from three Phase III trials, which found Capvaxive to be beneficial preventing invasive pneumococcal disease and pneumococcal pneumonia in both vaccine-naïve and vaccine-experienced adults.

The approval of Blincyto was based on results from the Phase III E1910 clinical trial, which found that the treatment significantly improved overall survival in CD19-positive, Ph-negative B-cell ALL compared to chemotherapy alone.

The approval of Imfinzi was based on the DUO-E Phase III trial, which indicated that in combination with chemotherapy, the drug reduced the risk of disease progression or death by 58% in mismatch repair deficient endometrial cancer.

Data presented at the European Hematology Association Congress indicated that patients with chronic lymphocytic leukemia treated with Imbrivica had a significantly longer median progression-free survival compared to patients treated with chlorambucil.

Approval for Augtyro was based on results from the Phase I/II TRIDENT-1 trial, which demonstrated significant response rates in both tyrosine kinase inhibitor (TKI) naïve and TKI-pretreated patients.

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses data presented at ASCO from ABBV-400 and ABBV-706 in multiple studies.

Investigators followed a group of people born from 1990-1996 to assess whether the association between preterm birth and income differs according to family socioeconomic status at birth.

The cobas is classified as a four-in-one molecular test that can identify SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus from a single nasopharyngeal or anterior nasal swab sample.

Approval for Kevzara was based on controlled studies, pharmacokinetic data from adults with rheumatoid arthritis, and pediatric-specific studies on pharmacokinetics.

Klisyri is now available in a 350 mg package size as a topical treatment for actinic keratosis on the face or scalp.

Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease.

Survodutide is the first glucagon/GLP-1 receptor dual agonist to show a high level of benefit in treating liver fibrosis associated with metabolic dysfunction-associated steatohepatitis.

Approval of Rytelo could provide patients with lower-risk myelodysplastic syndromes with extended periods without the need for red blood cell transfusions to alleviate symptomatic anemia.

According to the manufacturer, the LFR-260 features advanced technology that allows patients to compare multiple prescriptions simultaneously, eliminating the need for traditional refraction methods.

Data published in the New England Journal of Medicine from Gilead’s Phase IIb MYR204 found the bulevirtide/ pegylated interferon alfa-2a combination was more effective in achieving undetectable HDV RNA compared to bulevirtide 10 mg monotherapy in the treatment of chronic hepatitis D.