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In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics discusses how the data integrity landscape will evolve over the next five years and what extent bench scientists in the lab focused on data integrity.

Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding the safety and efficacy of donanemab for the treatment of early symptomatic Alzheimer disease.

BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies.

Starting June 1, Boehringer Ingelheim plans to cap inhaler products for respiratory diseases at $35 per month for eligible patients.

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Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.

Eli Lilly continues to emphasize the potential harm that could come with using GLP-1 receptor agonists for off-label purposes.

In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses the biggest challenges facing the broader adoption of novel cell and gene therapies from IQVIA's Global Trends in R&D 2024 report.

Researchers are debating whether to still include protection for this strain in vaccines.

Medication is the first tocilizumab biosimilar approved in the US for both IV and subcutaneous use for autoimmune diseases, such as rheumatoid arthritis and juvenile idiopathic arthritis.

Besponsa (inotuzumab ozogamicin) was initially approved in August 2017 for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

Results from Phase IV RESPOND study indicate a significant reduction in plasma neurofilament light chain (NfL) levels.

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The company plans to spend the coming years strengthening its market position and pipeline while also clearing its issues with litigation and debt.

Agreement to focus on research, option, and licensing for discovery of dual tumor-associated antigen-targeting antibodies.

In this Pharmaceutical Executive interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics, dives into the greatest threats to the integrity of data in R&D and threats presented by hackers.

Novel formulation of cabotegravir (CAB-ULA) allows for dosing intervals of at least four months.

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The biosimilars Wyost and Jubbonti (denosumab-bddz) were approved as interchangeable products for Prolia and Xgeva for the treatment of osteoporosis, hypercalcemia, and to prevent skeletal-related events associated with bone metastases from solid tumors.

This marks the first time that a hyaluronic acid dermal filler has received FDA approval for temple hollowing.

In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses findings from IQVIA's Global Trends in R&D 2024 report and what specific factors are causing this slowdown in clinical trial starts.

Letybo (letibotulinumtoxinA-wlbg) is expected to launch in in the United States toward the second half of the year for moderate-to-severe frown (glabellar) lines in adults.

The paper discusses multiple steps the industry can take to ensure that patients have access to these treatments.

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Rebranding aims to align company with its parent company and other subsidiaries.

Teens to be included in both placebo and open label studies for QRX003, a potential treatment for Netherton syndrome.

Regulatory action makes Rybrevant plus chemotherapy the first FDA-approved therapy for the first-line treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations.

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JAMA commentary suggests that issues such as high costs, access, and equity will stop patients from obtaining GLP-1 agonists to treat obesity.

New guidance suggests that CMS may be ramping up Sunshine Act auditing activities, potentially resulting in monetary liability for noncompliant reporting entities.