The FDA was unable to approve the Biologics License Application for zolbetuximab because of deficiencies found in a third-party manufacturing facility for the drug, which is under evaluation to treat patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
Industry stakeholders must come together to make meaningful changes to reimbursement and establish comprehensive policies that support essential healthcare providers.
Supplemental Biologics License Application would convert the accelerated approval granted to Tivdak (tisotumab vedotin-tftv) to a full approval for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
Rinatabart sesutecan (Rina-S; PRO1184) is under evaluation for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.
As the use of emerging technologies such as generative artificial intelligence continues to grow to support the innovation goals of Fortune 500 companies, so too does the risk of cybersecurity breaches.
In an interview with Pharmaceutical Executive associate editor Don Tracy, Ashley Gaines, VP, head of breast cancer franchise, discusses newly approved Truqap.
Scemblix (asciminib) plus investigators’ choice of tyrosine kinase inhibitor showed clinically meaningful and statistically significant data in patients newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
Trial data show 89Zr-DFO-girentuximab was more effective than traditional PET/CT imaging in identifying malignant renal cell carcinoma lesions.
Proposed acquisition would have given IQVIA a market-leading position in healthcare advertising.
Merck is actively enrolling patients across Phase III trials for four novel candidates for hematologic malignancies and solid tumors.
Tina Fresta, BA, MPH is the Strategic Solutions Senior Manager at epocrates, keeps a close eye on the pharmaceutical and bio science industry shifts, leveraging those insights to inform both our partners and our company of the most strategic approach to reach business goals.
Starting April 1, 2024, Hyrimoz and an unbranded version of Humira manufactured by Sandoz will be covered across all CVS formularies.
The LillyDirect platform will allow patients who are prescribed the popular weight loss drug Zepbound to obtain the drug via Lilly’s at-home prescription delivery service.
Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors.
JAMA study investigates whether physical or behavioral healthcare needs are associated with the risk of underinsurance across household income levels.
Company cites potential safety risks for patients who ignore the intended indication of Mounjaro and Zepbound.
VYD222 is a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents.
Over the past 15 years, on average, racial and ethnic diversity in multiple US regions has increased by 1% to 5%.
Study results show an estimated 71.4% survival rate after both 24 and 36 months with aglatimagene besadenovec (CAN-2409) in combination with valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma compared with 16.7% in the control group.
JAMA study evaluates the ability of artificial intelligence to transform electronic health.
Practical recommendations for a path forward for both biopharma C-Suites and their employees.
Merger agreement includes the Gracell FasTCAR platform, which could significantly improve the efficacy of CAR T-cell therapies.
Companies must address myriad challenges to improve upon issues such as data quality and transparency, process efficiency, and artificial intelligence/machine learning preparedness.
Five trends in pharmaceutical marketing from the past year.
Oxford Academic report explores the positive improvements these technological capabilities could bring to the industry.
American Heart Association survey suggests holiday stress has a major impact on health habits.
If approved by the FDA, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure, including peanut, milk, and egg allergies.
Filsuvez (birch triterpenes) is indicated to treat partial thickness wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa.
Garadacimab is a novel, first-in-class, recombinant monoclonal antibody for hereditary angioedema that targets activated Factor XII.
JAMA study aims to discover whether ignoring medical advice relates to financial status among patients with heart failure.
