Dupixent Gets FDA Label Update in Atopic Dermatitis With Uncontrolled Hand and Foot Involvement
January 16th 2024Trial shows 52% of patients with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement administered Dupixent experienced a clinically meaningful reduction in itch on hands and feet vs. 14% with placebo.
Climbing Health Care Costs Result in Elevated Employer Vigilance
January 16th 2024Soaring healthcare costs show little sign of abating in 2024, and concerns about the affordability of medications and medical services continue to grow, despite investments in technology, clinical innovation, and efforts to manage utilization and waste.
Emergent BioSolutions Awarded Contract to Supply US Military With Anthrax Vaccine
January 12th 2024The US Department of Defense awarded Emergent BioSolutions Inc. with a contract worth up to $235.8 million to supply all branches of the US military with BioThrax (Anthrax Vaccine Adsorbed) for use as pre-exposure prophylaxis against anthrax disease.
Shorla Oncology Announces FDA Acceptance of NDA for Novel Treatment for Breast, Ovarian Cancer
January 10th 2024The novel therapy in development to treat breast cancer and ovarian cancer is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s.
Astellas Pharma Issued Complete Response Letter for Zolbetuximab for GEJ Adenocarcinoma
January 9th 2024Astellas said it will work closely with the FDA and a third-party manufacturer to develop a timeline that will quickly resolve feedback from the complete response letter to a Biologics License Application for zolbetuximab.
sBLA for Tivdak Granted FDA Priority Review for Recurrent, Metastatic Cervical Cancer
January 9th 2024Tivdak (tisotumab vedotin-tftv), an antibody drug conjugate, was granted accelerated approval by the FDA in September 2021 for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
Chronic Myeloid Leukemia Treatment Combo Shows Promise in Phase III Trial
January 8th 2024Scemblix (asciminib) was approved by the FDA in October 2021 for patients with chronic phase chronic myeloid leukemia previously administered two or more tyrosine kinase inhibitors and for adults with chronic phase chronic myeloid leukemia with the T315I mutation.
Merck Highlights Robust Oncology, Hematology Pipeline With Four Agents in Phase III Trials
January 5th 2024Trials will evaluate four novel agents for cancers that include essential thrombocythemia, chronic lymphocytic leukemia, small lymphocytic lymphoma, non-small cell lung cancer, endometrial carcinoma, and metastatic castration-resistant prostate cancer.