Bristol Myers Squibb to Pay Up to $8.4 Billion to Codevelop Antibody-Drug Conjugate With SystImmune
December 12th 2023Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has shown promise treating non-small cell lung cancer and breast cancer.
Merck and Moderna to Launch Trial of mRNA-4157 Plus Keytruda in Non-Small Cell Lung Cancer
December 11th 2023Phase III trial to investigate novel individualized neoantigen therapy V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer.
Prevalence of Eight Chronic Health Conditions Reach Unprecedented Levels in US
December 7th 2023Arthritis, asthma, cancer, cardiovascular diseases, chronic kidney disease, COPD, depression, and diabetes reach the highest recorded levels since the America’s Health Rankings Annual Report began tracking them in 1990.
Merck Halts Phase III Trial of Keytruda Combination for Non-Small Cell Lung Cancer
December 7th 2023Trial of Keytruda (pembrolizumab) plus chemotherapy and maintenance Lynparza (olaparib; AstraZeneca, MSD) for the treatment of metastatic squamous non-small cell lung cancer stopped after data did not show a survival benefit.
FDA Grants Breakthrough Designation to Johnson & Johnson’s Novel Treatment for HR-NMIBC
December 5th 2023TAR-200 has a novel targeted releasing system for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for bladder removal surgery.
FDA Grants Priority Review to Bristol Myers Squibb's Opdivo Combination for Urothelial Carcinoma
December 5th 2023The FDA assigned a PDUFA date of April 5, 2024 for Opdivo (nivolumab) plus cisplatin-based chemotherapy for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.
Roche Bolsters Obesity, Diabetes R&D Portfolio With Acquisition of Carmot Therapeutics
December 4th 2023Roche announces definitive merger agreement to acquire Carmot Therapeutics, Inc., which has an R&D portfolio that includes clinical stage subcutaneous and oral incretins for the treatment of patients with obesity, both with and without diabetes.
FDA Approves Lilly's Jaypirca for Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
December 4th 2023Jaypirca (pirtobrutinib) granted accelerated approval by the FDA for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered least two prior lines of therapy that included a BTK inhibitor and a BCL2 inhibitor.
FDA Grants Priority Review to Keytruda Plus Padcev for Urothelial Carcinoma
December 1st 2023The FDA previously granted accelerated approval to the Keytruda plus Padcev combination for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
FDA Fast Tracks eFFECTOR Therapeutics' Zotatifin Combo for ER+/HER2– Breast Cancer
December 1st 2023FDA to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) as a second- or third-line treatment for patients with estrogen receptor–positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer whose disease progressed after treatment with endocrine therapy and a CDK4/6 inhibitor.