Novartis' Lutathera Shows Significant Survival Benefit as First-Line Treatment for GEP-NETs
January 19th 2024Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with somatostatin receptor-positive well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors.
FDA Fast Tracks Nurix Therapeutics, Inc’s Novel BTK Inhibitor for CLL, SLL
January 18th 2024NX-5948 is under evaluation for for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor.
FDA Accepts New Drug Application From Lantheus Holdings for Generic Lutathera in GEP-NETs
January 11th 2024If the FDA approves the abbreviated new drug application for Lutetium Lu 177 Dotatate, the drug will be eligible for 180 days of generic marketing exclusivity in the United States for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors.
FDA Approves Padcev/Keytruda Combo for Locally Advanced, Metastatic Urothelial Cancer
December 15th 2023In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer.
CDC Raises Urgent Alert for Low Vaccination Coverage for COVID-19, Influenza, RSV
December 15th 2023CDC data show hospitalizations among all age groups spiked by 200% for influenza, 51% for COVID-19, and 60% for respiratory syncytial virus over the past four weeks, emphasizing the need for improved outreach efforts among at-risk populations.
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.
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.