Positive final results from the Phase III COSMIC-311 trial for Cabometyx (cabozantinib) were reported by Exelixis for patients diagnosed with previously treated radioactive iodine-refractory differentiated thyroid cancer.
Non-small cell lung cancer (NSCLC) is one of the most devestating diagnoses and highest unmet needs in the oncology space. EQRx, which intends to solve pricing and access challenges for patients, unveiled new data at the European Society for Medical Oncology (ESMO) Congress 2021 showing that it might just have the answer to NSCLC too.
Fully integrated biopharmaceutical solutions organization Syneos Health announced the acquisition of StudyKIK, a leading technology-enabled clinical trial recruitment and retention company.
A study published in the BMJ suggests that about one-third of cancer indications receiving approval under an Accelerated Approval pathway are still on product labels even after follow-up studies did not confirm their benefits.
In MacroGenics’ SOPHIA Phase III study in adults with metastatic HER2-positive breast cancer, the biopharmaceutical company’s Margenza plus chemotherapy failed to show a statistically significant advantage when compared to trastuzumab plus chemotherapy in the intent-to-treat population.
For more than 50 years, randomized controlled trials (RCTs) have been used by the biopharmaceutical industry and regulators to evaluate the efficacy and safety of new medications as well as medical products that are being repurposed for new uses. But regulators and biopharmaceutical companies are being pushed to modernize their approaches to expedite drug development, which has resulted in increased attention to potential contributions of real world evidence (RWE).
Novartis said the company’s Kymriah CAR-T therapy did not meet the drug’s primary endpoint of event-free survival in a phase III study in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) after relapse or lack of response to first-line treatment.
Findings from the Phase III EMPOWER-Lung 3 trial, announced Aug. 5 by Regeneron Pharmaceuticals and Sanofi, show that a combination regimen comprising the PD-1 inhibitor Libtayo and platinum-doublet chemotherapy significantly improved overall survival compared with chemotherapy alone in patients with metastatic or locally advanced non-small cell lung cancer (NSCLC).
The U.S. Food and Drug Administration sent a letter to Ardelyx Inc. citing “deficiencies” found in the company’s evaluation of the biopharmaceutical firm’s new drug to treat chronic kidney disease (CKD).
Germany’s BioNTech is acquiring Kite’s solid tumor neoantigen T-cell receptor (TCR) research-and-development platform and the Gilead company’s clinical manufacturing plant in Gaithersburg, Maryland.