Regeneron and Sanofi’s checkpoint inhibitor Libtayo (cemiplimab-rwlc) won U.S. Food and Drug Administration approval for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression.
Texas-based Molecular Templates (MTEM) and Bristol Myers Squibb forged a strategic research collaboration worth a potential $1.3 billion to discover and develop multiple oncology therapies using a next-generation engineered toxin body platform.
AstraZeneca reported that the company’s Phase III KESTREL trial of Imfinzi (durvalumab) failed to meet the primary endpoint of improving overall survival compared to the EXTREME treatment regimen, which was chemotherapy plus cetuximab, a standard of care.
BeiGene announced topline data for tislelizumab for esophageal squamous cell carcinoma (ESCC), the anti-PD-1 monoclonal antibody’s fourth positive Phase III trial.
AstraZeneca Plc’s cancer drug Imfinzi was approved in Europe and Britain for a spaced-out regimen in a common type of lung cancer to help reduce the frequency of hospital visits while continuing treatment.
Drugmakers agreed to cut prices by around 50% on average for more than 100 medicines in order to have them included in China’s state medical insurance scheme from March, potentially heralding a massive leap in sales.
Surface Oncology agreed to grant exclusive worldwide licensing rights to GlaxoSmithKline for the development and commercialization of the Cambridge, Mass.-based biotech company’s SRF813, a fully human IgG1 antibody and immunotherapy designed to treat cancer.
The U.S. Food and Drug Administration requested ALX Oncology complete a standard safety study, which amounts to a partial clinical hold on a Phase II study pairing the company’s CD47 inhibitor ALX148 with Merck’s Keytruda in Head & Neck Squamous Cell Carcinoma (HNSCC).
The U.S. Food and Drug Administration’s PDUFA dates for the last week of November 2020 include a review of Liquidia Technologies’ NDA for LIQ861 for the treatment of pulmonary arterial hypertension (PAH).
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA-approved test.