Japan’s largest drugmaker, Takeda Pharmaceuticals, announced it is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel (darvadstrocel), a treatment for complex perianal fistulas in patients with Crohn’s disease, in the European Union (EU). 16 December 2024
AstraZeneca and development partner Daiichi Sankyo have withdrawn a marketing authorization application for datopotamab deruxtecan (Dato-DXd) in lung cancer. 24 December 2024
French specialty vaccine company Valneva has entered into an exclusive license agreement for its single-shot chikungunya vaccine that enables supply of the vaccine in Asia with Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses. 24 December 2024
Japanese drugmaker Shionogi has announced that it will acquire full ownership of its joint ventures with subsidiaries of Ping An Insurance. 23 December 2024
US pharma major Eli Lilly today announced the US Food and Drug Administration (FDA) approved Zepbound its (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 23 December 2024
AstraZeneca has secured European Commission approval for Tagrisso (osimertinib) to treat certain people with locally advanced, unresectable non-small cell lung cancer (NSCLC). 23 December 2024
New York-based Nuvation Bio today announced that the FDA has accepted the company’s new drug application (NDA) for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of advanced ROS1+ NSCLC (line agnostic), for priority review. 23 December 2024
French pharma major Sanofi says it has entered into a new chapter of the collaboration with South Korean firm SK bioscience in pneumococcal vaccines, with an expanded agreement to develop, license and commercialize next-generation PCVs for both pediatric and adult populations. 23 December 2024
US pharma giant Pfizer on Friday revealed that the US Food and Drug Administration (FDA) has approved its Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. 23 December 2024
The Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for the treatment of early Alzheimer’s disease (AD). 5 December 2024
Japanese drugmaker Shionogi has announced that it will acquire full ownership of its joint ventures with subsidiaries of Ping An Insurance. 23 December 2024