Sanofi and Regeneron Pharmaceuticals got effective results in reducing the risk of major adverse heart events in a clinical study of nearly 19,000 patients with the help of cholesterol drug Praluent. Drugmakers now hope that the results are good enough to convince insurers to pay for the pricey medicine. Treatment with Praluent was associated with fewer overall deaths, cutting down the risk of overall mortality by up to 15% as compared to the patients who received statin therapy. For improving the commercial scenario of the drug Sanofi and Regeneron showed willingness to reduce the net price of Praluent for certain high-risk patients only if U.S. payers agree to ease the restrictions that have so far limited access to the drug. Regeneron and Sanofi mentioned that they are planning to file a supplementary Biologics License Application to FDA by the mid of this year in hopes of adding the Odyssey data to Praluent’s label.
DelveInsight Blog
Related Article
TELA Bio Launched Hernia Mesh Fixation Devices; Stryker Acquisition of SERF SAS; FDA 510(k) Clearance for RedDrop Dx’s Blood Collection Device; FDA 510(k) Clearance for Next Generation Shaw Scalpel; LivaNova’s Sleep Apnoea Device Trial; Nanodropper’s Positive Impact on Glaucoma Treatment
TELA Bio Launched FDA-approved Hernia Mesh Fixation Devices On March 21, 2024, TELA Bio, Inc., a medical technology firm, launched its FDA-approved LIQUIFIX devices for hernia repairs in the United States. The LIQUIFIX FIX8™ and LIQUIFIX Precision™ are specifically engineered for laparoscopic and open femo...
Find MoreRegeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition
Regeneron Updates Progress on Biologics License Application for Odronextamab Regeneron Pharmaceuticals, Inc. has announced that the FDA has issued Complete Response Letters (CRLs) regarding the Biologics License Application (BLA) for odronextamab in cases of relapsed/refractory (R/R) follicular lymphoma (FL) and...
Find MoreVygon Launched Nutrisafe2 System; Butterfly Network Launched Third-Gen Ultrasound; Cosm Medical Won FDA Clearance; FDA Cleared Sequel Med Tech Automated Insulin Delivery System; IceCure Medical Reported Positive Topline Results; Cerus Announced Positive Results in Blood Purification Trial
Vygon Launched Neonatal Safety in India with Groundbreaking Nutrisafe2 System On March 15, 2024, Vygon, a leader in the production and marketing of specialized medical equipment, introduced Nutrisafe2, a technological leap forward. This state-of-the-art enteral feeding device for neonates guarantees the sa...
Find MoreEditor's Pick
Newsletter/Whitepaper
Recent Article
ASCO Conference 2023
The American Society of Clinical Oncology (ASCO) is one of the largest and most respected conferences in the field of oncology. Held annually, this conference brings together researchers, physicians, and other healthcare professionals from around the world to discuss the latest advances in cancer research, diagnosis, and treatment.