Six weeks ahead of its June 26 PDUFA date, the U.S. FDA has approved a priority NDA for Eli Lilly and Co.’s Mounjaro (tirzepatide), an injectable treatment for adults with type 2 diabetes (T2D). The once-weekly, first-in-class medicine activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, which leads to improved blood sugar control. The potential market is massive, as 462 million people across the planet have T2D. The numbers have been growing 1.4% annually as the population ages and grows more obese. Read More
UCB SA’s share price slumped after the U.S. FDA rejected the pharma’s filing for psoriasis drug Bimzelx (bimekizumab), citing issues with “inspection observations” that must be resolved before approval. Shares in Brussels-based UCB (Brussels:UCB) fell 13.6% following the announcement that the FDA had rejected Bimzelx for treatment of adults with moderate to severe plaque psoriasis. Read More
Signs of hope at the end of March were quickly dashed in the last several weeks as BioWorld’s Biopharmaceutical Index (BBI) plunged once again, albeit not as dramatically as the Nasdaq Biotechnology Index. The BBI is down by 4.4% for the year, as of May 11, while NBI has fallen 28.5%. The Dow Jones Industrial Average is down by 12.4%. It is a situation that several analysts say could provide an opportunity for investors. Read More
As the six-month interim analysis of phase II data for ATA-199 in progressive forms of multiple sclerosis (MS) nears, investors in Atara Biotherapeutics Inc. – not to mention patients – are growing more intrigued by the prospect, an off-the-shelf T-cell candidate that targets Epstein Barr virus-infected B cells and plasma cells in the central nervous system. Read More
Visus Therapeutics Inc. has out-licensed phase III candidates Brimochol and Carbachol to Hong Kong’s Zhaoke Ophthalmology Ltd. to develop and commercialize its long-acting, presbyopia-correcting eye drops in greater China, South Korea and select Southeast Asian territories. Read More
Although gene therapy is now “a clinical reality,” it still remains an early stage therapeutic modality. That’s the view of Caroline Man Xu, CEO and co-founder of Vigeneron GmbH, a German gene therapy company that has maintained a low profile while steadily staking out a promising position in gene therapies for inherited retinal disease. Read More
News that the U.S. Trade Representative (USTR) had signed off on a compromise World Trade Organization (WTO) proposal to waive IP rights for COVID-19 vaccines caught Congress by surprise earlier in early May. Now, some members, both Democrats and Republicans, are reminding USTR Katherine Tai that she has an obligation to consult with Congress on such trade issues. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acorda, Biopas, Aeterna Zentaris, Apirx, Blue Water, Emerald, Incannex, Myrtelle, St. Jude, Skye. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lava, Rockwell, Salarius, Stealth. Read More
