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Compounding pharmacies are currently allowed to produce versions of GLP-1 medications like tirzepatide, despite the FDA's recent decision to remove it from the national shortage list. This situation arose after a lawsuit from the Outsourcing Facilities Association, which argues that the FDA's actions were arbitrary given ongoing shortages. As the FDA re-evaluates its stance, compounding pharmacies are advised to prepare for potential revenue losses if they can no longer operate in this capacity.
Sanofi is investing 300 million euros for a 16% stake in a new joint venture with Orano Med to develop radiopharmaceuticals targeting rare cancers, particularly using the radioisotope lead-212. This partnership aims to leverage expertise in biopharma and nuclear technology to advance cancer treatment. The joint venture is valued at 1.9 billion euros, following Sanofi's recent licensing of an experimental drug for neuroendocrine tumors.
Lexicon Pharmaceuticals has sold the rights to its cardio drug, sotagliflozin, to Viatris for $25 million upfront, with potential milestone payments of up to $200 million. This move comes as Lexicon restructures and aims to expand into Type 1 diabetes, with an FDA advisory panel set to review the drug's use in this area on October 31. The approval could unlock a $400 million U.S. market for the drug, which is currently marketed as Inpefa for heart failure and related conditions.
Germany's pharmaceutical landscape faces challenges as Eli Lilly begins construction of a new plant in Rhineland-Palatinate, reportedly linked to a law change allowing confidential pricing for medicines. This shift, criticized for potentially raising health insurance costs, has sparked concerns among health officials about increased expenditures for the public. Eli Lilly denies any direct connection between its investment and the legislative change.
The FDA has temporarily halted a lawsuit regarding the removal of Eli Lilly’s Zepbound and Mounjaro from its shortage list, agreeing to reassess the situation amid strong demand for GLP-1 medications. Compounded versions of tirzepatide can continue to be sold while negotiations with the Outsourcing Facilities Association proceed. The FDA previously declared that manufacturing capacity now meets national demand, but the OFA argues this decision violated federal law by not following proper procedures.
The UK’s life sciences sector is set to receive a £279 million investment from Eli Lilly, the world’s largest pharmaceutical company, to address health challenges, particularly obesity. This collaboration will establish the first ‘Lilly Gateway Labs’ in Europe, supporting early-stage businesses with lab space and mentorship. The initiative aims to enhance health outcomes and economic growth while tackling obesity, which costs the NHS over £11 billion annually.
Novo Nordisk is significantly expanding its operations in India, planning to double its global process leaders and increase its workforce by 16% to 5,000 by next year. The company has partnered with 10 local AI start-ups to enhance data management and efficiency, aiming to mirror its Denmark headquarters in Bengaluru within three years. As demand for its Wegovy and Ozempic drugs surges, Novo's India center now handles half of its global safety assessment work, contributing to critical drug development processes.
A multibillion-dollar race is underway among pharmaceutical companies to develop superior obesity drugs, with key contenders like Eli Lilly's Zepbound and Novo Nordisk's Wegovy leading the market. Upcoming trial results for various drugs, including Amgen's maritide and Roche's CT-996, are highly anticipated and could reshape the competitive landscape. As companies explore innovative approaches, such as preserving muscle mass during weight loss, the future of obesity treatment remains dynamic and closely watched.
Eli Lilly has partnered with AI firm Insitro to advance drug development, focusing on metabolic diseases. The collaboration includes three agreements, allowing Insitro to retain global rights to its research while Lilly benefits from milestone payments and potential royalties. Insitro will utilize Lilly's delivery technology alongside its own innovations to target liver conditions and develop new treatments.
David Baker, Demis Hassabis, and John Jumper have won the Nobel Prize in Chemistry for their groundbreaking work in computational protein design and structure prediction, significantly advancing drug design capabilities. Alnylam Pharmaceuticals seeks FDA approval for vutrisiran to treat a severe form of transthyretin amyloidosis, while Johnson & Johnson halts a bladder cancer trial for TAR-200. AstraZeneca invests in a preclinical cholesterol-lowering drug, and Astellas acquires rights to an experimental gene therapy for frontotemporal dementia.
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The information provided herein is generated by experimental artificial intelligence and is for informational purposes only.
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