A roundup of news from Astellas, Merck & Co., Eli Lilly and Company, Purdue University, Novo Nordisk, and Vertex Pharmaceuticals. Highlights below.  

Leadership Changes 
* Astellas Names Chief Manufacturing Officer; Makes Other Leadership Changes 
Partnering News 
* Merck & Co., Lilly, Purdue University To Form Consortium for Sterile Mfg 
Drug Approvals 
* Novo Nordisk’s Ozempic Gets FDA OK for Chronic Kidney Disease
* Vertex Gains FDA Approval for Non-Opioid Pain Management Drug 

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Leadership Changes 

Astellas Names Chief Manufacturing Officer; Makes Other Leadership Changes 
Astellas has made a series of leadership appointments, including naming a new Chief Manufacturing Officer, establishing and appointing a Chief Research & Development Officer, establishing and appointing a Chief Commercial & Medical Affairs Officer, and appointing a General Counsel and Chief Ethics & Compliance Officer.  

Rao V. Mantri will be appointed as the company’s new Chief Manufacturing Officer (CMfgO), as of April 1, 2025. He joined Astellas on February 3, 2025, and has pharmaceutical industry experience in product development, manufacturing, supply, and management. Hideki Shima, the current CMfgO, will retire, effective March 31, 2025. 

Effective April 1, 2025, Astellas will establish the position of Chief Research & Development Officer (CRDO), overseeing R&D, with Tadaaki Taniguchi, M.D., Ph.D., the company’s current Chief Medical Officer (CMO), appointed to this role. 

Effective April 1, 2025, Astellas will establish the position of Chief Commercial & Medical Affairs Officer (CCMAO), consolidating previous positions, with Claus Zieler, the current Chief Commercial Officer (CCO), appointed to this role. With this change in management structure, the roles of CMO, CCO, and Chief Scientific Officer (CScO) will be eliminated. Yoshitsugu Shitaka, Ph.D., the current CScO, will retire, effective March 31, 2025. 

Effective April 1, 2025, Astellas will establish the position of General Counsel and Chief Ethics & Compliance Officer (GC & CECO), with Tatjana Dragovic, Head, Ethics & Compliance, Astellas, appointed to this role. Since joining Astellas in 2007, she has held leadership roles in legal and ethics & compliance. Catherine Levitt, the current GC, will retire, effective March 31, 2025. 

Source: Astellas 

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Partnering News 

Merck & Co., Lilly, Purdue University To Form Consortium for Sterile Mfg 
Purdue University, in collaboration with Eli Lilly and Company and Merck & Co., has announced the launch of the Young Institute Pharmaceutical Manufacturing Consortium, a collaboration with a focus on sterile injectables and innovative aseptic manufacturing technology. 

Elizabeth Topp, Director of the Young Institute, will serve as the new consortium’s Director. She is a professor in the Department of Industrial and Molecular Pharmaceutics and the Davidson School of Chemical Engineering at Purdue University with expertise in improving the shelf life and stability of pharmaceuticals. 

The members of the new consortium says they anticipate the consortium will attract broad participation throughout the sector from other pharmaceutical companies, pharma contract manufacturers, equipment manufacturers, start-ups, and venture capital firms. 

The consortium will look to create systems equipped with automated visual inspection and in-line process and product-quality monitoring, all of which will require a new generation of skilled pharmaceutical manufacturing engineers and scientists. The consortium will seek to bio/pharmaceutical advanced manufacturing by developing innovative technologies, autonomous systems, and smart artificial intelligence (AI) and digital technology, together with industrially relevant education and training for the next generation of scientific leaders and researchers. The collaboration also underscores a commitment to onshoring pharmaceutical manufacturing while bolstering domestic production. 

Source: Purdue University 

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Drug Approvals 

Novo Nordisk’s Ozempic Gets FDA OK for Chronic Kidney Disease 
The US Food and Drug Administration (FDA) has approved a new indication for Novo Nordisk’s Ozempic (semaglutide), the company’s blockbuster drug for treating Type 2 diabetes, for the reduction of the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with Type 2 diabetes and chronic kidney disease (CKD). The FDA initially approved Ozempic in 2017 to improve blood sugar (glucose), along with diet and exercise, in adults with Type 2 diabetes. In 2020, Ozempic was granted an additional indication to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with Type 2 diabetes with known heart disease.  

Source: Novo Nordisk 

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Vertex Gains FDA Approval for Non-Opioid Pain Management Drug 
The US Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals’ Journavx (suzetrigine), an oral, non-opioid drug for the treatment of adults with moderate-to-severe acute pain. The drug is a first-in-class, oral, non-opioid, highly selective pain signal inhibitor that is selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials). Because Journavx blocks pain signals only found in the periphery, not in the brain, it can provide effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids, according to the company 

Source: Vertex Pharmaceuticals