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10 September, 2025 |
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sponsored by
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Supporting scalable, integrated drug product manufacturing for complex biologics
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Our Stein expansion brings together cutting-edge infrastructure, deep technical expertise, and advanced technologies for commercial drug product manufacturing in the Lonza ecosystem. From liquid/lyo or PFS and sustainability by design to seamless DS/DP integration within the Lonza network, we offer modular, end-to-end solutions tailored to your molecule’s journey to simplify your supply chain, mitigate manufacturing risk and navigate regulatory challenges with a trustworthy CDMO partner. |
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The fight over state 340B laws is coming to a head. Three appeals courts are considering five separate laws that bar drugmakers from limiting their supply of discounted drugs to contract pharmacies. Drugmakers have been filing dozens of lawsuits, and they’re hoping for a circuit split so that they can get the issue to the Supreme Court. Read more from Nicole DeFeudis below. |
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Alexis Kramer |
Editor, Endpoints News
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by Nicole DeFeudis
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The pharma industry has been fighting for years to try to rein in a federal drug discount program that it says has grown rife with abuse. Now, more of those cases are reaching the higher courts. At least three appellate courts are mulling key challenges that pit drugmakers and states against each other over the limits of the program, with billions of dollars at stake. On Tuesday, the Fourth Circuit heard arguments over whether to stop Maryland and West Virginia from enforcing 340B laws, for now, that prohibit drugmaker restrictions on contract pharmacies. The Fifth Circuit last week heard arguments over a similar law in Louisiana, and could decide any day on whether to preliminarily enjoin a Mississippi law. The Eighth Circuit, which upheld an Arkansas 340B law last year, is now
considering a bid against a law in Missouri. |
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by Max Bayer
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Merck has decided to terminate plans for a $1.3 billion lab in London, citing the UK government’s lack of “meaningful progress” in life science investments. The company will more broadly “discontinue discovery research operations” in the UK, it said in a statement to Endpoints News on Wednesday. It also said
it would vacate existing labs at the London BioScience Innovation Centre and the Francis Crick Institute by the end of the year, and that 125 people will be laid off as a result. Merck said the “overall undervaluation of innovative medicines and vaccines by successive UK Governments” contributed to the move. The R&D facility had been in the works for years and had faced multiyear delays.
News of the scrapped plans was first reported Wednesday by the Financial Times. |
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Kiran Mazumdar-Shaw, Biocon executive chair (Indranil Aditya/NurPhoto via AP Images) |
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by Anna Brown
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Indian drugmaker Biocon says it’s preparing to break into the generic semaglutide market as it looks to file for regulatory approval this month. “Ozempic is coming off-patent next year. So there's a huge opportunity to play in the GLP-1 market,” Biocon founder Kiran Mazumdar-Shaw said in a Wednesday interview with Endpoints
News. Biocon is eyeing the opportunity to potentially become the first drugmaker to launch a cheaper version of semaglutide, the starting material for Novo Nordisk's blockbuster weight loss drugs Ozempic and Wegovy. The drugmaker is filing its generic semaglutide application “where market formation is expected in 2026 and beyond,” a Biocon spokesperson said, noting that it expects approval next year. Meanwhile, competitor Sandoz has already filed an application for
generic semaglutide in Canada and expects approval in the first quarter of 2026. |
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