U.S. President Donald Trump signed off on his threat this morning of most-favored nation (MFN) prescription drug pricing, putting other nations on notice that the U.S. is not going to continue subsidizing biopharma R&D for the rest of the world. In announcing what he called “one of the most consequential executive orders [EOs] in our country’s history” – at least in health care, Trump said the MFN pricing wasn’t a knock to biopharma – it’s a knock to other developed countries, especially those in the EU, that force manufacturers to accept artificially low drug prices that don’t reflect a country’s fair share of R&D costs. He noted that, while the U.S. is home to about 4% of the world’s population, it funds roughly 75% of global biopharma profits.
Lilly offers more Zepbound data, betters Wegovy
Eli Lilly and Co. highlighted detailed results from Surmount-5, a phase IIIb open-label trial evaluating the safety and efficacy of Zepbound (tirzepatide), a glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 (GLP-1) receptor agonist compared to Wegovy (semaglutide, Novo Nordisk A/S), a mono-GLP-1 receptor agonist, in adults with obesity, or overweight with at least one weight-related medical problem and without diabetes. At 72 weeks, Zepbound met the primary endpoint and all five key secondary endpoints, proving superiority compared to Wegovy across the trial. Detailed results were presented at the European Congress on Obesity in Malaga, Spain, and simultaneously published in The New England Journal of Medicine.
With trade agreement secured, US and UK await section 232 outcome
The U.K. became the first country to reach agreement with the U.S. over threatened tariffs in an “economic prosperity deal” (EPD) that leaves the pharma industry hanging on for the outcome of the U.S. section 232 probe into the implications of pharmaceutical imports for America’s national security. However, there is a commitment that once the conclusions of the section 232 investigation are published, the U.S. and the U.K. "intend to promptly negotiate significantly preferential treatment outcomes on pharmaceuticals and pharmaceutical ingredients." It remains to be seen what the preferential treatment of the U.K. will add up to, given the expectation that the section 232 investigation will lead to the imposition of tariffs on pharmaceutical imports to the U.S.
Qilu nabs China rights to Minghui’s B7-H3 ADC for up to $186M
Minghui Pharmaceutical Ltd. is out-licensing its antibody-drug conjugate (ADC) MHB-088C to Qilu Pharmaceutical Co. Ltd. for China rights for up to ¥1.345 billion (US$186.44 million). Under terms of the deal, Qilu gains rights to develop and manufacture the ADC in greater China, including mainland China, Hong Kong, Macau, and Taiwan. In exchange, Shanghai-based Minghui will be eligible to receive up to¥1.345 billion, including ¥280 million up front, and development, regulatory and sales milestone payments up to ¥1.065 billion. It is also eligible to receive double-digit royalties on net sales. Minghui retains global rights to MHB-088C outside greater China.
Sirius bags $50M series B2 for cardiovascular siRNA pipeline
Sirius Therapeutics Inc. raised nearly $50 million in a series B2 financing round May 9 to support its pipeline of small interfering RNA (siRNA) molecules for cardiovascular disease indications. SRSD-107, a long-acting Factor XI anticoagulant for thromboembolic disorders, is its lead candidate waiting on EMA clearance to begin a phase II study in Europe. Sirius has two other assets in phase I studies: SRSD-216 for lipoprotein(a) and SRSD-101 for dyslipidemia.
Liver is also immune organ, influenced by microbiome
Immunity is not a function most people particularly associate with the liver. But because of its connection to the gut, the liver is exposed to bacterial metabolites as few other organs are. And when either the liver or the gut is not functioning well, it can adversely affect immunity as well. The liver is connected to the gut via both the biliary system and the portal vein. Those two conduits allow metabolites from the gut microbiome to influence what’s going on in the liver. Both liver and gut damage can affect this communication for the worse. And surprisingly, one of the consequences is immune dysfunction.
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