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13 February, 2026 |
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HHS Secretary Robert F. Kennedy Jr. is shaking up his senior leadership staff with the removal of Peter Thiel ally Jim O’Neill as both CDC acting director and deputy HHS Secretary, according to the Washington Post. RFK also promoted MFN dealmaker and Medicare chief Chris Klomp to oversee all operations of HHS. FDA deputy commissioner Grace Graham also was named senior counselor for the FDA, according to Kennedy. |
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Alexis Kramer |
Editor, Endpoints News
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by Jared Whitlock
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The Pentagon on Friday briefly added WuXi AppTec to a list of companies that aid the Chinese military before withdrawing the filing with no explanation. If the list is reposted as is, the designation would heighten scrutiny of the biotech supplier and make it a target of the recently passed Biosecure Act that restricts federal contracts with biopharma suppliers that are deemed foreign adversaries. Biosecure defers to the Pentagon's 1260H list of Chinese military companies. The ultimate decision may have far-reaching consequences. The Shanghai-based company started out decades ago offering only lab services before expanding into drug discovery, development and manufacturing.
WuXi controls a large share of the contract research market and has said it works with the 20 largest pharmaceuticals. | |
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by Alexis Kramer
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Eli Lilly is challenging a decision over how the FDA classified its experimental, next-gen obesity shot, in a case that could affect the ability of compounders to rival it. On Thursday, Lilly filed a notice to appeal a September district court decision that said the FDA didn’t violate the law when it decided to classify
retatrutide as a drug instead of a biologic. Lilly is bringing the case to the US Court of Appeals for the Seventh Circuit. How a product is classified determines what marketing rules it’s subject to, the potential length of exclusivity and whether the product can legally be compounded. An appeals court ruling could have a significant impact on the extent to
which Lilly might face cheaper, compounded competitors once retatrutide hits the market. Biological products are not eligible for compounding, according to the FDA. | |
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by Anna Brown
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Eli Lilly is continuing to stockpile its obesity pill orforglipron months ahead of its expected US launch. In a Thursday SEC filing, the drugmaker said it has $1.5 billion in
“pre-launch inventories” as of Dec. 31, “primarily related” to orforglipron. Last February, Lilly said it had already stockpiled $548 million worth of the oral GLP-1 candidate, ready to be distributed as soon as the drug gains regulatory approval. Orforglipron is expected to be approved by the FDA in April. The Indianapolis-based company is readying its supply while rival Novo Nordisk has an early lead in the oral GLP-1 space. Novo launched its Wegovy pill last month, with prescription rates quickly ramping up. Novo said this week that it plans to expand a factory in Ireland to make its drug. | |
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by Kyle LaHucik
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Gilead is buying the global rights to an oral cancer drug from Genhouse Bio, a China-based biotech that filed for an IPO on the Hong Kong Stock Exchange last month. The California drugmaker is
dishing out $80 million upfront for GH31, a MAT2A-targeted synthetic lethality drug for select solid tumors. MAT2A plays a role in metabolic regulation and can be overexpressed in cancer cells. Genhouse could get up to $1.45 billion in biobucks, the company announced Friday on WeChat. A Gilead spokesperson confirmed the deal terms to Endpoints News. The deal gives Gilead access to another oral cancer treatment, after it inked pacts with Kymera and Repare in recent months. Much of the biotech's oncology focus in recent years, though, has been in cell therapy, antibody-drug conjugates and other antibody-based medicines. | |
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