Sanofi SA signed a whopper deal to buy out Amunix Pharmaceuticals Inc., paying about $1 billion up front and as much as $225 million in development milestone payments. Focused on immuno-oncology, South San Francisco-based Amunix brings several platforms to the table. Its lead candidate is the clinic-bound, masked T-cell engager AMX-818, which targets HER2-expressing solid tumors. The candidate emerged from the company’s XPAT technology.

COVID-19 data from Aridis and Moderna show strength against Omicron

Aridis Pharmaceuticals Inc. is one of several companies posting COVID-19 data just only days before Christmas. Its fully human monoclonal antibody cocktail AR-701 was shown to be broadly reactive against COVID-19 variants, including Omicron, in preclinical research. One component binds to the S2 stalk of the spike protein. Aridis said it expects the cocktail to provide relevant drug levels for up to a year from prophylactic or therapeutic treatment. The Los Gatos, Calif.-based company’s stock (NASDAQ:ARDS) took off on the news, with shares trading 18% higher at midday. Moderna Inc. also posted new data showing preliminary neutralizing data against Omicron following 50-mg and 100-mg dose boosters. Moderna’s booster candidates are in ongoing phase II/III studies.

Abbvie attempts to fight off unlicensed Humira competition

With licensed Humira (adalimumab) biosimilar competition a little more than a year away in the U.S., Abbvie Inc. is trying to fend off competitors that have not signed an agreement with the North Chicago-based company. In its latest action, Abbvie filed a complaint Dec. 17 with the U.S. International Trade Commission against Alvotech hf and Teva Pharmaceutical Industries Ltd. to keep their potential biosimilar from being marketed in the U.S. The Alvotech biosimilar referencing the mega-blockbuster biologic has yet to be approved, but if it or other unlicensed adalimumab biosimilars or interchangeables should launch before key Humira patent expirations, they could jeopardize Abbvie’s licensing agreements with companies such as Amgen Inc., Viatris Inc., Samsung Bioepis Co. Ltd., Sandoz Inc. and Boehringer Ingelheim GmbH.

Biosion licenses out anti-Trop2 humanized MAb to Obi Pharma

Obi Pharma Inc. has acquired global rights to BSI-04702, an anti-trophoblast antigen 2 (Trop2) humanized monoclonal antibody, from Biosion Inc. Obi is granted exclusive rights for further preclinical and clinical development, registration and commercialization of the candidate as an antibody-drug conjugate and other derivative products. Under the agreement, Taiwan-based Obi Pharma will pay licensing fees to Nanjing, China-based Biosion, including an up-front payment, future development milestones and net sales royalties. Specific terms were not disclosed.

U.S. can now rely on domestic supply of critical medical isotope

The U.S. hit a milestone this week in ensuring a stable domestic supply of molybendum-99 (Mo-99), a medical isotope critical to radiopharmaceuticals that are used in more than 40,000 diagnostic procedures in the U.S. each day. The Department of Energy and the FDA announced Dec. 20 that the U.S. no longer has to rely on international partners to process highly enriched uranium to produce Mo-99 for domestic use. “With more than 80% of diagnostic imaging in the U.S. relying on nuclear medicine isotopes like Mo-99, the FDA has a key role to play to ensure a sufficient supply is available for critical daily medical procedures,” said Acting FDA Commissioner Janet Woodcock.

U.S. SEC: More risk disclosure needed from China-based companies

Citing recent events highlighting the risks with investing in companies based in China, the U.S. SEC’s Division of Corporation Finance is seeking more specific and prominent disclosures from those companies about the legal and operational risks facing potential investors. That includes clear and prominent disclosure regarding the structure of the company, including the relationship between the entity conducting the offering and those handling operating activities. Other risks that need to be disclosed are those associated with a company’s use of the variable interest entity structure and the potential impact on the company’s operations if that structure were disallowed or the contracts were determined to be unenforceable.

Also in the news

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