| |   | Hiya, it's Meghana. Today, we learn why Moderna's not in China, we see a new approval for a rare bile duct cancer, discuss another NASH failure. | | | Why Moderna’s vaccines are not in China Moderna won’t share the intellectual property for its Covid-19 vaccines with China, which caused negotiations for selling it there to collapse, the Financial Times reports. Despite being “eager” to sell the mRNA vaccine in China, Moderna apparently refused in 2020 and 2021 on the basis of commercial and safety concerns. Beijing has presented two ways for foreign Covid-19 vaccine makers to sell their wares in China, FT writes: It’s either complete tech transfer to a domestic drugmaker, or building a manufacturing facility in China with a local partner, while holding onto the intellectual property. Moderna was expected to adhere only to the first option, though competitor BioNTech struck a deal in 2020 with Shanghai Fosun Pharmaceutical that allowed it to hang onto its proprietary technology. | Bile duct cancer drug gets a speedy approval Taiho Oncology’s cancer drug, futibatinib, has won accelerated approval from the FDA. The drug is specifically for patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma if they have gene fusions or rearrangements in the fibroblast growth factor receptor 2, or FGFR2. Bile duct cancers are rare, and notoriously difficult to treat. In a Phase 2b trial, the drug was tested in 103 patients with these FGFR2 genetic alterations. When patients were given 20mg of the oral drug once daily, the overall response rate was 42%, with a medium duration of response of 9.7 months. The FDA granted breakthrough status to futibatinib, or Lytgobi, last year, and it was accepted for priority review this past March. | In-depth analysis of biopharma and the life sciences Sign up for STAT+ to access in-depth analysis of biopharma, inside intelligence from Capitol Hill, the latest on medicine tech, and more. Subscribe today to and start your free 30-day trial. | Intercept’s NASH drug fails in phase 3 Intercept Pharmaceuticals has hit another hurdle in its effort to have its drug, Ocaliva, approved for NASH. The company had launched two clinical trials to expand the use of its biliary cirrhosis drug into NASH — a lucrative indication that has no approved treatments. But the drug, obeticholic acid, failed to meet its primary endpoints in the “Reverse” Phase 3 trial, sending the company’s stock crashing down more than 20%. But Intercept still plans on filing for the drug’s approval in NASH, based not on the Reverse trial, but on a re-analysis of another Phase 3 trial, called “Regenerate.” This past July, Intercept said it had a “very productive” meeting with the FDA, FierceBiotech points out. Based on the Regenerate study, Intercept still claims it has a “clear path forward” for a resubmission. But there have been failures from several companies in the NASH space, and this news is far from heartening for the company’s success. | What will open access look like? In August, the White House’s science office said that all federally funded research publications, and their respective data, should be made publicly available by the end of 2025. But the free access will only be available on “agency-designated repositories” like PubMed Central, not on the websites for journals like Nature or Science. And it’s still unclear how journals will shift their business models to accommodate these new, paradigm-shifting changes. The existing system can’t be completely dismantled and reassembled, publishers say “We have a $45 billion funding agency for biomedical research sciences, we have a $9 billion funding agency in the National Science Foundation, we have the $99 billion Horizon Europe … there is no starting from scratch,” Sudip Parikh, CEO of AAAS, told STAT's Brittany Trang. “There is ‘what do we do that both evolves and revolutionizes the current system?’ What that requires is a thoughtful process about how do you maintain the things that we care about in this system that have worked? How do we change the things that haven’t worked? I think that’s the better question.” Read more. | More reads - To prevent unnecessary biopsies, scientists train an AI model to predict breast cancer risk from MRI scans, STAT
- Scandion posts phase 2 trial flop just one month after the departure of two top execs, FierceBiotech
| Thanks for reading! Until tomorrow,  | | | |
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