Linagliptin

Welcome back to Endpoints Weekly! Fourth-quarter earnings season is in full swing, and our team covered reports this week from Teva, Roche, Sanofi, Takeda and Regeneron. CMS also unveiled the next 15 drugs subject to Medicare negotiations under the Inflation Reduction Act. The announcement comes as the Supreme Court weighs whether to step into drugmakers’ legal fight against the IRA. We’ve got the details below. Plus, we have reports on AstraZeneca’s $15 billion bet on China and Hengrui’s global aspirations. And Senior Science Correspondent Ryan Cross has the scoop on an upcoming clinical trial that will test a biotech startup’s experimental therapy that could bring about a “near total reset” for cells. We’ll be back next week with more earnings reports from Pfizer, Novo Nordisk, Eli Lilly, GSK and others. Stay warm this weekend, and see you on Monday! — Nicole DeFeudis 📊 After Johnson & Johnson reported earnings last week, Roche, Sanofi, Takeda, Regeneron and Teva followed up with their quarterly reports. Here are some of the highlights: 🔬 A startup called Life Biosciences got the FDA’s permission to start a clinical study of its gene therapy designed to rewind the clock on dying cells, the company told Endpoints News’ Ryan Cross in an exclusive interview. Life Biosciences was co-founded by Harvard biologist David Sinclair, who in the late 1990s proposed that aging is primarily due to the loss of epigenetic information. Life Bio’s therapy delivers a trio of proteins that Sinclair’s lab says has the ability to reset the epigenome to a more youthful state. Life Bio calls its approach partial epigenetic reprogramming, and its clinical trial will be the first to test the concept in humans, Ryan reported. The approach is similar to a Nobel Prize-winning lab technique that can turn adult cells into blank-slate stem cells, but Life Bio’s therapy intentionally stops short of that full rollback. Since the FDA doesn’t recognize aging itself as a disease, the company’s Phase 1 trial will test its gene therapy in two forms of vision loss. The bold approach may garner some skepticism. The anti-aging field has long been mired in audacious claims and drugs with fuzzy mechanisms. But Sinclair remains bullish about the therapy and believes the vision loss study will provide clear-cut evidence on whether partial epigenetic reprogramming is effective. “Shortly, maybe it’s in the next few months, we’ll have our first indication of whether age reversal can work in humans,” he said. Ryan has all the details here. 🇨🇳 Biotechs from China are catching up fast to their Western counterparts. No company embodies this acceleration more than Jiangsu Hengrui Pharmaceuticals , news reporter Lei Lei Wu wrote this week. Often shortened to Hengrui, the company was once virtually unknown outside China. Now, its market cap of $61 billion-plus ranks it among the top 25 pharma companies in the world, more than Takeda and Bayer. How did Hengrui get here? The company started over 50 years ago as a generic drugmaker, but began focusing on developing its own drugs within the last two decades or so. Currently, Hengrui has more than 100 experimental treatments being studied across some 400-plus clinical trials. That speed, particularly in the early stages of drug development, has become a hallmark of China biotech’s rise, Lei Lei writes. Now the company hopes to build up its commercial capabilities outside of China. That will be the next frontier and true test case to see if Chinese medicines can stack up against Western drugs. Though Hengrui has won US approvals for generic drugs, it hasn’t yet done so for its own therapies. The core economic argument from American biopharmas has been that American drugs are more expensive because patients get the best treatments first. Will that change? We’ll be watching. Read more of Lei Lei’s excellent story here . 🤝Eli Lilly’s GLP-1 diabetes drug Trulicity and Gilead’s HIV drug Biktarvy are among 15 drugs selected for the third round of Medicare negotiations under the IRA. Click here to see our reporting on the full list. Drugs payable under Medicare Part B were included for the first time this year. Also for the first time, CMS has selected one additional drug for renegotiation: Boehringer Ingelheim’s diabetes drug Tradjenta. Drugmakers have until Feb. 28 to opt into negotiations, which would take effect in 2028. Meanwhile, the pharma industry’s court battle is heating up. AstraZeneca, Bristol Myers Squibb, Johnson & Johnson, Novo Nordisk, Novartis and Boehringer Ingelheim have asked the high court to review their IRA challenges. Drugmakers and the industry trade group PhRMA have brought a range of constitutional and statutory challenges. But so far, drugmakers have lost every case where a court has ruled on the merits, with just a handful of cases pending in the lower courts. Some analysts say drugmakers will likely be able to handle the impacts of the third round of negotiations. They cited past negotiations, upcoming patent losses and new drug development as some reasons why the potential impacts may be modest. “With prior rounds of pricing negotiations reasonable, and several of these medicines set to lose exclusivity in the near-term, we continue to expect that the impacts will be manageable,” BMO Capital Markets analyst Evan Seigerman said in a note to investors. Read more here. 💰AstraZeneca will invest $15 billion to bolster manufacturing of medicines and ramp up R&D in China through 2030, the company announced this week. The investment was announced as a delegation of dozens of business executives and UK leaders, including Prime Minister Keir Starmer, visited China this week. AstraZeneca has been a driving force in the pharma industry’s move into China. The UK drugmaker set up shop in China in 1993 and has more than 17,000 employees there. It said this week that it wants to grow to more than 20,000 staffers in the country. About 7% of its 2024 revenue came from China. AstraZeneca quickly made good on its promise , agreeing to a $1.2 billion upfront deal with China-based CSPC Pharmaceutical. The deal spans eight programs, including a Phase 1-ready once-monthly GLP-1/GIP receptor agonist for obesity. DON’T MISS: