The first FDA-approved MASH drug doesn’t treat patients with liver cirrhosis. A new Boehringer Ingelheim/Ochre Bio collaboration is researching regenerative medicines that could treat patients in this most advanced stage of the fatty liver disease.
Acquiring CymaBay Therapeutics gives Gilead Sciences another drug for its liver disease portfolio. CymaBay’s molecule, seladelpar, is under FDA review for treating primary biliary cholangitis, a rare disease affecting the bile ducts of the liver.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Sanofi is acquiring Inhibrx to get its hands on a drug candidate in pivotal testing for the protein deficiency alpha-1 antitrypsin deficiency, which leads to lung and liver problems. Inhibrx’s remaining assets will be spun out into a new company.
Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.
The FDA again rejected Intercept Pharmaceuticals’ application seeking accelerated approval for its NASH drug and asked for more data. Instead, the biotech will stop all work in that fatty liver disease and focus on drugs for other serious but rare liver conditions.
Ipsen drug Bylvay is now FDA approved for treating pruritus, or severe itching, which is a complication of the rare liver disease Alagille syndrome. The oral drug was previously approved for treating pruritus in another rare inherited liver disease called PFIC.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
89bio reported its NASH drug candidate met the main endpoints of a mid-stage clinical trial. In addition to demonstrating efficacy and safety according to measures the FDA says are needed to support a regulatory submission, 89bio says the results also show its drug could offer a dosing edge over potential rivals.
Ochre Bio’s Series A financing will support development of RNA therapies for chronic liver disease. Longer term, the company aims to develop therapies that regenerate organs in patients, potentially avoiding the need for organ transplants.
Liver disease remains the focus of Genfit, despite a high-profile clinical trial failure in the fatty liver disease NASH. The company is building out its pipeline by acquiring Versantis, a clinical-stage biotech whose most advanced drug candidate brings a novel approach to treating a deadly chronic liver disease complication that has no FDA-approved therapies.
Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Satellite Bio has emerged from stealth with technology for bioengineering tissue to restore organ function. The regenerative medicine startup, based on research from MIT and Boston University, is backed by $110 million in financing.
Ipsen is paying €120 million up front to acquire global rights to elafibranor, a Genfit drug that fell short as a treatment for NASH, but is currently in Phase 3 testing in another liver disease, primary biliary cholangitis. Meanwhile, Genfit is adding an early-stage drug candidate to its own pipeline via a separate transaction.
Rectify Pharmaceuticals is taking an approach to disease that led to a successful franchise of Vertex Pharmaceutical lung drugs and expanding it to more diseases in more organs in the body. The startup has launched with $100 million in financing.
The Danville, Pennsylvania-based system plans to work with rabbittransit to help patients get to their appointments on time. Additionally, researchers from Geisinger and Regeneron Genetics Center recently found a gene variant that's associated with a reduction in the risk for chronic liver disease.
Gilead just lost one candidate, Bristol-Myers has licensed another; the race for non-alcoholic fatty liver disease drugs continues, as many companies eye its potential for a blockbuster drug.