Akero Therapeutics Inc. rolled out stellar non-COVID-19 (for a change) clinical news with long-acting fibroblast growth factor 21 (FGF21) analogue AKR-001 in biopsy-confirmed nonalcoholic steatohepatitis (NASH), but even in liver disease the pandemic became part of the discussion.
HONG KONG – Cadila Healthcare Ltd. (Zydus Cadila) has won approval for its saroglitazar to be used as the treatment of non-cirrhotic nonalcoholic steatohepatitis (NASH) in India. The green light from the Drug Controller General of India (DCGI) makes saroglitazar the first drug in the world approved for this indication.
NGM Biopharmaceuticals Inc. wowed investors with positive preliminary top-line results from the 24-week double-blind, randomized, placebo-controlled fourth cohort of an adaptive phase II study testing aldafermin in nonalcoholic steatohepatitis (NASH).
PERTH, Australia – Boehringer Ingelheim GmbH is discontinuing development of BI-1467335 for the treatment of nonalcoholic steatohepatitis (NASH) that it acquired from Sydney-based Pharmaxis Ltd. in 2015.
Ann Arbor, Mich.-based startup Endra Life Sciences Inc. started out focused on a photoacoustic imaging tool for mice in the lab, but in recent years it has shifted gears. Now, it aims to secure the go-ahead next year from European and U.S. regulators to launch a thermo-acoustic enhanced ultrasound system designed to quantitatively assess liver fat, known as TAEUS.
Due to the “dynamic nature of the situation,” officials of Cymabay Therapeutics Inc. declined to comment on the stoppage of work with PPAR-delta agonist seladelpar, but in a press release they pointed to “a series of investigative actions [that have begun in order] to better understand these findings.”
Fractyl Laboratories Inc. is pioneering a procedure known as duodenal mucosal resurfacing (DMR) to reverse chronic metabolic disorders. This month it has reported positive results from a couple of clinical trials that are shaping its planning for a pivotal trial that is slated to start next year in type 2 diabetes patients.
BOSTON – For diagnosing nonalcoholic steatohepatitis (NASH), liver biopsy is "the reference standard," Dean Hum, president of Genfit Corp., told BioWorld MedTech. "I'm not going to call it the gold standard."
BOSTON – For diagnosing nonalcoholic steatohepatitis (NASH), liver biopsy is "the reference standard," Dean Hum, president of Genfit Corp., told BioWorld. "I'm not going to call it the gold standard." Some of the reasons for denying biopsies a gold sticker are obvious. Biopsies are invasive, which makes them risky, expensive and loathed by patients and doctors alike. "In the real world, doctors don't always do biopsies – many say they very rarely do biopsies unless other data points in several directions and they need that for clarity," Gail Cawkwell told BioWorld.
Gilead Sciences Inc.'s third-quarter earnings, though deemed satisfactory, brought lukewarm responses from Wall Street, with analysts such as J.P. Morgan's Cory Kasimov writing in a report that "these days the company's quarterly progress seems to take a back seat to how they [will] ultimately deploy their substantial amount of capital. The Galapagos deal notwithstanding, this feels like a long wait that's quite frankly getting a bit stale." Still reverberating is the arrangement this summer with Galapagos NV, of Mechelen, Belgium, which signed a 10-year research and development pact with Gilead under which Galapagos is getting $3.95 billion up front in hard cash plus another $1.1 billion in equity, in return for which Gilead will essentially have an option to ex-European rights on everything emanating from the firm's clinical and preclinical pipeline.
