More than two years after the U.S. FDA shocked Intercept Pharmaceuticals Inc. with its rejection of obeticholic acid to treat fibrosis due to nonalcoholic steatohepatitis (NASH), the company has announced data it said will form the basis of a NDA refile in the disease for which there is no approved therapy.
Treating sooner in the disease course – “hit them hard, hit them early,” as CEO Tahir Mahmood put it – may change outcomes for the better with AMT-101, the candidate from Applied Molecular Transport Inc. (AMT) tested in a combo trial against ulcerative colitis (UC), officials said during a conference call with investors.
So near and yet so far for Nordic Nanovector ASA, which has ditched the phase IIb trial of its lead product, Betalutin, just short of completing recruitment, after an independent review cast doubts on the level of efficacy previously reported for the targeted radiopharmaceutical.
Israeli startup Synchrony Medical Ltd. is gearing up to begin a U.S. clinical trial testing an airway clearance method developed at Israel’s Sheba Medical Center. The Libairty device is designed to support chronic lung disease patients to clear mucus with a short home-based daily treatment.
Immuno-oncology company Imugene Ltd. reported median overall survival for patients receiving HER-Vaxx plus chemotherapy was 13.9 months compared to 8.3 months in patients treated with chemotherapy alone in its phase II study in HER2/neu overexpressing advanced gastric cancer.
As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how single-arm trials can be regulated, used to support the new drug application for cancer drugs, and accelerate oncology drug development.
Immunovia AB is progressing a study evaluating its Immray Pancan-d blood test for the early detection of pancreatic cancer in patients with new onset type 2 diabetes. Studies have found that type 2 diabetes is a major risk factor for developing pancreatic cancer, and the screening of molecular biomarkers may help patients access treatment before they develop symptoms. The company’s lab-developed test (LDT) measures nine serum biomarkers that, when combined in an algorithm, can detect pancreatic ductal adenocarcinoma.
As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how single-arm trials can be regulated, used to support the new drug application for cancer drugs, and accelerate oncology drug development.
Recently published real-world data with Firazyr (icatibant), the selective B2 bradykinin receptor antagonist from Takeda Pharmaceutical Co. Ltd. to treat acute hereditary angioedema (HAE) attacks, trained a spotlight on the space, where a handful of players compete. Among the prospects is the early stage but intriguing Star-0215 from Astria Therapeutics Inc., which could be the next advance in the kallikrein-inhibitor class.
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