SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
Zai Lab Ltd. has shared positive top-line data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint.
One of Pfizer Inc.’s last decisions of 2021 was to shell out $6.7 billion for San Diego’s Arena Pharmaceuticals Inc., a deal centered around the pipeline inflammatory disease pill etrasimod. A potential successor to Xeljanz (tofacitinib), the price New York-based Pfizer paid suggests blockbuster potential for etrasimod. Phase III results announced March 23 suggest Pfizer’s big acquisition, the fifth largest in biopharma in 2021, was money well spent.
Resapp Health Ltd. saw its stock shoot up 35% on the heels of positive clinical results for its new smartphone-based COVID-19 screening test. In a pilot clinical trial of 741 patients recruited in the U.S. and India, digital health company Resapp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, correctly detected COVID-19 in 92% of people with the infection.
Oric Pharmaceuticals Inc. is quitting development of ORIC-101 after interim analyses of two phase Ib studies concluded that the clinical activity does not justify going forward with the compound. The company was testing ORIC-101, a glucocorticoid receptor antagonist, combined with Abraxane in various solid tumors and paired with Xtandi in metastatic prostate cancer.
Shanghai Junshi Biosciences Co. Ltd. and Coherus Biosciences Inc. have disclosed positive data from a phase III trial of the anti-PD-1 antibody toripalimab in combination with chemotherapy in China.
After a challenging 2021, nerve repair company Axogen Inc. is focusing on building clinical data to turn around its luck. The Alachua, Fla.-headquartered company reported disappointing fourth quarter results, with procedure volume negatively impacted due to COVID-19 and hospital staffing. The Nasdaq-listed company is anticipating results from a major phase III pivotal study comparing its flagship nerve graft product Avance to commercially available products in the second quarter of 2022.
Wall Street was not as pleased as some might have expected by Immunogen Inc.’s full results from the pivotal study called Soraya testing mirvetuximab soravtansine (mirv) monotherapy in patients with folate receptor (FR) alpha-high, platinum-resistant ovarian cancer (PROC) who have been previously treated with Avastin (bevacizumab, Roche Holding AG). Analysts hailed the results as positive but shares (NASDAQ:IMGN) closed at $4.30, down 96 cents, or 18.25%.
Headlines the world over have been dominated by the resilience of the Ukrainian military – but the country’s clinical research body said that amid the chaos of war, trials are carrying on despite the destruction of hospitals and civilian infrastructure. As revealed by BioWorld, big pharma sponsors are putting clinical studies on hold in Russia, Ukraine and Belarus as the war plays havoc with medical supplies and the normal functioning of society.
Biological Dynamics Inc.’s Verita platform correctly identified 96% of patients with stage I pancreatic cancer, a study in Nature Communications Medicine demonstrated. The platform uses protein biomarkers present in extracellular vesicles and showed an overall 71% sensitivity and 99.5% specificity in pathologically confirmed stage I and II pancreatic, ovarian and bladder cancer.
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