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.
Clinical researchers from Karl Landsteiner University in Krems, Austria, have been conducting a prospective study of a new diagnostic technique for bronchoscopy tissue sampling aimed at patients with unclear diffuse parenchymal disease. They have assessed morbidity and 30-day and 90-day mortality following transbronchial lung cryobiopsy. The team recently published their findings in Therapeutic Advances in Respiratory Disease.
The recent start of Neurogene Inc.’s first-in-human trial testing NG-101 in ceroid lipofuscinosis type 5 (CLN5) Batten disease (BD) drew investor attention to the space, where a handful of developers vie for new therapies against the challenging indication.
At the AD/PD 2022 international conference on Alzheimer’s and Parkinson’s Diseases, AC Immune SA presented images showing its positron emission tomography (PET) tracer detecting pathological alpha-synuclein (a-syn) in human subjects’ brains. The abnormal accumulation of a-syn, a natively unfolded and soluble presynaptic protein, is a neuropathological feature of neurodegenerative disorders.
Despite global drops in COVID-19 infections and because variants never rest, Eiger Biopharmaceuticals Inc. is taking its strong top-line phase III data of pegylated interferon lambda to global regulatory agencies for approval. The type III interferon that stimulates immune responses significantly reduced the risk of COVID-19-related hospitalizations or emergency room visits longer than six hours by 50% and death by 60%. The results prompted Eiger to say it would submit the data to the FDA for an emergency use authorization – and also to the EMA and Asian agencies – as soon as it could.
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. Though already approved for several indications, they’re seeking to position it as a first-line treatment of advanced squamous or non-squamous non-small-cell lung cancer (NSCLC). The final data largely confirmed interim findings from the study, first reported in August 2021.
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