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BioWorld - Thursday, June 30, 2022
Home » Topics » Clinical

Clinical
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Hua Medicine’s dorzagliatin could be first drug to restore glucose homeostasis in type 2 diabetics

June 8, 2022
By Tamra Sami
No Comments
Hua Medicine Ltd. presented findings from two phase III trials of its first-in-class dual-acting glucokinase activator dorzagliatin that show the drug significantly improved early phase insulin secretion and glucose sensitivity in patients with type 2 diabetes, thereby restoring glucose homeostasis to treat the underlying cause of diabetes.
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Rigel probing geographical differences in ‘confounding’ phase III failure in wAIHA

June 8, 2022
By Jennifer Boggs
No Comments
Pointing to an anomalously high placebo response rate at eastern European trial sites in its Forward phase III trial testing fostamatinib in warm autoimmune hemolytic anemia (wAIHA), Rigel Pharmaceuticals Inc. executives remained confident there could be a path forward for the SYK inhibitor in treating the rare blood disorder. The disappointing top-line data, however, sent company shares (NASDAQ:RIGL) falling more than 60% June 8 to close at 70 cents, a penny above its same day 52-week low.
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Vaccine target

Moderna touts positive results for new COVID-19 booster candidate

June 8, 2022
By Lee Landenberger
No Comments
Based on a preliminary data analysis of its second and newest COVID-19 booster candidate, Moderna Inc. said it plans to ask the U.S. FDA to approve mRNA-1273.214 ahead of potential shipping in late summer 2022. The vaccine contains mRNA-1273 (Spikevax) and a vaccine candidate targeting omicron. New phase II/III results show the candidate hitting all the study’s primary endpoints when compared to Moderna’s original vaccine, mRNA-1273.
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DNA on digital background

Sophia Genetics teases early data for AI lung cancer study

June 7, 2022
By Catherine Longworth
No Comments
Sophia Genetics SA shared preliminary findings from its multimodal Deep-Lung-IV clinical study at the 2022 American Society of Clinical Oncology annual meeting. The study is utilizing Sophia’s cloud-based, artificial intelligence diagnostic platform to identify multimodal predictive signatures of response to immunotherapy for patients with advanced lung cancer.
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Omnipod 5, Dexcom G6 devices with mobile app on smartphone
ADA annual meeting

Automated insulin delivery systems post strong results, high acceptance

June 7, 2022
By Annette Boyle
No Comments
Several companies showed promising results for automated insulin delivery (AID) systems at the American Diabetes Association (ADA) annual meeting in New Orleans. Studies of the systems, also known as artificial pancreas systems, indicate that integration with continuous glucose monitoring (CGM) systems enables substantially improved glycemic control, with more time in range (TIR) and less hypoglycemia than seen with multiple daily injection (MDI) therapy or insulin-pump therapy.
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Izokibep hits its marks in phase II psoriatic arthritis trial

June 7, 2022
By Cormac Sheridan
No Comments
Affibody AB and its development partners, Acelyrin Inc. and Inmagene Biopharmaceuticals Co. Ltd., are accelerating plans to move izokibep into phase III studies in psoriatic arthritis following better-than-expected phase II efficacy combined with an apparently clean safety profile.
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Lung cancer data help move the market as ASCO 2022 begins

June 7, 2022
By Lee Landenberger
No Comments
The world’s biggest cancer-focused conference began June 3 as more than 40,000 attendees are expected at the American Society of Clinical Oncology’s (ASCO) annual gathering. The conference is being held in live in Chicago and is also available virtually. Among the more than 2,500 abstract presentations in about 120 subject subcategories are potential breakthroughs in treating non-small-cell lung cancer from Immutep Ltd., Cullinan Oncology Inc. and Surface Oncology Inc. Each company has seen upticks in their stock value, some as much as 10%, during the week as the conference approached and their data are presented.
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CALD shoulder in briefing docs for Bluebird’s eli-cel no surprise as beti-cel makes grade

June 7, 2022
By Randy Osborne
No Comments
Wall Street took in stride mixed FDA briefing documents with regard to the upcoming adcom review of Bluebird Bio Inc.’s two gene therapy prospects, and shares of the company (NASDAQ:BLUE) closed at $3.61, up 63 cents, or 21%.
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Lung cancer illustration

Henlius’ PD-1 drug shows positive data in phase III trial to treat ES-SCLC

June 7, 2022
By Doris Yu
No Comments
Shanghai Henlius Biotech Inc.’s anti-PD-1 monoclonal antibody serplulimab has generated positive data in a phase III trial as a first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC).
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Colorectal cancer illustration

Takeda-Amgen treatment improves survival in metastatic colorectal cancer

June 7, 2022
By Lee Landenberger
No Comments
Five-year survival rates for people with metastatic colorectal cancer haven’t budged much in recent decades but new data presented at the American Society of Clinical Oncology’s annual conference pushed the boundary enough to be notable.
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