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Home » Topics » Clinical

Clinical
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ASCO 2025: It’s time for more trust in AI, panel says

May 30, 2025
By Lee Landenberger
No Comments
Despite the advancement of AI and machine learning technologies and their incorporation into cancer treatment and drug development, a lack of trust and understanding of these new approaches is impeding care and treatment.
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Consistency not enough? Summit falls on lung cancer survival miss

May 30, 2025
By Jennifer Boggs
No Comments
For the second time in as many months, the lack of statistically significant overall survival data sent shares of Summit Therapeutics Inc. sliding, despite otherwise positive findings for PD-1/VEGF bispecific candidate ivonescimab in non-small-cell lung cancer. But analysts noted the stock reaction overlooks the consistency of the efficacy data to date, as well as the fact that the phase III Harmoni study marks the first pivotal trial testing ivonescimab in a global population.
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Lungs wireframe illustration

Split ends itepekimab in COPD? Regeneron phase III setup hairy

May 30, 2025
By Randy Osborne
No Comments
Facing erosion of its mighty Eylea (aflibercept) franchise and near-term loss of exclusivity with Dupixent (dupilumab), Regeneron Pharmaceuticals Inc. took a blow as one of two phase III trials with IL-33-blocking monoclonal antibody itepekimab failed in chronic obstructive pulmonary disease (COPD). The Tarrytown, N.Y.-based firm’s shares (NASDAQ:REGN) closed May 30 at $490.28, down $115.11, or 19%. Partner Sanofi SA, of Paris, saw its stock (NASDAQ:SNY) dip somewhat, too, and ended at $49.37, down $2.98. Cantor analyst Carter Gould opined that the latest news “all but [ruled] out a path forward short of a new study” with the compound.
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Product image

FDA greenlights Distalmotion’s Dexter for gallbladder removal

May 29, 2025
By Shani Alexander
The U.S. FDA granted 510(k) clearance to Distalmotion SA's Dexter, its surgical robotic system, for use in cholecystectomy in adults. The greenlight from the regulatory body is the second nod Dexter has received following de novo clearance granted in 2024 for use in inguinal hernia repair.
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Daiichi and Merck pull accelerated approval BLA for ADC

May 29, 2025
By Lee Landenberger
No Comments
Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have voluntarily pulled the BLA for accelerated approval tied to their HER3-directed antibody-drug conjugate (ADC) in treating EGFR-mutated non-small-cell lung cancer. The partnership in the expanding ADC space began nearly two years ago in a $22 billion deal.
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Immune

Glycoera raises a $130M series B to advance GE-8820

May 29, 2025
By Nuala Moran
No Comments
Glycoengineering specialist Glycoera AG is preparing to take its extracellular protein degrader constructs into the clinic in the treatment of autoimmune diseases, after closing a $130 million series B.
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Boston Scientific Acurate Prime Aortic Valve System

In TAVR setback, Boston Sci pulls plug on Acurate valves

May 28, 2025
By Holland Johnson
Boston Scientific Corp. reported the latest setback in its transcatheter aortic valve replacement (TAVR) aspirations with the news that it is officially discontinuing worldwide sales of its Acurate neo2 and Acurate Prime systems
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Glycoera raises a $130M series B to advance GE-8820

May 28, 2025
By Nuala Moran
No Comments
Glycoengineering specialist Glycoera AG is preparing to take its extracellular protein degrader constructs into the clinic in the treatment of autoimmune diseases, after closing a $130 million series B.
Read More

Anatara takes a second look at Garp after phase II IBS miss

May 28, 2025
By Tamra Sami
No Comments
After reporting in April that its gastrointestinal reprogramming product (Garp) failed to meet the primary efficacy endpoint in a phase II trial in irritable bowel syndrome (IBS), Anatara Lifesciences Ltd. conducted a further analysis that shows a positive trend toward efficacy.
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Spero with white knight GSK succeed with UTI treatment

May 28, 2025
By Lee Landenberger
No Comments
GSK plc knew a good thing when it swooped in nearly three years ago to rescue Spero Therapeutics Inc.’s oral antibiotic from a complete response letter (CRL). New pivotal phase III study data showed tebipenem pivoxil hydrobromide (HBr) for complicated urinary tract infections (cUTI), including pyelonephritis, hit its primary endpoint.
Read More
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