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Home » Topics » Clinical

Clinical
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Blood glucose chart and monitor, stethoscope, injector pen

Hightide’s HTD-1801 meets phase III endpoints in type 2 diabetes

April 15, 2025
By Tamra Sami
Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met primary and secondary endpoints in the Symphony 1 and Symphony 2 phase III trials in type 2 diabetes in Chinese patients. Based on the data, Shenzhen-based Hightide will submit an NDA to China’s National Medical Products Administration (NMPA) later this year.
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Sanofi advances asthma drug despite phase II miss

April 15, 2025
By Lee Landenberger
Despite missing a phase II study’s primary endpoint in moderate to severe asthma, Sanofi SA sees a way forward to a phase III program in the crowded disease space. Preliminary results showed the annualized exacerbation rate endpoint wasn’t met at the highest dosage of amlitelimab. Those numbers, at week 48, showed nominal significance at the medium dose.
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Spruce acquires Biomarin’s Sanfilippo drug, tralesinidase alfa

April 15, 2025
By Karen Carey
After dropping development in December of its lead program, Spruce Biosciences Inc. has found new life by acquiring a BLA-ready enzyme replacement therapy for the rare genetic neurodegenerative disease Sanfilippo syndrome type B. If approved, the therapy, tralesinidase alfa, could bring Spruce a priority review voucher.
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Illustration of intestinal track

Ironwood: FDA nay on PK means another apraglutide study

April 14, 2025
By Randy Osborne
More than a year after Ironwood Pharmaceuticals Inc.’s phase III hitch with apraglutide in short bowel syndrome, the other shoe fell from regulators as did the Boston-based firm’s shares (NASDAQ:IRWD), which ended April 14 at 64 cents, down 29 cents, or 31.5%.
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Pfizer’s loss offers boost to competitors in obesity space

April 14, 2025
By Jennifer Boggs
Pfizer Inc. is ending work on oral GLP-1 candidate danuglipron for weight loss following the report of a single potentially drug-induced liver injury, a move that appears to open the door for other firms working on oral therapies in the high-dollar obesity space, even as industry watchers seek further details to determine whether similar safety signals could emerge for those competitors.
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Illustration of human heart with DNA structure background

Early stage cardio data from Verve bump the stock

April 14, 2025
By Lee Landenberger
Positive early stage data for Verve Therapeutics Inc.’s base editing therapy points to a range of development options, including bringing partner Eli Lilly and Co. in a little closer. The new data helped ease the company’s pain from the April 2 enrollment pause of a similarly designed therapy from Verve. Verve’s Heart-2 phase Ib of VERVE-102 in treating 14 patients with heterozygous familial hypercholesterolemia and/or premature coronary artery disease showed one infusion led to dose-dependent decreases in blood PCSK9 protein levels and low density lipoprotein cholesterol.
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Bradley Burnam, CEO, Turn Therapeutics

Spevigo so-so, innovator takes another Turn at IL-36 in eczema

April 11, 2025
By Randy Osborne
With a promising IL-36 inhibitor for atopic dermatitis (AD, or eczema) at the phase II stage, Turn Therapeutics Inc. has gained $75 million in post-public commitments and meanwhile is pursuing a grassroots strategy to keep the coffers in balance.
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3D illustration showing presence of tumor inside prostate gland

Saliva test predicts prostate cancer better than PSA

April 10, 2025
By Shani Alexander
U.K. scientists developed a saliva-based test which better predicts the risk of prostate cancer than current prostate-specific antigen (PSA) blood tests by analyzing DNA to look for genetic variants linked to prostate cancer and calculating a polygenic risk score.
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Lunit Insight MMG

AI-enhanced mammogram readings are better, but ignored

April 10, 2025
By Marian (YoonJee) Chu
AI could significantly improve the value of patient recalls following mammography, but so far radiologists seem reluctant to rely on computer-aided readings. Radiologists tend to trust their own judgment – and that of their colleagues – in mammogram readings far more than AI-based diagnostics, even when the AI is much more accurate, a prospective trial analysis published in Radiology by Karolinska Institutet researchers found.
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UK government invests £500M in health data research service

April 10, 2025
By Nuala Moran
The U.K. government is to invest £500 million (US$645 million) in a health data research service that will provide a single point of access to national-scale anonymized patient records, ending the need to navigate different systems or make multiple applications to use information.
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