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BioWorld - Wednesday, April 22, 2026
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Hands holding holographic intestine
Inflammatory

Ensho debuts to target gut inflammation with oral α4β7 inhibitors

July 31, 2024
By Marian (YoonJee) Chu
Ensho Therapeutics Inc. launched in July after licensing a pipeline of four oral α4β7 inhibitors for inflammatory and gastrointestinal disorders, including inflammatory bowel disease (IBD), from EA Pharma Co. Ltd. “Millions of people worldwide are living with IBD,” Ensho founder, president and executive chair Neena Bitritto-Garg recently told BioWorld, “and while there are a number of approved medications to address the symptoms of IBD, it remains a difficult-to-treat disease with high relapse rates for a considerable proportion of patients.”
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Hands holding holographic intestine
Newco news

Ensho debuts to target gut inflammation with oral α4β7 inhibitors

July 30, 2024
By Marian (YoonJee) Chu
Ensho Therapeutics Inc. launched in July after licensing a pipeline of four oral α4β7 inhibitors for inflammatory and gastrointestinal disorders, including inflammatory bowel disease (IBD), from EA Pharma Co. Ltd. “Millions of people worldwide are living with IBD,” Ensho founder, president and executive chair Neena Bitritto-Garg recently told BioWorld, “and while there are a number of approved medications to address the symptoms of IBD, it remains a difficult-to-treat disease with high relapse rates for a considerable proportion of patients.”
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FDA Approved stamp with pills

Sun Pharma’s JAK inhibitor for severe alopecia gets US FDA nod

July 30, 2024
By Lee Landenberger
The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. This is the third FDA-approved treatment for severe alopecia areata in the past three years.
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SK Bioscience invests SAFE-ly in Sunflower

July 30, 2024
By Marian (YoonJee) Chu
SK Bioscience Co. Ltd. signed a simple agreement for a future equity (SAFE) deal totaling $2 million with Hingham, Mass.-based Sunflower Therapeutics PBC on July 25 to secure both Sunflower’s equity and its yeast-based protein manufacturing technology. The conditional agreement will grant SK Bioscience future equity rights in Sunflower without the need for immediate valuation, allowing for minimal investment.
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Blood Brain Barrier Visual

Sunbird blood test shines with 92% accuracy in detecting Alzheimer’s

July 30, 2024
By Annette Boyle
Sunbird Bio Inc.’s Neural EV-tau aggregate assay demonstrated 92% correlation with PET scans in identifying individuals with Alzheimer’s disease, a study presented at the Alzheimer’s Association International Conference in Philadelphia, on July 30 found.
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U.S. FDA headquarters

US FDA eyes overhaul of guidance for maxillofacial systems

July 30, 2024
By Mark McCarty
The U.S. FDA proposed to overhaul guidances for maxillofacial systems that accumulated at least 18 years' of dust, in an effort to keep up to date with modern medical technology.
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WHO preps for human avian flu spread with mRNA vaccine project

July 30, 2024
By Mari Serebrov
With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
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Close up image of shoulder and back with severe urticaria or hives

CIndU breakthrough? Celldex phase II scores with barzolvolimab

July 30, 2024
By Randy Osborne
Succeeding where others have failed in an indication with high unmet need, Celldex Therapeutics Inc. disclosed top-line data from the phase II trial with barzolvolimab (barzo) against two common forms of chronic inducible urticaria (CIndU): cold urticaria (ColdU) and symptomatic dermographism (SD).
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Ovarian cancer gene therapy shows promise; Imunon preps for phase III

July 30, 2024
By Karen Carey
Phase II data showing an 11.1-month improvement in overall survival for advanced ovarian cancer patients treated with the IL-12 immunotherapy IMNN-001 drove up shares of Imunon Inc. by 181% July 30. The results “could usher in the first immune-based therapy for ovarian cancer,” said Stacy Lindborg, president and CEO of the Lawrenceville, N.J.-based company.
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Neurons with dendrites affected by amyloid plaques in Alzheimer's disease

C2N, Quanterix blood tests diagnose 90% of early-stage Alzheimer's

July 29, 2024
By Annette Boyle
C2N Diagnostics LLC’s two-factor blood test, Precivity AD2, showed 90% accuracy in diagnosing Alzheimer’s disease in a study presented at the Alzheimer’s Association International Conference in Philadelphia on July 28 and simultaneously published in the Journal of the American Medical Association. The following day, Quanterix Corp. presented results from its study that showed a multi-marker approach could maintain the 90% accuracy of its Lucentad test, while reducing the percentage of uncertain results from more than 30% to 10%, in line with the intermediate results demonstrated by Precivity.
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