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BioWorld - Friday, May 29, 2026
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BioJapan 2023: Fear of failure at heart of Japan’s failure to deliver innovation

Oct. 11, 2023
By Tamra Sami
Insanity has often been defined as doing the same thing and expecting different results, and Japan seems to be trapped in that rut largely because it can’t seem to do innovation differently, said speakers at the BioJapan 2023 meeting held Oct. 11 in Yokohama, Japan.
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Concept art for blood sugar.
Endocrine/Metabolic

Atrogi presents dual adrenergic agonist for diabetes, obesity and steatohepatitis

Oct. 11, 2023
A team from Atrogi AB has reported the activity of ATR-127, a novel dual adrenergic agonist targeting β2- and β3-adrenoceptors (ARs), for the potential treatment of steatohepatitis, obesity and diabetes.
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Doctor measuring patient's waist
Endocrine/Metabolic

Long-acting dual GDF-15 and GLP-1 agonist shows efficacy in rodent models of obesity and diabetes

Oct. 11, 2023
Researchers from Yuhan Corp. presented the discovery and preclinical evaluation of a novel long-acting dual agonist of the glucagon like peptide-1 (GLP-1) and growth differentiation factor 15 (GDF-15), YH-40863.
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Neurology/Psychiatric

Novel 15-PGDH inhibitor improves muscle force in models of SMA and muscle atrophy

Oct. 11, 2023
It has been previously demonstrated that therapeutic inhibition of the prostaglandin E2 (PGE2)-degrading enzyme, 15-prostaglandin dehydrogenase (15-PGDH), was able to improve muscle strength in aged mice. Researchers from Epirium Bio Inc. have now reported the discovery and preclinical characterization an orally bioavailable small molecule inhibitor of 15-PGDH – MF-300 – being developed for the treatment of neuromuscular dysfunction.
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Laptop displaying FDA logo
2023 Med Tech Conference

PCCP concept at risk of being subsumed in debate over artificial intelligence

Oct. 10, 2023
By Mark McCarty
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit this policy to artificial intelligence (AI) and machine learning (ML) products. Nonetheless, the PCCP concept is starting to show signs of being consumed by the debate over AI and ML medical software, so much so that industry may be losing sight of the opportunities the PCCP concept offers in other types of medical technologies.
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2023 Med Tech Conference

Advamed’s Whitaker more bullish on VALID Act in light of FDA draft rule for LDTs

Oct. 10, 2023
By Mark McCarty

The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was a long time in coming, much longer than any legislative proposals to overhaul the agency’s regulatory mechanisms for these tests. Nonetheless, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), believes that the FDA draft rule is likely to prompt Congress to pass the Verifying Accurate, Leading-edge IVCT development (VALID) Act, a development that would truncate an FDA final rule that would almost certainly face litigation.


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Biomarkers

Cathepsin C and PDGFR-α as novel biomarkers of prevalent distal sensorimotor polyneuropathy

Oct. 10, 2023
Researchers from Heinrich-Heine-Universität Düsseldorf and affiliated organizations presented data from a study that aimed to identify novel neurological biomarkers in distal sensorimotor polyneuropathy (DSPN).
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AI generated illustration of a brain on fire
Neurology/Psychiatric

ECNP 2023: Look for antibodies in idiopathic psychoses? First, maybe better tests

Oct. 10, 2023
By Anette Breindl
For individuals who develop an unexpected psychosis, there is something to be said for testing them for autoimmune antibodies. And something against. At the 36th Congress of the European College of Neuropsychopharmacology (ECNP) this week, the topic was worth a controversy session, where speakers presented the pros and cons of the approach. Currently used tests have a specificity of 99%. But as Ester Coutinho, consultant neurologist at the University of Coimbra, pointed out, the validity of diagnostic tests depends on the prevalence of the disorder one is looking for as well. Coutinho estimated that autoimmune psychoses account for 1% of psychoses overall.
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Light micrograph and 3D illustration of adipose tissue.
Biomarkers

miR-29b-3p as extracellular biomarker of adipose tissue fibrosis

Oct. 9, 2023
Researchers from the Universities of Malaga and Cordoba (Spain) presented data from a study that aimed to identify matrisome regulator miRNAs in obesity and prediabetes that could represent novel noninvasive circulating biomarkers of adipose tissue (AT) fibrosis.
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3D cross-section illustration of muscle anatomy
Neurology/Psychiatric

RKER-065 improves muscle function and prevents bone loss in prednisolone-treated mice

Oct. 9, 2023
While glucocorticoids are used as first-line therapy for Duchenne muscular dystrophy (DMD), these agents are associated with several adverse events, including accelerated bone loss and muscle atrophy. As a result, prolonged glucocorticoid treatment is one of the primary contributors to the high fracture rate in patients with DMD.
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