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China’s NMPA clears Transcenta’s IND for solid tumour treatment

Pharmaceutical Technology

The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted clearance for Transcenta’s investigational new drug (IND) application for its TST003 to treat solid tumours. TST003 is a first-in-class Gremlin1 targeting humanised monoclonal antibody.

Antibody 242
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Topical products: Aiming for quality, simplicity, and cost-efficiency in their development, scale-up, and manufacturing

Pharmaceutical Technology

Formulating products that have the proper composition, viscosity, texture, and stability, and can also be shown to be safe and effective, is both a science and an art. Without proper precautions, knowledge gaps can occur and important details may be overlooked when a product is transferred from one site to another. Simplicity matters.

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FDA Designations for Rare Disease Products, Part 2: Orphan Drug Designation

Camargo

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Definition of a Rare Disease or Condition.

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How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

Camargo

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. Approaches to Pharmacokinetic Analysis.

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Tests indicate modern oral nicotine products elicit lower toxicity responses than cigs

Scienmag

Credit: Bat-science.com New research by BAT indicates that modern oral products (MOPs) showed lower toxicity responses in certain assays than traditional cigarettes. Scientists analysed the toxicological impact of one of BAT’s nicotine pouch products, formerly called Lyft and now known as Velo, in an in vitro laboratory-based test.

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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound.

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Parkinson’s and Melanoma Share an Amyloid Link, Says New Research

XTalks

Now, thanks to a study funded by the National Institutes of Health Intramural Research Program, scientists have discovered that ?-synuclein, The scientists found that the amyloid-forming protein is expressed at higher levels in melanoma cells than in normal healthy skin. Additionally, higher levels of ?-synuclein Excessive levels of ?-synuclein