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

Pharmaceutical Technology

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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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. Criteria for Orphan Drug Designation.

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Novo Nordisk moves to strengthen obesity efforts

pharmaphorum

Under the joint research plan, the Danish giant will work with EraCal to identify novel drug targets relevant for food intake regulation and additional metabolic phenotypes. Central nervous system-controlled behaviour, such as food intake, is notoriously difficult to explore in vitro.

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Are All Excipients Truly Inert? Maybe Not, Suggests New Study

XTalks

For decades, formulation scientists have relied on the assumption that common pharmaceutical excipients are biologically inert. For example, Advil tablets contain 18 inactive ingredients alongside ibuprofen, the drug’s active pharmaceutical ingredient (API). But just how inert are these excipients?

Protein 103
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6th Annual 3D Cell Culture Conference

pharmaphorum

Exploring the implementation of complex in-vitro models for drug development. The pharmaceutical industry globally is realising the growing potential of in vitro tissue models for drug discovery, pathology modelling and validation, safety and toxicity. Etienne De Braekeleer, Senior Research Scientist, AstraZeneca.

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Receptor Occupancy Assays by Flow Cytometry: Benefits for Clinical Trials

XTalks

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. All drug development processes evaluate a drug’s pharmacokinetics (PK) to gather data about its absorption, distribution, metabolism, and excretion in the body.