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Innovation in immuno-oncology: Leading companies in in-vitro T-cell activation

Pharmaceutical Technology

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: In-vitro T-cell activation. Immatics is the leading patent filer in in-vitro T-cell activation.

In-Vitro 130
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EMA CHMP recommends authorisation of AstraZeneca’s Evusheld for Covid-19

Pharmaceutical Technology

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). The combination therapy was also found to retain in vitro neutralisation of SARS-CoV-2 virus’ Omicron BA.5

In-Vitro 279
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A Holiday Surprise; FTC Published Its Health Products Compliance Guidance

FDA Law Blog

20, 2022, FTC announced the publication of its Health Products Compliance Guidance (“new Guidance”). We are inclined to agree, given that the new Guidance applies to all products making health-related claims, including food, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps.

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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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FDA Designations for Rare Disease Products, Part 3: Rare Pediatric Disease 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.

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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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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