Sun.Jul 07, 2024

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Drug Developers Tap the Immune System to Supercharge ADCs

BioSpace

With the antibody drug conjugate market projected to hit $28 billion by 2028, some companies are looking to harness the drugs for immunotherapy.

Drugs 120
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Semaglutide vs Tirzepatide for Weight Loss in Adults With Overweight or Obesity

JAMA Internal Medicine

This cohort study compares treatment-associated weight loss and rates of gastrointestinal adverse events among adults with overweight or obesity receiving tirzepatide or semaglutide labeled for type 2 diabetes in a clinical setting.

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Beyond GLP-1s: The Next Obesity Treatments

BioSpace

Eli Lilly, Rivus Pharmaceuticals and more target different biological processes in hopes of generating higher-quality weight loss and avoiding metabolic issues.

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Four drugmakers found to have breached ABPI code

pharmaphorum

Novartis, Pfizer, Otsuka and Novo Nordisk have been called out for breaching the ABPI code of practice

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Patient Assistance Programs: A Source of Real-World Data?

BioSpace

Patient assistance programs may actually be a two-way street, providing patients with drugs and companies with data.

Drugs 84
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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

By Gail H. Javitt — In its final rule on laboratory developed tests (LDTs) (see our prior blog here ), FDA acknowledged that “some laboratories may lack familiarity, experience, or existing infrastructure for complying with FDA requirements” and made multiple references to a “small entity compliance guidance” that the agency intended to publish to “provide additional guidance to small businesses.

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

Drugs 59
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Subjective Measures, Objective Outcomes: Data Quality in Atopic Dermatitis Clinical Trials

VirTrial

Introduction Atopic Dermatitis (AD) is one of the most prevalent skin conditions worldwide. In recent years, there has been significant activity in the AD clinical trial landscape, including the approval of novel systemic therapies. Accurate measurement of AD severity over time is crucial for evaluating treatment efficacy in these trials. This blog post explores the key measurement tools used in AD trials, specifically the Eczema Area and Severity Index (EASI) and Total Body Surface Area (BSA),

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Which pharmaceutical drugs have the most drug patents in France?

Drug Patent Watch

This chart shows the drugs with the most patents in France. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.

Drugs 59
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Subjective Measures, Objective Outcomes: Data Quality in Atopic Dermatitis Clinical Trials

VirTrial

Introduction Atopic Dermatitis (AD) is one of the most prevalent skin conditions worldwide. In recent years, there has been significant activity in the AD clinical trial landscape, including the approval of novel systemic therapies. Accurate measurement of AD severity over time is crucial for evaluating treatment efficacy in these trials. This blog post explores the key measurement tools used in AD trials, specifically the Eczema Area and Severity Index (EASI) and Total Body Surface Area (BSA),

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Subjective Measures, Objective Outcomes: Data Quality in Atopic Dermatitis Clinical Trials

VirTrial

Introduction Atopic Dermatitis (AD) is one of the most prevalent skin conditions worldwide. In recent years, there has been significant activity in the AD clinical trial landscape, including the approval of novel systemic therapies. Accurate measurement of AD severity over time is crucial for evaluating treatment efficacy in these trials. This blog post explores the key measurement tools used in AD trials, specifically the Eczema Area and Severity Index (EASI) and Total Body Surface Area (BSA),