Sun.May 21, 2023

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Future of Intercept’s NASH drug in doubt after FDA panel rejection

Bio Pharma Dive

The safety risks of obeticholic acid were too great for an advisory committee to recommend approval without clear proof of its benefits. But collecting that data may not be “economically feasible,” an executive said.

Drugs 183
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A Popular New Weight-Loss Drug May Help Prevent Dementia

AuroBlog - Aurous Healthcare Clinical Trials blog

Over 55 million people worldwide have dementia. This mind-robbing condition has a huge impact on society and the economy, so scientists are working hard to find ways to treat or prevent it. One of the avenues being explored is the new weight-loss jab, Wegovy.

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Chronic Obstructive Pulmonary Disease and Pneumonia in New Users of Combination Maintenance Inhalers

JAMA Internal Medicine

This cohort study uses commercial insurance claims to compare the incidence of first moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation and first pneumonia hospitalization among patients with COPD who started using inhalers with long-acting muscarinic antagonists and long-acting β-agonists (LABAs) vs inhalers containing inhaled corticosteroids and LABAs.

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Ayush ministry informs HC that it has instructed drug regulators against use of Unani label for Ayurveda drug

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

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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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Phase III Results Prime Dupixent as First Potential Biologic Approval for COPD

BioSpace

Phase III Results Prime Dupixent as First Potential Biologic Approval for COPD 5/22/2023

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FDA clears Vyjuvek as first topical gene therapy

pharmaphorum

FDA clears Vyjuvek as first topical gene therapy Phil.

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Drug Patent Expirations for the Week of May 21, 2023

Drug Patent Watch

SELZENTRY (maraviroc) Viiv hlthcare Patent: 7,368,460 Expiration: May 25, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or… The post Drug Patent Expirations for the Week of May 21, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Biopharma Targets the Untapped Potential of the Human Healthspan

BioSpace

Biopharma Targets the Untapped Potential of the Human Healthspan 5/22/2023

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Comparative Effects of Glucose-Lowering Medications on Kidney Outcomes in Type 2 Diabetes

JAMA Internal Medicine

This randomized clinical trial evaluates kidney function with the use of medications added to metformin treatment in patients with type 2 diabetes.

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Opinion: Sarepta Enters Uncharted Territory with Adcomm Approval

BioSpace

Opinion: Sarepta Enters Uncharted Territory with Adcomm Approval 5/22/2023

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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CD20 market heats up as FDA OKs AbbVie, Genmab bispecific

pharmaphorum

CD20 market heats up as FDA OKs AbbVie, Genmab bispecific Phil.

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Hepion Claims Phase II NASH Victory Following Intercept’s Adcomm Defeat

BioSpace

Hepion Claims Phase II NASH Victory Following Intercept’s Adcomm Defeat 5/22/2023

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Which pharmaceutical drugs have the most drug patents in Philippines?

Drug Patent Watch

This chart shows the drugs with the most patents in Philippines. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Philippines? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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ReCode–a New Contestant in the mRNA Race

BioSpace

ReCode–a New Contestant in the mRNA Race 5/22/2023

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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AbbVie, Genmab Score FDA Nod for DLBCL as Blood Cancer Space Heats Up

BioSpace

AbbVie, Genmab Score FDA Nod for DLBCL as Blood Cancer Space Heats Up 5/22/2023

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FDA Action Alert: Blueprint, Opiant and Lexicon

BioSpace

FDA Action Alert: Blueprint, Opiant and Lexicon 5/22/2023

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