Sun.Oct 22, 2023

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What Are Pragmatic Clinical Trials?

Rethinking Clinical Trials

What Are Pragmatic Clinical Trials? Description In this video, Dr. Lesley Curtis describes pragmatic clinical trials. Speaker Lesley Curtis, PhD Professor of Population Health Sciences and Medicine, Duke University Duke Clinical Research Institute Collaboratory Steering Committee Chair Related Why Should I Do A Pragmatic Trial? The post What Are Pragmatic Clinical Trials?

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NASH on the Cusp: An Emerging Market Opportunity

BioSpace

The non-alcoholic steatohepatitis space is still a “big mystery,” analysts tell BioSpace, but its connection to weight loss could provide an additional opportunity for contenders.

Marketing 110
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Why Should I Do A Pragmatic Trial?

Rethinking Clinical Trials

Why Should I Do A Pragmatic Trial? Description Dr. Lesley Curtis discusses reasons to conduct pragmatic clinical trials. Speaker Lesley Curtis, PhD Professor of Population Health Sciences and Medicine, Duke University Duke Clinical Research Institute Collaboratory Steering Committee Chair Related What Are Pragmatic Clinical Trials? The post Why Should I Do A Pragmatic Trial?

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Opinion: The Potential of Neurofilament Light Chain as a Biomarker in Parkinson’s Disease

BioSpace

While sensitive and specific biomarkers for Alzheimer’s disease have recently taken a leap forward, the Parkinson’s space has lagged behind. Neurofilament Light Chain could change that.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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UPDATED ESMO: Seagen, Astellas and Merck knock it out of the park with Padcev-Keytruda combo in bladder cancer

Fierce Pharma

Lennon and McCartney. Simon and Garfunkel. Richards and Jagger. Padcev and Keytruda? Can the cancer-fighting duo rock on in bladder cancer? | The results are in for a phase 3 bladder cancer trial assessing the combination of Seagen and Astellas' Padcev, plus Merck's Keytruda, versus standard of care chemotherapy. The figures indicate that the combo can be transformative in the indication.

Trials 102
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FDA Approves BioMarin’s Voxzogo for Young Children with Dwarfism

BioSpace

The label for the achondroplasia drug, which promotes endochondral bone growth, now covers children under five years of age with the rare genetic disease causing the most common form of dwarfism.

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Merck, BMS Score Separate Late-Stage Victories in Bladder Cancer at ESMO

BioSpace

The competitors posted promising survival data for their respective blockbuster PD-1 inhibitors—Keytruda and Opdivo—emphasizing the potential of these therapies in bladder cancer patients.

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ESMO: Rain in Spain doesn’t dampen spirits of 33,000 oncologists

Fierce Pharma

MADRID—Attendees for the European Society for Medical Oncology Congress 2023 arrived in Madrid to torrential downpours Thursday evening, a gloomy atmosphere that did not reflect the overall excitem | ESMO attendees arrived in Madrid to torrential downpours Thursday evening, a gloomy atmosphere that did not reflect the overall excitement of an industry conference that promised to showcase breakthroughs in breast, lung and prostate cancer.

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Roche Pays $7.1B to Roivant for Rights to Telavant’s IBD Candidate

BioSpace

The Swiss drugmaker gains rights to RVT-3101 in the U.S. and Japan. Telavant was formed in late 2022 by Roivant and Pfizer, which had a 25% stake in the venture and retains rights to the antibody in other countries.

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Endogenous and Exogenous Thyrotoxicosis and Risk of Incident Cognitive Disorders in Older Adults

JAMA Internal Medicine

This cohort study assesses whether endogenous and exogenous thyrotoxicosis is associated with higher risk of cognitive disorders in adults 65 years and older.

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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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Achieving Data Diversity Through AI in Drug Development

BioSpace

AI and machine learning could transform drug discovery, but first, practitioners must overcome ethical challenges en route to medicines for all.

Drugs 108
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ESMO: Novartis' booming Pluvicto posts mixed results in earlier prostate cancer

Fierce Pharma

Novartis has high hopes for its radiotherapy Pluvicto. | As Novartis aims to move its radiotherapy Pluvicto into an earlier treatment setting in prostate cancer, it has posted a mixed bag of trial data that cast a cloud of uncertainty over its regulatory path forward.

Trials 69
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ESMO: Roche’s Alecensa claims a first in ALK-positive NSCLC

pharmaphorum

ESMO: Roche’s Alecensa claims a first in ALK-positive NSCLC Phil.

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New tentative approval for Sandoz drug sugammadex sodium

Drug Patent Watch

Sugammadex sodium is the generic ingredient in two branded drugs marketed by Msd Sub Merck, Aspiro, Mylan, and Sandoz and, and is included in four NDAs. There is one patent… The post New tentative approval for Sandoz drug sugammadex sodium appeared first on DrugPatentWatch - Make Better Decisions.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Federal Court: Transferring drug submission does not require re-serving Notice of Allegation

Pharma in Brief

The Federal Court has upheld a decision of the Minister of Health ( Minister ) that the new owner of a biosimilar new drug submission ( NDS ) could adopt the notice of allegation ( NOA ) served by its predecessor. Consequently, the new owner was properly added as a defendant to an on-going action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ).

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New tentative approval for MYLAN drug sugammadex sodium

Drug Patent Watch

Sugammadex sodium is the generic ingredient in two branded drugs marketed by Msd Sub Merck, Aspiro, Mylan, and Sandoz and, and is included in four NDAs. There is one patent… The post New tentative approval for MYLAN drug sugammadex sodium appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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ESMO: Opdivo chases Keytruda in perioperative lung cancer

pharmaphorum

ESMO: Opdivo chases Keytruda in perioperative lung cancer Phil.

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Which pharmaceutical drugs have the most drug patents in Malaysia?

Drug Patent Watch

This chart shows the drugs with the most patents in Malaysia. 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 Malaysia? appeared first on DrugPatentWatch - Make Better Decisions.

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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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RNA Therapeutics: A Novel Approach to Treating Diseases

Roots Analysis

RNA therapeutics are a novel class of biopharmaceuticals that harness the power of RNA molecules for the treatment and prevention of a wide range of disorders, including oncological, and genetic disorders as well as infectious diseases. These therapeutics are broadly classified into two categories, namely coding RNAs and non-coding RNAs. Coding RNAs include messenger RNA (mRNA) and short interfering RNA (siRNA), which encode proteins and silence gene expression, respectively.

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