Mon.May 27, 2024

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Scientists Think This Psychedelic Drug Could Help Treat Anorexia

AuroBlog - Aurous Healthcare Clinical Trials blog

The psychedelic drug psilocybin (as found in ‘magic’ mushrooms) has promising potential as a treatment for the eating disorder anorexia nervosa, according to new research that looked at its effects on an animal model of the condition.

Scientist 199
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South Korea’s MFDS approves Eisai-Biogen’s LEQEMBI for Alzheimer’s

Pharmaceutical Technology

South Korea has approved Eisai and Biogen’s LEQEMBI for adults with mild cognitive impairment due to mild Alzheimer's disease (AD).

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Healthcare ads emerge as most violative as ASCI releases Annual Complaints Report

AuroBlog - Aurous Healthcare Clinical Trials blog

The Advertising Standards Council of India (ASCI) has released its Annual Complaints Report, which offers a comprehensive analysis of advertisements that were considered objectionable in the fiscal year 2023–24. ASCI examined 10,093 complaints and investigated 8,299 advertisements.

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Dr. Reddy’s and Novartis sign distribution agreement for anti-diabetes products

Pharmaceutical Technology

Dr. Reddy's Laboratories' Russian subsidiary and Novartis Pharma signed a deal for the distribution of anti-diabetes products.

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

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Novo Nordisk’s Once-Weekly Insulin Loses FDA Adcomm Vote for Type 1 Diabetes

BioSpace

Flagging a risk of hypoglycemia, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Friday did not recommend the approval of Novo Nordisk’s once-weekly insulin icodec for type 1 diabetes.

Insulin 131
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Dimerix and Taiba enter DMX-200 commercialisation deal in Middle East

Pharmaceutical Technology

Dimerix has entered into an agreement with Taiba to commercialise DMX-200 for treating FSGS kidney disease in the Middle East.

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More Trending

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Lilly doubles investment in Indiana site to enhance API manufacturing

Pharmaceutical Technology

Eli Lilly has annaounced a $5.3bn investment at its site in Lebanon, Indiana, US, to enhance API manufacturing capacity.

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Precision Medicine and Novel Approaches on Cusp of Breaking Through in Psychiatry

BioSpace

Approaches and targets for depression and other mental health illnesses have remained stagnant for decades. With several readouts for novel therapies on the horizon, that could be changing.

Medicine 128
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AZ’s Dato-DXd misses survival endpoint in lung cancer trial

pharmaphorum

The overall survival (OS) data has come in from the TROPION-Lung01 study of AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in lung cancer – and the result likely isn’t what they were hoping for.

Trials 128
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Asahi Kasei Offers $1.1B for Swedish Pharma Calliditas Therapeutics

BioSpace

The potential purchase by the Japanese conglomerate could secure access to Calliditas’ IgA nephropathy therapy Tarpeyo, which won the FDA’s full approval in December 2023.

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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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FDA sets date for Sarclisa in first-line multiple myeloma

pharmaphorum

Sanofi should hear from the FDA in September about its filing for Sarclisa as a first-line therapy for multiple myeloma after a priority review

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Despite Progress, ADCs Still Stalled in Non-small Cell Lung Cancer

BioSpace

Until compelling surface targets for lung cancer are developed, antibody-drug conjugates will fail to treat most patients with lung cancer, experts told BioSpace.

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Nippon Shinyaku’s DMD drug fails confirmatory trial

pharmaphorum

The future of Nippon Shinyaku’s Duchenne muscular dystrophy (DMD) therapy Viltepso has been thrown into doubt after it failed a confirmatory clinical trial

Trials 105
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Novartis Eyes Rare Kidney Disease Approvals on Heels of Two Phase III Wins

BioSpace

With back-to-back victories in IgA nephropathy and C3 glomerulopathy, Novartis on Saturday said it is planning to make regulatory submissions for the rare kidney diseases this year.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Lilly ups spend on diabetes, obesity drug production to $9bn

pharmaphorum

Eli Lilly is determined not to be left behind when it comes to manufacturing capacity for new diabetes and obesity therapies, raising its spending on a new plant in Indiana, US, to $9 billion.

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AstraZeneca, Daiichi Sankyo ADC Misses Endpoint in Phase III NSCLC Study

BioSpace

AstraZeneca and Daiichi Sankyo’s investigational antibody-drug conjugate Dato-DXd failed to significantly improve overall survival in non-small cell lung cancer patients versus docetaxel.

Antibody 120
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Breaking Down Financial Barriers in Clinical Trials: Enhancing Equity and Access for Patients

Cloudbyz

Although participation in clinical trials is essential to medical progress, a little-known fact is that they are not sufficiently diverse. Ultimately addressing these financial barriers is crucial for the optimal participation of all individuals in clinical trials. Diversity of Patients Racial and ethnic diversity are large barriers in clinical trials.

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NS Pharma’s DMD Candidate Viltespo Fails Confirmatory Phase III Trial

BioSpace

NS Pharma, a subsidiary of Nippon Shinyaku, announced Monday that its Duchenne muscular dystrophy candidate Viltepso failed a late-stage confirmatory trial, showing no significant motor function improvements over placebo.

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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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Drug Patent Expirations for the Week of May 26, 2024

Drug Patent Watch

ACULAR LS (ketorolac tromethamine) Abbvie Patent: 9,216,167 Expiration: May 28, 2024 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.

Drugs 59
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30 Years After Genetic Discovery, Huntington’s Patients Still Waiting

BioSpace

Following a series of clinical failures, optimism builds for the first disease-modifying treatment.

Genetics 125
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Jennifer Newberger Returns to HPM as a Director After Stints with Apple, Abbott Laboratories, and Cognito Therapeutics

FDA Law Blog

Hyman, Phelps & McNamara, P.C. (HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills.

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J&J Inks $1.25B Deal to Buy Rights to Atopic Dermatitis Candidate from Numab

BioSpace

Johnson & Johnson’s deal for Numab Therapeutics’ bispecific antibody NM26, slated to enter Phase II studies, comes on the heels of J&J’s $850 million Proteologix bispecific antibody acquisition.

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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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Pharma Pulse 5/27/24: Cyberattack at Ascension Hospitals Causing Delays in Patient Care, Optimizing Pharmaceutical Innovation Through AI & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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New patent expiration for Abbvie drug ACULAR LS

Drug Patent Watch

Annual Drug Patent Expirations for ACULAR+LS Acular Ls is a drug marketed by Abbvie and is included in one NDA. It is available from three suppliers.

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Neurocosmetics

Pharma Tutor

Neurocosmetics admin Mon, 05/27/2024 - 16:30 Vinay Kumar Singh. Head-Formulation Kumar Organic Products Research Centre Pvt. Ltd., Bengaluru Email : formulation_krc@kopresearchcentre.

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Get Involved in Understanding Your Brain and Genes

Trialfacts

Contents Background Why Participate? Your Rights Who Can Participate? Study Location Research Centre: Monash Biomedical Imaging Location: 770 Blackburn Road, Clayton 3168 Lead Doctor: Professor Alex Fornito Ethics Committee: This study has been reviewed and approved by the Monash University Human Research Ethics Committee (Project #12692) Background People show differences in several characteristics, such as personality traits, that may make some people more prone to conditions such as anxiety a

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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I Am Curious About Cannabis Edibles—What Should I Know?

JAMA Internal Medicine

This JAMA Internal Medicine Patient Page describes the advantages, risks, and safe use of cannabis edibles.

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Resource Label Group Purchases Beyer Graphics

Pharmaceutical Commerce

The transaction serves as way to expand customers’ access to products and capabilities.

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How Should Medicare Pay For Artificial Intelligence?

JAMA Internal Medicine

This Viewpoint examines artificial intelligence–enabled clinical services, existing payment structures, and the economics of artificial intelligence pricing.

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Which pharmaceutical companies have the most drug patents in Lithuania?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Lithuania.

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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.