Sun.May 19, 2024

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Alzheimer’s Could Be Caused by Brain Cells That Age Too Fast

AuroBlog - Aurous Healthcare Clinical Trials blog

Different types of brain cells could age at different speeds, and that may help explain the development of Alzheimer’s disease.

Engineer 207
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Parenteral Solutions in Contract Manufacturing for the Pharmaceutical Industry 

Pharmaceutical Technology

Discover what industry professionals seek in contract manufacturing for parenteral solutions. Ensure quality, compliance, and innovation with our comprehensive guide. Click to learn more.

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Advent of decentralised clinical trials spurs need for robust rules like USFDA’s Cancer Clinical Trial Eligibility Criteria

AuroBlog - Aurous Healthcare Clinical Trials blog

As India sees the emergence of decentralised clinical trials driven by digital health technologies remote patient monitoring, Electronic Health Records andpatient data capture, it also sees robust rules like the US FDA’s Cancer Clinical Trial Eligibility Criteria as an advantage.

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Rucaparib camsylate by Pharmaand for Adenocarcinoma Of The Gastroesophageal Junction: Likelihood of Approval

Pharmaceutical Technology

Rucaparib camsylate is under clinical development by pharmaand and currently in Phase II for Adenocarcinoma Of The Gastroesophageal Junction.

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

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GLP-1 Receptor Agonist Market to Reach $125B by 2033: GlobalData

BioSpace

While Eli Lilly and Novo Nordisk currently dominate the GLP-1 receptor agonist space, there are more than 50 candidates in clinical development for obesity and type 2 diabetes, according to analytics firm GlobalData.

Marketing 119
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Rucaparib camsylate by Pharmaand for Pancreatic Ductal Adenocarcinoma: Likelihood of Approval

Pharmaceutical Technology

Rucaparib camsylate is under clinical development by pharmaand and currently in Phase II for Pancreatic Ductal Adenocarcinoma.

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Rucaparib camsylate by Pharmaand for Metastatic Biliary Tract Cancer: Likelihood of Approval

Pharmaceutical Technology

Rucaparib camsylate is under clinical development by pharmaand and currently in Phase II for Metastatic Biliary Tract Cancer.

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Moderna Gets Win in COVID-19 Patent Dispute with Pfizer, BioNTech

BioSpace

The European Patent Office last week upheld one of Moderna’s key patents, handing the biotech an important victory in its protracted COVID-19 vaccine battle with Pfizer and BioNTech.

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Rucaparib camsylate by Pharmaand for Metastatic Pancreatic Cancer: Likelihood of Approval

Pharmaceutical Technology

Rucaparib camsylate is under clinical development by pharmaand and currently in Phase II for Metastatic Pancreatic Cancer.

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Rapport Therapeutics and Telix Pharma File IPOs as Number of Biotechs Going Public Slows

BioSpace

Neuroscience-focused Rapport Therapeutics and radiopharma developer Telix Pharma announced their respective plans Friday for initial public offerings on the Nasdaq for undisclosed dollar amounts.

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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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Rucaparib camsylate by Pharmaand for Renal Cell Carcinoma: Likelihood of Approval

Pharmaceutical Technology

Rucaparib camsylate is under clinical development by pharmaand and currently in Phase II for Renal Cell Carcinoma.

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AstraZeneca to Build $1.5B ADC Manufacturing Plant in Singapore

BioSpace

To support its growing antibody-drug conjugate portfolio, AstraZeneca on Monday said it is investing $1.5 billion in a Singapore production site that will include all steps of the ADC manufacturing process.

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Olverembatinib by Ascentage Pharma Group International for Chronic Myelocytic Leukemia (CML, Chronic Myeloid Leukemia): Likelihood of Approval

Pharmaceutical Technology

Olverembatinib is under clinical development by Ascentage Pharma Group International and currently in Phase II for Chronic Myelocytic Leukemia (CML, Chronic Myeloid Leukemia).

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AstraZeneca to Pay Pfizer $107.5M in Damages in Tagrisso Patent Tussle

BioSpace

Pfizer’s Wyeth unit notched a legal victory over AstraZeneca on Friday as a federal jury found the British-Swedish company violated two key patents in developing and marketing its lung cancer drug Tagrisso.

Marketing 100
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Afamitresgene autoleucel by Adaptimmune Therapeutics for Peripheral Nerve Sheath Tumor (Neurofibrosarcoma): Likelihood of Approval

Pharmaceutical Technology

Afamitresgene autoleucel is under clinical development by Adaptimmune Therapeutics and currently in Phase II for Peripheral Nerve Sheath Tumor (Neurofibrosarcoma).

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Time- vs Step-Based Physical Activity Metrics for Health

JAMA Internal Medicine

This cohort study compares the association of duration and intensity of physical activity with mortality and cardiovascular disease outcomes in female individuals older than 60 years.

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Rucaparib camsylate by Pharmaand for Adenocarcinoma Of The Gastroesophageal Junction: Likelihood of Approval

Pharmaceutical Technology

Rucaparib camsylate is under clinical development by pharmaand and currently in Phase II for Adenocarcinoma Of The Gastroesophageal Junction.

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Opinion: How Biopharma Companies Should Prepare for Non-Compete Bans

BioSpace

Life science companies can protect intellectual property in multiple ways, including leveraging IP rights.

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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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Furmonertinib mesylate by Shanghai Allist Pharmaceuticals for Lung Adenocarcinoma: Likelihood of Approval

Pharmaceutical Technology

Furmonertinib mesylate is under clinical development by Shanghai Allist Pharmaceuticals and currently in Phase II for Lung Adenocarcinoma.

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Edible Cannabis Legalization and Cannabis Poisonings in Older Adults

JAMA Internal Medicine

This cross-sectional study examines the association between edible cannabis legalization and emergency department visits for cannabis poisonings in older adults.

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Elixcyte by Unicocell Biomed for Chronic Kidney Disease (Chronic Renal Failure): Likelihood of Approval

Pharmaceutical Technology

Elixcyte is under clinical development by Unicocell Biomed and currently in Phase II for Chronic Kidney Disease (Chronic Renal Failure).

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The Promise and Challenge of Value-Based Payment

JAMA Internal Medicine

This Viewpoint discusses the benefits and challenges of transitioning to a value-based payment design for health care rather than a fee-for-service system.

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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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Afamitresgene autoleucel by Adaptimmune Therapeutics for Neuroblastoma: Likelihood of Approval

Pharmaceutical Technology

Afamitresgene autoleucel is under clinical development by Adaptimmune Therapeutics and currently in Phase II for Neuroblastoma.

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Drug Patent Expirations for the Week of May 19, 2024

Drug Patent Watch

ADASUVE (loxapine) Alexza pharms Patent: 9,370,629 Expiration: May 20, 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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Afamitresgene autoleucel by Adaptimmune Therapeutics for Osteosarcoma: Likelihood of Approval

Pharmaceutical Technology

Afamitresgene autoleucel is under clinical development by Adaptimmune Therapeutics and currently in Phase II for Osteosarcoma.

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Upcoming EveryLife Foundation Scientific Workshop on May 21, 2024 will Address Challenges in Developing Therapies for Ultra-Rare Diseases

FDA Law Blog

By Sarah Wicks — On May 21, 2024, the EveryLife Foundation for Rare Diseases (ELF) will host a Scientific Workshop at the National Press Club in Washington, D.C. aimed at identifying and characterizing the challenges in developing therapies for ultra-rare diseases and conditions that affect exceedingly small populations. The workshop will drive in-depth discussions from leaders across federal agencies, the patient advocacy community, industry, academia and policy to examine the current state of

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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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Rucaparib camsylate by Pharmaand for Pancreatic Ductal Adenocarcinoma: Likelihood of Approval

Pharmaceutical Technology

Rucaparib camsylate is under clinical development by pharmaand and currently in Phase II for Pancreatic Ductal Adenocarcinoma.

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New patent expiration for Alexza Pharms drug ADASUVE

Drug Patent Watch

Annual Drug Patent Expirations for ADASUVE Adasuve is a drug marketed by Alexza Pharms and is included in one NDA. It is available from one supplier.

Drugs 59
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Rucaparib camsylate by Pharmaand for Metastatic Biliary Tract Cancer: Likelihood of Approval

Pharmaceutical Technology

Rucaparib camsylate is under clinical development by pharmaand and currently in Phase II for Metastatic Biliary Tract Cancer.

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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.

Drugs 59
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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.