Sat.Jun 01, 2024 - Fri.Jun 07, 2024

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Underutilized Opportunities: Exploring Patent Term Extensions for Medical Devices

Drug Patent Watch

In a recent study published in the Expert Review of Medical Devices, researchers investigated the utilization of patent term extensions (PTEs) to extend regulatory timeframes for medical devices in the… Source

Research 111
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Reversible Molecular Changes Can Cause Cancer, Study Shows

AuroBlog - Aurous Healthcare Clinical Trials blog

Though one in two people will develop some form of cancer in their lifetime, there’s still much we don’t know about this disease. But thanks to continued research efforts, we keep learning more about the biology of cancer. One of these recent discoveries could even transform our understanding of how cancers develop.

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FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns

Bio Pharma Dive

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

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Bristol Myers puts more than 860 jobs on chopping block in NJ as $1.5B savings campaign rolls ahead

Fierce Pharma

The scope of Bristol Myers Squibb’s $1.5 billion savings drive is beginning to come into focus. | Starting this month, BMS will begin the process of laying off around 863 employees in Lawrenceville, New Jersey, according to a Worker Adjustment and Retraining Notification (WARN) alert from the state. The move forms part of BMS’ campaign to shave off $1.5 billion in costs by the end of 2025, a company spokesperson said over email.

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

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GSK shares fall 9% in wake of Zantac court ruling

Pharmaceutical Technology

Monday saw a 9% drop in GlaxoSmithKline’s (GSK) share price on the London Stock Exchange (LSE) following a Delaware judge’s ruling on 31 May that over 72,000 lawsuits over discontinued heartburn drug Zantac, known generically as ranitidine, could go ahead.

Drugs 243
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Researchers at IISc find Pranlukast has potential applications for TB therapy

AuroBlog - Aurous Healthcare Clinical Trials blog

Researchers at the Indian Institute of Science (IISc) have found that Pranlukast have the potential applications in tuberculosis (TB) therapy. The researchers are of the view that it could enhance the healing process of lung tissues infected with TB.

Research 191

More Trending

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June 5, 2024: This Week’s PCT Grand Rounds to Feature PCORnet-Based COVID-19 and Diabetes Assessment (CODA) Study

Rethinking Clinical Trials

Dr. Russell Rothman and Dr. Jason Block In this Friday’s PCT Grand Rounds, Russell Rothman of Vanderbilt University Medical Center and Jason Block of Harvard Medical School will present “The NIH COvid-19 and Diabetes Assessment (CODA) Study: Leveraging PCORnet for a Novel Cohort Study.” The Grand Rounds session will be held on Friday, June 7, 2024, at 1:00 pm eastern.

Medicine 173
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Climate change may aggravate multiple sclerosis

Pharmaceutical Technology

A June 2024 literature review has revealed that climate change has the potential to intensify MS symptoms, as well as the incidence, prevalence, and severity of other major neurological disorders.

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DCGI emphasises need for sample test for standards for medical devices and IVDs

AuroBlog - Aurous Healthcare Clinical Trials blog

Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi has emphasised that the medical devices and in-vitro diagnostics (IVD) sold in the county should be tested for the standards prescribed by the Bureau of Indian Standards (BIS) for its quality and performance in the country.

In-Vitro 173
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After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next

Bio Pharma Dive

A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

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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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After 33 years, Geron finally crosses FDA finish line with blood cancer med Rytelo

Fierce Pharma

Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.

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Data needed to forge the link between AI and mRNA

Pharmaceutical Technology

While the potential for using AI to develop mRNA therapeutics is now a real possibility, accurate and diverse data is needed to make it a reality.

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Growing number of lifesciences GCCs underscores India’s importance in R&D and clinical trials

AuroBlog - Aurous Healthcare Clinical Trials blog

India’s is now a key hub for lifesciences Global Capability Centers (GCCs). This according to multinational majors like Amgen, GSK, Eli Lily, Bayer, Mylan, AstraZeneca among others indicated that it underscores India’s importance in R&D and clinical trials.

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[Podcast] The Power of Persistence: From Biotech Incubator to Product Launch

Bio Pharma Dive

How can small and mid-sized biotech companies better manage pharmacovigilance during clinical trials? Listen to the podcast to learn how strategic alliances are helping.

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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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Pharmacogenomics and IVDR: Overcoming transition challenges

pharmaphorum

Understanding the challenges and opportunities in transitioning to IVDR for pharmacogenomics can be complex. Learn more about how to overcome these challenges effectively.

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NIH AI tool predicts cancer patients’ immunotherapy outcomes

Pharmaceutical Technology

Scientists at the NIH have introduced an AI tool to predict the response to immune checkpoint inhibitors for cancer patients.

Scientist 281
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Orange Peels Could Have Surprising Health Benefits For Your Heart

AuroBlog - Aurous Healthcare Clinical Trials blog

The bitter peel of an orange is there to protect the fruit, and it could protect our own insides, too, if only we stopped throwing the rinds away. The zest of oranges has now been found to contain a novel, bioactive compound, called feruloylputrescine (FP), that could benefit heart health when eaten.

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GSK builds case for return of multiple myeloma drug Blenrep

Bio Pharma Dive

Study results showed the antibody-drug conjugate helped stave off disease progression better than a standard treatment. But eye-related side effects remained common.

Drugs 296
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Lilly wins NICE endorsement for tirzepatide in obesity—with a catch

Fierce Pharma

A little less than a year after Eli Lilly won the blessing of England's drug value watchdog for tirzepatide in Type 2 diabetes, the National Institute for Health and Care Excellence (NICE) has retu | A little less than a year after Eli Lilly won the blessing of England's drug value watchdog for tirzepatide in Type 2 diabetes, the National Institute for Health and Care Excellence (NICE) has returned with an endorsement in obesity.

Drugs 120
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ASCO 2024: Alligator shares positive data for pancreatic cancer drug

Pharmaceutical Technology

Alligator Bioscience’s CEO says that its pancreatic cancer drug may mark a meaningful improvement on current treatment standards.

Drugs 273
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Are Frozen Vegetables as Healthy as Fresh? You Might Be Surprised.

AuroBlog - Aurous Healthcare Clinical Trials blog

The cost of living crisis is affecting how we spend our money. For many people, this means tightening the budget on the weekly supermarket shop. One victim may be fresh fruit and vegetables. Data from the Australian Bureau of Statistics (ABS) suggests Australians were consuming fewer fruit and vegetables in 2022–23 than the year before.

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Structure pill leads to competitive weight loss in obesity study

Bio Pharma Dive

Shares in the company soared by more than 50% as study data showed the pill led to similar levels of weight loss as a rival drug being developed by Eli Lilly.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ASCO: AstraZeneca, Daiichi's Enhertu looks to make history again in HER2-ultralow breast cancer

Fierce Pharma

After Enhertu pioneered the HER2-low category in breast cancer treatment, AstraZeneca and Daiichi Sankyo are now hopeful that the antibody-drug conjugate can reach tumors with an even lower express | After Enhertu pioneered the HER2-low category in breast cancer treatment, AstraZeneca and Daiichi Sankyo are now hopeful that the antibody-drug conjugate can reach tumors with an even lower expression of the protein biomarker.

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I-Mab and BMS assess givastomig for gastric and oesophageal cancer

Pharmaceutical Technology

I-Mab has agreed with Bristol Myers Squibb (BMS) to assess the givastomig regimen for advanced gastric and oesophageal cancers.

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Gujarat FDCA’s online WHO-GMP certificate verification to boost exports: Dr H G Koshia

AuroBlog - Aurous Healthcare Clinical Trials blog

With the effective implementation of its flagship e-governance programme, Gujarat Food and Drug Control Administration (FDCA)’s online WHO-GMP certificate verification is all poised to boost pharma exports, informs Gujarat FDCA commissioner Dr H G Koshia. Good Manufacturing Practice (GMP) is a critical concept in the pharmaceutical industry.

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Oral cancer medications: The adherence paradox

Bio Pharma Dive

The number of oral cancer medications is increasing, opening new possibilities for improved convenience, but some studies show much lower adherence rates with oral oncolytics.

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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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Key takeaways from ViVE: AI, security concerns, and industry transactions take centre stage

pharmaphorum

ViVE conference highlights the key takeaways on artificial intelligence, cybersecurity concerns, and industry transactions. Stay updated on the latest trends and partnerships shaping these fields.

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ArriVent partners Alphamab to develop ADCs for cancer

Pharmaceutical Technology

ArriVent BioPharma has entered a partnership with Jiangsu Alphamab Biopharmaceuticals for developing new ADCs to treat cancer.

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The Time You Take Blood Pressure Drugs May Lower Heart Attack Risk

AuroBlog - Aurous Healthcare Clinical Trials blog

Taking blood pressure medication at a time that aligns with your personal chronotype – the way your body’s circadian rhythm affects when you go to sleep and get up – could help to protect the heart against the risk of heart attack, a new study shows.

Drugs 157
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A true liquid biopsy hub – Menarini Silicon Biosystem

Bio Pharma Dive

Liquid biopsy has emerged as a revolutionary tool for clinical trials, offering cellular and cell-free methods that provide valuable insights into disease progression and treatment response.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.