Sat.Jul 29, 2023 - Fri.Aug 04, 2023

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US FDA approves Merck’s Ebola vaccine for under-18s

Pharmaceutical Technology

The US FDA has granted approval for an expanded indication of Merck’s Ebola vaccine, Ervebo, for usage in the paediatric population.

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Moderna looks to new COVID booster, RSV shot to curb falling sales

Bio Pharma Dive

Sales of the company’s COVID-19 vaccine plummeted 94% year over year. But executives believe newer products can help revenue rebound.

Sales 246
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Experimental Alzheimer’s Vaccine Shown to Delay Symptoms in Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

An experimental vaccine that aims to slow down or prevent the progression of Alzheimer’s disease has been trialed in mice with promising early results. Mice engineered with genes that put them at greater risk of an Alzheimer’s-like disease had fewer amyloid plaques following the vaccine.

Vaccine 246
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Swimming with the Sharks: Translation of Pragmatic Trial Results

Rethinking Clinical Trials

Swimming with the Sharks: Translation of Pragmatic Trial Results Description Dr. Greg Simon discussing translating pragmatic clinical trial results. Biography Gregory Simon, MD, MPH Senior Investigator, Kaiser Permanente Washington Health Research Institute SPOT Demonstration Project PI Health Care Systems Interactions Core Chair Related View more content from the Disseminating, Implementing, and Sustaining Evidence-Based Practices into Clinical Care: NIH-Hosted Workshop.

Trials 130
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Generative AI has the potential to revolutionise drug discovery

Pharmaceutical Technology

The impact of artificial intelligence has been profoundly felt in the drug discovery space, with increased interest in AI in recent years.

Drugs 246
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Amgen says KRAS drug met goal in late-stage colon cancer trial

Bio Pharma Dive

The company disclosed the study result alongside second quarter earnings showing Lumakras sales were flat versus the same period one year prior.

Sales 246

More Trending

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August 3, 2023: NCI’s David Chambers Discusses Role of Implementation Science in Pragmatic Research

Rethinking Clinical Trials

This year’s Annual Steering Committee Meeting for the NIH Pragmatic Trials Collaboratory featured implementation science as one of the topics of focus. In an interview after his keynote presentation, Dr. David Chambers, deputy director for implementation science at the National Cancer Institute, shared his thoughts on opportunities for implementation science in the context of pragmatic trials.

Research 130
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FDA warns of reduced efficacy for oral birth control pill Tydemy

Pharmaceutical Technology

Two lots of Lupin’s Tydemy have been recalled due to a decrease in ascorbic acid levels leading to reduced effectiveness.

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Steve Jobs’ son raises $200M for cancer-focused venture fund

Bio Pharma Dive

Yosemite is one of a new class of biotech venture funds that also includes the recently launched Dimension and Cure Ventures.

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Scientists Discover a New, Unexpected Way That Cancer Cells Spread

AuroBlog - Aurous Healthcare Clinical Trials blog

One of the challenges in treating cancer is stopping it from metastasizing, and a new study reveals one of the fundamental mechanisms through which this happens. Now we know about this mechanism, perhaps we can stop it. Key to this newly discovered process is GRP78, and it’s what’s known as a chaperone protein.

Scientist 242
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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August 2, 2023: Want to Play a Game? AI and Machine Learning in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Eric Perakslis In this Friday’s PCT Grand Rounds, Eric Perakslis of Duke University will present “AI & ML: Want to Play a Game?” The Grand Rounds session will be held on Friday, August 4, 2023, at 1:00 pm eastern. Bergstrom is a professor in population health sciences and the chief research technology strategist in the Duke University School of Medicine.

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BioNTech acquires tech company InstaDeep for $549m

Pharmaceutical Technology

BioNTech has acquired all the remaining shares of technology company InstaDeep in a deal valued at €500m ($549m) in cash.

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A once buzzy gene therapy startup lays off staff and shuts down

Bio Pharma Dive

Intergalactic, a developer of non-viral gene therapies built by ex-Biogen executive Michael Ehlers, is folding less than two years after its launch.

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Living a Varied Life Boosts Brain Connectivity in Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

The brains in mice benefit from an active and varied lifestyle by forming enhanced neural connections.Researchers in Germany compared the brain activity of mice raised in different environments and found those raised in an ‘enriched’ environment had more activity in their hippocampus, suggesting the presence of a more robust and connected neural network.

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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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August 1, 2023: NIH Collaboratory Expands LinkedIn Presence to Join Growing Community of Researchers

Rethinking Clinical Trials

From left: NIH Collaboratory Coordinating Center co–principal investigators Lesley Curtis, Adrian Hernandez, and Kevin Weinfurt With the NIH Pragmatic Trials Collaboratory entering its second decade, we are expanding our presence on the LinkedIn social media platform to promote research that advances the design, conduct, and dissemination of pragmatic clinical trials.

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Removing snags in cell and gene therapy manufacturing processes with robotics

Pharmaceutical Technology

Deploying robots in pharmaceutical manufacturing will remove snags in cell and gene therapies and enable breakthroughs

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Sarepta offers early look at closely watched gene therapy launch

Bio Pharma Dive

One patient received its Duchenne gene therapy, Elevidys, this week and a handful more could follow shortly, surprising some analysts and raising near-term sales expectations.

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DoP rejects Zydus’ review petition against NPPA for fixing retail price of sitagliptin-metformin combo

AuroBlog - Aurous Healthcare Clinical Trials blog

In a significant decision, the Department of Pharmaceuticals (DoP) has rejected a review petition filed by Zydus Healthcare against the National Pharmaceutical Pricing Authority (NPPA) for fixing the retail price of anti-diabetic combination formulation comprising sitagliptin and metformin, observing that while the NPPA has not acted strictly by the books, it protected the public interest.

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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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July 31, 2023: NIH Announces Funding Opportunity for Pain Management Collaboratory Pragmatic Trials

Rethinking Clinical Trials

The NIH this month published notice of a funding opportunity to support the next round of pragmatic clinical trials within the NIH-DoD-VA Pain Management Collaboratory (PMC). Read the full notice of funding opportunity (RFA-AT-24-004). The PMC was established in 2017 with an initial cohort of 11 pragmatic trials. The new funding opportunity leverages the experience, expertise, and leadership of the PMC Coordinating Center with a new round of pragmatic trials evaluating nonpharmacologic solutions

Trials 130
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Personalised mRNA cancer vaccines: Moderna and Merck & Co versus BioNTech and Roche

Pharmaceutical Technology

While messenger ribonucleic acid (mRNA)-based cancer vaccines have been in development for decades, their development had languished.

Vaccine 246
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BridgeBio explores path forward for muscular disease drug

Bio Pharma Dive

According to the company, FDA officials have signaled openness to using a surrogate endpoint for assessing accelerated approval of a treatment for limb-girdle muscular dystrophy.

Drugs 246
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Industry concerned over lack of discussion on proposed New Drugs, Medical Devices & Cosmetics Bill

AuroBlog - Aurous Healthcare Clinical Trials blog

Even as the Centre has listed the New Drugs, Medical Devices and Cosmetics Bill, 2023 to be tabled in Parliament during the current session, industry members are apprehensive that the new bill may mean centralisation of licensing and other powers to the Central drug regulatory authority and it may also have provisions which may harm […]

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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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Partnership aims to boost mental health research

Pharma Times

The University of Strathclyde, the NHS and New York University join forces to increase knowledge - News - PharmaTimes

Research 120
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Bangladesh and the dengue vaccine question

Pharmaceutical Technology

Amid one of the worst dengue fever outbreaks in decades, Bangladesh has recorded the highest number of hospitalised cases of the disease in a day.

Vaccine 246
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Regeneron gets ‘clarity’ in plan to defend top-selling eye drug, but is set back elsewhere

Bio Pharma Dive

The surprise rejection of a high-dose form of Eylea could be resolved earlier than anticipated. But some of the company’s pipeline projects have stumbled.

Drugs 244
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IISc researchers find picolinic acid’s broad-spectrum antiviral abilities, scouts for partners in pharma companies

AuroBlog - Aurous Healthcare Clinical Trials blog

Researchers at the Indian Institute of Science (IISc) have found that picolinic acid, a natural compound produced by mammalian cells, can block several disease-causing viruses such as SARS-CoV-2 and influenza A viruses. The Institute is now looking for partners in pharma companies to pursue further clinical development of the findings.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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First patient dosed in Immutep’s soft tissue sarcoma trial

Pharma Times

The phase 2 study involves company’s eftilagimod alpha therapy - News - PharmaTimes

Trials 118
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Rx Machina: How AI is transforming pharma sales

Pharmaceutical Technology

Pharma sales have undergone a seismic transformation after Covid-19, with the adoption of artificial intelligence tools.

Sales 246
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RSV antibody from Sanofi, AstraZeneca backed by CDC for use in infants

Bio Pharma Dive

The treatment, which won FDA approval in July, is expected to be available by the start of the typical RSV season this fall.

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India’s advanced wound care market on growth trajectory with faster healing & minimised scarring

AuroBlog - Aurous Healthcare Clinical Trials blog

India’s advanced wound care market is on the growth trajectory with faster healing & minimised scarring. This is where the positive acceptance of Negative Pressure Wound Therapy (NPWT) that uses a vacuum dressing to ensure healing in acute and chronic conditions in India is gaining popularity.

Marketing 183
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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.