Sat.Jun 15, 2024 - Fri.Jun 21, 2024

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New data showcase promise, growing pains of CAR-T in autoimmune disease

Bio Pharma Dive

One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.

Trials 349
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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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Your Body’s Internal Clock May Boost Cancer Treatments, Scientists Say

AuroBlog - Aurous Healthcare Clinical Trials blog

(Peter Dazeley/The Image Bank/Getty Images) Our body’s circadian clock affects everything from sleepiness to metabolism – and it might also influence how effective certain cancer treatments are, according to recent research.

Scientist 242
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June 17, 2024: This Week’s PCT Grand Rounds to Feature Trial of Electronic Cigarettes for Smoking Cessation

Rethinking Clinical Trials

Dr. Reto Auer In this Friday’s PCT Grand Rounds, Reto Auer of the University of Bern will present “Efficacy and Safety of Electronic Cigarettes for Smoking Cessation: Keeping a Trial on a Polarizing Topic Running Under Regulatory and Epidemic Changes.” The Grand Rounds session will be held on Friday, June 21, 2024, at 1:00 pm eastern.

Trials 173
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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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Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention

Fierce Pharma

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

Drugs 144
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Duchenne approval exposes FDA rift over Sarepta gene therapy

Bio Pharma Dive

Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote.

More Trending

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There’s a Strange Link Between Depression And Body Temperature, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

(VioletaStoimenova/Getty Images) To better treat and prevent depression, we need to understand more about the brains and bodies in which it occurs. Curiously, a handful of studies have identified links between depressive symptoms and body temperature, yet their small sample sizes have left too much room for doubt.

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Exploring the Future of Oncology with ADCs and TILs: Key Insights From ASCO  

Worldwide Clinical Trials

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Worldwide Clinical Trials attends each year to hear from the research community, connect with our sponsors and sites, and explore potential partnerships to drive forward novel treatments.

Antibody 162
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Twice-yearly shots of Gilead HIV drug effective in large prevention study

Bio Pharma Dive

Researchers recommended Gilead end testing early as lenacapavir proved 100% effective in protecting cisgender women in the Phase 3 trial.

Drugs 321
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Can supermarket pharmacies plug urgent healthcare gaps?

Pharmaceutical Technology

As Asda sets up a nationwide retail pharmacy in the UK and US grocer pharmacies expand, scaling up this model will be the next frontier.

Pharmacy 263
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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The Blood of Exceptionally Long-Lived People Reveals Crucial Differences

AuroBlog - Aurous Healthcare Clinical Trials blog

(Bloomberg Creative/Getty Images) Centenarians, once considered rare, have become commonplace. Indeed, they are the fastest-growing demographic group of the world’s population, with numbers roughly doubling every ten years since the 1970s. [link] How long humans can live, and what determines a long and healthy life, have been of interest for as long as we know.

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June 18, 2024: NIH Pragmatic Trials Collaboratory to Hold Virtual Workshop July 15-16 Featuring NIH Director as Keynote

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop July 15-16, 2024, on “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues.” Dr. Monica Bertagnolli, director of the NIH, will deliver the keynote presentation exploring how to identify high-priority healthcare issues that require the effort, time, and funding of a trial.

Trials 150
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FDA lifts hold on PTC Huntington’s disease trial

Bio Pharma Dive

The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.

Trials 312
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WHO warns of “harmful” fake Ozempic in circulation in Americas and Europe

Pharmaceutical Technology

Both Novo Nordisk and Eli Lilly have filed lawsuits against unapproved sellers of their diabetes and weight loss drugs.

Drugs 246
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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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Tiny Algae Microrobots Could Transform Lung Cancer Treatment

AuroBlog - Aurous Healthcare Clinical Trials blog

Part algae, part red blood cell, these microrobots can travel to hard-to-reach tumors deep in the lungs. (Zhang et al., Sci. Adv., 2024/CC BY-NC) Tumors that travel to the lungs, or lung metastases, pose a formidable challenge in the realm of cancer treatment. Conventional chemotherapy often falls short because it’s inefficient.

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Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit

Fierce Pharma

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

Vaccine 145
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Obesity drug from Zealand shows potential in early trial

Bio Pharma Dive

Interim study data suggest the Danish drugmaker can remain in the race to develop new kinds of weight loss drugs as doctors seek alternatives to the now dominant GLP-1s.

Drugs 289
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EHA 2024: Monoclonal antibodies continue to dominate multiple myeloma treatments

Pharmaceutical Technology

Trial investigators anticipate that the FDA will decide on approval for linvoseltamab in relapsed/refractory multiple myeloma by the end of 2024.

Antibody 246
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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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Commerce ministry issues new directive on RCMC for medical devices to avail benefits under RODTEP scheme

AuroBlog - Aurous Healthcare Clinical Trials blog

The Directorate General of Foreign Trade (DGFT), under the Union ministry of commerce & industry, has issued a directive addressing the issuance of Registration-Cum-Membership Certificate (RCMC) for medical devices.

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US study suggests BMS’ cancer drug could target Parkinson’s-causing protein

Pharma Times

The progressive neurodegenerative condition affects more than ten million people worldwide

Protein 140
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The critical role of comprehensive RNA sequencing in liquid biopsy for biomarker discovery and clinical trials

Bio Pharma Dive

Elevate precision medicine: dose optimization and immune monitoring through advanced liquid biopsies.

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Ability Biologics closes extended $18m seed funding round

Pharmaceutical Technology

Since emerging from stealth in December 2023, the company has begun establishing its laboratories in Montreal.

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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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Report recommends ways to improve availability and affordability of essential medical devices

AuroBlog - Aurous Healthcare Clinical Trials blog

Incentivising domestic production of essential medical devices, building a robust logistics infrastructure and supplier network with stringent quality control measures and certification standards, and proper pricing policies are some of the ways to grow the medical devices sector in the country and to improve availability and affordability across the country, according to a recent report.

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Leuko device to remotely monitor cancer patients during chemotherapy

Pharma Times

Cancer was estimated to be responsible for more than 18 million cases worldwide in 2020

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Syncona melds two gene therapy biotechs for better shot at new nervous system treatments

Bio Pharma Dive

The new company, Spur Therapeutics, is getting another $50 million from Syncona to support its broadened pipeline, which targets Parkinson’s disease as well as heart conditions.

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CRTE-7A2 by Beijing Corregene Biotechnology for Anal Cancer: Likelihood of Approval

Pharmaceutical Technology

CRTE-7A2 is under clinical development by Beijing Corregene Biotechnology and currently in Phase I for Anal Cancer.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ICMR-NIREH to host online training on ethical research practices

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council for Medical Research (ICMR)-National Institute for Research in Environmental Health (NIREH) will conduct an online training programme titled “Ethical Principles and Practices for Research Involving Human Participants with Environmental-Associated Ailments.

Research 187
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Merck gets shot in the arm with FDA approval for first pneumococcal vaccine designed for adults

Fierce Pharma

The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by senio | The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection.

Vaccine 138
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Sarepta Duchenne gene therapy wins broader use from FDA

Bio Pharma Dive

The decision makes Elevidys available to Duchenne patients at least 4 years of age, despite mixed trial results that have led to skepticism about its effectiveness.

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FDA approves MSD’s KEYTRUDA for advanced endometrial cancer

Pharmaceutical Technology

The US FDA has granted approval for MSD’s KEYTRUDA regimen to treat primary advanced or recurrent endometrial carcinoma in adults.

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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.