Sat.Oct 07, 2023 - Fri.Oct 13, 2023

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A decade later, biotech’s CRISPR revolution is still going strong

Bio Pharma Dive

Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.

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Malaria Could Be Eliminated by 2040: New Vaccine Offers Hope

AuroBlog - Aurous Healthcare Clinical Trials blog

The World Health Organization has approved a new vaccine that scientists argue will be a game-changer in the fight against malaria, which kills half a million people in Africa every year.

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The Future of Clinical Trials, Patient Engagement, and Technology

Imperical Blog

Clinical trial recruitment and patient engagement practices have evolved and so has clinical trial technology. What does the future look like? I recently spoke with Matthew Stumm, founder and president of the Boston-based patient recruitment agency Stark / Raving Health. I’ve known Matt for many… The post The Future of Clinical Trials, Patient Engagement, and Technology appeared first on Imperial Clinical Research Services Blog.

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CRF study smashes diversity targets in trials with three times national average

Outsourcing Pharma

Complete clinical trials solution company, Hawthorne Effect, announced today (October 10) announced it had successfully recruited more than 1,000 patients in 48 states plus Hawaii for a study to qualify the prevalence of valvular heart disease (VHD).

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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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Common Questions About Clinical Research Trials

My Local Study

Clinical research trials play a pivotal role in advancing medical science and improving patient care. They are essential for testing the safety and efficacy of new treatments, medications, and medical procedures. However, they can also be quite complex and raise numerous questions for both participants and the general public. In this blog, we will address.

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Could greater adoption of remote nursing visits lead to faster study results?

Pharmaceutical Technology

As sponsors seek to minimize trial delays and get new therapies to market faster, we explore whether increased adoption of a more patient-centric approach could make a difference to timelines.

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More Trending

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Antifibrotic Drug Development Summit

pharmaphorum

Antifibrotic Drug Development Summit Mike.

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Biotech Bankruptcies Skyrocket

BioSpace

From Statera Biopharma and Sorrento Therapeutics to Aceragen and Infinity Pharmaceuticals, 2023 has seen a record high 28 bankruptcies in the biotech space so far. Here’s why.

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Pfizer to cut costs, lay off staff on waning demand for COVID products

Bio Pharma Dive

Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.

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FDA fast tracks MimiVax’s glioblastoma vaccine SurVaxM

Pharmaceutical Technology

The Phase IIb SurVaxM vaccine study will enrol 265 patients and has an estimated completion date in Q2 2024.

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

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Long COVID Patients Are Far More Likely to Have Multiple Organ Abnormalities

AuroBlog - Aurous Healthcare Clinical Trials blog

It wasn’t that long ago that some people speculated that long COVID was all in the mind – a psychosomatic illness. Thankfully, that period of speculation is now behind us. We have compelling evidence that long COVID is very real and can affect major organs in people who were previously hospitalised with the disease.

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October 12, 2023: GRACE Team Shares Lessons About Monitoring Signals of Suicidality in Pragmatic Clinical Trials

Rethinking Clinical Trials

In a new article published this week in Contemporary Clinical Trials Communications, the GRACE Demonstration Project team recommends that suicidality should be monitored in pragmatic clinical trials that measure depression as an outcome. The work builds on their experience conducting research involving patients with sickle cell disease and on previous work from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core.

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Novo Nordisk’s Ozempic shows kidney benefit in large study

Bio Pharma Dive

The finding from the study of its diabetes drug, which Novo didn’t detail, could help the company in its competition with rival drugmaker Eli Lilly.

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FDA lifts clinical hold on PepGen’s myotonic dystrophy type 1 candidate

Pharmaceutical Technology

The dose-selection Phase I trials for evaluating PepGen’s peptide-conjugated antisense oligonucleotide have been cleared to begin in the US.

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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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Want to Cut Heart Disease Risk? Here’s How Many Flights of Stairs to Climb Daily

AuroBlog - Aurous Healthcare Clinical Trials blog

Getting up at least 50 steps a day is associated with a more than 20 percent cut in the risk of cardiovascular disease, new research shows – so you may only need to climb five flights of stairs per day to significantly boost your heart health.

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October 9, 2023: Registration Opens for Pragmatic Trials Workshop at AcademyHealth Dissemination & Implementation Conference

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 16th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Raising the Bar for Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health

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After summer slump, biotech M&A has a good week

Bio Pharma Dive

There have been few bigger-ticket acquisitions recently. But a string of deals announced in early October may affirm the forecasts of analysts who expect M&A to tick up in the coming months.

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GSK and Zhifei sign deal for shingles vaccine in China

Pharmaceutical Technology

GSK and Chongqing Zhifei have signed an exclusive agreement for co-promoting the former’s shingles vaccine, Shingrix, in China.

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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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Doctors Discover Needle Lodged in 80-Year-Old Woman’s Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

An elderly woman in Russia’s Far East was revealed on Wednesday to have lived for 80 years with an inch-long needle in her brain, after doctors made the unexpected discovery during a CT scan.

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UKRI awards £41m to enhance UK research and innovation

Pharma Times

The scheme will help ten projects establish research and innovation clusters - News - PharmaTimes

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Pfizer wins FDA approval for its $7B colitis drug

Bio Pharma Dive

Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.

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Why are haemophilia gene therapies so expensive?

Pharmaceutical Technology

Biomarin and CSL Behring’s haemophilia gene therapies have boosted innovation in the field, but assessing their cost effectiveness is less than straightforward.

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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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There’s One Critical Thing We Can Do to Keep Alzheimer’s Symptoms at Bay

AuroBlog - Aurous Healthcare Clinical Trials blog

Deep sleep could be key to forestalling slow declines in brain health that may one day lead to Alzheimer’s disease, the most common form of dementia.

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October 11, 2023: In This Friday’s PCT Grand Rounds, Incorporating Social Determinants of Health Into PCORnet

Rethinking Clinical Trials

Keith Marsolo, PhD In this Friday’s PCT Grand Rounds, Keith Marsolo of Duke University will present “Incorporating Social Determinants of Health Into PCORnet.” The Grand Rounds session will be held on Friday, October 13, 2023, at 1:00 pm eastern. Marsolo is an associate professor of population health sciences at Duke University and a cochair of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records Core Working Group.

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Bayer opens California plant to make cell therapies

Bio Pharma Dive

The pharma plans for the new Berkeley facility to produce clinical, and potentially commercial, supplies of a Parkinson’s disease cell therapy being tested by its subsidiary BlueRock.

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Cybersecurity in pharma: Q&A with GlobalData thematic analyst

Pharmaceutical Technology

GlobalData analyst Wafaa Hasan discusses key topics around cybersecurity for the pharmaceutical industry.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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MDC recommends exemption for Cadila Pharma’s Vitamin D3 injection from price control

AuroBlog - Aurous Healthcare Clinical Trials blog

The Multi Disciplinary Committee (MDC) of Experts of the National Pharmaceutical Pricing Authority (NPPA) has recommended exemption of Cadila Pharmaceuticals’ dietary supplement Vitamin D3 Injection (cholecalciferol aqueous injection 6,00,000 IU/2ml) from the drug price control for certain period as it is covered under the scope of patent granted by the Patent Office.

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October 10, 2023: Ethics Consultation Documents Now Available for BEST-ICU, Chat 4 Heart Health, and TAICHIKNEE

Rethinking Clinical Trials

Ethics and regulatory onboarding documentation for the NIH Pragmatic Trials Collaboratory’s newest Demonstration Projects are now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the BEST-ICU, Chat 4 Heart Health, and TAICHIKNEE studies. The consultations took place by video conference and included representation from the studies’ principal investigators, members of the NIH Coll

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‘Project NextGen’ picks new mRNA, intranasal COVID vaccines for funding

Bio Pharma Dive

The awards, to biotechs Gritstone, Codagenix and CastleVax, are part of the program’s plan to develop vaccines with broader or longer-lasting benefits.

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Amneal partners with mAbxience for denosumab biosimilars

Pharmaceutical Technology

Amneal adds Prolia and Xgeva biosimilars to its oncology portfolio which already has three biosimilars products launched in the US.

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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.