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September 25, 2024: Randomizing Entire Countries, in This Week's PCT Grand Rounds

Tom Lietman of UCSF presents 'Azithromycin for Childhood Mortality: Randomizing Entire Countries' at PCT Grand Rounds on Sept 27, 2024, 1:00 pm eastern.
morningstar.com
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NomicĀ® and Parker Institute for Cancer Immunotherapy (PICI) Launch Large-Scale Protein ...

Nomic and PICI collaborate to profile ~3000 blood samples from RADIOHEAD study using nELISAā„¢ to understand immunotherapy responses, aiming to improve patient care through precision medicine.

Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

Kadakia et al. analyzed 137 Class I recall events affecting 157 cardiovascular devices from 2013 to 2022, finding 71.3% approved via 510(k) and 55.6% of PMA devices as PMA supplements. Most recalls lacked robust clinical evidence, with design issues (31.4%) and process control (16.1%) as common reasons. Median recall units were 7,649, and 13.5 incidents per recall with rare deaths. Implantable devices were most recalled. The study calls for more rigorous premarket testing and postmarket follow-up, and better education on device regulation.
source.washu.edu
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WashU research funding exceeds $1 billion for first time

WashU's annual research funding surpasses $1 billion, supporting diverse projects from Alzheimerā€™s to air pollution, driving local economic growth. Funding from federal agencies and others nearly doubled in a decade, attributed to increased faculty, research quality, and infrastructure. WashU Medicine, ranked No. 2 in NIH funding, leads in innovative research and faculty growth. New facilities like the Jeffrey T. Fort Neuroscience Research Building foster collaboration and discoveries, while regional research addresses local issues. WashU's partnerships and startups contribute to the local economy, with expectations of continued funding growth in neuroscience, public health, and more.
thecardiologyadvisor.com
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Rethinking Beta-Blocker Use Following Acute Myocardial Infarction

Recent REDUCE-AMI trial results suggest beta-blockers may not benefit patients with preserved left ventricular ejection fraction (LVEF) post-AMI, prompting reconsideration of current guidelines recommending their use. Experts emphasize the need for individualized treatment decisions and ongoing trials to refine post-AMI care.
eurekalert.org
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Clinical trial could move the needle in traumatic brain injury

A Department of Defense-funded study, led by UC San Francisco and TRACK-TBI Network, launches a clinical trial at 18 trauma sites to test existing drugs for treating traumatic brain injury (TBI). The adaptive platform trial aims to improve treatment outcomes by simultaneously testing multiple drugs and adjusting therapies based on effectiveness. The study leverages recent biomarker breakthroughs to better screen and monitor participants, with the goal of leading to effective treatments and future collaborations with pharmaceutical companies.
abcnews.go.com
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Two Georgia deaths are tied to abortion restrictions. Experts say abortion pills they took are safe

Kamala Harris to speak on abortion in Georgia after two women's deaths linked to state law banning procedure after six weeks. FDA-approved mifepristone, used in over 60% of abortions, has rare complications requiring emergency care. Anti-abortion groups challenged FDA approval, but Supreme Court upheld access. Medical groups report less than 0.32% of patients experience major adverse events with mifepristone.
cen.acs.org
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R&D for long COVID is collapsing

Lack of funding and understanding of long COVID's mechanisms hinder drug development, frustrating patients and researchers. Despite initial positive results with Ampligen, Aim ImmunoTech faced funding challenges. The NIH's RECOVER initiative focuses on observational studies rather than new compounds, and private investors avoid long COVID due to perceived risk. Small biotech companies struggle to sustain research efforts, with some shifting focus or shutting down. Public-private partnerships and increased federal funding are suggested as solutions to advance long COVID treatment research.
finance.yahoo.com
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Pioneering ePRO and eCOA innovations for next-generation clinical trials

The pharmaceutical industry is transforming with digital solutions like ePRO and eCOA, crucial for clinical trials. Datacubed Health offers customized tools, enhancing data accuracy and patient engagement, vital for remote and hybrid trials. Security and compliance are paramount, ensuring patient data protection.
morningstar.com
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Second generation of I-SPY 2 TRIAL design is driving the ā€œpreciseā€ in precision medicine

Quantum Leap Healthcare Collaborative's I-SPY 2.2 trial aims to personalize treatment for high-risk early-stage breast cancer patients, potentially preventing recurrence and improving outcomes. The trial's adaptive design allows for treatment optimization based on individual responses, accelerating drug development and delivery for various diseases.
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