Sat.Sep 07, 2024 - Fri.Sep 13, 2024

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Prodrugs and patents: Enhancing therapy adherence and reducing side effects 

Pharmaceutical Technology

As the approval date for Bristol Myers Squibb’s schizophrenia drug KarXT looms, a prodrug approach emerges to potentially address dosing challenges.

Drugs 277
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HPV Linked to Disturbing Changes in Human Sperm, Scientists Find

AuroBlog - Aurous Healthcare Clinical Trials blog

(Derek Berwin/Getty Images) TThe human papillomavirus (HPV) is responsible for the vast majority of cervical cancer cases, but this isn’t a sexually transmitted infection that just one half of the population needs to worry about.

Scientist 237
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Building Inclusive Science: The Vital Role of Diversity, Equity and Inclusion in Clinical Research

XTalks

Diversity, equity and inclusion (DEI) have become important elements in the landscape of clinical research. It is important for the principles of DEI to be understood for their goals, intended outcomes and applications; otherwise, they may be regarded as mere buzzwords or just another box to tick on organizational mandates. DEI are critical components of building a thriving, fair, all-encompassing, respectful and innovative society.

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Leveraging Nanotechnology in Generic Drug Development: Enhancing Efficacy and Safety

Drug Patent Watch

The pharmaceutical industry has witnessed significant advancements in recent years, particularly in the realm of nanotechnology. This innovative field has revolutionized the way drugs are developed, manufactured, and delivered to patients.

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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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Investors are waking up to Centessa’s sleepiness drug

Bio Pharma Dive

A small, early study produced what one analyst called “highly compelling” results that lifted the company’s shares by as much as 15% Tuesday.

Drugs 200
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After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned

Fierce Pharma

After much anticipation and concern, the BIOSECURE Act—which would prevent U.S. companies from working with certain Chinese biotech service providers—has passed a key threshold. | Late Monday, the U.S. House of Representatives voted 306-81 in favor of the BIOSECURE Act, which was introduced in January and seeks to halt federal contracts with five named Chinese life-sci companies: WuXi AppTec, WuXi Biologics, BGI Group, MGI and Complete Genomics.

Genome 131

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Therapy for aggressive brain cancer receives FDA clearance to start phase 1

BioPharma Reporter

Adaptin Bio has announced that the FDA has given the green light to start phase 1 clinical trials for its program APTN-101 targeting glioblastoma, the most common and aggressive form of brain cancer.

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Grand Rounds September 6, 2024: Conventional, Complementary, and Integrative Pain Therapies in a Military Population with Chronic Musculoskeletal Pain: Results of a Pragmatic Clinical Trial Using SMART Design (Ardith Z. Doorenbos, PhD, RN; Diane M. Flynn, MD, MPH)

Rethinking Clinical Trials

                      Speakers Ardith Z. Doorenbos, PhD, RN Professor Department of Biobehavioral Nursing Science College of Nursing University of Illinois, Chicago Diane M. Flynn, MD, MPH Primary Care Pain Management Advisor Interdisciplinary Pain Management Center Madigan Army Medical Center Tacoma, WA Slides Keywords Chronic Pain; Military; Rehabilitative Care; Pain Therapies; SMART Design Key Points Physical and occupational therapies are standard rehabilitative care (S

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Meet MILTON, AZ's AI that can predict 1,000+ diseases

pharmaphorum

A machine-learning tool developed by AstraZeneca and trained on UK Biobank data, called MILTON, can predict over 1,000 diseases, before diagnosis

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Summit lung cancer drug shows ‘striking’ benefit over Keytruda

Bio Pharma Dive

Study results provide much-anticipated details to Summit’s claim earlier this year that its drug “decisively beat” Merck’s dominant immunotherapy.

Drugs 340
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Into the unknown: How quickly can vaccines be developed for Disease X

Pharmaceutical Technology

R&D frameworks are in place for the next pandemic-causing pathogen, but ways to derisk development are unclear.

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Scientists Destroy 99% of Cancer Cells in Lab With Vibrating Molecules

AuroBlog - Aurous Healthcare Clinical Trials blog

Illustration of a cancer cell. (Science Photo Library/Canva Pro) Scientists have discovered a remarkable way to destroy cancer cells. Stimulating aminocyanine molecules with near-infrared light caused them to vibrate in sync, enough to break apart the membranes of cancer cells. [link] Aminocyanine molecules are already used in bioimaging as synthetic dyes.

Scientist 246
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September 12, 2024: NIH Collaboratory Biostatisticians Evaluate Analytic Models for Individually Randomized Group Treatment Trials

Rethinking Clinical Trials

Dr. Jonathan Moyer To avoid inflation in the rate of type 1 error, or false positives, in individually randomized group treatment (IRGT) trials, researchers should choose an analytic model that accounts for the correlations in outcome measures that arise when study participants receive an intervention from the same source, according to a report from the NIH Pragmatic Trials Collaboratory’s Biostatistics and Study Design Core.

Trials 173
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Three biotechs raise $700M in rare burst of IPO activity

Bio Pharma Dive

The offerings by Bicara, Zenas and MBX give a glimpse into what industry insiders describe as a backlog of mature startups waiting for the right opportunity to test public markets.

Marketing 331
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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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Teva agrees to pay Baltimore City $80m for fuelling opioid epidemic

Pharmaceutical Technology

Baltimore opted out of a national settlement last year, instead pursuing its own claim against the opioid manufacturer.

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Type 2 Diabetes Drug Linked to 35% Lower Dementia Risk in Patients

AuroBlog - Aurous Healthcare Clinical Trials blog

(nomadsoulphotos/Canva) A Korean study published recently suggests people with type 2 diabetes who are prescribed a particular class of drug might be at a significantly lower risk of dementia.

Drugs 245
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September 11, 2024: HARMONIE and a New Approach to Commercial Clinical Trials, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Professor Saul Faust In this Friday’s PCT Grand Rounds, Saul Faust of the University of Southampton will present “The HARMONIE Trial: Reimagining How to Design and Deliver Contract Commercial Clinical Trials.” The Grand Rounds session will be held on Friday, September 13, 2024, at 1:00 pm eastern. The HARMONIE trial was a pragmatic trial of the effect of nirsevimab on hospitalizations for respiratory syncytial virus–associated lower respiratory tract infection when administered

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Fulcrum shares collapse as Sanofi-partnered muscular dystrophy drug fails key test

Bio Pharma Dive

The biotech will now suspend development of a drug prospect that Sanofi acquired partial rights to just four months ago.

Drugs 299
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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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FDA approves Roche’s Tecentriq Hybreza for cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer immunotherapy.

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A Common Sleeping Pill May Reduce Buildup of Alzheimer’s Proteins, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

(Tero Vesalainen/iStock/Getty Images) There’s still so much we don’t know about Alzheimer’s disease, but the link between poor sleep and worsening disease is one that researchers are exploring with gusto.

Protein 245
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Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer

Fierce Pharma

The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. | The Keytruda-beating data from Akeso and Summit’s ivonescimab that oncology industry watchers had been awaiting are here. The China-only data are impressive, signaling the PD-1/VEGF bispecific antibody’s potential as a new standard of care in non-small cell lung cancer.

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Gene therapy startup emerges with green light for first-of-its-kind trial

Bio Pharma Dive

Spun out of research at Nationwide Children’s Hospital, Vironexis claims it will be the first company to start a study testing a cancer drug delivered via the adeno-associated viruses commonly used in genetic medicines.

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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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EASD 2024: Innovent shows off mazdutide’s efficacy in diabetes and obesity

Pharmaceutical Technology

The data from two Phase III trials demonstrated GLP-1/glucagon agonist’s efficacy in reducing blood glucose and weight.

Trials 246
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Ophthalmologists eye gene therapies for vision-threatening conditions as NGS facilitates precision diagnosis

AuroBlog - Aurous Healthcare Clinical Trials blog

The convergence of gene therapies and clinical research is pushing the boundaries of what’s possible in ophthalmic care, offering hope for more effective treatments and potential cures for a range of vision-threatening conditions.

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With another phase 3 win, Gilead races toward 2025 launch for long-acting PrEP drug

Fierce Pharma

Gilead Sciences is no stranger to making history in HIV. | In a study of more than 3,000 participants, Gilead's twice-yearly lenacapavir delivered a 96% reduction in HIV infections compared with background HIV incidence.

Drugs 132
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Moderna, trailing rivals, checks its RSV shot expectations

Bio Pharma Dive

During an investor presentation Thursday, executives admitted to being overly optimistic their vaccine could wrest significant market share away from GSK's and Pfizer's products this year.

Vaccine 277
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Japan approves updated Covid-19 vaccine to tackle JN.1 variant

Pharmaceutical Technology

Distribution of the self-amplifying mRNA vaccine Kostaive is set to align with a planned October 2024 Covid-19 vaccination campaign.

Vaccine 245
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Scientists Reveal The Absolute Worst Thickness For a Paper Cut

AuroBlog - Aurous Healthcare Clinical Trials blog

(cookiecatagency/Getty Images) It’s happened to the best of us. There you are, minding your own business, sealing envelopes or replacing the printer ream, and tsssss ouch! A freshly minted paper cut, oozing ruby-red human juice, all over the clean white surface.

Scientist 235
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AI-Powered chest X-Rays detect lung cancer early

Pharma Times

New evidence highlights AI’s potential in early lung cancer detection

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House backs bill restricting China role in US biotech

Bio Pharma Dive

The Biosecure Act, which limits contracts with WuXi AppTec, WuXi Biologics and three other companies, still needs Senate support to advance.

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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.