Sat.Nov 09, 2024 - Fri.Nov 15, 2024

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ADHD Diagnoses Keep Rising Higher. This Is Why It’s Happening.

AuroBlog - Aurous Healthcare Clinical Trials blog

(PeopleImages/Getty Images) For a long time it was assumed that somewhere between 5 and 6% of children have attention-deficit hyperactivity disorder ( ADHD). But the rates, in practice, are often higher. The American Centers for Disease Control and Prevention put the prevalence at 11.4% in children in 2022.

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On Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned

Bio Pharma Dive

Negative drug results cost AbbVie billions of dollars in market value and convinced analysts that Bristol Myers had placed a better bet in buying Karuna Therapeutics.

Drugs 316
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Pfizer considers divestiture of hospital drugs business

Pharmaceutical Technology

Pfizer is currently assessing the potential divestiture of its hospital drugs unit, a division mainly focused on antibiotics and sterile injectables used in hospitals and clinics, Reuters reported.

Drugs 246
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November 13, 2024: Pragmatic Trial of Smartphone Nudges to Prevent Distracted Driving, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Kit Delgado of the University of Pennsylvania will present “Pragmatic Randomized Trial of Smartphone-Based Nudges to Reduce Distracted Driving Among US Auto Insurance Customers.” The Grand Rounds session will be held on Friday, November 15, 2024, at 1:00 pm eastern. Delgado is an associate professor of emergency medicine and epidemiology at the University of Pennsylvania and the director of the Penn Medicine Nudge Unit, which “designs an

Trials 174
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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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Forever Chemicals May Damage Kidney Function, Evidence Shows

AuroBlog - Aurous Healthcare Clinical Trials blog

(Rasi Bhadramani/Getty Images) Forever chemicals are falling in the rain, running through our waterways, and swimming in our bloodstreams, and now, initial research suggests these potentially harmful pollutants are ‘clogging up’ a crucial drainage system in our bodies.

Research 161
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Surviving in biotech’s new normal: 5 tips from industry VCs and CEOs

Bio Pharma Dive

At an event hosted by BioPharma Dive, drugmaker executives and investors discussed the importance of focus, smart spending and maintaining lines of sight to the clinic.

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Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Worldwide Clinical Trials

By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. CGTs address rare and complex diseases at the root cause with increasing use in cancer, genetic disorders, and autoimmune diseases.

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

AuroBlog - Aurous Healthcare Clinical Trials blog

PET scans were used to measure protein levels in the brain. (JohnnyGreig/Getty Images) 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.

Protein 186
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Merck, facing threat to Keytruda, buys into new kind of cancer immunotherapy

Bio Pharma Dive

The company is paying China-based biotech LaNova Medicines $588 million for the type of dual-pronged antibody drug that recently bested Keytruda in a clinical trial.

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EMA’s CHMP recommends Sanofi’s Sarclisa approval for multiple myeloma

Pharmaceutical Technology

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi’s Sarclisa combined with Velcade, plus Revlimid, plus dexamethasone (VRd) for treating newly diagnosed multiple myeloma (MM).

Medicine 240
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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November 14, 2024: Interagency Pain Research Coordinating Committee is Accepting Nominations for New Members

Rethinking Clinical Trials

The Interagency Pain Research Coordinating Committee (IPRCC) is accepting nominati ons for new members to help advance the diagnosis, prevention, and treatment of pain and diseases and disorders associated with pain. The committee will include: health professionals and scientists who are leaders in the field of pain research patients with pain-related conditions, patient-advocates, and community organizations for individuals with pain-related conditions.

Research 130
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Osteoporosis Is a ‘Silent Killer’. Here’s How to Avoid It.

AuroBlog - Aurous Healthcare Clinical Trials blog

(Taokinesis/Canva) Because there are typically no symptoms until the first fracture occurs, osteoporosis is considered a silent disease. Some call it a silent killer. Osteoporosis is a bone disease characterized by decreased bone density and strength, leading to fragile, brittle bones that increase the risk of fractures, especially in the spine, hips and wrists.

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Eisai wins over European regulators on Alzheimer’s drug Leqembi

Bio Pharma Dive

A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.

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Autolus secures FDA approval for CAR-T cell therapy use in ALL  

Pharmaceutical Technology

Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.

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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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Running Through Life with Type 1 Diabetes

Worldwide Clinical Trials

By; Brooke Kaplan, Director, People Partner- HR Compliance & Human Capital Initiatives In April 2007, at 19 years old, I was a sophomore at the University of Maryland. I had always been relatively healthy, exercised recreationally, and worked part-time at the campus gym. I’d just returned from spring break at Disney World with my boyfriend (now husband), Zak, and we were gearing up for the Jewish holiday of Passover.

Insulin 130
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AIOCD urges DCGI to immediately stop partnership between Swiggy & PharmEasy for rapid drug delivery

AuroBlog - Aurous Healthcare Clinical Trials blog

Raising deep concern over the partnership between Swiggy Instamart and PharmEasy for a rapid drug delivery model, the All India Organization of Chemists and Druggists (AIOCD) has apprised the Drug Controller General of India (DCGI) that this move is against the standards set under Indian law and may lead to serious health and safety problems […]

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BioNTech to buy Biotheus, gaining control of cancer bispecific

Bio Pharma Dive

Biotheus’ antibody drug targets PD-L1 and VEGF, a design that’s high on drugmakers’ radars after the success of Summit Therapeutics’ ivonescimab over Keytruda.

Antibody 286
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Adaptimmune nears second sarcoma approval as Phase II trial hits endpoints 

Pharmaceutical Technology

Adaptimmune’s Phase II IGNYTE-ESO trial investigating experimental T cell therapy lete-cel has achieved its primary endpoint.

Trials 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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Veterans Day Spotlight: Jorge Araneta’s Transition from the U.S. Navy to a Career at Worldwide

Worldwide Clinical Trials

Jorge Araneta, Senior Director of Technical Delivery at Worldwide, served three years on active duty in the U.S. Navy and an additional four years in the reserves. Watch this interview as he shares his journey transitioning from military service to a career at Worldwide. The post Veterans Day Spotlight: Jorge Araneta’s Transition from the U.S. Navy to a Career at Worldwide appeared first on Worldwide Clinical Trials.

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DBT soon to begin research on consequences of viral infection on cardiovascular health & prevention strategies

AuroBlog - Aurous Healthcare Clinical Trials blog

The Department of Biotechnology (DBT) has invited researchers, scientists and clinicians to collaborate in multicentric projects to study consequences of viral infection including post Covid-19 impact on cardiovascular health, and prevention strategies, in order to gain insights into the therapeutic segment.

Research 176
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FDA approves new CAR-T competitor to Gilead’s Tecartus

Bio Pharma Dive

Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the brand name Aucatzyl.

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EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease

Pharmaceutical Technology

Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.

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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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Grand Rounds November 8, 2024: The Effect of Cash Benefits on Health Care Utilization and Health: A Randomized Study of an Income Support (Sumit Agarwal, MD, MPH, PhD)

Rethinking Clinical Trials

                         Speaker Sumit Agarwal, MD, MPH, PhD Assistant Professor Division of General Medicine University of Michigan Slides Keywords Income Support; Cash Benefits; Low-Income Population Key Points Low-income patients face several barriers to care and achieving better health. Co-pays prevent people from filling prescriptions; transportation barriers prevent patients from attending appointments; emergency departments take the place of primary care; and peop

Vaccine 130
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Scientists Reveal How Much Sleep You Need For ‘Successful Aging’

AuroBlog - Aurous Healthcare Clinical Trials blog

(Yulia Petrova/Getty Images) We all want to ‘age successfully’ with as few health issues as possible. A new study suggests getting more than seven hours of sleep a night could go a long way to achieving that goal.

Scientist 161
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FDA lifts pause on Novavax flu vaccine trials

Bio Pharma Dive

After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.

Vaccine 258
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Pharmaceutical Technology Excellence Awards 2024: BostonGene 

Pharmaceutical Technology

BostonGene is a winner in four categories in the 2024 Pharmaceutical Technology Excellence Awards.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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November 13, 2024: NIH Hosts Workshops to Inform Strategic Priorities of the NIH HEAL Initiative

Rethinking Clinical Trials

To build upon the progress of the Helping to End Addiction Long-term ® Initiative, or NIH HEAL Initiative ® , NIH is holding workshops to gather input to inform strategic research priorities and advance the mission of HEAL pain research. The workshops will be held over the next few months (ET), as follows: Non-Addictive Pain Therapeutics Development November 15 @ 10:00 am – 2:00 pm Co-led by John Markman and Ted Price Research Workforce and Training November 18 @ 1:00 – 5:00 pm Co-le

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SEC recommends approval for MSN Laboratories’ sleep disorder drug

AuroBlog - Aurous Healthcare Clinical Trials blog

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.

Drugs 139
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How a Biogen drug set the stage for a new biotech targeting ALS

Bio Pharma Dive

Trace Neuroscience, which launched this week with $101 million, benefited from last year’s approval of Qalsody. Its CEO spoke with BioPharma Dive about how the company came together.

Drugs 169
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FDA clears Novavax to resume trials of Covid-19 and flu combo vaccine 

Pharmaceutical Technology

The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.

Vaccine 229
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time