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 328
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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

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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 246
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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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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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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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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.

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

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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.

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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.

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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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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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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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PTC wins FDA approval for first brain-delivered gene therapy Kebilidi

Fierce Pharma

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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ICMR announces call for CAR proposals under extramural research programme

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council of Medical Research (ICMR) has issued a call for proposals for its Centre for Advanced Research (CAR) initiative under the Extramural Research Programme, inviting experienced research teams to apply for funding aimed at advancing healthcare research in critical areas.

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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.

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FDA grants accelerated approval for PTC’s AADC deficiency gene therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted accelerated approval for PTC Therapeutics’ KEBILIDI, the first gene therapy in the US that is directly delivered to the brain.

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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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World Pneumonia Day 2024: New Treatments and Innovations

XTalks

On World Pneumonia Day 2024, observed on November 12, the focus shifts to one of the world’s most preventable and treatable diseases that remain a leading cause of death for children under five and a significant risk to vulnerable populations globally. Pneumonia is a lung infection that can be caused by viruses, bacteria or fungi and can result in millions of hospitalizations and deaths annually.

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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.

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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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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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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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AI tool spots long COVID in electronic health records

pharmaphorum

Mass General Brigham researchers have developed an AI that can spot hidden cases of long COVID from electronic health records

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Lilly unwraps detailed data showing tirzepatide kept nearly 99% of prediabetic patients diabetes-free over 3 years

Fierce Pharma

Lilly unwraps detailed data showing tirzepatide kept nearly 99% of prediabetic patients diabetes-free over 3 years fkansteiner Wed, 11/13/2024 - 14:37

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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.

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BioNTech signs agreement to acquire Biotheus

Pharmaceutical Technology

BioNTech has signed a definitive agreement to acquire Biotheus to obtain complete worldwide rights to BNT327/PM8002, a programmed death-ligand 1 and vascular endothelial growth factor A-targeting bispecific antibody.

Antibody 246
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The evolving role of AI in drug submission and approval: An expert perspective

pharmaphorum

Discover an expert perspective on how artificial intelligence is transforming the drug submission and approval process in the pharmaceutical industry. Explore the evolving role of AI in drug development.

Drugs 127
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Autolus readies its CAR-T Aucatzyl to go after heavy hitter competition following FDA nod

Fierce Pharma

Watch out, Gilead and Novartis: there's a new CAR-T in town. | Autolus' Aucatzyl has become the first CAR-T approved by the FDA without a REMS mandate. And the company is ready to hit the ground running, facing Gilead and Novartis as its competitors.

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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 182
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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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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.