AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 13, 2024
(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.
Bio Pharma Dive
NOVEMBER 11, 2024
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.
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Pharmaceutical Technology
NOVEMBER 13, 2024
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.
Rethinking Clinical Trials
NOVEMBER 13, 2024
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
Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group
Let’s face it—most ethics and compliance training programs aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, captivating, and maybe even enjoyable! Join learning design expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training. We'll explore innovative strategies to bring traditionally dry topics to life, making them resonate with learners and drive tangible change.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 12, 2024
(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.
Worldwide Clinical Trials
NOVEMBER 12, 2024
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
NOVEMBER 13, 2024
Merck KGaA recently shared positive results from its Phase III MANEUVER trial on pimicotinib, an investigational oral therapy for tenosynovial giant cell tumor (TGCT). TGCT is a rare, aggressive joint condition caused by overactive colony-stimulating factor 1 (CSF-1). A generally non-cancerous growth that forms in the tissue lining the joints, tendons or fluid-filled sacs around joints, TGCT often leads to abnormal joint tissue growth, painful swelling and stiffness.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 11, 2024
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.
Worldwide Clinical Trials
NOVEMBER 13, 2024
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.
Bio Pharma Dive
NOVEMBER 14, 2024
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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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness
XTalks
NOVEMBER 14, 2024
PTC Therapeutics has gained US Food and Drug Administration (FDA) approval for its new gene therapy, Kebilidi (eladocagene exuparvovec), for treating aromatic L-amino acid decarboxylase (AADC) deficiency. This therapy, the first of its kind to be administered directly into the brain, addresses a rare genetic disorder that severely affects motor function and dopamine production.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 14, 2024
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.
Pharmaceutical Technology
NOVEMBER 11, 2024
Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.
Bio Pharma Dive
NOVEMBER 14, 2024
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.
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
XTalks
NOVEMBER 15, 2024
Syros Pharmaceuticals announced that its cancer drug tamibarotene failed to meet its primary endpoint in the SELECT-MDS-1 Phase III trial. The trial was evaluating the drug in combination with the chemotherapy azacitidine for the treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome (HR-MDS) who harbor overexpression of the RARA (retinoic acid receptor alpha) gene.
Rethinking Clinical Trials
NOVEMBER 14, 2024
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.
Pharmaceutical Technology
NOVEMBER 11, 2024
BostonGene is a winner in four categories in the 2024 Pharmaceutical Technology Excellence Awards.
Bio Pharma Dive
NOVEMBER 13, 2024
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.
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
XTalks
NOVEMBER 12, 2024
Bayer recently announced that it has received US Food and Drug Administration (FDA) clearance for its MEDRAD Centargo computed tomography (CT) injection system, a multi-patient injector that aims to improve workflow efficiency in CT imaging procedures. The system has design features that integrate with Bayer’s portfolio of products, particularly in high-volume CT suites, said Bayer in a press release.
Advarra
NOVEMBER 14, 2024
In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy. These independent committees are entrusted with the task of safeguarding study participant’s interests while ensuring the trial’s scientific integrity.
Pharmaceutical Technology
NOVEMBER 12, 2024
The FDA agreed for Novavax to continue trials of its vaccine combo after addressing a serious adverse event that paused trials.
Bio Pharma Dive
NOVEMBER 11, 2024
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.
Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk
In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?
XTalks
NOVEMBER 11, 2024
World Antimicrobial Resistance Awareness Week 2024, observed from November 18 to 24, 2024, centers on the theme “Educate. Advocate. Act now.” This theme addresses antimicrobial resistance (AMR), a critical issue where bacteria, viruses, fungi and parasites develop resistance to treatments, making infections harder — or sometimes impossible — to treat effectively.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 14, 2024
(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.
Pharmaceutical Technology
NOVEMBER 14, 2024
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.
Bio Pharma Dive
NOVEMBER 11, 2024
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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XTalks
NOVEMBER 15, 2024
Longboard Pharmaceuticals recently announced the launch of its Phase III DEEp OCEAN study to assess the potential of bexicaserin, a drug aimed at reducing seizures linked to developmental and epileptic encephalopathies (DEEs). This study, deemed the first of its kind by Chad Orevillo, Longboard’s executive vice president, marks a critical step in addressing a previously underserved need in epilepsy treatment.
pharmaphorum
NOVEMBER 10, 2024
Recent funding rounds in the digital health arena feature digital pathology startup Aignostics, remote care specialists TCC, Yazen Health, and Nema Health, wearables developer Alimetry, and clinical trial automation startup Research Grid.Digital pathology specialist Aignostics, which develops artificial intelligence algorithms to glean information from medical images and combine it with epidemiological, clinical, and genomic data, has completed a $34 million Series B financing.
Pharmaceutical Technology
NOVEMBER 14, 2024
Adaptimmune’s Phase II IGNYTE-ESO trial investigating experimental T cell therapy lete-cel has achieved its primary endpoint.
Rethinking Clinical Trials
NOVEMBER 12, 2024
On November 18, 2024 at 2 pm eastern, the Duke Margolis Institute for Health Policy and Duke Health will co-host “ From Principles to Practice: Exploring AI Governance in Health Systems. ” In this public webinar, Duke-Margolis and Duke Health will discuss their newly released white paper on how health systems are navigating the role of AI governance.
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