UK doctors sceptical of AI's role in treatment
pharmaphorum
SEPTEMBER 11, 2024
One in two UK doctors would not use GenAI to treat patients, but there was more willingness to use it for diagnostic purposes, survey finds
Wed.Sep 11, 2024
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Prodrugs and patents: Enhancing therapy adherence and reducing side effects
Pharmaceutical Technology
SEPTEMBER 11, 2024
As the approval date for Bristol Myers Squibb’s schizophrenia drug KarXT looms, a prodrug approach emerges to potentially address dosing challenges.
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Type 2 Diabetes Drug Linked to 35% Lower Dementia Risk in Patients
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 11, 2024
(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.
EASD 2024: Are tetra-agonists the future of metabolic diseases treatment?
Pharmaceutical Technology
SEPTEMBER 11, 2024
EASD 2024 participants are looking for the hottest efficacy data to make predictions on the next trend in the metabolic space.
How to Turn “Check-the-Box” Compliance Trainings Into Real Learning
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.
Health ministry adds primary hyperoxaluria under NPRD to offer financial assistance
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 11, 2024
The Union ministry of health and family welfare (MoHFW) included primary hyperoxaluria, a rare genetic metabolic disorder that affects kidney and other organ systems, under the National Policy for Rare Diseases (NPRD), 2021, with financial assistance to be provided for transplants.
BridgeBio trims gene therapy budget after seeing data on adrenal gland medicine
Bio Pharma Dive
SEPTEMBER 11, 2024
Data from an early trial of the therapy fell short of the company’s “threshold to warrant additional capital investment,” an executive said.
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Dupixent succeeds in chronic hives study, giving Sanofi, Regeneron a chance to rebound
Bio Pharma Dive
SEPTEMBER 11, 2024
Following an FDA rejection last year, the drugmakers plan to resubmit their application for an expanded approval of Dupixent in chronic spontaneous urticaria.
September 11, 2024: HARMONIE and a New Approach to Commercial Clinical Trials, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
SEPTEMBER 11, 2024
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
Scotland first in UK to approve new myeloma treatment
Pharma Times
SEPTEMBER 11, 2024
Patients with relapsed multiple myeloma gain access to life-extending therapy
IBA venture PanTera gains €134m in funding to scale up actinium-225 production
Pharmaceutical Technology
SEPTEMBER 11, 2024
The IBA-SCK CEN joint venture secured funds to increase production of the radioisotope used in cancer therapies.
Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle
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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness
Meet MILTON, AZ's AI that can predict 1,000+ diseases
pharmaphorum
SEPTEMBER 11, 2024
A machine-learning tool developed by AstraZeneca and trained on UK Biobank data, called MILTON, can predict over 1,000 diseases, before diagnosis
EASD 2024: Novo Nordisk’s Saxenda shows weight loss in children
Pharmaceutical Technology
SEPTEMBER 11, 2024
Children aged 6-12 years achieved a 5.8% reduction in BMI with Novo Nordisk's Saxenda at 52 weeks in a Phase IIIa trial.
The benefits of ePI for patients and the planet
pharmaphorum
SEPTEMBER 11, 2024
Discover the advantages of paperless medicine information for patients and the environment. Learn how electronic product information benefits both your health and the planet.
FDA grants breakthrough therapy status to Arrowhead’s plozasiran
Pharmaceutical Technology
SEPTEMBER 11, 2024
The US FDA has granted breakthrough therapy designation to Arrowhead Pharmaceuticals’ plozasiran, a RNA interference (RNAi) therapeutic.
Can Your Organization Spot a Conflict Before It’s a Crisis?
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?
Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc
Fierce Pharma
SEPTEMBER 11, 2024
For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming. | Ahead of an advisory committee meeting slated for Friday, the FDA unleashed damning briefing documents calling into question the effectiveness and safety of Intercept’s rare liver disease drug Ocaliva. The regulator specifically raised an eyebrow at the post-marketing trials Intercept has used in a bid to keep hold of the accelerated approval it won back in 2016.
NanoSyrinx secures funds to develop biologic therapeutics
Pharmaceutical Technology
SEPTEMBER 11, 2024
NanoSyrinx has secured £10m ($13m) aimed at advancing its technology for targeted intracellular delivery of biologic therapeutics.
J&J’s Tremfya, following in Stelara’s footsteps, enters crowded ulcerative colitis arena with FDA nod
Fierce Pharma
SEPTEMBER 11, 2024
Johnson & Johnson already has a major presence in the crowded inflammatory bowel disease (IBD) space with its popular Stelara. | Tremfya will enter the UC space as J&J’s older Stelara, which is approved to treat both forms of IBD, nears biosimilar competition and Inflation Reduction Act-mandated price concessions.
Gilead and Genesis partner to create novel therapies using AI
Pharmaceutical Technology
SEPTEMBER 11, 2024
Gilead Sciences has partnered with Genesis Therapeutics to discover and develop new small molecule therapies using AI.
White Paper - A Roadmap to AI Data Readiness in R&D Labs
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Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control
FDA Law Blog
SEPTEMBER 11, 2024
By John W.M. Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. One specific kind of nitrosamines called N-nitrosamine drug substance-related impurities, or NDSRIs, are especially vexing to FDA and to industry because they mimic the structure of the specific active pharmaceutical ingredients (API),
Sanofi inaugurates vaccine plant in Neuville-sur-Saône, France
Pharmaceutical Technology
SEPTEMBER 11, 2024
Sanofi has announced the inauguration its new modular vaccine and biomedicine production unit, Modulus, in Neuville-sur-Saône, France.
Pharma Pulse 9/11/24: Cutting-Edge Tech is Fast-Tracking the Future of Medicine, It’s the Business Model, Stupid. & more
Pharmaceutical Commerce
SEPTEMBER 11, 2024
The latest news for pharma industry insiders.
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
SEPTEMBER 11, 2024
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
Bridging Innovation & Patient Care: The Growing Role of AI
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!
Leveraging Nanotechnology in Generic Drug Development: Enhancing Efficacy and Safety
Drug Patent Watch
SEPTEMBER 11, 2024
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.
Tower Cold Chain, CRYOPDP Collaborate on Growing Temperature-Controlled Offerings
Pharmaceutical Commerce
SEPTEMBER 11, 2024
The parties’ want to provide customers with a “one-stop-shop,” with the hopes that their services will be easier to navigate.
ESMO: Despite checkered past, Merck's Keytruda-Lenvima pairing looks to change practice in liver cancer subtype
Fierce Pharma
SEPTEMBER 11, 2024
After a surprise failure in advanced liver cancer, Merck & Co. and Eisai are hoping new data can make their Keytruda-Lenvima combination a standard of care in intermediate-stage disease. | After a surprise failure in advanced liver cancer, Merck & Co. and Eisai are hoping new data can make their Keytruda-Lenvima combination a standard of care in intermediate-stage disease.
Viridian takes aim at Amgen's Tepezza with veligrotug data
pharmaphorum
SEPTEMBER 11, 2024
Viridian's thyroid eye disease drug veligrotug clears its first phase 3 trial, with data suggesting it could be competitive with Amgen's Tepezza
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
ESMO: Bristol Myers moves Opdualag into phase 3 trials in competitive first-line lung cancer field
Fierce Pharma
SEPTEMBER 11, 2024
More than two years after an initial FDA approval in melanoma, Bristol Myers Squibb is moving its PD-1/LAG-3 combo Opdualag into registrational testing in one of the most important oncology disease | More than two years after an initial FDA approval in melanoma, Bristol Myers Squibb is moving its PD-1/LAG-3 combo Opdualag into registrational testing in one of the most important disease areas—first-line non-small cell lung cancer.
Women in Science - Emmanuelle Cameau on growing stronger from challenges
BioPharma Reporter
SEPTEMBER 11, 2024
Emmanuelle Cameau is strategic technology partnership leader at Cytiva.
Study backs role of Novo Nordisk obesity drug in children
pharmaphorum
SEPTEMBER 11, 2024
A clinical trial has backed the safety and efficacy of Novo Nordisk's weight-loss drug Saxenda in children as young as six with obesity.
India's Zydus hit with warning letter as FDA flags glass contamination concerns and more
Fierce Pharma
SEPTEMBER 11, 2024
Last week, Zydus Lifesciences confirmed the receipt of an FDA warning letter at its Waghodia plant in Gujarat, India, marking the latest in a string of production reprimands for the India | Last week, Zydus Lifesciences confirmed the receipt of an FDA Warning Letter at its Waghodia plant in Gujarat, India, marking the latest in a string of production reprimands for the Indian drugmaker.
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