Wed.Sep 11, 2024

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UK doctors sceptical of AI's role in treatment

pharmaphorum

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

Doctors 111
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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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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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EASD 2024: Are tetra-agonists the future of metabolic diseases treatment?

Pharmaceutical Technology

EASD 2024 participants are looking for the hottest efficacy data to make predictions on the next trend in the metabolic space.

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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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BridgeBio trims gene therapy budget after seeing data on adrenal gland medicine

Bio Pharma Dive

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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Health ministry adds primary hyperoxaluria under NPRD to offer financial assistance

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Genetics 174

More Trending

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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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GSK discontinues herpes vaccines; Roivant launches new ‘vant’ around hypertension drug

Bio Pharma Dive

The British pharma said its shot didn’t meet the efficacy goals of a Phase 2 study. Elsewhere, Zealand reported more obesity drug data and Lilly appointed a new CFO.

Drugs 162
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IBA venture PanTera gains €134m in funding to scale up actinium-225 production

Pharmaceutical Technology

The IBA-SCK CEN joint venture secured funds to increase production of the radioisotope used in cancer therapies.

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

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EASD 2024: Novo Nordisk’s Saxenda shows weight loss in children

Pharmaceutical Technology

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.

Trials 130
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Scotland first in UK to approve new myeloma treatment

Pharma Times

Patients with relapsed multiple myeloma gain access to life-extending therapy

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FDA grants breakthrough therapy status to Arrowhead’s plozasiran

Pharmaceutical Technology

The US FDA has granted breakthrough therapy designation to Arrowhead Pharmaceuticals’ plozasiran, a RNA interference (RNAi) therapeutic.

RNA 130
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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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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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NanoSyrinx secures funds to develop biologic therapeutics

Pharmaceutical Technology

NanoSyrinx has secured £10m ($13m) aimed at advancing its technology for targeted intracellular delivery of biologic therapeutics.

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The benefits of ePI for patients and the planet

pharmaphorum

Discover the advantages of paperless medicine information for patients and the environment. Learn how electronic product information benefits both your health and the planet.

Medicine 111
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Gilead and Genesis partner to create novel therapies using AI

Pharmaceutical Technology

Gilead Sciences has partnered with Genesis Therapeutics to discover and develop new small molecule therapies using AI.

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Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc

Fierce Pharma

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.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Sanofi inaugurates vaccine plant in Neuville-sur-Saône, France

Pharmaceutical Technology

Sanofi has announced the inauguration its new modular vaccine and biomedicine production unit, Modulus, in Neuville-sur-Saône, France.

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J&J’s Tremfya, following in Stelara’s footsteps, enters crowded ulcerative colitis arena with FDA nod

Fierce Pharma

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.

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Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control

FDA Law Blog

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),

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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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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.

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Pharma Pulse 9/11/24: Cutting-Edge Tech is Fast-Tracking the Future of Medicine, It’s the Business Model, Stupid. & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Medicine 104
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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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Tower Cold Chain, CRYOPDP Collaborate on Growing Temperature-Controlled Offerings

Pharmaceutical Commerce

The parties’ want to provide customers with a “one-stop-shop,” with the hopes that their services will be easier to navigate.

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ESMO: Bristol Myers moves Opdualag into phase 3 trials in competitive first-line lung cancer field

Fierce Pharma

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.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Viridian takes aim at Amgen's Tepezza with veligrotug data

pharmaphorum

Viridian's thyroid eye disease drug veligrotug clears its first phase 3 trial, with data suggesting it could be competitive with Amgen's Tepezza

Trials 69
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Women in Science - Emmanuelle Cameau on growing stronger from challenges

BioPharma Reporter

Emmanuelle Cameau is strategic technology partnership leader at Cytiva.

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Study backs role of Novo Nordisk obesity drug in children

pharmaphorum

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.

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ESMO: Despite checkered past, Merck's Keytruda-Lenvima pairing looks to change practice in liver cancer subtype

Fierce Pharma

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.

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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.