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.
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.
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.
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.
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GSK discontinues herpes vaccines; Roivant launches new ‘vant’ around hypertension drug
Bio Pharma Dive
SEPTEMBER 11, 2024
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.
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.
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.
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
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
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.
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.
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.
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.
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),
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.
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.
The New Age of Decentralized Clinical Trials
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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.
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.
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.
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.
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
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
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.
AI-Powered chest X-Rays detect lung cancer early
Pharma Times
SEPTEMBER 11, 2024
New evidence highlights AI’s potential in early lung cancer detection
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.
Gene therapy restores vision in first-of-its-kind trial
Drug Discovery World
SEPTEMBER 11, 2024
A gene therapy developed by University of Florida scientists restored useful vision to most patients with rare condition Leber congenital amaurosis type I (LCA1) in a small trial. Patients who received the highest dose of the gene therapy saw up to a 10,000-fold improvement in their light sensitivity, were able to read more lines on an eye chart, and improved in their ability to navigate a standardised maze.
How Machine Learning Drives Clinical Trial Efficiency
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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.
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
Industry/research collaboration to automate human brain studies
Drug Discovery World
SEPTEMBER 11, 2024
The Jan and Dan Duncan Neurological Research Institute (Duncan NRI) at Texas Children’s Hospital, a neuroscience research institute based in Houston, has advanced its research capabilities with the implementation of an automation platform for human cellular model generation, maintenance, and characterisation, in collaboration with Automata Technologies.
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.
Charles River hosts drug discovery seminars
Drug Discovery World
SEPTEMBER 11, 2024
Charles River Laboratories is hosting two drug discovery seminars in the UK in September. The first will be in Cambridge on 25 September covering drug discovery capabilities, with the second at the company’s Portishead, UK site covering immuno-oncology, infectious disease capabilities on 26 September. Both events are free of charge and will feature guest speakers, networking time, refreshments, equipment demos and lab tours.
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
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