Bio Pharma Dive
OCTOBER 23, 2023
Three essential components to create impactful real-world evidence with a 360-degree patient journey.
Pharmaceutical Technology
OCTOBER 24, 2023
The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.
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pharmaphorum
OCTOBER 24, 2023
Pharma dips toe into tech adoption, but is it deep enough? Mike.
Bio Pharma Dive
OCTOBER 26, 2023
Company shares fell Thursday as the company adjusted its medium-term guidance for sales of new products like Reblozyl, Camzyos and Abecma.
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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.
Pharmaceutical Technology
OCTOBER 24, 2023
Pear Therapeutics was a pioneer in developing DTx for neurological conditions traditionally treated by evidence-based behavioural or psychological management strategies.
pharmaphorum
OCTOBER 26, 2023
The longitudinal history of medicines innovation: Part One Mike.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
OCTOBER 26, 2023
Fall marks the beginning of the “flu season,” the period during the year when influenza (flu) viruses are in increased circulation and cause illness at higher rates than usual. The season also marks the increased circulation of other respiratory viruses, including SARS-CoV-2, which causes COVID-19, and respiratory syncytial virus (RSV). In the US, the flu or respiratory virus season typically begins in the fall and peaks in the winter, usually between December and February, but it can last as la
Bio Pharma Dive
OCTOBER 23, 2023
Effective marketing measurement requires objectivity, connected data, transparency, a track record of innovation and a proven ability to execute.
Rethinking Clinical Trials
OCTOBER 25, 2023
In this Friday’s PCT Grand Rounds, Harlan Krumholz of Yale University will present “Digital, Decentralized and Democratized: Lessons From the Yale PaxLC Trial.” The Grand Rounds session will be held on Friday, October 27, 2023, at 1:00 pm eastern. The PaxLC Trial is a decentralized study of Paxlovid in adult participants with long COVID.
Pharmaceutical Technology
OCTOBER 24, 2023
SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.
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The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 26, 2023
Many tiny organisms including bacteria, fungi and viruses normally live on our bodies, and even inside us. These are called the microbiome. The large number of these organisms living in the gastrointestinal tract are collectively known as the gut microbiome.
Bio Pharma Dive
OCTOBER 27, 2023
In a wide-ranging interview, Bristol Myers’ Ken Rhodes talked biomarkers, diseases of interest and why the company is far from done with neuroscience-focused deals.
Fierce Pharma
OCTOBER 26, 2023
Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. | Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. Now, the Swiss pharma giant wants a peek at Takeda’s business records to find out whether its confidential information has been used improperly.
Pharmaceutical Technology
OCTOBER 27, 2023
The UK NICE has recommended the use of AbbVie’s foslevodopa–foscarbidopa (Produodopa) for the treatment of advanced Parkinson’s disease.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 25, 2023
Adults diagnosed with attention-deficit/hyperactivity disorder ( ADHD) are almost three times more likely to go on to develop dementia, according to a new study that looked at 109,218 adults with and without the condition over a period of 17 years. The researchers, from institutions in Israel and the US, found that 13.
Bio Pharma Dive
OCTOBER 26, 2023
Executives at the biotech say they’re trying to get ahead of the payer and production challenges that will face their gene editing treatment exa-cel, which is now under FDA review.
Fierce Pharma
OCTOBER 24, 2023
In the biopharma industry, post-merger layoffs are often a question of when and how many. | In the biopharma industry, post-merger layoffs are often a question of when and how many. In the case of Amgen’s $27.8 billion buyout of Horizon, they came quickly. Around 350 former Horizon employees are being told this week that their positions will be eliminated.
Pharmaceutical Technology
OCTOBER 26, 2023
The potential for using gene therapies to treat sickle cell disease is high, but their durability and high price point invite scrutiny.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 24, 2023
If the idea of driving down a winding road makes you feel queasy, spare a thought for the mice employed in a new study, which sought to pinpoint the brain cells responsible for motion sickness.
Bio Pharma Dive
OCTOBER 23, 2023
The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.
BioSpace
OCTOBER 22, 2023
The non-alcoholic steatohepatitis space is still a “big mystery,” analysts tell BioSpace, but its connection to weight loss could provide an additional opportunity for contenders.
Pharmaceutical Technology
OCTOBER 26, 2023
The EC announced new initiatives to tackle critical medicine shortages in winter, introducing more flexibility to strengthen supplies.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 26, 2023
The Indian Council of Medical Research (ICMR) has invited proposals to establish Ayush-ICMR Advanced Centre for Integrative Health Research (AI-ACIHR) at the All India Institute of Medical Sciences (AIIMS) under Extramural Programme. This is following a Memorandum of Agreement (MoA) signed between the Union Ministry of Ayush and the ICMR at an inter-ministerial level.
Bio Pharma Dive
OCTOBER 27, 2023
The restructuring came as the French company forecast an earnings drop in 2024, prompting a stock selloff that erased about $20 billion in market value.
BioSpace
OCTOBER 22, 2023
While sensitive and specific biomarkers for Alzheimer’s disease have recently taken a leap forward, the Parkinson’s space has lagged behind. Neurofilament Light Chain could change that.
Pharmaceutical Technology
OCTOBER 25, 2023
The AD and PD drug aims to reduce the level of neurotoxic proteins, thereby improving information flow across the axonal transport
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As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. Deviations from the intended supply chain can delay timelines and affect these high value products, which can be detrimental to budgets, but more importantly can have dire effects on the patients whose lives depend on receiving these critical doses safely and on time.
Fierce Pharma
OCTOBER 27, 2023
Sanofi acolytes are none too happy with the latest chapter of CEO Paul Hudson’s "Play to Win" strategy. | Sanofi acolytes are none too happy with the latest chapter of CEO Paul Hudson’s "Play to Win" strategy. After unveiling the pivot alongside third-quarter earnings Friday, Sanofi’s stock plunged nearly 20%, with one analyst group suggesting the plan came “at the wrong time.
Bio Pharma Dive
OCTOBER 24, 2023
The money will be spread across three investment funds and comes at a time when investment into biotech remains shakier than in years past.
pharmaphorum
OCTOBER 27, 2023
At CAR-TCR in Boston last month, pharmaphorum’s Jonah Comstock caught up with Matt Lakelin, co-founder of TrakCel, a software company that helps makers of advanced therapies manage their supply chain.
Pharmaceutical Technology
OCTOBER 26, 2023
A pivotal Phase III trial will be initiated in the coming months to further evaluate the lead formulations of the combination vaccine.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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