pharmaphorum
JANUARY 4, 2024
Amplifying the patient voice is essential for the success of clinical trials. Learn why it is crucial for patient engagement, recruitment, and overall trial success, and how it can address challenges such as transportation and financial barriers.
XTalks
DECEMBER 9, 2024
The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions. This guidance focuses on improved accountability, earlier confirmatory studies and greater clarity on novel endpoints.
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ACRP blog
OCTOBER 10, 2024
The increased accessibility of generative artificial intelligence (Gen AI) models like OpenAI’s ChatGPT and DALL-E has captured the popular imagination. You’d be hard-pressed now to find any leadership team in any sector that isn’t at least considering ways to leverage Gen AI. The technology uses patterns learned from data to create new content. Most industries have applied it to routine back office or administrative tasks, such as note-taking, helping to increase the efficiency of everyday pr
Rethinking Clinical Trials
NOVEMBER 21, 2024
In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. The article, “Untapped Potential? Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA.
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
Bio Pharma Dive
JANUARY 2, 2024
A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.
Worldwide Clinical Trials
OCTOBER 14, 2024
Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
FDA Law Blog
NOVEMBER 10, 2024
By Sarah Wicks & James E. Valentine — The U.S. Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
Drug Patent Watch
DECEMBER 30, 2024
The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market.
Bio Pharma Dive
OCTOBER 4, 2024
An experimental Alzheimer’s therapy from Cassava Sciences is still being tested in two Phase 3 studies, even as the company has come under regulatory scrutiny.
Pharmaceutical Technology
SEPTEMBER 13, 2024
Distribution of the self-amplifying mRNA vaccine Kostaive is set to align with a planned October 2024 Covid-19 vaccination campaign.
Velocity Clinical Research
NOVEMBER 12, 2024
Over the past decade, Germany’s share of global clinical trial activities has dropped year on year. The country accounted for just 3.9% of trials in 2021 , down from 7.2% in 2012. Late last year, the German Government published its National Pharma Strategy, which is designed to reverse this trend. Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinical research and drug development issues.
Bio Pharma Dive
OCTOBER 16, 2024
The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.
Bio Pharma Dive
OCTOBER 22, 2024
Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.
Bio Pharma Dive
NOVEMBER 6, 2024
Pioneers like Alnylam Pharmaceuticals have led the RNA interference field for years. Now, a crop of young biotechs is building on that foundation by taking the drugmaking technology in new directions.
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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
Pharmaceutical Technology
JUNE 17, 2024
Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.
Bio Pharma Dive
AUGUST 29, 2024
Far fewer venture funding rounds were closed by cell and gene therapy developers over the first six months of 2024 than in prior years. Experts say there are several factors.
Pharmaceutical Technology
MAY 1, 2024
AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.
Bio Pharma Dive
MAY 7, 2024
Pfizer said the patient, a young boy who was treated earlier last year, had died suddenly. The company is working with trial researchers to investigate further.
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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.
Bio Pharma Dive
SEPTEMBER 4, 2024
Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.
Pharmaceutical Technology
JANUARY 29, 2024
At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.
Bio Pharma Dive
MAY 16, 2024
The biotech, tentatively named Hercules CM Newco, has rights to three incretin drugs discovered by Jiangsu Hengrui Pharmaceuticals, two of which are in clinical testing.
Pharmaceutical Technology
FEBRUARY 29, 2024
India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.
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.
Bio Pharma Dive
NOVEMBER 18, 2024
The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.
Pharmaceutical Technology
FEBRUARY 12, 2024
The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.
Bio Pharma Dive
OCTOBER 17, 2024
Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.
Bio Pharma Dive
JUNE 17, 2024
One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.
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.
Pharmaceutical Technology
JULY 22, 2024
As the use of AI soared across healthcare, NVIDIA fit the bill in providing the necessary technology – and its stock tells the same story.
Bio Pharma Dive
JANUARY 30, 2024
Since a landmark paper in 2022, drugmakers have begun nearly a dozen trials of cell therapies for lupus, with more set to start. Here’s why their efforts are worth watching.
Bio Pharma Dive
JUNE 27, 2024
A growing cohort of biotechs, from Biohaven to Neurocrine to Jazz, hope research on ion channels will bring them new drugs and big business — much like it has done for Vertex.
Bio Pharma Dive
SEPTEMBER 8, 2024
Study results provide much-anticipated details to Summit’s claim earlier this year that its drug “decisively beat” Merck’s dominant immunotherapy.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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