Sat.Dec 09, 2023 - Fri.Dec 15, 2023

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Decentralized Clinical Trials in 2024: A Look Ahead

Crucial Data Soutions

Decentralized clinical trials (DCTs) are growing. We may not be seeing the deep and widespread adoption of decentralized approaches some. The post Decentralized Clinical Trials in 2024: A Look Ahead appeared first on Crucial Data Solutions.

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3 Tips to Avoid the Holiday Season from Impacting Participant Compliance

Imperical Blog

We often refer to participants as the heroes of research. Trials, and the medical advances made through research, don’t happen without them. But here come the holidays – will your study participant compliance waver during these busy times? Patient recruitment, retention, and compliance with study… The post 3 Tips to Avoid the Holiday Season from Impacting Participant Compliance appeared first on Imperial Clinical Research Services Blog.

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‘No tolerance for failure’: An oral history of the first CRISPR medicine

Bio Pharma Dive

A new sickle cell disease therapy developed by CRISPR Therapeutics and Vertex Pharmaceuticals is now approved in the U.S. and U.K. This is the story of how it came to be.

Medicine 357
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Quality and sustainability: The balancing act for pharma manufacturing  

Pharmaceutical Technology

Trends in sustainability and quality assurance were key themes discussed at the recent CPHI Europe 2023 meeting, although the data reveals a lack of implementation of sustainable solutions.

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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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December 13, 2023: In This Week’s PCT Grand Rounds, a Path Forward for Diversifying Clinical Trials

Rethinking Clinical Trials

In this Friday's PCT Grand Rounds, Roxana Mehran of the Icahn School of Medicine at Mount Sinai will present "Diversifying Clinical Trials: A Path Forward." The Grand Rounds session will be held on Friday, December 15, 2023, at 1:00 pm eastern. Mehran is a professor of medicine and the director of interventional cardiovascular research and clinical trials at the Zena and Michael A.

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How Clario is improving clinical trials: 'Therapies that hold immense promise may never see the light of day'

BioPharma Reporter

Dr. Michael OâNeal, chief medical officer at Clario, believes that many drugs ultimately fail due to common operational and data challenges that could, and should, be corrected.

More Trending

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Pancreatic Cancer Clinical Trials: Insights from PanCAN’s Senior Director

XTalks

Pancreatic cancer is one of the leading causes of cancer-related deaths worldwide. It’s known for its low survival rate, as it is often diagnosed at a late stage due to subtle early symptoms. The most common type is pancreatic adenocarcinoma, which accounts for about 95 percent of cases. This type begins in the cells that line the pancreatic ducts.

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Trade & Channel Strategies 2023: Aligning Patient Access

Pharmaceutical Commerce

Panel uncovers ways to handle the increasing complexities and risks surrounding commercialization.

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ASH23: Pharma branding, Editas’ high bar and clinical trial diversity

Bio Pharma Dive

Editas had the tall task Monday of convincing ASH attendees its gene therapy for sickle cell disease could improve on Casgevy and Lyfgenia.

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How simulations help device makers meet booming autoinjector demand

Pharmaceutical Technology

Advanced simulation methods and tools are not only paving the way for more efficient manufacturing operations. At SHL Medical, they’re also speeding up the development of new production facilities around the globe.

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

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PharmaKure and UiTM enter research partnership for Alzheimer’s disease

Pharma Times

The collaboration aims to develop biomarker-based diagnostics for the condition - News - PharmaTimes

Research 150
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December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

Investigators from the NIH Pragmatic Trials Collaboratory in 2023 shared study results, generated new knowledge, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups , analyses from the Distributed Research Network , and study designs and results from the NIH Collaboratory Trials.

Trials 147
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Tome Biosciences debuts with $213M and a new way to edit the genome

Bio Pharma Dive

Based on the work of MIT scientists, the well-funded startup is developing ways to insert large sizes of genetic material anywhere in the genome without damaging or breaking DNA.

Genome 334
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First gene therapies for sickle cell disease secure FDA approval

Pharmaceutical Technology

The FDA has approved Vertex/CRISPR’s Casgevy and bluebird bio’s Lyfgenia gene therapies for the red blood cell disorder.

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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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Study confirms safety of new flow-diverting stent to treat brain aneurysms

Pharma Times

In England, ruptured brain aneurysms occur in around one in 15,000 people every year - News - PharmaTimes

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Done deal: Pfizer completes $43B acquisition of Seagen, doubling its oncology pipeline

Fierce Pharma

Pfizer’s $43 billion acquisition of Seagen is in the books, the company said on Thursda | It’s a done deal. Pfizer’s $43 billion acquisition of Seagen is in the books, as it becomes the largest M&A transaction in the biopharma industry since AbbVie snatched up Allergan for $63 billion in 2019. The buyout of the antibody-drug conjugate specialist has doubled Pfizer’s pipeline to 60 programs.

Antibody 145
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ASH23: CAR-T for autoimmune disease, real-world questions and sickle cell’s social media mentions

Bio Pharma Dive

Study results disclosed at the American Society of Hematology meeting Saturday suggested potential for cell therapy in lupus and pointed out drug trial limitations.

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Acadia victorious in court for Parkinson’s drug Nuplazid patent litigation

Pharmaceutical Technology

Acadia received two patent rulings that strengthen Nuplazid’s patent position and protect the drug into 2038.

Drugs 173
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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.

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UKHSA urges individuals from ethnic minority groups to get vaccinated

Pharma Times

New data highlights the inequalities in emergency hospital rates and vaccinations - News - PharmaTimes

Vaccine 145
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Pfizer warns of further sales decline for COVID products, plots $500M in additional cost cuts

Fierce Pharma

Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be | Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be finalized on Thursday—Pfizer sandwiched its bad news, which came on Wednesday with its 2024 guidance. The company expects revenue to reach between $58.5 billion and $61.5 billion next year, coming up short of the analyst consensus of $63.2 billion, largely because of the plummeting demand for its COVID-19 products.

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Apellis eye drug likely to be rejected in Europe, company says

Bio Pharma Dive

According to Apellis executives, reviewers in Europe are skeptical of the benefits of its geographic atrophy medicine, Syfovre, and appear poised to recommend against approval at a meeting next month.

Medicine 321
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Sanofi and AstraZeneca to supply additional RSV doses to US

Pharmaceutical Technology

The US government is set to receive an additional 230,000 doses of RSV injection Beyfortus from Sanofi and AstraZeneca in January 2024.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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NHS rolls out online GP registration to over 2,000 practices

Pharma Times

Around 2,100 GP surgeries had enrolled into the digital service by the end of November - News - PharmaTimes

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Europe names hundreds of critical medicines in quest to counter drug shortages

Fierce Pharma

Over the past several years, drug shortages have vexed doctors and patients on both sides of the Atlantic, prompting lawmakers and government agencies to take action in both Europe and the U.S. | Tuesday, the European Medicines Agency laid out a list of more than 300 critical generic drugs that could fall prey to future shortages. Inclusion in the list doesn’t mean a particular drug is likely to experience a shortage anytime soon, the EMA said.

Medicine 144
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FTC, in unusual move, leads Sanofi to terminate a drug research deal

Bio Pharma Dive

Just before clearing Pfizer’s buyout of Seagen, the regulator threatened to block Sanofi’s licensing deal with Maze Therapeutics, a challenge the biotech called ‘‘unprecedented.

Licensing 309
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FDA approves US WorldMeds’s iwilfin for neuroblastoma

Pharmaceutical Technology

The US FDA granted approval for US WorldMeds’ iwilfin for use as an oral maintenance treatment for high-risk neuroblastoma.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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New filtering system to combat spread of infections in hospitals

Pharma Times

The combined system works to detect and eliminate airborne pathogens - News - PharmaTimes

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Arcutis' Zoryve bags 2nd FDA nod, this time as a foam to treat 'the great neglected disease in dermatology'

Fierce Pharma

About a year after Arcutis Biotherapeutics unveiled positive data on roflumilast foam at the European Academy of Dermatology and Venereology congress 2022, the company has clinched a second FDA OK. | About a year after Arcutis Biotherapeutics unveiled positive data on roflumilast foam at the European Academy of Dermatology and Venereology congress 2022, the company has clinched a second FDA OK.

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Humira leads ICER’s latest list of ‘unsupported’ price hikes

Bio Pharma Dive

AbbVie’s blockbuster medicine topped a list of treatments that, combined, elevated U.S. healthcare spending by $1.3 billion in 2022, according to the price watchdog’s latest yearly report.

Medicine 306
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Daiichi Sankyo and Depixus partner to accelerate RNA-targeted drug discovery

Pharmaceutical Technology

Daiichi Sankyo plans to leverage the French startup’s technology to develop its RNA-targeted therapeutics pipeline.

RNA 147
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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.