Crucial Data Soutions
DECEMBER 12, 2023
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.
Imperical Blog
DECEMBER 13, 2023
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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Bio Pharma Dive
DECEMBER 10, 2023
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.
Pharmaceutical Technology
DECEMBER 11, 2023
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.
Rethinking Clinical Trials
DECEMBER 13, 2023
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.
BioPharma Reporter
DECEMBER 11, 2023
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
DECEMBER 11, 2023
Editas had the tall task Monday of convincing ASH attendees its gene therapy for sickle cell disease could improve on Casgevy and Lyfgenia.
Pharmaceutical Technology
DECEMBER 13, 2023
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.
Rethinking Clinical Trials
DECEMBER 12, 2023
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.
Fierce Pharma
DECEMBER 14, 2023
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.
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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
Bio Pharma Dive
DECEMBER 12, 2023
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.
Pharmaceutical Technology
DECEMBER 11, 2023
The FDA has approved Vertex/CRISPR’s Casgevy and bluebird bio’s Lyfgenia gene therapies for the red blood cell disorder.
Antidote
DECEMBER 12, 2023
Achondroplasia, a term meaning “without cartilage formation,” is a genetic disorder leading to disproportionate short stature. Sometimes called achondroplastic dwarfism or ACH , this condition has few treatment options and no known cure. However, individuals diagnosed with this condition can typically lead fulfilling, healthy lives with proper management.
Fierce Pharma
DECEMBER 13, 2023
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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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
DECEMBER 14, 2023
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.
Pharmaceutical Technology
DECEMBER 14, 2023
Acadia received two patent rulings that strengthen Nuplazid’s patent position and protect the drug into 2038.
Pharma Times
DECEMBER 14, 2023
The collaboration aims to develop biomarker-based diagnostics for the condition - News - PharmaTimes
Fierce Pharma
DECEMBER 12, 2023
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.
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
DECEMBER 9, 2023
Study results disclosed at the American Society of Hematology meeting Saturday suggested potential for cell therapy in lupus and pointed out drug trial limitations.
Pharmaceutical Technology
DECEMBER 15, 2023
The US government is set to receive an additional 230,000 doses of RSV injection Beyfortus from Sanofi and AstraZeneca in January 2024.
Pharma Times
DECEMBER 13, 2023
In England, ruptured brain aneurysms occur in around one in 15,000 people every year - News - PharmaTimes
Fierce Pharma
DECEMBER 15, 2023
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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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
Bio Pharma Dive
DECEMBER 12, 2023
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.
Pharmaceutical Technology
DECEMBER 13, 2023
Pfizer has obtained all necessary regulatory approvals for concluding the acquisition of biotechnology company Seagen for $43bn in cash.
XTalks
DECEMBER 13, 2023
In 2023, biotechnology and pharmaceutical companies leverage cutting-edge technology and significant investments in research and development (R&D) to continue pushing the boundaries of innovation in the healthcare sector, transcending the challenges posed by the pandemic. This groundwork ensures a more efficient and effective approach to combatting diseases in the future.
Fierce Pharma
DECEMBER 12, 2023
To complete its acquisition of Seagen, what did Pfizer need to do to satisfy antitrust concerns of the Federal Trade Commission? | By agreeing to donate royalties on its U.S. sales of bladder cancer drug Bavencio, Pfizer has received the go-ahead to finalize its $43 billion buyout of Seagen, the company said on Tuesday. Pfizer expects to close the merger on Thursday.
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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.
Bio Pharma Dive
DECEMBER 11, 2023
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.
Pharmaceutical Technology
DECEMBER 13, 2023
The sale, which will see Aditxt take on Evofem’s debt, follows a strategic review by the women’s health company earlier this year.
XTalks
DECEMBER 12, 2023
Plasma medicine is a critical and specialized field within healthcare, centering on the use of human plasma for the development and administration of life-saving treatments. Human plasma, the clear, liquid portion of blood, is composed of water, electrolytes, nutrients and crucial proteins such as antibodies, clotting factors and albumin. These components make plasma an invaluable resource for treating various medical conditions, especially those that are rare and chronic.
Fierce Pharma
DECEMBER 15, 2023
Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. | Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor.
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