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In an invited commentary published this month in Circulation: Cardiovascular Quality and Outcomes , authors from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core describe the recurring and emerging ethical issues in pragmatic clinical trials. Coauthors Caleigh Propes, Stephanie Morain, and Pearl O’Rourke discuss 3 key challenges facing pragmatic trials researchers: waivers and alterations of informed consent and their implications for transparency managing and resp
Ultra long, thick eyelashes might be in vogue but are they worth the expense – and the risk to health? Our natural eyelashes perform important functions. The eye is exposed to the elements so it’s a window for bacteria and viruses to enter the body – potentially causing death.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Over the last two years, Sahyadri Hospitals in Pune has observed a troubling trend of increase in cases of pulmonary embolism (PE) associated with long-haul international travel. This insight comes after the successful treatment of 17 PE cases through mechanical thrombectomy at the hospital—a procedure chosen for its efficacy when traditional clot-dissolving medications are unsuitable.
The drug, a rival to Sanofi and AstraZeneca’s fast-selling Beyfortus, met its main goals in a Phase 3 trial. But undisclosed study results leave its full potential unclear.
The US government will not give bluebird bio the opportunity to offer fertility support to patients covered by federal insurance programmes like Medicaid.
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
Former Welsh rugby union captain Alum Wyn Jones is the face of a new awareness campaign launching in the UK today to draw attention to atrial fibrillation (AF), an irregular and potentially life-threatening heart rhythm abnormality.
Irina Spirieva, from Besins Healthcare, answers 12 intriguing questions about her journey in the healthcare industry. Learn more about her experiences and insights.
Agilent has boosted its contract development and manufacturing organisation (CDMO) capacity with a $925 million deal to buy Biovectra, a Canadian provider of fill-and-finish services and active pharmaceutical ingredients (APIs).It's a statement of intent from Agilent, whose primary business is lab instrumentation and equipment, suggesting that it intends to grow the outsourcing side of its business, which is currently focused on the production of oligonucleotide and peptide medicines.
By Adrienne R. Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. EPRs were usually requested in the context of design controls, although 21 C.F.R. § 820.30 does not use this term.
GSK has challenged Gilead's HIV behemoth Biktarvy, presenting data that its competing therapy Dovato is equally effective and associated with less weight gain.
Google has announced that it will not proceed with its initial plan – previously covered in this POV – to phase out third-party cookies on Chrome. Instead, Google will maintain the use of third-party cookies for those who do not disable them. This decision marks a shift from its previous strategy, which was aimed at enhancing user privacy while preserving advertising effectiveness.
Ionis plans phase 3 trial of its antisense therapy for Angelman syndrome, shortly after Biogen decided against exercising an option to license the drug
The contract development and manufacturing organization (CDMO) arm of the Israeli company Pluri will deploy automated and 3D cell expansion technology to produce cell therapies developed by compatriot firm Kadimastem.
AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.
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.
Dr. Antonella Favit-VanPelt, a distinguished neurologist, has had a lifelong passion for understanding the 'why' behind sickness, ignited by her childhood curiosity.
After making major manufacturing outlays in places like China and the United States earlier this year, Novo Nordisk is returning to its Danish roots. | Earlier this month, Novo Nordisk purchased a 200-acre site in Odense, Denmark’s third largest city, the company has confirmed. Novo is now set to kick off preparatory excavation work for a potential new production plant.
As a strategic brand consultant at ramarketing, Laura Childs combines her extensive background in clinical research with strategic leadership and creative expression.
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
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