Medicare names first 10 drugs for price negotiations
Bio Pharma Dive
AUGUST 29, 2023
The list includes the top-selling blood thinners Eliquis and Xarelto, as well as the arthritis drug Enbrel and heart failure medicine Entresto.
August, 2023
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Novo Nordisk acquires Embark and lead asset metabolic programme
Pharmaceutical Technology
AUGUST 31, 2023
Novo Nordisk has acquired Embark Biotech and its lead asset targeting obesity and other cardiometabolic diseases.
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Does Drinking Lots of Water Help You Lose Weight? An Expert Explains.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 31, 2023
It’s often claimed that if you’re trying to lose weight, one of the things you should do each day is drink plenty of water – with some internet advice even suggesting this should be as much as a gallon (about 4.5 liters).
3 Key Takeaways from Psychedelic Science 2023
Worldwide Clinical Trials
AUGUST 10, 2023
As one of the more recent fields to emerge in the clinical space, psychedelics have gained significant traction as a potential treatment for various neuropsychiatric diseases. With so many exciting developments in the last few years, it’s critical for the psychedelic community to come together to reflect on our progress, share the latest discoveries, and discuss the future of psychedelic research.
Bridging Innovation & Patient Care: The Growing Role of AI
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!
August 22, 2023: Distributed Research Network Shares Opportunities and Challenges for Pragmatic Research Embedded in Health Insurance Plans
Rethinking Clinical Trials
AUGUST 22, 2023
In an article published this month in Clinical Trials , researchers from the NIH Pragmatic Trials Collaboratory’s Distributed Research Network share opportunities for conducting pragmatic trials embedded in health insurance plans. “There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensing
UCB announces approval of Bimzelx
Pharma Times
AUGUST 31, 2023
The therapy is used to treat patients with psoriatic arthritis and axial spondyloarthritis - News - PharmaTimes
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Clinical trials: How AI can help providers stay TMF inspection-ready
Pharmaceutical Technology
AUGUST 29, 2023
The clinical trials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits
Brain Autopsies Reveal Potential New Culprit Behind Alzheimer’s Disease
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 29, 2023
Analysis of human brain tissue reveals differences in how immune cells behave in the brains with Alzheimer’s disease compared to healthy brains, indicating a potential new treatment target.
9 Ways Worldwide Optimizes Clinical Development for Your Biotech Growth Journey
Worldwide Clinical Trials
AUGUST 15, 2023
Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. At Worldwide, we understand the significance of this collaboration and are dedicated to becoming an extension of your team, providing personalized clinical development solutions that align with your corporate objectives and milestones.
August 31, 2023: FDA’s Robert Califf and Coauthors Assert More Is Needed to Achieve Learning Health Care
Rethinking Clinical Trials
AUGUST 31, 2023
In an article published this month in the American Journal of Bioethics , FDA Commissioner Robert Califf and coauthors suggest that—despite the potential of embedded pragmatic research to generate information to improve clinical practice and public health policy—it is still relatively uncommon in US healthcare. “Simply stated, what we are currently doing does not work, and in the face of declining health status we lack answers to critical questions about what we should be doing in health care an
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
BenevolentAI doses participants in BEN-8744 study
Pharma Times
AUGUST 31, 2023
The candidate is a peripherally restricted small-molecule PDE10 inhibitor to treat ulcerative colitis - News - PharmaTimes
Bristol Myers gets key FDA approval for bone marrow disease drug
Bio Pharma Dive
AUGUST 29, 2023
A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.
EC grants approval to Merck’s Keytruda for gastric cancer
Pharmaceutical Technology
AUGUST 30, 2023
The EC has granted approval for Merck’s Keytruda regimen for gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Amazing Brain Implant Gives a Voice to People Who Couldn’t Speak For Years
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 27, 2023
There’s new hope for people who have lost their ability to speak. In two separate cases, scientists have successfully used brain implants and machine learning to give patients back their voice after theirs was taken; one by a stroke, the other a result of amyotrophic lateral sclerosis (ALS).
Why Including Patients in FDA Engagement Will Benefit Your Trial
Worldwide Clinical Trials
AUGUST 23, 2023
Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.
August 30, 2023: NIH Pragmatic Trials Collaboratory Welcomes New Demonstration Project: I CAN DO Surgical ACP
Rethinking Clinical Trials
AUGUST 30, 2023
We are excited to welcome I CAN DO Surgical ACP (Improving Completion, Accuracy, and Dissemination of Surgical Advanced Care Planning) to our portfolio of innovative Demonstration Projects. This project is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Institute on Aging (NIA). Despite advance care planning (ACP) being incorporated into national quality metrics and society guidelines for surgical care for older adults, effective integration of ACP into the p
Amid shortage, FDA clears several generics of Takeda's popular ADHD drug Vyvanse
Fierce Pharma
AUGUST 30, 2023
After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff. And the FDA's approval of several generics comes amid a U.S. shortage of the drug.
Sage, reeling from depression drug decision, to lay off 40% of workforce
Bio Pharma Dive
AUGUST 31, 2023
Two founding executives are leaving Sage alongside a major restructuring announced weeks after the FDA approved the medicine, Zurzuvae, for much narrower use than the company had hoped.
The New Age of Decentralized Clinical Trials
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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
Specialised Therapeutics partners with Treeway to license ALS drug
Pharmaceutical Technology
AUGUST 28, 2023
Specialised Therapeutics has entered into a licensing agreement with Treeway for TW001, designed for treating amyotrophic lateral sclerosis.
Can Drinking Coffee Save You From Sleep Deprivation? A Psychologist Explains
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 21, 2023
There is no denying the importance of sleep. Everyone feels better after a good night of sleep, and lack of sleep can have profoundly negative effects on both the body and the brain. So what can be done to substitute for a lack of sleep?
Prioritizing the Biotech Growth Journey in the CRO-Biotech Partnership
Worldwide Clinical Trials
AUGUST 15, 2023
Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. At Worldwide, we understand the significance of this collaboration and are dedicated to becoming an extension of your team, providing personalized clinical development solutions that align with your corporate objectives and milestones.
August 23, 2023: PCT Grand Rounds to Highlight a Pragmatic Trial of an EHR Display of Real-Time PRO Data
Rethinking Clinical Trials
AUGUST 23, 2023
In this Friday’s PCT Grand Rounds, Gabriela Schmajuk of the University of California, San Francisco, will present “Pragmatic Trial of an EHR Application to Display Real-Time PRO Data: Successes and Challenges.” The Grand Rounds session will be held on Friday, August 25, 2023, at 1:00 pm eastern. Schmajuk is a professor of medicine at UCSF and the chief of rheumatology at the San Francisco VA Health Care System.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Why participating in research can be a rewarding experience
Antidote
AUGUST 30, 2023
At the outset, many people may experience apprehension when considering joining a clinical trial. Opting to participate in a research study is a personal one — but it can also be quite gratifying. Various types of clinical studies play a pivotal role in ensuring the approval of life-saving medications and treatments. For this to happen, we need volunteers to take part.
Novo, continuing deal streak, buys another obesity drug startup
Bio Pharma Dive
AUGUST 30, 2023
The acquisition of Embark Biotech, which Novo helped found, gives the company another prospect to add to its arsenal of weight-loss medicines.
FDA shuns Outlook Therapeutics with wet AMD drug BLA rejection
Pharmaceutical Technology
AUGUST 30, 2023
Shares in the company tanked 80% following the FDA issued a CRL for its bevacizumab formulation.
Your Body Can Be ‘Younger’ Than You Are. Here’s How That’s Possible.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 22, 2023
The saying goes that money can’t buy you love. But can it buy you time? This is what US billionaire Bryan Johnson is hoping to find out. The 45-year-old reportedly spends millions each year in an attempt to reverse ageing and regain his 18-year-old body (presumably sans acne).
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.
Artificial intelligence: The prime mover in drug discovery
Bio Pharma Dive
AUGUST 28, 2023
With its ability to process vast amounts of data and identify patterns, AI can significantly reduce the time and cost involved in developing new drugs.
Bayer reports positive early data for Parkinson’s cell therapy
Bio Pharma Dive
AUGUST 28, 2023
The treatment, developed by a biotech Bayer acquired in 2019, appeared safe in a small trial and showed signs of an effect on disease progression.
Superluminal draws RA Capital, Nvidia as investors in GPCR drug hunt
Bio Pharma Dive
AUGUST 28, 2023
GPCRs, a ubiquitous family of proteins that are prime drug targets, have drawn the interest of companies like Structure Therapeutics, Septerna and now Superluminal Medicines.
Neumora, a richly funded brain drug developer, readies for an IPO
Bio Pharma Dive
AUGUST 25, 2023
Neumora’s filing late Friday, along with that of radiopharmaceutical startup RayzeBio earlier this week, could be an important test of the biotech IPO market.
2022 Research: The Rapid Rise of Ocean Freight Visibility
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.
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