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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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.
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
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
Experimental Alzheimer’s Vaccine Shown to Delay Symptoms in Mice
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 3, 2023
An experimental vaccine that aims to slow down or prevent the progression of Alzheimer’s disease has been trialed in mice with promising early results. Mice engineered with genes that put them at greater risk of an Alzheimer’s-like disease had fewer amyloid plaques following the vaccine.
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.
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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
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
AI May Be Able to Warn Us Before The Next Pandemic Strikes
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 10, 2023
The global COVID-19 pandemic has shown us just how devastating these outbreaks can be – and it could have been much worse. Now, scientists have developed an AI application that promises to warn us about dangerous variants in future pandemics.
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.
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.
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.
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
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
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).
FDA turns down Outlook's ophthalmic version of Roche's Avastin over manufacturing, data shortfalls
Fierce Pharma
AUGUST 30, 2023
Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. | Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Outlook Therapeutics has been trying to get an official approval for a reformulated version, but instead got a rejection letter.
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.
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.
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.
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.
We Just Got An Unprecedented Look At The Details of Cell Division
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 15, 2023
By replacing fluorescent molecules in an existing imaging process with ones that instead scatter light, researchers have revealed a whole new level of dazzling details within our living cells. The innovative tweak will allow scientists to directly observe molecular behavior over a much longer period, opening a window onto pivotal biological processes like cell division.
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.
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.
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.
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.
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.
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.
AstraZeneca scores its second paediatric approval for Soliris in Japan
Pharmaceutical Technology
AUGUST 25, 2023
Soliris is already approved to treat refractory generalised myasthenia gravis in adults in different regions.
Pfizer’s first-ever bispecific antibody Elrexfio holds promise in multiple myeloma
Pharmaceutical Technology
AUGUST 25, 2023
The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
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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