Bio Pharma Dive
JANUARY 20, 2023
The drugmaker had sought an accelerated approval based on promising data from a small mid-stage trial. Results from a larger study are due in the second quarter.
Pharmaceutical Technology
JANUARY 20, 2023
This week, at the World Economic Forum Annual Meeting, Moderna CEO Stéphane Bancel, said the company plans to build on its exponential growth through the pandemic by expanding its operations globally over the next few years. In 2020, Moderna made a net loss of $747 million while its investigational mRNA vaccines were under development. However, during the Covid-19 pandemic, the US-based biotech rose to prominence as it was one of the first companies to develop Covid-19 vaccines with its mRNA tec
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
JANUARY 20, 2023
Analysts argue the FDA’s choice to decline accelerated approval for donanemab, while surprising, is not the main factor that will determine whether it eventually becomes a commercial success.
Pharmaceutical Technology
JANUARY 20, 2023
BeiGene has received marketing authorisations for Brukinsa (zanubrutinib) in Great Britain from the Medicines and Healthcare products Regulatory Agency (MHRA) to treat chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL). Brukinsa has been approved to treat CLL and MZL in adult patients who have previously received a minimum of one anti-CD20-based therapy.
Advertisement
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
JANUARY 20, 2023
The regulator’s decision ends a seven-month study pause that followed a report of one participant experiencing mild symptoms of peripheral neuropathy.
STAT News
JANUARY 20, 2023
In December, delegates from more than 180 countries met in Switzerland to discuss the International Treaty for Pandemic Prevention, Preparedness, and Response, which had initially been proposed in December 2021. Support for it gained traction as the Covid-19 pandemic highlighted concerns about global vaccine inequity, genomic data-sharing, and more.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
JANUARY 20, 2023
The onset of the Covid-19 pandemic led to a sea change in addiction medicine — in particular, increased access to buprenorphine , a drug commonly used to treat opioid use disorder. Now, new data show that despite the medication’s wider availability, deaths involving buprenorphine still constitute a small fraction of overall drug mortality.
NPR Health - Shots
JANUARY 20, 2023
One of the world's poorest countries, Somalia is coping with conflict, a historic drought and a devastating food crisis. But there's another side to the country. Just take a look at the capital city.
Medical Xpress
JANUARY 20, 2023
Scientists have long sought to better understand the human body's immune responses that occur during various diseases, including cancer and inflammatory diseases.
STAT News
JANUARY 20, 2023
In an attempt to tackle the root causes of inflated insulin prices, the state of California filed a lawsuit last week accusing drug manufacturers and pharmacy benefit managers of artificially and illegally jacking up the price of insulin. The sausage-making of how insulin is priced is not for the faint of heart. It’s a complex tangle of drug manufacturers who’ve been resisting generics , health insurance companies trying to keep up impressive profits , plus the wholesalers who dist
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Fierce Pharma
JANUARY 20, 2023
JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets zbecker Fri, 01/20/2023 - 14:48
Medical Xpress
JANUARY 20, 2023
While the internet is remains agog over the new viral 'Butter Board' trend, snack board purists will remember the blueprint: the charcuterie board. Choc full of cheese, crackers, and occasionally a marmalade and some dark chocolate, the boards are a hallmark of book clubs and housewarmings alike.
Fierce Pharma
JANUARY 20, 2023
Martin Shkreli runs afoul of FTC for potentially skirting lifetime pharmaceutical industry ban fkansteiner Fri, 01/20/2023 - 15:34
Medical Xpress
JANUARY 20, 2023
The recent explosion in anti-LGBTQ rhetoric across the country is dramatically affecting LGBTQ youth—especially transgender and nonbinary kids and young adults—according to a poll released Thursday.
Advertisement
When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
NPR Health - Shots
JANUARY 20, 2023
Seven months after overturning the constitutional right to an abortion, anti-abortion rights activists are celebrating their victories and planning their next steps at their annual march in D.
Medical Xpress
JANUARY 20, 2023
The sport of orienteering, which draws on athleticism, navigational skills and memory, could be useful as an intervention or preventive measure to fight cognitive decline related to dementia, according to new research from McMaster University.
STAT News
JANUARY 20, 2023
The U.S. Federal Trade Commission asked a federal judge to hold “pharma bro” Martin Shkreli in contempt for failing to provide the agency with information needed to determine whether he is violating an order that permanently banned him from working in the pharmaceutical industry. In a motion filed federal court in New York, the FTC and seven state regulators argued that Shkreli has failed to comply with their requests to provide documents and sit for an interview as part of their i
Medical Xpress
JANUARY 20, 2023
The national uninsurance rate for adults under age 65 with schizophrenia decreased by 50% after the implementation of the Affordable Care Act (ACA) in 2014, according to University of Massachusetts Amherst research published this week in JAMA Psychiatry.
Advertisement
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.
STAT News
JANUARY 20, 2023
On Target is a recurring feature from STAT that dives deep into the most promising drug targets in oncology. This column is adapted from a new STAT report , “Targeting cancer: the new frontier of immunotherapy and precision oncology.” Scientists working to produce immunotherapies for solid tumor cancers have spent decades searching for biological targets that can help them distinguish between healthy cells and cancerous ones.
Medical Xpress
JANUARY 20, 2023
Contrary to popular belief, rest from school may not always be the best after a concussion, a new study published in JAMA Network Open finds. In fact, an early return to school is associated with a lower symptom burden after suffering a concussion and, ultimately, faster recovery.
STAT News
JANUARY 20, 2023
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still in the works. For now, we expect to engage in our usual ritual of promenading with the official mascot, take a drive in the countryside with the radio turned up, and hold another listening party with Mrs.
Medical Xpress
JANUARY 20, 2023
With the constant need for blood and platelet donations, frequent, regular blood donors are crucial to having a continuous national blood supply. Across Mayo Clinic in Rochester, for example, anywhere between 50 and 70 units of red cells and between 20 and 30 units of platelets are used daily to help save lives.
Advertisement
As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
STAT News
JANUARY 20, 2023
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
Medical Xpress
JANUARY 20, 2023
Scientists have discovered there is a "Goldilocks" effect in identifying the size of a "vaccine adjuvant" that can trigger strong immune responses and, as an example, have shown that a safe, biodegradable adjuvant can boost the action of cancer-killing cells—if the particles are the correct size.
Fierce Pharma
JANUARY 20, 2023
AbbVie jacks up Humira price by 8%, joining many other companies with January hikes: report kdunleavy Fri, 01/20/2023 - 10:06
Medical Xpress
JANUARY 20, 2023
Apple cider vinegar has become a popular home remedy in recent years and has been used for centuries in cooking and medicine. It's thought to help with a wide range of health issues, including high cholesterol, blood sugar levels, obesity and high blood pressure. It's also said to help with eczema and stomach acid reflux, but this has not been scientifically proven.
Advertisement
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.
Fierce Pharma
JANUARY 20, 2023
Ipsen's Onivyde proves its worth in aggressive pancreatic cancer zbecker Fri, 01/20/2023 - 10:48
Medical Xpress
JANUARY 20, 2023
One-fifth of U.S. kids have obesity, and many have related conditions such as high blood pressure, type 2 diabetes and high cholesterol. Last week, the American Academy of Pediatrics released the first new clinical guidance in 15 years for treating obesity and overweight in children. We spoke with UCSF experts about their takeaways on the guidance.
NPR Health - Shots
JANUARY 20, 2023
Researchers estimate at least 65 million people worldwide have suffered from long COVID. NPR's Steve Inskeep talks to Dr. Eric Topol about a paper he co-authored on what we know about long COVID.
Medical Xpress
JANUARY 20, 2023
A protective mutation found in most cells in the human esophagus reduces tumor growth in mice, potentially highlighting new ways to prevent or treat cancer in similar tissues.
Advertisement
The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
Expert insights. Personalized for you.
325 
Let's personalize your content