Bio Pharma Dive
FEBRUARY 10, 2023
The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine.
Pharmaceutical Technology
FEBRUARY 10, 2023
4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310). 4DMT had paused enrollment of patients to two of its trials for 4D-310 last month following a significant adverse event where three patients experienced kidney issues; however, these were treated and resolved in a four-week period. 4DMT has stated that
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
FEBRUARY 10, 2023
CMS laid out how it plans to implement a key provision of the Inflation Reduction Act, which requires drugmakers to pay rebates on price hikes within Medicare that are greater than inflation.
Pharmaceutical Technology
FEBRUARY 10, 2023
On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world. This is not the first treatment to come with a high price tag.
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
FEBRUARY 10, 2023
The drugmaker converted Jemperli’s accelerated approval in endometrial cancer, while outside advisers endorsed its plan to study the Keytruda rival in rectal tumors.
Pharmaceutical Technology
FEBRUARY 10, 2023
AbbVie has reported full-year 2022 net revenues of $58.054bn, representing a 3.3% rise on a reported basis and 5.1% on an operational basis. The company reported an increase of 1.6% on a reported basis in global net revenues to $15.121bn for the fourth quarter (Q4) of 2022. For the full-year, worldwide net revenues from the Immunology portfolio stood at $28.924bn, increasing 14.4% on a reported basis.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
FEBRUARY 10, 2023
Takeda has concluded the previously announced acquisition of the complete shares of Nimbus Therapeutics’ tyrosine kinase 2 (TYK2) programme subsidiary Nimbus Lakshmi. The latest move comes following clearance from the United States Federal Trade Commission and after satisfaction of other conditions related to the deal closure. Takeda originally signed the acquisition agreement in December last year.
Medical Xpress
FEBRUARY 10, 2023
Researchers from The University of Queensland have discovered the active compound from an edible mushroom that boosts nerve growth and enhances memory.
NPR Health - Shots
FEBRUARY 10, 2023
In the hit HBO show, the world has been devastated by a pandemic caused by a deadly fungus. Is that even possible? Could the next pandemic come from fungi? Turns out it's a very real question.
STAT News
FEBRUARY 10, 2023
The American Heart Association has released its 2023 Statistical Update and the results are grim: In 2020, the first year of the Covid-19 pandemic, more people died from cardiovascular-related causes than ever before: a staggering 928,741 deaths. While there are many causes of this increase, one is the increased burden that Covid-19 wrought on individuals’ bodies and entire systems.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
NPR Health - Shots
FEBRUARY 10, 2023
Ten former players are suing the National Football League, claiming its doctors were biased and purposely gave them unfavorable reports so the NFL could justify not paying for disability benefits.
STAT News
FEBRUARY 10, 2023
The CAR-T cancer therapy called Abecma reduced the risk of multiple myeloma relapse by half compared to standard treatment, according to results of a Phase 3 clinical trial published Friday. The positive study outcome could lead to Abecma being used earlier in the course of treatment for patients with multiple myeloma, a type of blood cancer affecting cells in the bone marrow.
Medical Xpress
FEBRUARY 10, 2023
Alterations in the biochemical makeup of bulk plasma IgG, or Fc glycosylation, can predict COVID-19 disease severity and vaccine antibody response, according to a recent study by researchers at RUSH University and Northwestern. The results of the study were recently published in Cell Reports.
STAT News
FEBRUARY 10, 2023
Google and Facebook. Coca-Cola and Pepsi. Those tech and pop conglomerates are considered to be duopolists in their fields. But even they can’t hold a candle to hospitals’ market power. A recent financial filing from a large, tax-exempt hospital system in Orlando provides a glimpse, and serves as a reminder, of just how concentrated America’s hospital markets are.
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.
Medical Xpress
FEBRUARY 10, 2023
A large international clinical study finds that patients with large strokes had a dramatically better recovery after endovascular thrombectomy plus medical management than patients receiving only standard medical management.
STAT News
FEBRUARY 10, 2023
CVS Health’s acquisition of Oak Street Health , a Medicare-focused primary care provider, for $10.6 billion is just the latest in a string of primary care clinic buyouts by other retailers and insurance companies. Amazon, Walgreens Boots Alliance, and Cigna have already thrown their chips on the table, investing in or outright purchasing primary care clinic organizations.
Medical Xpress
FEBRUARY 10, 2023
Researchers have conducted one of the first studies to examine the effectiveness of nirmatrelvir-ritonavir (Paxlovid) in non-hospitalized patients during an omicron period of the COVID-19 pandemic that includes BA.4 and BA.5 subvariants.
STAT News
FEBRUARY 10, 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.
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.
XTalks
FEBRUARY 10, 2023
Food processing and packaging solutions company Tetra Pak is partnering with synchrotron radiation laboratory MAX IV to launch the next generation of food packaging: fiber based packaging. The duo will uncover new insights into the nanostructure of fiber materials, with the first application to optimize the composition of materials for use in paper straws.
Medical Xpress
FEBRUARY 10, 2023
Cancer is a disease driven by gene mutations. These mutated genes in cancer fall into two major categories: tumor suppressors and oncogenes. Mutations in tumor suppressor genes can allow tumors to grow unchecked—a case of no brakes—while mutations in oncogenes can activate cell proliferation, pushing the gas pedal all the way to the floor.
XTalks
FEBRUARY 10, 2023
The US Food and Drug Administration (FDA) has granted approval to Regeneron’s Eylea (aflibercept) injection for the treatment of preterm infants with retinopathy of prematurity (ROP). With the FDA nod for ROP, Eylea is now approved to treat five retinal conditions, which include macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy.
Medical Xpress
FEBRUARY 10, 2023
A Lancet Series published on Feb. 8, 2023, highlights the continuing struggle that women across the globe face to meet their breastfeeding goals. Yale School of Public Health Professor Rafael Pérez-Escamilla, a leading authority on breastfeeding and early childhood nutrition, is co-author of all three Series articles and the lead author of the first paper featured in the Series.
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.
Drug Channels
FEBRUARY 10, 2023
Today’s guest post comes from ConnectiveRx’s Lauren Cole, Senior VP of Launch Excellence at ConnectiveRx. Lauren outlines key success factors when transitioning or launching a patient hub. To learn more, join Lauren on April 4th at 1:00 p.m. ET for a free online panel discussion: Lessons from the Edge—Six Things That Can Make a Hub Launch Go Wrong. Lauren will also be exploring hub launch excellence at Informa Connect’s Hub and Specialty Pharmacy Models East conference on March 20-22.
Medical Xpress
FEBRUARY 10, 2023
For years, the sweeping physical and emotional midlife change that women undergo has been shunted to the shadowy corners of public view, and barely even discussed among friends.
Pharma Times
FEBRUARY 10, 2023
Collaboration has created method for heart failure patients to receive at-home treatment
Medical Xpress
FEBRUARY 10, 2023
Researchers at the National Institutes of Health have discovered a new neurological condition characterized by issues with motor coordination and speech. They report their findings in npj Genomic Medicine.
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.
Pharma Times
FEBRUARY 10, 2023
Study involves the treatment of adults with moderate-to-severe chronic hand eczema
Medical Xpress
FEBRUARY 10, 2023
There are harmful associations between long-term exposure to air pollution and an increased risk for late-life depression, according to a study published online Feb. 10 in JAMA Network Open.
NPR Health - Shots
FEBRUARY 10, 2023
NPR asked COVID-19 experts how we should keep weighing risk as we enter the fourth year of the pandemic.
Medical Xpress
FEBRUARY 10, 2023
In recent years, a mass spectrometry process that can detect the amounts of drugs in a biological sample, such as blood, has become a powerful diagnostic tool for helping medical professionals identify and monitor levels of therapeutic drugs in patients, which can cause unwanted or dangerous side effects.
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.
358 
Let's personalize your content