Bio Pharma Dive
FEBRUARY 7, 2023
The health insurer’s national formulary considers Amylyx Pharmaceuticals’ Relyvrio to be "experimental, investigational or unproven for any use,” and now does not recommend covering it.
Pharmaceutical Technology
FEBRUARY 7, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes.
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Bio Pharma Dive
FEBRUARY 7, 2023
The company said the experimental injection matched Soliris in a Phase 3 study and would soon be submitted to regulators around the world.
Pharmaceutical Technology
FEBRUARY 7, 2023
The European Commission (EC) has granted approval for AstraZeneca ’s Forxiga (dapagliflozin), a first-in-class, oral, once-daily SGLT2 inhibitor, to treat symptomatic chronic heart failure (HF). Forxiga has received approval in the EU to extend the indication for HF with reduced ejection fraction (HFrEF). It will now include patients across the complete spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).
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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 7, 2023
The reported reorganization of J&J’s infectious disease division leaves the fate of Arrowhead's multibillion-dollar partnership with the big drugmaker unclear.
Pharmaceutical Technology
FEBRUARY 7, 2023
Australia’s Therapeutic Goods Administration (TGA) has granted approval for Vifor Fresenius Medical Care Renal Pharma’s (VFMCRP) Tavneos (avacopan) along with a rituximab or cyclophosphamide-based regimen to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The orally administered small molecule Tavneos is a selective inhibitor of the complement C5a receptor C5aR1.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
FEBRUARY 7, 2023
The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. Denosumab will be used to treat several conditions, including osteoporosis in postmenopausal women and in men with high fractures risk, treatment-induced bone loss. The BLA covers all indications which are covered by Prolia (denosumab) and Xgeva (denosumab) reference medicines.
Medical Xpress
FEBRUARY 7, 2023
The short-term effects of vaporized cannabis do not differ between adolescents and adults, while cannabidiol (CBD) does not dampen the effects of the drug, finds a new study led by UCL and King's College London researchers.
Rethinking Clinical Trials
FEBRUARY 7, 2023
The US Food and Drug Administration last week issued draft guidance for the use of “externally controlled clinical trials” to provide evidence of the safety and effectiveness of drugs and biologics. An externally controlled trial uses patient-level data from a source outside the clinical trial—such as a registry, electronic health records, or administrative claims data—to provide a historical or concurrent control group for the study.
STAT News
FEBRUARY 7, 2023
In a setback to the pharmaceutical industry, a federal judge has tossed a lawsuit that sought to prevent state governments from importing medicines from Canada. The decision is likely to embolden more states to now consider the approach as they look to lower the cost of prescription drugs In a 26-page opinion , U.S. District Court Judge Timothy Kelly ruled that drug companies failed to prove they would face a “concrete risk of harm” from a federal rule that would allow states to im
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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
NPR Health - Shots
FEBRUARY 7, 2023
"This is an awful situation that has caused unnecessary trauma for the impacted resident and her loved ones," the New York attorney general's office told NPR.
STAT News
FEBRUARY 7, 2023
From the color of our eyes to our odds of developing cancer, we’re all shaped by the genetic legacy of our ancestors. But a new study in mice provides the clearest evidence yet that acquired traits can be passed down from one generation to the next in mammals without DNA changes, challenging centuries of evolutionary dogma and raising fresh questions about the factors that affect our health.
NPR Health - Shots
FEBRUARY 7, 2023
Hispanic patients had a 40% higher risk of staph than white patients, a study found, and black patients are more at risk as well. The report outlines steps doctors can take to keep patients safer.
STAT News
FEBRUARY 7, 2023
A bipartisan group of senators fiercely criticized several prominent telehealth startups for failing to protect sensitive health information, citing an investigation by STAT and The Markup which found dozens of telehealth companies sharing patient data with Facebook, Google and other major advertising platforms. “This data is extremely personal, and it can be used to target advertisements for services that may be unnecessary or potentially harmful physically, psychologically, or emotional
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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
FEBRUARY 7, 2023
A growing hospital movement aims to improve health outcomes of homeless patients with what might be considered the ultimate preventive care: providing them with a home.
Fierce Pharma
FEBRUARY 7, 2023
Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics fkansteiner Tue, 02/07/2023 - 10:08
Medical Xpress
FEBRUARY 7, 2023
For the first time, a team of researchers has observed changes in how different parts of the brain interact with each other after a person's body is immersed in cold water. The findings explain why people often feel more upbeat and alert after swimming outside or taking cold baths.
STAT News
FEBRUARY 7, 2023
In a bid to expand access to pricey cystic fibrosis treatments, a coalition of families and activists are petitioning four governments — South Africa, India, Brazil, and Ukraine — to make it possible to obtain generic versions of a medicine sold by Vertex Pharmaceuticals. And the coordinated effort underscores the growing global battle over equal access to medicines.
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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.
Medical Xpress
FEBRUARY 7, 2023
Intuitively, people commonly believe that making music is good for their mental health. Music therapies also rely on a positive influence of music on mental health problems. However, compared to musically inactive people, musicians more often seem to suffer from depression and anxiety disorders. How can this be explained?
STAT News
FEBRUARY 7, 2023
Complete Genomics, a U.S. firm affiliated with Chinese sequencing giant BGI, on Tuesday announced plans to launch a new line of sequencers it says can decode DNA in larger amounts — and at lower costs — than any instrument on the market. The company claims the sequencer, dubbed DNBSEQ-T20, can read up to 50,000 human genomes a year, 2.5 times the max output of a line of new high-end sequencers that Illumina , the market leader, recently launched.
FDA Law Blog
FEBRUARY 7, 2023
By Adrienne R. Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. For founders new to the medical device industry, especially with device types that are often considered novel, the learning curve can be steep.
STAT News
FEBRUARY 7, 2023
Like so many health care workers, I have seriously considered giving up my clinical practice multiple times — even more since the onset of the pandemic. For me, wanting to bail out of my job as a primary care physician has nothing to do with the risk of contracting Covid-19 or any other communicable disease. The real reason is best summarized by the unimaginably annoying Lamb Chop’s Play-Along Song.
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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.
Medical Xpress
FEBRUARY 7, 2023
Dopamine is a neurotransmitter that's made in the brain and acts as a chemical messenger, communicating between nerve cells in the brain and the rest of the body. Dopamine can impact how people think and feel. While it's most often associated with being a "feel-good" hormone, its role in functions such as movement, cognition and learning is an area of current research.
STAT News
FEBRUARY 7, 2023
Major advances in the study and treatment of rare diseases occurred in 2022, from a better understanding of just how many of these diseases exist to the start of new clinical trials that may lead to new therapies. For the last decade or so, the number of accepted rare diseases has stood between 7,000 and 8,000, though the number had been ticking up.
Medical Xpress
FEBRUARY 7, 2023
Engineers at the University of Waterloo have developed artificial intelligence (AI) technology to predict if women with breast cancer would benefit from chemotherapy prior to surgery.
STAT News
FEBRUARY 7, 2023
WASHINGTON — President Biden strived with Tuesday night’s State of the Union address to find a plank of bipartisan support in a split Congress, with health care priorities holding up the frame. The president, halfway through his term, pointed to a slew of populist policies he still hopes Congress could achieve, from battling the addiction crisis to improving mental health care access and bolstering support for at-home caregivers.
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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.
Medical Xpress
FEBRUARY 7, 2023
Commonly used systems to identify sepsis fail to detect many cases in patients initially admitted to hospital for severe traumatic injuries, researchers at the University of Washington School of Medicine in Seattle have found.
STAT News
FEBRUARY 7, 2023
Kathy High, a scientist and executive who led the development of the first gene therapy approved in the U.S., has left Bayer subsidiary AskBio two years after joining. An AskBio spokesperson confirmed her departure, adding in an email that High “decided to leave AskBio to begin a sabbatical at Rockefeller University and spend more time with her family, before focusing on ventures in new spaces.
Medical Xpress
FEBRUARY 7, 2023
Oregon Health & Science University researchers measured wide differences among U.S. states in the number of people who turn to hospital emergency departments for treatment of mental health conditions through Medicaid, highlighting the lack of suitable care in many states.
STAT News
FEBRUARY 7, 2023
Rise and shine, another busy day is on the way. We can tell because the official mascot got an early start chasing down cats, squirrels, and other creatures darting about the Pharmalot campus. And then there is the noisy parade of vehicles passing nearby on their way to who knows what? As for us, you guessed it, we are firing up the trusty coffee kettle to brew cups of stimulation.
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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.
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