Bio Pharma Dive
JANUARY 24, 2023
The agency plans to convene a panel of experts on March 22 to discuss the approval application for tofersen, a closely watched medicine Biogen submitted to the FDA despite its failure in a key clinical trial.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 24, 2023
People asking for exercise advice are usually looking for a simple answer. Do this over that. Do this many of that thing, for this long. Get these gains. In reality, things are never that simple. That’s certainly true for the age-old question of how often one should change up one’s exercise routine.
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Bio Pharma Dive
JANUARY 24, 2023
The drugmaker reported fourth quarter revenue that fell short of forecasts, but reiterated confidence in reaching a $60 billion pharmaceutical sales goal.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 24, 2023
Exports of Ayush related products from the country have gone up around 53 per cent in five years from the financial year 2016-17 to 2020-21, according to the Ministry of Ayush.
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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
JANUARY 24, 2023
The company blamed a range of factors in its decision, including limited funding, slower-than-anticipated trial enrollment and “broader sector trends.
Pharma Mirror
JANUARY 24, 2023
Belgium team to expand under Country Manager, Dr Pierre-Hervé Brun, providing CNS treatments to patients Brussels and Düsseldorf – Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announces the establishment of Neuraxpharm Belgium to cover Belgium and Luxembourg, completing its presence in Benelux as it continues its expansion pathway in Europe.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Mirror
JANUARY 24, 2023
Science-based innovation for manufacturing high quality cells challenges dogma and terminology Cell and gene therapies are dominating the world of drug development. With the promise of significant breakthroughs in treatment of diabetes, cancer, and congenital conditions, it is no wonder that research and development is predicted to reach $232.5 billion by 2026, up from $186 billion in 2019 according to the Evaluate Pharma report.
Rethinking Clinical Trials
JANUARY 24, 2023
Dr. Shruti Gohil The INSPIRE Demonstration Project went live this month, with a new order entry screen being activated in the electronic health record at 51 hospital sites randomized to the intervention. Congratulations to lead investigator Dr. Shruti Gohil, co–principal investigators Dr. Susan Huang and Dr. Richard Platt, and the INSPIRE team! INSPIRE is studying the effectiveness of a personalized clinical decision support program in improving antibiotic prescribing for non–critically ill pat
Pharmaceutical Technology
JANUARY 24, 2023
Novartis division Sandoz has entered an agreement to buy the global product rights for the antifungal agent Mycamine (micafungin sodium) from Japanese company Astellas Pharma. Under the agreement, Astellas Pharma will receive an upfront of $62.5m to 75m depending on the transaction closing date, along with milestone payments based on sales. Sandoz will have the rights to sell the product globally after the deal’s completion.
NPR Health - Shots
JANUARY 24, 2023
Since early in the pandemic, people on Medicaid have been able to stay enrolled without reapplying. That will change in April and millions of eligible people will lose the coverage.
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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
Pharmaceutical Technology
JANUARY 24, 2023
BioCryst Pharmaceuticals is collaborating with Swixx BioPharma for Orladeyo (berotralstat) commercialisation in Central and Eastern Europe (CEE). Under the deal, Swixx BioPharma will handle the commercialisation activities of oral therapy in 15 CEE markets. The plasma kallikrein inhibitor Orladeyo has been specifically designed to prevent hereditary angioedema (HAE) attacks in adult and paediatric patients aged 12 years and above.
Medical Xpress
JANUARY 24, 2023
Recreational running offers a lot of physical and mental health benefits—but some people can develop exercise dependence, a form of addiction to physical activity which can cause health issues. Shockingly, signs of exercise dependence are common even in recreational runners. A study published in Frontiers in Psychology investigated whether the concept of escapism can help us understand the relationship between running, well-being, and exercise dependence.
STAT News
JANUARY 24, 2023
The claims have become almost ubiquitous. Hospital CEO after hospital CEO stands at a podium and promises the merger being announced will improve quality and lower costs. Once deals close, though, there tends to be little, if any, follow-up to determine whether those things actually happened. A new Journal of the American Medical Association study adds to the growing body of evidence that they don’t.
Medical Xpress
JANUARY 24, 2023
A team of researchers at the University of Vienna has found evidence showing that listening to music when stressed can boost a person's mood and help them relax. In their paper published on the JAMA Network Open site, the group describes an experiment they conducted with volunteers under stress caused by living under the rules of the lockdown during the early days of the global pandemic.
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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.
STAT News
JANUARY 24, 2023
Cassava Sciences had long claimed that its experimental treatment for Alzheimer’s disease was capable of improving the cognition of patients — a benefit no other Alzheimer’s drug has ever shown. But mid-stage study results updated on Tuesday now show the cognitive status of patients worsening to the point where Cassava’s drug, called simufilam, doesn’t look any more effective than a placebo.
Outsourcing Pharma
JANUARY 24, 2023
Research emerging from the University of Toronto found that using machine learning models was able to guide the design of long-acting drug formulations.
STAT News
JANUARY 24, 2023
Emily was combing her baby daughter’s hair when she first felt the lumps. It was a week before Christmas, and her youngest daughter, Isadora, had been feverish and listless, unwilling to play or take a bottle. The lumps were clustered on the back of Isadora’s neck, the size of small beans. Something was very wrong. At an urgent care clinic, the doctor found more lumps under Isadora’s arms and in her groin.
Medical Xpress
JANUARY 24, 2023
The orbitofrontal cortex (OFC) is a region in the frontal lobe of the brain known to be involved in decision-making and information processing. The lateral part of this brain region, known as the lOFC, has been identified as a particularly salient region for the creation of so-called "cognitive maps.
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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.
STAT News
JANUARY 24, 2023
It was the summer of 2020, and she couldn’t have scripted a better start as a new M.D.-Ph.D. student — at least until everything went so very wrong. She’d just been admitted to Washington University in St. Louis. And for a young trainee fascinated with the complex crosstalk between the immune and nervous systems, she’d struck scientific gold — the chance to work in one of the world’s top neuro-immunology labs.
Medical Xpress
JANUARY 24, 2023
Herzliya-2023, Prof. Ruth Feldman, director of the Center for Developmental Social Neuroscience at Reichman University's Baruch Ivcher School of Psychology, together with her research partners, examined whether it is possible to build an intervention for teenagers from polarized groups in a society that has experienced multigenerational conflict, based on findings from the field of neuroscience.
STAT News
JANUARY 24, 2023
When a patient is suffering from depression and considering medication, practically all physicians have the same go-to treatment: a selective serotonin reuptake inhibitor. Patients start on a low dose and slowly increase it. It may take weeks for the drug to work, if it works. If not, a cycle begins. Wean off the SSRI, wean onto a new medication. All the while, the patient must manage depressive symptoms along with any side effects of a medication, which, counterintuitively, can include suicidal
pharmaphorum
JANUARY 24, 2023
In this final instalment of IQVIA EMEA Thought Leadership’s Nine for 2023 three-part series, focusing on issues that will change the direction of healthcare and the pharmaceutical industry this year, three key competitive issues for pharmaceutical companies in 2023 are assessed. 1. Competing for attention: Bandwidth stress Healthcare systems will continue to be hugely stretched in 2023, and that limits the engagement that pharmaceutical companies have with healthcare professionals to promote the
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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.
STAT News
JANUARY 24, 2023
Should we pity the “poor historians” — the individuals or family members who can’t give a clear accounting of their illness or symptoms — or embrace them? They have important stories to offer their clinicians, but can’t tell them. Who is really to blame here? And should the term poor historian ever be part of an individual’s permanent record?
Medical Xpress
JANUARY 24, 2023
A team of researchers at the University of Victoria, working with a colleague from York University, both in Canada, has found that going for a short walk outdoors provides people with more mental health benefits than going for a same-length walk inside. In their study, published in the journal Scientific Reports, the group asked volunteers to walk indoors or outdoors and tested them before and after their walk.
STAT News
JANUARY 24, 2023
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BioPharma Reporter
JANUARY 24, 2023
In the US, 2022 heralded the next chapter for biosimilars, including US FDA approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation relating to biosimilars of more recent biologics.
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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.
STAT News
JANUARY 24, 2023
Amazon is launching a new prescription service that lets patients on Amazon Prime get eligible generic medications for a $5 monthly subscription, including free delivery. The program, called RxPass, is the latest addition to Amazon’s growing line of direct-to-consumer health care businesses. In November, the company announced the launch of Amazon Clinic, a telehealth service that lets patients message with a third-party provider to get prescriptions for common conditions.
Medical Xpress
JANUARY 24, 2023
About 13,200 men and another 2,300 women in the United States over age 50 are estimated to have VEXAS syndrome, according to a new study. Long considered a mystery illness until its genetic basis was identified in 2020, the latest findings, led by researchers at NYU Grossman School of Medicine, offer the first indication of how common the illness is domestically.
STAT News
JANUARY 24, 2023
For low-income patients, the challenges of pregnancy are only compounded by the challenges of prenatal care: the dozen or so doctors’ appointments, the time off work or childcare, the cost of parking and public transit. “Even just getting to appointments can be huge trouble,” said Kathryn Marko, an OB-GYN at George Washington, a Washington, D.C.
pharmaphorum
JANUARY 24, 2023
Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates. Recent years have brought a revolution to the way in which patients receive treatment.
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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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