Bio Pharma Dive
FEBRUARY 17, 2023
Apellis’ Syfovre is the first marketed treatment for geographic atrophy, a common and irreversible eye condition. But questions linger about its benefit and safety.
Pharmaceutical Technology
FEBRUARY 17, 2023
Oncology-focused bioinformatics firm M2GEN has entered a multi-year strategic collaboration with Zephyr AI to identify treatments and cures for cancer patients. The collaboration will expedite the discovery of drugs and expand the use of investigations for cancer treatments. It will use the machine learning platform from Zephyr AI and a real-world data set (RWD) from M2GEN for creating an oncology discovery product.
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Bio Pharma Dive
FEBRUARY 17, 2023
Violations of study standards by a “third-party clinical trial site operator” prompted the partners to stop evaluating a large portion of the volunteers in their trial, the largest test of a Lyme disease vaccine in decades.
Pharmaceutical Technology
FEBRUARY 17, 2023
Capricor Therapeutics and Japanese pharmaceutical firm Nippon Shinyaku have entered a collaboration for exclusively commercialising and distributing the former’s CAP-1002 to treat duchenne muscular dystrophy (DMD) in Japan. The latest move follows an exclusive distribution deal signed by the companies for CAP-1002 in the US in January last year. Under the new partnership deal, Nippon Shinyaku will have exclusive rights to commercialise and distribute the Capricor’s lead asset in Japan once appro
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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 17, 2023
Shaw, who joined Gilead in 2019 from Eli Lilly, helped build Kite into a leading producer of cell therapies, convincing Wall Street skeptics in the process.
Medical Xpress
FEBRUARY 17, 2023
Physicians routinely prescribe an infusion containing gadolinium to enhance MRI scans, but there is evidence that nanoparticles of the toxic rare earth metal infiltrate kidney cells, sometimes triggering severe side effects, University of New Mexico researchers have found.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
FEBRUARY 17, 2023
One day last fall, Kiran’s period cramps became so painful they woke her up from a nap. The 19-year-old took some ibuprofen, but found little relief. “The pain was so bad, it felt like someone was punching me,” said Kiran, who asked to be referred to by only her first name for privacy. It felt “like I was giving birth.
Bio Pharma Dive
FEBRUARY 17, 2023
The company’s shot sparked a strong enough immune response against only one of two groups of influenza strains it was tested against in a closely watched Phase 3 trial.
NPR Health - Shots
FEBRUARY 17, 2023
For decades researchers have struggled to find a contraceptive methods for males. A new fast-acting compound shows promise — assuming it turns out to work as well in men as in mice.
Medical Xpress
FEBRUARY 17, 2023
Transcendental Meditation (TM) is a viable and effective intervention to decrease burnout and depression among academic physicians, according to a study published online Jan. 26 in the Journal of Continuing Education in the Health Professions.
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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 17, 2023
Willis family announced Thursday that his previous diagnosis of aphasia has progressed to frontotemporal dementia. The disease can cause issues with speaking and writing.
STAT News
FEBRUARY 17, 2023
A recent study of medical error published in The New England Journal of Medicine reached a shocking conclusion about patient safety: Nearly a quarter century after a highly publicized Institute of Medicine report on the prevalence of patient harm sparked vows to cut the rate by half in five years , “in-hospital adverse events” remain so common that they affect roughly one in four patients.
NPR Health - Shots
FEBRUARY 17, 2023
They came to tell Congress about their "recovery plan" for physicians, which includes a Medicare pay boost and an end to some frustrating insurance company requirements.
STAT News
FEBRUARY 17, 2023
The Food and Drug Administration approved on Friday the first treatment for geographic atrophy, a progressive eye disease and a leading cause of blindness in older people. The new drug, called Syfovre, is made by Apellis Pharmaceuticals.
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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 17, 2023
Marburg virus is hard to detect early on--and goes on to kill about half its victims. Researchers hope to work quickly during this outbreak to make progress on emerging vaccines and treatments.
STAT News
FEBRUARY 17, 2023
Pfizer and partner Valneva are scrapping data from roughly half of the participants in a Phase 3 trial of a Lyme disease vaccine candidate after uncovering quality issues with a third-party clinical trial operator. The companies disclosed Friday that violations of Good Clinical Practice, the international ethical and quality standards used by all clinical researchers, had been found at sites run by an undisclosed trial operator, leading Pfizer and Valneva to drop trial participants at those loca
Medical Xpress
FEBRUARY 17, 2023
Asking patients to take a short survey on a tablet before their appointments may help mental health providers identify young people at risk of psychosis. A UC Davis Health study found that when patients took a 21-question pre-visit survey, more than twice as many were identified at risk of psychosis compared to those who did not complete the survey.
STAT News
FEBRUARY 17, 2023
The federal government needs to boost its oversight of the institutional review boards that approve scientific studies and protect clinical trial participants, especially since more for-profit companies are taking running these reviews, a report from a government watchdog warns. Also known as ethics committees, institutional review boards occupy a crucial, but behind- the-scenes role in ensuring clinical studies are conducted properly.
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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.
Pharma Times
FEBRUARY 17, 2023
Research concerning candidate VLA15 has been discontinued across certain trial sites
STAT News
FEBRUARY 17, 2023
Nearly 31.2 million seniors and people with disabilities are now enrolled in a private Medicare plan, known as Medicare Advantage, according to new federal government data analyzed by STAT. That total is 7.1% higher than the 29.1 million people who had a Medicare Advantage plan in 2022. Although that annual growth rate is the lowest since 2016, the private plans now catch roughly half of the entire Medicare population.
Medical Xpress
FEBRUARY 17, 2023
Researchers at the National Institutes of Health and their colleagues have found that a toxic protein made by the body called DUX4 may be the cause of two very different rare genetic disorders. For patients who have facioscapulohumeral muscular dystrophy (FSHD), or a rare facial malformation called arhinia, this research discovery may eventually lead to therapies that can help people with these rare diseases.
STAT News
FEBRUARY 17, 2023
SAN DIEGO — Travere Therapeutics, a biotech focused both on treating rare diseases and distancing itself from controversial founder Martin Shkreli, on Friday won accelerated approval for a drug that treats IgA nephropathy, a rare and deadly autoimmune disease that attacks the kidneys and can lead to organ failure. The drug, which will be sold under the name Filspari, is a once-a-day oral tablet that comes in 200-milligram and 400-milligram doses.
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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 17, 2023
A team at UNC Charlotte's Center for Computational Intelligence to Predict Health and Environmental Risks (CIPHER) and Tuple, a Charlotte-based genomics consulting firm, has used artificial intelligence to rapidly assess the public health implications of the newly emergent SARS-CoV-2 XBB.1.5 variant. Results from simulations run by the team indicate the antibodies currently in our arsenal are effective to neutralize SARS-CoV-2 XBB.1.5.
STAT News
FEBRUARY 17, 2023
The shortage of health care workers in Maine, where I live and work, is a harbinger for the struggles the rest of the country will increasingly confront to hire and retain the individuals who make up the backbone of health care. Maine’s population is the oldest in the nation and is tied with Vermont as being the most rural state. Maine’s health care workers are also among the oldest in the country, with many practitioners approaching or even exceeding retirement age.
Medical Xpress
FEBRUARY 17, 2023
A unique collaboration between imaging science, vascular medicine and rehabilitation at Vanderbilt University Medical Center is transforming the diagnosis and treatment of lipedema, a debilitating, abnormal deposition of fatty tissue that afflicts an estimated 17 million women in the United States.
STAT News
FEBRUARY 17, 2023
Last week there was a change at the top of PhRMA, the trade group representing the drug industry. Novartis CEO Vas Narasimhan became the chair of the board of directors. Narasimhan has been CEO of Novartis since 2018. He sat down with STAT to discuss the industry’s struggles in Washington, the future of Novartis, and whether the deflated biotech sector is still a little overvalued.
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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 17, 2023
A new study has found that people with a university degree were less likely to believe in COVID-19 misinformation and more likely to trust preventive measures than those without a degree.
STAT News
FEBRUARY 17, 2023
The Inflation Reduction Act of 2022 , which includes provisions requiring Medicare to negotiate lower drug prices for some of the United States’ most costly drugs, marks the first time in decades that the pharmaceutical industry has lost a major policy battle. So, as expected, drug corporations are attacking the new law. The industry’s latest red herring ?
Medical Xpress
FEBRUARY 17, 2023
An imaging process that today is used mainly in research labs could potentially detect early-stage lung disease if developed for use in hospitals and clinics, a new research study shows.
STAT News
FEBRUARY 17, 2023
Ginkgo Bioworks CEO Jason Kelly has spent much of the last decade talking to almost anyone who will listen — investors, journalists, TV presenters, congressional committees — about the importance of biotechnology to the future of, well, just about everything. This year, Kelly will have a chance to advocate more formally. In December, he was named chairman of a new 12-person congressional commission tasked with issuing a set of policy recommendations for how the U.S. governmen
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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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