Bio Pharma Dive
NOVEMBER 10, 2022
Viehbacher, who ran Sanofi from 2008 to 2014, will take over as CEO on Nov. 14, more than six months after Biogen began its search for a new leader.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 10, 2022
For some years now, scientists have been investigating how psilocybin, the psychedelic compound in magic mushrooms, can ease the symptoms of depression. More evidence of the link has arrived with a phase 2, double-blind trial involving 233 participants, the largest study on this subject carried out so far in terms of sample size. The volunteers […].
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Bio Pharma Dive
NOVEMBER 10, 2022
The buzzy startup, which planned to undercut big pharma on price, also dropped plans to seek U.S. approval in lung cancer of an immunotherapy competitor to Keytruda.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 10, 2022
It’s 11 pm on a weeknight and your teenager still has their bedroom light on. You want them to get enough sleep for school the next day, but it’s a struggle. Our new research shows what happens to the brains and behavior of young teenagers, years after they’ve become “night owls” We found this shift […].
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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
NOVEMBER 10, 2022
The startup, which focused on biomolecular condensates, is calling it quits after “the science did not progress sufficiently to meet our bar for further investment,” a spokesperson said.
Pharmaceutical Technology
NOVEMBER 10, 2022
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Swedish Orphan Biovitrum AB ’s (Sobi) Kineret (anakinra) to treat Covid-19 in adult patients who are hospitalised with pneumonia. Kineret is indicated for such patients needing supplemental oxygen and are at increased risk of advancing to severe respiratory failure.
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Pharmaceutical Technology
NOVEMBER 10, 2022
NRG Therapeutics has raised Series A funds worth $18.3m (£16m) to progress the development of mitochondrial therapeutics to treat neurodegenerative ailments such as Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Led by Omega Funds, the financing round saw participation from new investor Brandon Capital and founding investor, The Parkinson’s Virtual Biotech. .
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 10, 2022
In a bid to bring down stillbirths to single digits by 2030, the Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, has taken an initiative to encourage collaborative, multi-center/multi-institutional interdisciplinary research to investigate and examine the issue of stillbirths and find appropriate antenatal […].
Pharmaceutical Technology
NOVEMBER 10, 2022
Royalty Pharma has purchased a royalty interest in Amgen ’s small interfering ribonucleic acid (siRNA) therapy, olpasiran, from Arrowhead Pharmaceuticals for an upfront payment of $250m in cash. Additionally, Royalty Pharma is entitled to receive further payments of up to $160m subject to meeting some clinical, regulatory and sales milestones. According to the deal, Royalty Pharma will acquire Arrowhead’s complete royalty interest in olpasiran, which amounts to a royalty of up to the low double
STAT News
NOVEMBER 10, 2022
The country is heading into its third Covid winter without crucial tools we’ve relied on at previous points in the pandemic, both as governments roll back their responses and as the virus outruns some of our most important medicine-cabinet defenses. Free at-home tests are no longer showing up at people’s doorsteps. States are reporting outbreak data less frequently, and globally, testing and surveillance programs have been curtailed.
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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
Medical Xpress
NOVEMBER 10, 2022
In recent years, genetically re-engineered immune cells—armed with molecular weaponry to recognize and destroy tumor cells—have changed the landscape of cancer treatment. Now, UC San Francisco researchers have developed a new method for comparing massive numbers of these CAR-T cells, each with slightly different molecular features, to determine which is most effective and long-lasting against cancer.
STAT News
NOVEMBER 10, 2022
SAN DIEGO — Rayyan Gorashi is keeping her options open. After all, she’s still a second-year bioengineering Ph.D. student at UC San Diego, and there are so many careers to explore. Patent law has been high up on her list ever since a class she took in college. There’s also regulatory affairs. Oh, and science publishing sounds interesting, too.
NPR Health - Shots
NOVEMBER 10, 2022
A listeria outbreak has led to 16 infections and one death across six states, with New York having the most cases. The CDC has not yet pinpointed specific products that could be causing the outbreak.
STAT News
NOVEMBER 10, 2022
Changing the way cancer drugs are priced in the U.S. is apparently even harder than it sounds. EQRx, a company founded to upend the costly U.S. system for pricing new drugs, said Thursday it would abandon that goal for the two products that are closest to the market.
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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
NOVEMBER 10, 2022
Montana voters rejected a referendum proponents said was necessary to protect survivors of botched abortions. Opponents called it redundant to infanticide laws already on the books.
Medical Xpress
NOVEMBER 10, 2022
Researchers at the University of Pennsylvania's Basser Center for BRCA at the Abramson Cancer Center have discovered factors that may make breast and ovarian cancers associated with BRCA1/2 gene mutations more likely to recur.
NPR Health - Shots
NOVEMBER 10, 2022
In Montana and across the nation, homeless shelters report the worrisome trend that seniors are a growing proportion of their residents.
STAT News
NOVEMBER 10, 2022
Longtime Sage Therapeutics executive Jeff Jonas is leaving the biotech company to launch a biotech incubator with global investment giant CBC Group. Sage announced this week that Jonas would leave the company to join a private equity firm. He has been part of the C-suite at Sage Therapeutics since 2013. He helped the company go public, build a pipeline of new antidepressants and other psychiatric medications, and sign a $1.5 billion deal with Biogen.
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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.
Fierce Pharma
NOVEMBER 10, 2022
AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments. aliu. Thu, 11/10/2022 - 09:02.
Medical Xpress
NOVEMBER 10, 2022
Healthier plant-based dietary patterns are associated with better environmental health, while less healthy plant-based dietary patterns, which are higher in foods like refined grains and sugar-sweetened beverages, require more cropland and fertilizer, according to a new study led by researchers at Harvard T.H. Chan School of Health and Brigham and Women's Hospital.
STAT News
NOVEMBER 10, 2022
Colorado looks set to legalize magic mushrooms in this week’s midterm elections, with the group opposing the ballot question conceding defeat. As of Thursday afternoon, Proposition 122 was passing with 51.4% of the vote, though the referendum is still too close to call officially, with 89% of the vote counted. Colorado would be the second state to legalize psychedelics, following Oregon’s 2020 passage of a similar ballot question.
Medical Xpress
NOVEMBER 10, 2022
The American Journal of Medicine has published an article recognizing the link between unhealthy lifestyle behaviors and the one million COVID-19 deaths in the United States. Dr. Carl "Chip" Lavie, Medical Director Cardiac Rehabilitation and Prevention at the John Ochsner Heart and Vascular Institute was a senior author on this manuscript.
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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
NOVEMBER 10, 2022
If you want to understand the fickleness of pregnancy and the American laws that regulate it, one place to start would be a gas station in Iowa City, where a 31-year-old sat in the passenger seat of a gray Hyundai, making frantic calls. Her name was Stephanie Dworak, it was September 2021, and she was 20 weeks and five days pregnant. She’d already looked into the abortion clinics in her home state of Nebraska.
NPR Health - Shots
NOVEMBER 10, 2022
Since the outbreak began in September, eight children have died — and there is no approved vaccine. But doctors are hopeful that public health measures may be enough to stop the spread.
STAT News
NOVEMBER 10, 2022
Read in English | Leer en inglés. H ARLINGEN, Texas — Aquí en el Valle del Río Grande casi todo el mundo conoce, o cuida, a alguien con demencia. No es ninguna sorpresa. La región presenta algunas de las tasas más altas de la enfermedad en el país. Pero lo que se aprecia menos es la enormidad de la carga que soportan los cuidadores, en su mayoría mexicano-americanos.
Medical Xpress
NOVEMBER 10, 2022
Researchers from Barts Cancer Institute at Queen Mary University of London have identified a new channel of communication through which non-cancerous cells drive the invasion of cancer cells in pancreatic cancer.
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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
NOVEMBER 10, 2022
The World Health Organization defines mental health as a state of mental well-being in which people cope well with the many stresses of life, can realize their own potential, function productively and fruitfully, and contribute to their communities. By that standard, health care workers are in deep trouble. While no group of people or profession is immune to mental health challenges, health care workers face disproportionate stress and burnout , putting them at greater risk of anxiety, depressio
Medical Xpress
NOVEMBER 10, 2022
Using a protocol developed at UC San Francisco, physicians have successfully treated a fetus with a devastating genetic disorder for the first time, and the child is now thriving as a toddler, a case study in the New England Journal of Medicine reports.
STAT News
NOVEMBER 10, 2022
A high-ranking Viatris executive was charged with insider trading for tipping a friend and former colleague about earnings, drug approvals, and a pending merger with a Pfizer division. In court documents, federal authorities alleged that Ramkumar Rayapureddy, the chief information officer at the drug company, which was previously known as Mylan, provided “material” information to Dayakar Mallu, who also worked in the IT department.
Medical Xpress
NOVEMBER 10, 2022
A hallmark of autism spectrum disorder, ASD, is the reluctance to make eye contact with others in natural conditions. Although eye contact is a critically important part of everyday interactions, scientists have been limited in studying the neurological basis of live social interaction with eye-contact in ASD because of the inability to image the brains of two people simultaneously.
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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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