Wed.Nov 30, 2022

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Sana reshuffles drug pipeline, becoming latest biotech to cut staff

Bio Pharma Dive

The richly funded drugmaker will cut 15% of its workforce, or about 75 employees, as well as stop work on one of its preclinical research programs.

Drugs 339
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Current pipeline developments could bring new hope for patients with PPMS

Pharmaceutical Technology

Multiple sclerosis (MS) is an autoimmune disease causing chronic inflammation and demyelination of the nerves, affecting around 2.5 million people worldwide. While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options.

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Gene editing startup iECURE returns to investors for fresh funding

Bio Pharma Dive

The company, which draws on research by Jim Wilson’s lab at UPenn, says the $65 million it raised will support the start of human testing of its lead drug through to initial clinical data.

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UTMB and HDT Bio receive US funding for vaccine development

Pharmaceutical Technology

The University of Texas Medical Branch (UTMB) and HDT Bio have received a funding worth up to $87.4m in a project agreement from the US government for developing self-amplifying RNA (saRNA) vaccine technology against advanced and emergent viral threats. The award is provided by Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) of the US Department of Defense (DOD) and Biomedical Advanced Research and Development Authority (BARDA) of the US Dep

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Bluebird sells regulatory fast pass to Argenx for $102M

Bio Pharma Dive

The priority review voucher is one of two Bluebird received for winning FDA approvals of its gene therapies Zynteglo and Skysona, and its sale gives the company needed cash.

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CMO Moves: Regulatory Catalysts for Drug Manufacturing-November

Pharmaceutical Technology

Crossing the approval hurdle for a new drug is a big milestone for pharmaceutical companies. However, efficiently manufacturing the drug represents another barrier to cross before realizing the full revenue potential then successfully. Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them.

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November 30, 2022: This Week in PCT Grand Rounds, a Pragmatic Trial of an mHealth Intervention for Heart Failure and Diabetes

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Dr. Michael Felker of Duke University will present “A Randomized Controlled Trial of a Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned.” The Grand Rounds session will be held on Friday, November 18, 2022, at 1:00 pm eastern. Felker is a professor of medicine in the Duke University School of Medicine and the director of cardiovascular and metabolism research at the Duke Clinical Research Institute.

Trials 130
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Biocon Biologics acquires biosimilars business of Viatris for $3bn

Pharmaceutical Technology

Biocon subsidiary Biocon Biologics has acquired the international biosimilars business of Viatris in a deal totalling $3bn. In February, the companies signed a definitive agreement for the acquisition, which would aid Biocon Biologics in establishing a completely integrated international biosimilars enterprise, with eight products currently in the market.

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NYC Mayor Adams faces backlash for move to involuntarily hospitalize homeless people

NPR Health - Shots

Mayor Eric Adams announced this week that officials will begin hospitalizing more homeless people by involuntarily providing care to those deemed to be in "psychiatric crisis." (Image credit: Michael M.

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Stanford is investigating its president over allegations of research misconduct

STAT News

Stanford University has opened an investigation into its president, Marc Tessier-Lavigne, a renowned neuroscientist and former biotech executive, for research misconduct after experts alleged papers on which he was an author included altered images, the university confirmed. The university’s board will oversee the investigation.

Research 124
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Study: Alzheimer's drug shows modest success slowing declines in memory, thinking

NPR Health - Shots

In a large study, the experimental Alzheimer's drug lecanemab reduced the rate of cognitive decline by 27 percent in people in the early stages of the disease.

Drugs 138
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Elon Musk says Neuralink’s brain-machine interface could enter human studies next year

STAT News

Elon Musk’s brain-machine interface company Neuralink aims to put its first implant in a human subject in the next six months, he said during an event Wednesday. Musk said the company has been “working hard to be ready for our first human,” and has submitted most of the required paperwork to the Food and Drug Administration to launch a study in humans.

Drugs 119
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Is China's 'zero COVID' policy even possible with omicron and its subvariants?

NPR Health - Shots

For nearly three years, China has enforced incredibly strict rules to keep coronavirus transmission in check. Can they continue those policies as they face an omicron surge. And will they still work?

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FDA approves first microbiome drug from Ferring Pharmaceuticals

STAT News

The Food and Drug Administration approved the first therapy using bacteria from stool samples to treat a bowel disorder on Wednesday, paving the way for several similar treatments in development.  The drug, called Rebyota, is given as a one-dose treatment for clostridium difficile infection s, commonly known as C. diff., in which the toxin-producing bacteria disrupts the normal balance in a person’s digestive system.

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The New Age of Decentralized Clinical Trials

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.

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Non-surgical treatment relieves carpal tunnel syndrome

Medical Xpress

A minimally invasive treatment for carpal tunnel syndrome provides complete and long-term relief to patients without the use of corticosteroids, according to research being presented today at the annual meeting of the Radiological Society of North America (RSNA).

Radiology 108
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Covid evolution wipes out another antibody treatment, threatening the country’s medicine cabinet

STAT News

The Food and Drug Administration on Wednesday ended its emergency authorization for the only remaining Covid-19 antibody therapy cleared for use, saying variants that render it ineffective are now dominant in the United States. The news about bebtelovimab makes official what has been anticipated for several weeks, as the Omicron sublineages BQ.1 and BQ.1.1 have been growing in prevalence.

Antibody 111
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New AI method for public health analysis shows trends in substance use among high schoolers

Medical Xpress

High school students who have a large weekly allowance, friends who smoke and low levels of physical activity are more likely to use multiple substances over time. Conversely, being older, being Black and eating breakfast daily were factors associated with a smaller chance of transitioning to multiple use.

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STAT+: On the long road to treating Huntington’s genetic stutter, scientists return to overlooked clues

STAT News

In the spring of 1981, a geneticist from Indianapolis and a neurologist from Chicago got in a car and for three days they crisscrossed the yellowing cornfields of Iowa. Every now and then, they stopped at a house to draw blood from the inhabitants — more than 30 members of one extended family spread across the state. The scientists sent the blood 950 miles east to Massachusetts General Hospital in Boston, to a tiny lab (recently converted from a storeroom) where a 28-year-old postdoc name

Genetics 111
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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Eisai and Biogen present promising lecanemab study results

Pharma Times

Phase 3 research shows that Alzheimer’s disease treatment meets primary and secondary endpoints

Research 133
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‘This actually changes everything’: Altered image in 1999 paper raises potential peril for Stanford president

STAT News

New findings of altered images in research co-authored by Stanford University president Marc Tessier-Lavigne add to the weight of allegations against him, according to experts on research misconduct. On Tuesday, Stanford announced an investigation into its president following allegations of altered images in four papers co-authored by Tessier-Lavigne over a seven-year period earlier in his research career.

Research 105
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Excess oxygen during surgery linked to higher risk of organ damage

Medical Xpress

Giving patients excess levels of oxygen during surgery is associated with a higher risk of subsequent kidney, heart, and lung injury, finds a large U.S. study published by The BMJ today.

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Opinion: Better lab test standards can ensure precision medicine is truly precise

STAT News

Cancer is becoming less deadly in America. According to the recently released Annual Report to the Nation on the Status of Cancer , overall cancer death rates have continued to decline by about 2% per year over the last several years for Americans of all ages, races, and genders. The decline in cancer death rates is clearly welcome news and coincides with a significant shift in cancer treatment through the development of new targeted therapies and accompanying diagnostic tests that guide their u

Medicine 105
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How Machine Learning Drives Clinical Trial Efficiency

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.

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Squamous cell carcinoma study: Cancer stem cells are fueled through dialogue with their environments

Medical Xpress

What drives tumor growth? Is it a few rogue cells imposing their will upon healthy tissue, or diseased tissue bringing out the worst in otherwise peaceable cells? Or is it a back-and-forth, a dialogue between the two? According to a new study, it may be the latter, at least when it comes to the progression of one common skin cancer.

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Opinion: Excise taxes on tobacco, alcohol, and sugary beverages benefit health and public budgets

STAT News

The Covid-19 pandemic blew up budget deficits in low- and middle-income countries, pushing many toward or into precarious financial straits. There is also growing pressure on policymakers to soften the impact of food and energy inflation with temporary tax and tariff cuts and consumption subsidies, measures that will need to be offset by other fiscal responses to fill budget holes.

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Effectiveness of COVID vaccines against death remains high in children regardless of variant

Medical Xpress

The effectiveness of COVID-19 vaccines in preventing death remains high in children and adolescents regardless of the predominant circulating variant, suggests a large study from Argentina published by The BMJ today.

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CDC launches initiative to test wastewater for polioviruses in some communities

STAT News

With growing concern about the circulation of vaccine-derived polioviruses in the United States, the Centers for Disease Control and Prevention said Wednesday that it would work with select communities across the country to conduct wastewater surveillance for the viruses. The launch of the initiative follows the discovery over the summer of vaccine-derived polioviruses circulating in the sewage of a number of counties in and around New York City.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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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Talk of the Towne Episode 05: Diversity in research with Allison Kalloo

Antidote

Antidote’s podcast, Talk of the Towne , focuses on the ultimate sweet spot: that special place where science and patients converge. Our host, Dr. Rich Towne, was trained in pharmacy and currently works in Clinical Informatics at Antidote. In each episode, Rich welcomes a new guest from an Antidote partner organization, and takes an in-depth look at a particular area of interest, zeroing in on the story that Antidote's data is telling about how best to connect patients and research.

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STAT+: ‘This actually changes everything’: Altered image in 1999 paper raises potential peril for Stanford president

STAT News

New findings of altered images in research co-authored by Stanford University president Marc Tessier-Lavigne add to the weight of allegations against him, according to experts on research misconduct. On Tuesday, Stanford announced an investigation into its president following allegations of altered images in four papers co-authored by Tessier-Lavigne over a seven-year period earlier in his research career.

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Study finds that online learning during COVID-19 was detrimental to teen mental health, school satisfaction, performance

Medical Xpress

The COVID-19 pandemic changed the social and school world for teens as virtual learning or hybrid learning became the norm in 2020-21. The unprecedented shutdown of classroom learning caused undue stress, low levels of social inclusion and low satisfaction with school for many—and mental health issues for some, according to a new study led by researchers at the University of California, Davis.

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With no exit strategy from ‘zero Covid’ policy, China could face tsunami in cases, experts fear

STAT News

As the world watches the rare spectacle of protesters challenging China’s authoritarian leadership over its increasingly perplexing “zero Covid” policy, people who study the disease see threats ahead for China — and beyond. The zero Covid policy, which has kept cases and deaths in China to negligible numbers throughout the pandemic, seems doomed to fail in the face of the highly transmissible Omicron variant of the SARS-CoV-2 virus, they believe.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.