Wed.Jan 18, 2023

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Large study of J&J’s HIV vaccine stopped after shot found ineffective

Bio Pharma Dive

The result from the nearly 4,000-person trial is the latest setback in a long-running effort to develop a safe and effective shot for HIV infections.

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Healthcare sector looks at govt for working capital and preferential funding support

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian healthcare sector is now looking at the government for working capital and preferential funding support. This is because there are no incentives to stimulate the establishment of smaller hospitals and nursing homes in rural regions, making it difficult for firms to establish chains of smaller hospitals.

Nurses 153
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Moderna reports positive RSV vaccine results, pressuring Pfizer, GSK

Bio Pharma Dive

The biotech’s results appear competitive to past data for RSV shots being developed by GSK and Pfizer. Moderna plans to follow those companies in asking for FDA approval.

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Procrastinating Could Be a Sign of Serious Health Problems, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

University students have a lot of freedom but not much structure. This can be bad for habitual procrastinators. Studies have shown that at least half of university students procrastinate to a level that is potentially harmful to their education.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Neurology startup merges with Wilbur Ross-backed SPAC

Bio Pharma Dive

The deal, which comes during a prolonged downturn in SPAC activity among biotechs, will help fund development of an Alzheimer’s drug that’s in late-stage testing in China.

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January 18, 2023: PCT Grand Rounds Will Spotlight the EVOLVE-MI Pragmatic Trial

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Mikhail Kosiborod of the University of Missouri-Kansas City will present “Collaborative Pragmatic Trials in Action: EVOLVE-MI.” The Grand Rounds session will be held on Friday, January 20, 2023, at 1:00 pm eastern. Kosiborod is a cardiologist, the vice president of research at Saint Luke’s Health System, and a professor of medicine at the University of Missouri-Kansas City.

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HIV vaccine being developed by Johnson & Johnson fails clinical trial

STAT News

Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinical trial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. The vaccine was being developed by Janssen, the vaccine division of Johnson & Johnson.

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China’s NMPA approves Henlius’ monoclonal antibody to treat ES-SCLC

Pharmaceutical Technology

The National Medical Products Administration (NMPA) of China has approved Shanghai Henlius Biotech ’s monoclonal antibody Hansizhuang (serplulimab injection) along with carboplatin and etoposide to treat extensive stage small cell lung cancer (ES-SCLC). Hansizhuang is the company’s first self-developed anti-PD-1 monoclonal antibody (mAb). It is claimed to be the first anti-PD-1 mAb approved as the first-line treatment for SCLC worldwide.

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Mix-it-yourself Wegovy? Some are trying risky sources for weight-loss drugs

STAT News

With a few clicks, Daniel added the chemical to his online cart and ordered it. In less than a week, a vial containing white powder arrived at his house. He used a syringe to measure out sterile water and eject it into the vial to dissolve the powder. Then, with a different syringe, he drew up about a quarter of a milliliter of the solution and injected it into his lower abdomen.

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Can you get COVID and the flu at the same time?

NPR Health - Shots

And what about a cold or RSV? With all the illness spreading, it's virus soup out there these days. Some people feel so sick they're wondering if they're fighting more than one germ at once.

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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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In the search for therapies for solid tumors, companies are turning to a novel target: claudin-6

STAT News

On Target is a recurring feature from STAT that dives deep into the most promising drug targets in oncology. This column is adapted from the new STAT Report : Targeting cancer: the new frontier of immunotherapy and precision oncology. Targeted immunotherapies like CAR-T have been remarkably successful in combating blood cancers like chronic lymphocytic leukemia.

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COVID-19 patients retain elevated risk of death for at least 18 months after infection, finds large-scale study

Medical Xpress

COVID-19 is associated with higher risks of cardiovascular disease and death in the short- and long-term, according to a study in nearly 160,000 participants published today in Cardiovascular Research, a journal of the European Society of Cardiology (ESC). Compared to uninfected individuals, the likelihood of COVID-19 patients dying was up to 81 times higher in the first three weeks of infection and remained five times higher up to 18 months later.

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Mental health benefits of gender-affirming hormones for teens persist for two years in new study

STAT News

Trans and nonbinary teenagers who receive gender-affirming hormones experience less depression and anxiety and more satisfaction with life than before the treatment, according to a new study published Wednesday in the New England Journal of Medicine. Researchers followed over 300 adolescents across the U.S. for two years after initiating hormone treatment.

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World first test to detect diabetics at risk of kidney disease

Medical Xpress

In a world first international study led by Monash University researchers in Australia, the genetic markers for people with diabetes at risk of developing kidney disease have been identified.

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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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U.S. plans crackdown on nursing homes that sedate patients with unnecessary antipsychotics

STAT News

WASHINGTON (AP) — The federal government says it will begin a targeted crackdown on nursing homes’ abuse of antipsychotic drugs and misdiagnoses of schizophrenia in patients. The Centers for Medicare and Medicaid Services is launching investigations this month into select nursing homes, aimed at verifying whether patients have been properly diagnosed with the psychiatric disorder.

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Premature birth linked to poorer school grades in adolescence

Medical Xpress

Premature birth, before 34 weeks of pregnancy, is linked to lower scores in math and language tests as a teenager compared with those born at 40 weeks, finds a large Danish population study published today in The BMJ.

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STAT+: Hip and knee replacements go better when performed by high-volume surgeons, new study finds

STAT News

A new study underscores the importance of the adage “practice makes perfect,” especially when it comes to surgery. It’s long been understood that the frequency at which surgeons perform and hospitals host complex procedures has a bearing on how patients fare, but the study from the Clarify Health Institute makes the link even clearer.

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Calling patients after heart failure may save lives

Medical Xpress

Phone calls from a nurse may improve survival for patients treated for heart failure, according to a new study by investigators from the Smidt Heart Institute at Cedars-Sinai.

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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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HHS needs better oversight of research that alters pathogens, government watchdog says

STAT News

WASHINGTON — The health department’s oversight of research that could enhance dangerous pathogens has vague parameters, a lack of transparency, and “does not fully meet the key elements of effective oversight,” a nonpartisan federal watchdog found in a report released Wednesday. The Government Accountability Office’s report is a precursor to a debate that will heat up at the National Institutes of Health over the next few weeks.

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With less access to paid leave, rural workers face hard choices about health, family

NPR Health - Shots

Coastal and politically progressive states have passed stronger paid sick and family leave policies than many states with larger rural populations.

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STAT+: Verily leans into Onduo as it looks to enter the lucrative world of running medical research

STAT News

The new, streamlined Verily will have one very recognizable component: its virtual care company Onduo, whose prodigious data collection from chronic disease patients will help power Verily’s significant push into research into new drugs, devices, and treatment approaches. Onduo was largely absent from a memo released last week in which Verily’s new CEO said that the Alphabet spinout was cutting 15% of its workforce and focusing on efforts that could either improve clinical research

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AbbVie, Novartis and more win national coverage in China even as Pfizer's Paxlovid gets left out

Fierce Pharma

AbbVie, Novartis and more win national coverage in China even as Pfizer's Paxlovid gets left out. aliu. Wed, 01/18/2023 - 14:00.

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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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Scottish Medicines Consortium recommends Merck’s Tepmetko

Pharma Times

Therapy is the first oral MET inhibitor treatment option for certain advanced NSCLC adult patients

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Opinion: Biopharma leaders helped save democracy. Now what?

STAT News

The rule of law must be upheld for free societies and free markets to flourish, and only a well-functioning democracy offers the levers for rational majorities to prevail. Americans support causes and candidates. We debate and organize. Then we vote, respecting the outcome, knowing that soon enough, we’ll have the sacred right to do so again.

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Omega 3 fatty acids in seafood linked to lower risk of chronic kidney problems

Medical Xpress

Higher levels of omega 3 fatty acids found in seafood are associated with a moderately lower risk of chronic kidney disease and a slower decline in kidney function, finds a study published by The BMJ.

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Opinion: Leaders at Davos need to pay attention to the crossroads of climate change, health, and security

STAT News

As CEOs and world leaders gather for the World Economic Forum in Davos, Switzerland, this week, they might be surprised to see less snow out of the window than usual on the country’s luminous peaks. Record-breaking temperatures in the Alps are just one sign of the effect climate change is having on planet Earth. Longer rainy seasons and a warmer climate are leading to more dengue fever, the worsening famine in the Sahel caused in part by erratic rainfall driven by climate change, and temp

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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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Study: Gender-affirming hormones improve mental health in transgender and nonbinary youth

Medical Xpress

Transgender and nonbinary youth experienced significant improvement in appearance congruence (or the degree to which physical characteristics align with gender) and sustained improvements in depression and anxiety over two years after starting treatment with gender-affirming hormones, according to a multicenter U.S. study published in the New England Journal of Medicine.

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STAT+: Pharmalittle: HIV vaccine study is stopped early; Merck has a plan to combat carcinogen found in diabetes drugs

STAT News

Top of the morning to you. The middle of the week is upon us and, since you made it this far, why not forge ahead? After all, there is always light at the end of the proverbial tunnel. You never know what you may accomplish. So please join us as we celebrate this notion with a cup or three of delicious stimulation. Our choice today is blueberry cobbler.

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Family dynamics and doctors' emotions drive useless end-of-life care, says study

Medical Xpress

Researchers from Rutgers and other universities have developed a behavioral model that explains a long-standing health care mystery: Why do so many terminally ill patients undergo intense last-ditch treatments with little chance of meaningful life extension?

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Why early participant engagement is now a top priority in genetic disease research

pharmaphorum

In 2016, scientists behind a study called the Resilience Project analysed genetic data from 589,000+ people and found 13 adults who carried genetic variants that should have resulted in serious – even deadly – childhood disease, but who were apparently healthy. The DNA of these so-called ‘genetic superheroes’ may contain clues about how to treat severe disease.

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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.