Mon.May 30, 2022

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At ESMO, three studies show promise of antibody-drug conjugates in breast cancer

pharmaphorum

The American Society of Clinical Oncology, or ASCO, conference is just around the corner, but one subgroup of cancer researchers just had their own gathering, as breast cancer researchers came together in person for the first time since the start of the pandemic at the ESMO Breast Cancer congress. pharmaphorum sat down with Sunil Verma, global head of oncology, medical, at AstraZeneca, to discuss three studies that were presented at the show, which demonstrate a few of the ways oncology is advan

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Pfizer opens access to portfolio for low-income countries

BioPharma Reporter

The company will provide its current and future portfolio of patented medicines to 45 lower-income countries, but the move is not without controversy.

Medicine 105
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Blood drawing robot heading for pivotal trials

pharmaphorum

In future, blood samples may be taken by an autonomous robot rather than a healthcare professional – if Dutch developer Vitestro can get its prototype approved for marketing. Vitestro’s blood drawing (phlebotomy) robot is designed to offer a solution to what the company says is a growing shortage of healthcare personnel, coupled with rising demand for blood tests with billions carried out every year worldwide.

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CureVac increases focus on cancer vaccine development

BioPharma Reporter

A partnership with myNEO represents the first step in CureVacâs targeted expansion of its mRNA approach for the development of cancer vaccines, says the company.

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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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As cases rise, WHO says monkeypox risk is “moderate”

pharmaphorum

The World Health organisation’s latest assessment of the monkeypox outbreak is that it poses a moderate threat to public health, as cases of the infection continue to rise. In an update posted yesterday, the WHO said it had received reports of 257 confirmed cases of monkeypox from 23 countries, 106 of them from the UK and 49 from Portugal, with another 120 suspected cases being investigated.

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Global warming increases risks of East China flooding

Scienmag

The Western Pacific Subtropical High (WPSH) is an anticyclonic atmospheric system hovering over the middle and lower troposphere of the northwestern Pacific, dominating summer climate extremes in the densely populated countries of East Asia. Credit: FU Yunfei The Western Pacific Subtropical High (WPSH) is an anticyclonic atmospheric system hovering over the middle and lower troposphere […].

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EUROAPI supports Sanofi’s mRNA vaccine projects with lipid nanoparticle development

BioPharma Reporter

EUROAPI has expanded a collaboration with Sanofi, which will see it support Sanofi's mRNA vaccine platform with the development of lipid nanoparticles.

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Sweetened and unsweetened coffee consumption associated with lower death risk

Scienmag

1. Sweetened and unsweetened coffee consumption associated with lower death risk Abstract: [link] Editorial: [link] Note : HD soundbites of the author explaining study findings are available for download at [link] URLs go live when the embargo lifts A cohort study has found that compared to non-coffee drinkers, adults who drank moderate amounts (1.5 to […].

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Using technology to reassess the clinical trial landscape

pharmaphorum

Josh Sackman, president and co-founder of AppliedVR, and Web Sun, president and co-founder of Komodo Health, relay how their newly formed collaboration reshapes the clinical trial process by using data, helping to cut costs and allowing for evaluation of broader patient populations. . AppliedVR and Komodo Health are collaborating to perform a clinical trial using the first FDA-authorised virtual reality (VR) platform and extensive data sets to look at the primary endpoints of chronic pain inten

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Ian David Hickson to present at the 9th Aging Research & Drug Discovery Meeting 2022

Scienmag

May 30, 2022 — Ian David Hickson, Ph.D., will present the latest research on the topic Chromosome instability as a driver of human disease at the world’s largest annual Aging Research and Drug Discovery conference (9th ARDD). Dr. Hickson is the Director at the Center for Chromosome Stability, Department of Cellular and Molecular Medicine, the […].

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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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NICE approves Merck’s Keytruda for adult patients with rare triple negative breast cancer

Pharma Times

The injection is given in combination with chemotherapy and administered once every three weeks

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Very high doses of CBD, a cannabis component, don’t affect driving

Scienmag

Millions of consumers and patients around the world will be heartened by the results of the latest study on cannabis and driving. The University of Sydney-led research finds that 1500mg, the highest daily medicinal dose of cannabidiol (CBD), has no impact on people’s driving or cognitive abilities. CBD is a cannabis component widely used for […].

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Drug Channels News Roundup, May 2022: SaveonSP Sued, RIP Medicaid Accumulator Rule, CVS/ABC Deal, Buy-and-Bill Profits, and Aetna’s Prior Authorizations

Drug Channels

Summer unofficially began over the weekend. Let’s turn up the heat with these sizzling news bites straight from the Drug Channels grill: SaveonSP gets sued Thoughts on the Medicaid accumulator rule opinion CVS buys AmerisourceBergen’s specialty pharmacy Fresh data on hospitals’ cancer drug profiteering Plus, Dr. Glaucomflecken explains Aetna’s prior authorization policies.

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The paired perils of breast cancer and diabetes

Scienmag

Breast cancer and type 2 diabetes would seem to be distinctly different diseases, with commonality only in their commonality. Breast cancer is the second most diagnosed malignancy after some types of skin cancer; approximately 1 in eight U.S. women will develop invasive breast cancer over the course of their lifetime. More than 10 percent of […].

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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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NRG receives £2.68m funding boost for neurodegenerative disorders

Pharma Times

NRG Therapeutics announces multi-million Innovate UK Award to develop treatments for Parkinson’s and motor neurone disease

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Cambridge University Herbarium gains national significance accolade

Scienmag

This award recognises the Herbarium’s natural history collections as being of great historical and scientific importance for the country. Credit: Cambridge University Herbarium This award recognises the Herbarium’s natural history collections as being of great historical and scientific importance for the country. Established in 1761 it holds an estimated 1.1 million plant specimens from all […].

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RhoVac pummelled as lead cancer vaccine fails study

pharmaphorum

Shares in Swedish biotech RhoVac were down 94% in mid-morning trading today after the company revealed a phase 2b trial of its prostate cancer vaccine RV001 showed it was no more effective than placebo. In the 180-subject BRaVac trial, treatment with RV001 (onilcamotide) was unable to top placebo in preventing disease progression among patients who had curative therapy for localised prostate cancer but subsequently saw a rise in levels of PSA, a biomarker for recurrence.

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COVID-19’s toll on global cardiac services – International Version

Scienmag

University of Leeds Press Release Credit: University of Leeds University of Leeds Press Release Under embargo until 00.01 (UK time) on Tuesday, May 31 With audio clips COVID-19’s toll on global cardiac services Across the world, heart services were severely disrupted Cardiac disease expected to worsen post pandemic Repercussions will be with us for ‘years […].

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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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New patent expiration for Horizon drug VIMOVO

Drug Patent Watch

Annual Drug Patent Expirations for VIMOVO Vimovo is a drug marketed by Horizon and is included in one NDA. It is available from one supplier. There are nine patents protecting…. The post New patent expiration for Horizon drug VIMOVO appeared first on DrugPatentWatch - Make Better Decisions.

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MIT engineers boost signals from fluorescent sensors

Scienmag

CAMBRIDGE, MA — Fluorescent sensors, which can be used to label and image a wide variety of molecules, offer a unique glimpse inside living cells. However, they typically can only be used in cells grown in a lab dish or in tissues close to the surface of the body, because their signal is lost when […].

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Racial and Ethnic Bias in Pulse Oximetry

JAMA Internal Medicine

Assessment of blood oxygen saturation is an important measure of health on which many diagnostic and treatment decisions are based. Blood oxygen saturation is most commonly assessed via pulse oximetry, with increasing use across the home, clinic, and hospital settings during the COVID-19 pandemic. However, inaccuracies in pulse oximetry measurement have come under scientific scrutiny over the past 2 years.

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Cancer immunotherapy capable of modulating tumor immunophenotypes

Scienmag

Innovations in cancer immunotherapy have achieved clinical success by considerably increasing the survival rate of patients undergoing cancer treatment. However, there still exists an unmet medical need due to the low response rate to checkpoint inhibitors caused by the low immune reactivity of cancer cells in “cold” tumors. In their efforts to turn “cold” tumors […].

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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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Sanofi’s plans for OTC Cialis hit a snag in US

pharmaphorum

It has been eight years since Sanofi licensed rights to an over-the-counter version of erectile dysfunction (ED) drug Cialis from Eli Lilly, and the FDA has just thrown a spanner into its plans to bring it to market in the US. Sanofi said this morning that the US regulator has imposed a clinical hold on its Actual Use Trial (AUT) of the OTC formulation over “matters surrounding the protocol design.” According to the French pharma group the study has not yet recruited any patients, an

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Fjords emit as much methane as all the deep oceans globally

Scienmag

During heavy storms, the normally stratified layers of water in ocean fjords get mixed, which leads to oxygenation of the fjord floor. But these storm events also result in a spike in methane emissions from fjords to the atmosphere. Credit: R Lindblom During heavy storms, the normally stratified layers of water in ocean fjords get […].

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Racial and Ethnic Discrepancies in Pulse Oximetry and COVID-19 Treatment Eligibility

JAMA Internal Medicine

This cohort study examines the differential inaccuracy of pulse oximetry by race or ethnicity among patients with COVID-19.

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Ultrasound-guided microbubbles boost immunotherapy efficacy

Scienmag

HOUSTON ? Researchers at The University of Texas MD Anderson Cancer Center have developed an ultrasound-guided cancer immunotherapy platform that generates systemic antitumor immunity and improves the therapeutic efficacy of immune checkpoint blockade. The findings from the preclinical study were published today in Nature Nanotechnology. As the first-of-its-kind platform, the Microbubble-assisted UltraSound-guided Immunotherapy of Cancer […].

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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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New patent expiration for Genus Lifesciences drug YOSPRALA

Drug Patent Watch

Annual Drug Patent Expirations for YOSPRALA Yosprala is a drug marketed by Genus Lifesciences and is included in one NDA. It is available from two suppliers. There are five patents…. The post New patent expiration for Genus Lifesciences drug YOSPRALA appeared first on DrugPatentWatch - Make Better Decisions.

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Acute stress may be detrimental to fighting off COVID-19 and influenza

Scienmag

Manuscript Title: Brain motor and fear circuits regulate leukocytes during acute stress Journal: Nature – Embargo Lifts May 30, 11am EST Corresponding Author: Filip Swirski, PhD, Director of the Cardiovascular Research Institute at the Icahn School of Medicine at Mount Sinai Bottom Line: Acute stress can be detrimental to fighting off infection, especially COVID-19, and […].

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High cost of cancer care in the U.S. doesn’t reduce mortality rates

The Pharma Data

While the U.S. spends twice as much on cancer care as the average high-income country, its cancer mortality rates are only slightly better than average, according to a new analysis by researchers at Yale University and Vassar College. The results were published May 27 in JAMA Health Forum. “There is a common perception that the U.S. offers the most advanced cancer care in the world,” said lead author Ryan Chow, an M.D.

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Scientists solve long-standing mystery: Why do some asthma patients respond poorly to treatment?

Scienmag

Patients with the most severe form of asthma produce special substances in their airways when taking medicine during an asthma attack that block the treatment from working, according to a study where Rutgers scientists collaborated with researchers at Genentech, a member of the Roche Group. Reporting in the journal Science Translational Medicine, scientists said two […].

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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.