Mon.Jan 16, 2023

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AI continues to gain momentum in the biopharmaceutical industry in 2023

Pharmaceutical Technology

While the biopharmaceutical industry has been impacted and pressured by various factors such as the Covid-19 pandemic, inflation, the Ukraine-Russia war, ongoing supply chain issues, and a challenging economic environment, collaboration between pharma companies and emerging technologies providers continues to grow, especially in the research and development (R&D) field, offering some resilience in times of geopolitical and economic disruptions.

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Huge Study Reveals 4 Eating Patterns Linked to Lower Risk of Early Death

AuroBlog - Aurous Healthcare Clinical Trials blog

There’s a lot of dietary advice out there, but the science that links food and health isn’t always clear-cut. A new study on the topic is one of the most comprehensive to date and has identified four eating patterns associated with lower mortality risk. Analyzing the eating patterns of 119,315 people over 36 years, researchers […].

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Ono Pharmaceutical enters research deal with Monash University

Pharmaceutical Technology

Ono Pharmaceutical and Monash University have entered an option and research collaboration for the discovery and development of antibodies that target G protein-coupled receptors (GPCRs). The collaboration is focused on developing anti-GPCR antibodies, which enable the creation of new treatments for autoimmune and inflammatory diseases. Under the deal terms, the Biomedicine Discovery Institute of Monash University will lead the antibody discovery campaign for targeting two GPCRs, which are said

Research 130
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Centre changes name of CPCSEA to CCSEA to simplify & better define role & purpose of the Committee

AuroBlog - Aurous Healthcare Clinical Trials blog

The Ministry of Fisheries, Animal Husbandry and Dairying has changed the name of the committee controls and monitors the experiments on animals from the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), to the Committee for Control and Supervision of Experiments on Animals (CCSEA). The change in name simplifies and […].

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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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988 Lifeline sees boost in use and funding in first months

NPR Health - Shots

The 3-digit suicide and crisis lifeline – 988 – fielded nearly half a million more calls, texts and chats in its first 5 months than the old 10-digit Lifeline did during the same time in 2021. (Image credit: PATRICK T.

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COVID long-haulers face stigma: Study

Medical Xpress

High levels of stigma experienced by some COVID long-haulers are associated with more intense symptoms, reduced physical function and loss of employment due to disability, according to newly published research in eClinicalMedicine.

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More Trending

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The link between mental health and ADHD is strong—so why aren't we paying attention?

Medical Xpress

Adults with high levels of attention-deficit hyperactivity disorder (ADHD) symptoms are more likely to experience anxiety and depression than adults with high levels of autistic traits, according to new research led by psychologists at the University of Bath in the UK.

Research 122
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STAT+: Liquid biopsy study suggests a better way to decide which colorectal cancer patients need chemo

STAT News

They’re far too small to be seen by even the most sophisticated medical imaging device. But bits of tumor DNA adrift in a patient’s blood are an important bellwether for whether cancer will return — and, as a new study shows, can predict which treatments are likely to work. Scientists reported in the journal Nature Medicine on Monday that colorectal cancer patients who had tumor DNA in their blood after surgery were far more likely to have their cancer return.

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US eyes link between Pfizer bivalent COVID jab and stroke

pharmaphorum

Regulatory authorities in the US are investigating a possible link between the new Pfizer/BioNTech bivalent COVID-19 booster vaccine and strokes in people aged 65 or over, but still recommend the shots. Monitoring has pointed to a possible higher risk of ischaemic stroke in the 21-day period post-vaccination in this age group compared to 22 to 44 days post-vaccination, according to an announcement on the Centre for Disease Control and Prevention (CDC) website. “Although the totality of the

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COVID-19 associated with fetal brain hemorrhages

Medical Xpress

New research from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London has found evidence of small hemorrhages in the brain tissue of fetuses during the peak of COVID-19 cases in the UK.

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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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Celadon receives good manufacturing practice approval

Pharma Times

MHRA approval relates to the company’s midlands-based drug development facilities

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Animal testing no longer required for drug approval, but high-tech substitutes aren't ready

Medical Xpress

For generations people have associated the terms "lab rat" and "guinea pig" with scientific research. Animal testing remains a standard and has been required for drug approval.

Drugs 98
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New UK biobank offers stem cell and regenerative medicine research potential  

Drug Discovery World

BioGrad, a company offering medical and scientific support for education and research organisations, is to open the UK’s second largest biobank facility in Liverpool, as part of a £7.6m investment into a new headquarters at Wavertree Technology Park. . In collaboration with the University of Leicester, BioGrad biobank has already welcomed up to 261,000 samples from the largest long-Covid study in the UK.

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STAT+: Invitae’s new CEO on why the genetic testing firm stopped chasing ‘volume at all costs’

STAT News

SAN FRANCISCO — Invitae, a Bay Area genetic testing company with a mission to use genomic information to improve health care, has struggled to turn that mantra into a solid business model. It’s now trying to turn things around. The company, which offers genetic tests for people who are pregnant or planning to have a child as well as for conditions such as heart disease and hereditary cancers, announced last July that it would lay off more than 1,000 employees , more than a third of

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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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Diagnostic tests 'just to be on the safe side' not recommended

Medical Xpress

Paradoxical maybe, but it's what often happens in the health services: When you ask for an MRI to be on the safe side, your uncertainty increases, says Bjørn Hoffman, a professor at the Department of Health Sciences at the Norwegian University of Science and Technology, Gjøvik.

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Rybelsus (semaglutide) New Label Update Allows for Early Use in Type 2 Diabetes Treatment

XTalks

Novo Nordisk announced in a press release last week that a label update for their type 2 diabetes treatment Rybelsus (semaglutide) was approved from the US Food and Drug Administration (FDA). The approval allows for earlier intervention and treatment with Rybelsus in adults with type 2 diabetes, when previously it was not approved as an initial (first-line) treatment option.

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Soccer goalkeeper foot forward, allowed by a 2019 law change, improves penalty diving save performance

Medical Xpress

For many soccer fans, penalties are moments of utmost tension and potential glory. In 2019, the International Football Association Board (IFAB), which establishes the laws of the sport, decided to allow goalkeepers to put one foot in front of the goal line as a penalty is kicked, giving in to the demands of goalkeepers and overruling fears that referees would have to repeat too many penalties.

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AbbVie and Eli Lilly snub drug pricing agreement

Pharma Times

Major industry names depart leaving UK pricing deal in serious jeopardy

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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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Blood vessel protein found to reduce mortality in infectious disease

Medical Xpress

Pipes play an essential role in bringing water to the faucets in your home, but if one of those pipes springs a leak, damage can result. Similarly, the vascular system plays an essential role in carrying oxygen and nutrients throughout the body, but too much vascular permeability, or space between the cells lining the blood vessels, can have devastating results.

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Prevalence of Colorectal Neoplasia 10 or More Years After a Negative Screening Colonoscopy

JAMA Internal Medicine

This cross-sectional study examines the prevalence of advanced colorectal neoplasms at least 10 years after a negative screening colonoscopy in repeated screening colonoscopy participants in Germany.

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Researchers create a cell therapy based on STAb cells for a type of leukemia with few treatment options

Medical Xpress

Researchers of the Hospital Universitario 12 de Octubre in Madrid and the Josep Carreras Leukaemia Research Institute in Barcelona have developed a cell therapy for a type of leukemia which currently has very few treatment options. This STAb therapy is based on STAb-T cells and could be used for the treatment of T-Cell Acute Lymphoblastic Leukemia (T-ALL) in those patients for whom chemotherapy or bone marrow transplantation have not worked.

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Study adds to HRT and Alzheimer’s debate

pharmaphorum

Hormone replacement therapy (HRT) could cut the risk of Alzheimer’s in some women at elevated risk of the disease, according to researchers in the UK. The study by a team at the Universities of East Anglia and Edinburgh shows that HRT use is associated with better memory, cognition, and larger brain volumes in later life among women carrying the APOE4 gene, a well-established risk factor for Alzheimer’s.

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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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Long-term low-dose hydroxychloroquine use associated with low risk for retinopathy

Medical Xpress

A cohort study of more than 3,000 persons who received hydroxychloroquine for 5 or more years with guideline-recommended serial retinopathy screening found that the overall risk for incident retinopathy was low, with most documented cases being mild. Higher hydroxychloroquine dose was associated with progressively greater risk. The findings are published in Annals of Internal Medicine.

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AbbVie, Lilly pull out of UK voluntary drug pricing agreement

pharmaphorum

Two top pharma companies have exited the UK’s voluntary medicines pricing agreement in protest at what the industry has said is a “punitive” system of revenue clawbacks, casting doubt on the future of the scheme in its present form. AbbVie and Eli Lilly have left the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), according to an update issued this morning by the Association of the British Pharmaceutical Industry (ABPI), which said the move has “sent a w

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New drug combination may effectively treat often fatal childhood brain tumor

Medical Xpress

Researchers at the University of Colorado Anschutz Medical Campus have discovered a drug combination that may offer a better prognosis for children diagnosed with MYC amplified Medulloblastoma, an often deadly form of brain cancer. The research was conducted in collaboration with the German Cancer Consortium (DKTK) University Hospital Dusseldorf.

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Florida woman jailed for lying to FDA about children's drugs trial

Outsourcing Pharma

A Florida doctor has been sent to prison after submitting a false affidavit claiming she had screened children in a clinical study looking at the effectiveness of drugs given to children with asthma when she had not.

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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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What is the heart-healthy DASH diet?

Medical Xpress

A common eating plan with a catchy acronym—the DASH diet—is designed to help you lower your blood pressure, but exactly what can you eat while on it?

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AMR Action Fund invests in first European antimicrobial company

Outsourcing Pharma

AMR joins a Series C funding raise for BioVersys, which is developing antimicrobials against common drug-resistant bacteria that threaten public health.

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Slit2 signaling stimulates Ewing sarcoma growth

Medical Xpress

A new research paper was published in Genes & Cancer on December 14, 2022, entitled, "Slit2 signaling stimulates Ewing sarcoma growth.".

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When the Going Gets Tough – FDA AdComms in 2022

Eye on FDA

Through its Human Drugs Advisory Committee process FDA has a vast array of outside experts to consult on matters related to product approval as well as questions about policy or safety issues concerning approved products. The mechanism provides an open and transparent process whereby people can see and hear the deliberations and have input during open public comment as well as through a docket established for that purpose.

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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.