Wed.May 11, 2022

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In first, Verve gets clearance to test base editing inside the body

Bio Pharma Dive

Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S. and U.K., too.

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The antimicrobial pipeline is ‘dry’ and that’s a problem

pharmaphorum

Antimicrobial resistance is a growing problem and one that is already claiming over a million lives per year. The situation is urgent but finding a sustainable solution is a difficult prospect, finds Ben Hargreaves. Alexander Fleming discovered the world’s first antibiotic, penicillin, in 1928. However, the difficulty in developing a method to adequately produce sufficient levels of the product meant that the age of the antibiotic did not truly begin until the 1940s.

Bacteria 144
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Moderna's finance head is out as former employer conducts investigation

Bio Pharma Dive

Jorge Gomez, who officially took the CFO reins Monday, lasted one day on the job. His departure comes as Gomez's previous company, Dentsply Sirona, looks into financial allegations against current and former executives.

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Novo Nordisk forges close ties with biotech VC Flagship

pharmaphorum

Danish drugmaker Novo Nordisk has traditionally generated its pipeline mainly from internal R&D, but a new alliance with venture capital firm Flagship Pioneering signals another departure from that strategy. The partnership with Flagship will bring Novo Nordisk into closer contact with the VC’s portfolio of 41 biotech companies, with the aim of creating a portfolio of “transformational” medicines for cardiometabolic and rare diseases.

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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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Roche cancer immunotherapy fails another trial, casting doubt on emerging drug class

Bio Pharma Dive

A treatment combination involving Roche's anti-TIGIT medicine tiragolumab missed its goal in a Phase 3 lung cancer study that was viewed as a proof point for the drug class.

Drugs 195
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Abzena announces appointment of Petra Dieterich as Scientific Lead

Pharma Mirror

Abzena, the leading Partner Research Organization (PRO) providing integrated discovery, development and manufacturing of biologics and antibody drug conjugates (ADCs) has announced the appointment of Dr. Petra Dieterich, DPhil, MBA, as scientific lead. Reporting to Abzena’s chief technology officer Dr. Louise Duffy, Dr. Dieterich will use her extensive technical knowledge and leadership experience to support Abzena’s successful drug development and manufacturing operations, ultimately assisting

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ACM celebrates technical achievements that drive far-reaching advances in technology

Scienmag

ACM, the Association for Computing Machinery, today announced the recipients of four prestigious technical awards. These leaders were selected by their peers for making contributions to groundbreaking research and practical applications that impact people using technology every day. Credit: ACM ACM, the Association for Computing Machinery, today announced the recipients of four prestigious technical awards. […].

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PrecisionLife and Sano Genetics partnership will help identify treatments for long COVID

Pharma Times

The project will analyse risks from Sano Genetics’ data from 3,000 UK adults suffering from long COVID

Genetics 113
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Discovered: 150-year-old platypus and echidna specimens that proved some mammals lay eggs

Scienmag

Jars of tiny platypus and echidna specimens, collected in the late 1800s by the scientist William Caldwell, have been discovered in the stores of Cambridge’s University Museum of Zoology. Credit: Jacqueline Garget Jars of tiny platypus and echidna specimens, collected in the late 1800s by the scientist William Caldwell, have been discovered in the stores […].

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Common Medications Can Prolong Back Pain When Overused, Study Says

NY Times

A clinical trial will be needed to verify the research, which offered a warning about taking steroids or nonprescription drugs for weeks on end.

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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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Laser bursts drive fastest-ever logic gates

Scienmag

A long-standing quest for science and technology has been to develop electronics and information processing that operate near the fastest timescales allowed by the laws of nature. Credit: University of Rochester illustration / Michael Osadciw A long-standing quest for science and technology has been to develop electronics and information processing that operate near the fastest […].

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FDA’s CDER Introduces New ARC Program to Accelerate Rare Disease Cures

XTalks

The mission of the ARC Program by the FDA’s Center for Drug Evaluation and Research (CDER) is to drive regulatory and scientific innovation and engagement to speed up the availability of treatments for patients with rare diseases. The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the launch of the Accelerating Rare disease Cures (ARC) Program.

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Volunteers receive first dose in clinical trial of Melbourne-made COVID-19 vaccines

Scienmag

Funding: Medical Research Future Fund, mRNA Victoria, Jack Ma Foundation, IFM Investors, Australian Research Council and National Health and Medical Research Council Credit: Royal Melbourne Hospital Funding: Medical Research Future Fund, mRNA Victoria, Jack Ma Foundation, IFM Investors, Australian Research Council and National Health and Medical Research Council The first six participants in the clinical […].

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Mental health record specialist Osmind raises $40 million

pharmaphorum

US digital health firm Osmind – which had developed an electronic health record (EHR) system for patients with mental illness – has added to its finances with a $40 million Series B financing. The San Francisco-based company says it will use the proceeds of the financing to expand its workforce and make improvements to its EHR platform, which is directed towards novel interventions for mental health such as psychedelic medicines and neuromodulation therapies like transcranial magnetic stimulatio

Doctors 59
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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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For outdoor workers, extreme heat poses extreme danger

Scienmag

Las Vegas (May 11, 2022) – Working outdoors during periods of extreme heat can cause discomfort, heat stress, or heat illnesses – all growing concerns for people who live and work in Southwestern cities like Las Vegas, where summer temperatures creep higher each year. But, did you know that female outdoor workers are experiencing disproportionate […].

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Roche’s TIGIT ambitions take another blow

pharmaphorum

Roche’s anti-TIGIT antibody tiragolumab has failed a second phase 3 trial, dousing expectations for the programme and its hopes of finding a companion to its cancer immunotherapy blockbuster Tecentriq. When tiragolumab missed the mark in the SKYSCRAPER-02 trial in extensive stage small-cell lung cancer (ES-SCLC) in January, Roche said it was a challenging indication, and it was hoping for better results in the SKYSCRAPER-01 study in non-small cell lung cancer (NSCLC).

Trials 59
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Regular blueberry consumption may reduce risk of dementia, study finds

Scienmag

The old adage says that an apple a day keeps the doctor away, but new research from the University of Cincinnati shows the potential benefit of a different fruit for your health. Credit: Photo/University of Cincinnati The old adage says that an apple a day keeps the doctor away, but new research from the University […].

Doctors 89
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Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11

NY Times

Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.

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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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Study points to need for substantial improvement in heart attack outcomes across high-income nations

Scienmag

The best way to treat acute myocardial infarctions, commonly known as heart attacks, has been long established by international consensus. The types of treatments and recommended procedures are well-defined, widely known, and readily available in modern hospitals. Yet, a newly published analysis of heart attack care and outcomes across six high-income nations has found baffling […].

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New patent for COVIS drug MAKENA

Drug Patent Watch

Annual Drug Patent Expirations for MAKENA Makena is a drug marketed by Covis and is included in one NDA. It is available from two suppliers. There are nine patents protecting…. The post New patent for COVIS drug MAKENA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Ludwig MSK study modeling tumor evolution reveals a vulnerability for cancer prevention and therapy

Scienmag

MAY 11, 2022, NEW YORK – Though the mutations accumulated by cancer cells occur more or less randomly, certain regions of genes essential to cancer growth appear to be more frequently mutated than others in established tumors. Now, a study led by researchers at the Ludwig Center at Memorial Sloan Kettering (MSK), MSK, Weill Cornell […].

Gene 86
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New patent for COVIS drug MAKENA PRESERVATIVE FREE

Drug Patent Watch

Annual Drug Patent Expirations for MAKENA+PRESERVATIVE+FREE Makena Preservative Free is a drug marketed by Covis and is included in one NDA. It is available from two suppliers. The generic ingredient…. The post New patent for COVIS drug MAKENA PRESERVATIVE FREE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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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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Rena Bizios elected to American Academy of Arts and Sciences

Scienmag

Rena Bizios, Lutcher Brown Endowed Chair in Biomedical Engineering and professor of biomedical engineering in UTSA’s Margie and Bill Klesse College of Engineering and Integrated Design (Klesse College), has been elected to the American Academy of Arts and Sciences (AAA&S). Credit: The University of Texas at San Antonio Rena Bizios, Lutcher Brown Endowed Chair in […].

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New patent for COVIS drug MAKENA (AUTOINJECTOR)

Drug Patent Watch

Annual Drug Patent Expirations for MAKENA+%28AUTOINJECTOR%29 Makena (autoinjector) is a drug marketed by Covis and is included in one NDA. It is available from two suppliers. There are nine patents…. The post New patent for COVIS drug MAKENA (AUTOINJECTOR) appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Illinois Tech Political Science Professor Matthew Shapiro named Fulbright Scholar

Scienmag

CHICAGO, May 10, 2022—Illinois Institute of Technology Professor of Political Science Matthew A. Shapiro has been awarded a Fulbright United States Scholar Program award in political science/international relations for the 2022–2023 academic year. Credit: Illinois Institute of Technology CHICAGO, May 10, 2022—Illinois Institute of Technology Professor of Political Science Matthew A.

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New patent for Bausch drug ARAZLO

Drug Patent Watch

Annual Drug Patent Expirations for ARAZLO Arazlo is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. The generic ingredient in ARAZLO…. The post New patent for Bausch drug ARAZLO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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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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New research in JNCCN encourages harnessing health technology to help cancer patients quit smoking

Scienmag

PLYMOUTH MEETING, PA [May 11, 2022] — New research in the May 2022 issue of JNCCN—Journal of the National Comprehensive Cancer Network finds the inclusion of the smoking cessation tool Electronic Health Record-Enabled Evidence-Based Smoking Cessation Treatment (ELEVATE, from Epic) into electronic health records (EHRs) can increase self-reported patient quit rates by more than 5 […].

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FDA Approves Bristol Myers’ Cardiac Drug for HCM + New Ovarian Cancer Blood Test – Xtalks Life Science Podcast Ep. 60

XTalks

In this episode, Ayesha discussed Bristol Myers Squibb’s new heart drug Camzyos (mavacamten), which has received approval from the US Food and Drug Administration (FDA) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The drug is the first to target the pathophysiology of obstructive HCM and may be Bristol Myers’ next blockbuster cardiac drug.

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A brain circuit in the thalamus helps us hold information in mind

Scienmag

CAMBRIDGE, MA — As people age, their working memory often declines, making it more difficult to perform everyday tasks. One key brain region linked to this type of memory is the anterior thalamus, which is primarily involved in spatial memory — memory of our surroundings and how to navigate them. Credit: Dheeraj Roy and Ying […].

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NPD Gallery: Technology Insider

BioPharma Reporter

We track developments and launches in process engineering tools and research components over the past few weeks.

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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.