Fri.Jan 15, 2021

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Dana-Farber launches venture fund targeting incurable cancers

Bio Pharma Dive

Binney Street Capital plans to invest in eight to 10 companies over the next three years. Developing new drugs will be a core focus, though investments could also go toward health services, digital health or diagnostics.

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Pharma agency babble

World of DTC Marketing

HEY NOW: If you want a great example of why pharma needs to build expertise in-house and rely less on agencies, read the newest white paper from Intouch Group. I read the whitepaper, and it was full of vague obscurities that are, frankly, embarrassing. Want a great example of agency babble? Read this. “Pharma needs to turn what was a very smart, fast patchwork of change into something that becomes sustainable, durable and scalable, and start supporting HCPs in a complete shift in paradigm,

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US pushes for wider use of 'underutilized' COVID-19 antibody drugs as pandemic worsens

Bio Pharma Dive

A $2.6 billion deal with Regeneron this week is part of a renewed effort by government officials to bolster uptake of the treatments, which haven't gained traction.

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Things to Consider When You are Making Your Own Scrubs

Pharma Mirror

Whenever you see physicians, nurses, or any hospital worker, there’s a good chance that they’re wearing scrubs. This sanitary clothing or uniform was originally designed for use by surgeons and their support staff while in surgery rooms. It came to be known as scrubs because surgeons typically put them on as they sterilize or scrub themselves clean before entering the operating room.

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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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Former FDA chief Kessler tapped as top Biden adviser for COVID-19 response

Bio Pharma Dive

David Kessler, who served in both the first Bush and Clinton administrations, will be joined by former acting Medicare head Andy Slavitt in a revamped effort from the new administration.

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Health professions ask public to take concrete actions to help safeguard underfunded COVID-affected health systems

Pharma Mirror

Geneva – The presidents of all five international organisations that make up the World Health Professions Alliance (WHPA) have called for continued support for health and care workers in 2021 in a joint video message released today. International Council of Nurses president Ms Annette Kennedy, said: “As health professionals, most of us have been fighting the COVID-19 pandemic.

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More Trending

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J&J single-shot COVID-19 vaccine shows early promise

pharmaphorum

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month. The UK has caused controversy in recent weeks by tinkering with the dosing regimens for coronavirus vaccines from AstraZeneca and Pfizer/BioNTech, which are being rolled as part of the country’s mass vaccination programme.

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Ortho Clinical’s COVID-19 Antigen Test Gets FDA Authorization, Hoping to Aid with Mass Testing

XTalks

Ortho Clinical Diagnostics received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its VITROS SARS-CoV-2 antigen test for detection of active COVID-19 infection. The rapid antigen test can run up to 130 tests in an hour with and can deliver same-day results, making it useful for mass-scale COVID-19 testing. The antigen test provides precise, clinically reliable results generated on the company’s high-volume VITROS systems, which are installed in more than 5,

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GSK’s Neale Belson on building trust with employees and society

pharmaphorum

Pharma’s reputation is currently riding high as the industry comes together to tackle COVID-19, but GSK’s UK general manager Neale Belson says there is always more companies can do to build their culture and make sure employees and customers trust they are doing the right thing. When we spoke with Belson about the GSK’s response to COVID-19 , he pointed out how the pandemic has allowed him to get to know his colleagues even better than he anticipated.

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Umbilical Cord Stem Cells Show Promise as COVID-19 Therapy

BioSpace

Mesenchymal stem cells derived from umbilical cord tissue could help treat ARDS in COVID-19 patients, according to results of a Phase I/IIa clinical trial published by University of Miami researchers.

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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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NICE recommends interim funding for GSK’s Zejula in ovarian cancer

pharmaphorum

Women with newly-diagnosed advanced ovarian cancer have a new treatment option in England after NICE recommend interim funding for GlaxoSmithKline’s Zejula (niraparib) in final guidance. Zejula competes with AstraZeneca/Merck & Co’s PARP inhibitor class rival Lynparza (olaparib) but in this case it has an advantage in this maintenance therapy use as it can be used regardless of whether the BRCA mutation is present.

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New patent for Vertex Pharms drug SYMDEKO (COPACKAGED)

Drug Patent Watch

Annual Drug Patent Expirations for SYMDEKO+%28COPACKAGED%29 Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty patents protecting this drug. This…. The post New patent for Vertex Pharms drug SYMDEKO (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.

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How to Comply with the New Revision of USP 1058 Under a Lockdown Quiz

XTalks

Analytical laboratories required to demonstrate the suitability of their equipment will generally follow USP Chapter <1058> on analytical instrument qualifications (AIQ). Test your knowledge by engaging in this quiz and find out more on this topic by registering for this webinar here.

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180 Life Sciences Poised to Break Ground with Anti-TNF Program

BioSpace

Despite a storied career in drug design that has spanned multiple decades, James Woody believes there is still a significant amount of work left to be accomplished with the development of tumor necrosis factor inhibitor biologics.

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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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Biden Picks Former F.D.A. Chief to Lead Federal Vaccine Efforts

NY Times

Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official at Operation Warp Speed.

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Howard University professor to receive first Joseph A. Johnson Award

Scienmag

Thomas A. Searles honored for inspiring young Black physicists to pursue cutting-edge optics and quantum research Credit: Searles WASHINGTON, January 15, 2021 — The American Institute of Physics and the National Society of Black Physicists congratulate physicist Thomas A. Searles as the winner of the inaugural Joseph A. Johnson III Award for Excellence.

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Final Highlights from the 2021 J.P. Morgan Healthcare Conference

BioSpace

As the 2021 virtual JP Morgan Healthcare Conference wrapped up, there was still news from companies regarding their deals, pipeline and regulatory updates. Here’s a look.

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Celltrion closes in on COVID-19 antibody market after trial success

pharmaphorum

South Korea’s Celltrion has announced encouraging top-line results for its potential antibody therapy for COVID-19, with the first part of a phase 2/3 trial showing it could cut recovery times and chances of progression from moderate to more severe disease. Several other companies are also working on antibody therapies and Eli Lilly’s bamlanivimab gained an FDA Emergency Use Authorization in November last year, shortly after Regeneron’s cocktail of casirivimab and imdevimab.

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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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Nanodiamonds feel the heat

Scienmag

An international team of researchers created nanodiamond sensors that can act as both heat sources and thermometers, and is using them to measure the thermal conductivity inside living cells, which may lead to new diagnostics tools and cancer therapies Credit: Osaka University Osaka, Japan – A team of scientists from Osaka University, The University of […].

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A Mix of Pride and Doubts as Modi Launches India’s Covid-19 Vaccine Drive

NY Times

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

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Enabling new models of care: pursuing pharma’s partnership potential

pharmaphorum

There is a huge, ongoing shift in how health and wellness is approached in the UK, and the changes will have important implications for NHS-industry partnerships. Transformative change is coming to the NHS and is set to radically alter how the UK’s health service cares for people at a population level. The NHS Long Term Plan signposted this change, with its emphasis on preventative health, and the forthcoming expansion of the Integrated Care Systems programme continues this direction of travel o

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Verona completes enrolment in pilot study of potential COVID-19 inhaler

Pharma Times

Ensinfentrine is a first-in-class inhaled inhibitor of the enzymes phosphodiesterase 3 and 4

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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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Conductive nature in crystal structures revealed at magnification of 10 million times

Scienmag

University of Minnesota study opens up possibilities for new transparent materials that conduct electricity Credit: Mkhoyan Group, University of Minnesota In groundbreaking materials research, a team led by University of Minnesota Professor K. Andre Mkhoyan has made a discovery that blends the best of two sought-after qualities for touchscreens and smart windows–transparency and conductivity.

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Protocol Deviations in Clinical Research From a CRA Perspective

Clinical Trial Gurus

Protocol deviations are normal parts of clinical research that occur for various reasons. Most deviations are minor and don’t need to be reported to the IRB because they do not affect patient safety. In any event, sites should make every effort to document both minor and major deviations.

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Scientists’ discovery is paving the way for novel ultrafast quantum computers

Scienmag

Credit: wikipedia.org Scientists at the Institute of Physics of the University of Tartu have found a way to develop optical quantum computers of a new type. Central to the discovery are rare earth ions that have certain characteristics and can act as quantum bits. These would give quantum computers ultrafast computation speed and better reliability […].

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Thermo Fisher boosts viral vector manufacturing capabilities with Henogen acquisition

BioPharma Reporter

The growing global pipeline of cell and gene therapy projects has prompted Thermo Fisher Scientific to invest again, with it announcing today that it had bought Henogen, Novasepâs viral vector manufacturing business based in Belgium, for about US$879.72m (â725m) in cash.

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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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Rapid blood test identifies COVID-19 patients at high risk of severe disease

Scienmag

Measuring mitochondrial DNA could predict who will need ICU care, intubation Credit: WANDY BEATTY One of the most vexing aspects of the COVID-19 pandemic is doctors’ inability to predict which newly hospitalized patients will go on to develop severe disease, including complications that require the insertion of a breathing tube, kidney dialysis or other intensive […].

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Thermo Fisher Takes Deep Dive into Cell and Gene Therapy with Viral Vector Business Buy

BioSpace

Thermo Fisher Scientific announced the completion of Henogen SA, Groupe Novasep SAS’s viral vector manufacturing business in Belgium. The deal was for €725 million in cash.

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Hubble pinpoints supernova blast

Scienmag

Credit: NASA, ESA, and J. Banovetz and D. Milisavljevic (Purdue University) The NASA/ESA Hubble Space Telescope has observed the supernova remnant named 1E 0102.2-7219. Researchers are using Hubble’s imagery of the remnant object to wind back the clock on the expanding remains of this exploded star in the hope of understanding the supernova event that […].

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New patent for Vertex Pharms drug SYMDEKO (COPACKAGED)

Drug Patent Watch

Annual Drug Patent Expirations for SYMDEKO+%28COPACKAGED%29 Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty patents protecting this drug. This…. The post New patent for Vertex Pharms drug SYMDEKO (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.

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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.