Thu.Feb 18, 2021

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Lilly wagers almost $1B on Rigel's drugs for immune and nervous systems

Bio Pharma Dive

For $125 million up front, Lilly secures rights to a drug about to enter mid-stage testing for autoimmune and inflammatory diseases, as well as preclinical assets targeting the central nervous system.

Drugs 332
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QS-21, the ‘Gold Standard’ of immune system activators used in Covid-19 and other vaccines to be presented by CEO Gaston Salinas at BIO CEO & Investor Conference

Pharma Mirror

A novel approach for ensuring the virtually unlimited production of QS-21, the ‘Gold Standard’ adjuvant for improving vaccine efficacy, will be the subject of an upcoming presentation at the BIO CEO & Investor Digital Conference, starting February 16. BSI is well- positioned to become the industry’s most reliable and cost-effective supplier of GMP quality QS-21 worldwide.

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Investment firm raises $300M to fund medical research for overlooked diseases

Bio Pharma Dive

Adjuvant Capital's first fund drew interest from Merck and Novartis as well as philanthropies and other investment firms.

Research 222
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South Africa starts administering Janssen COVID-19 vaccine to health workers

BioPharma Reporter

South Africa has started administering the Janssen COVID-19 vaccine to health workers this week after the first doses arrived in the country. Meanwhile, J&J has submitted an application for Conditional Marketing Authorisation in the EU, following its application for EUA in the US.

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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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White House picks Brooks-LaSure to head Medicare, Medicaid, with big challenges ahead

Bio Pharma Dive

Brooks-LaSure takes over CMS with potentially significant changes coming to the structure of the Affordable Care Act and Medicare eligibility.

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UK will start first COVID-19 challenge study “within a month”

pharmaphorum

Sometime within the next few weeks, young and healthy volunteers will be deliberately exposed to the COVID-19 coronavirus in the UK in what looks set to be the first study of its type worldwide. . The human challenge study has just secured ethics committee approval and will recruit up to 90 volunteers aged 18-30 years, according to the UK government, which is backing it with £33.6 million ($47 million) in funding.

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GSK expands coronavirus antibody tie-up to include potential flu therapies

pharmaphorum

GlaxoSmithKline is expanding a coronavirus antibody collaboration with US biotech Vir, to include potential therapies for flu and other respiratory viruses. The big UK pharma is already working with Vir on antibody therapies for coronaviruses, and already have the antibody VIR-7831 in clinical trials including the US National Institutes of Health-backed ACTIV-3 study.

Antibody 112
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Research Shows Climate Change Could Have Driven the Appearance of SARS-CoV-2

XTalks

With new variants of the novel coronavirus popping up across the world, a recent study has shed light on the origins of SARS-CoV-2, pointing to climate change as a potential driver of its emergence. The study , published in the journal Science of the Total Environment , offers the first lines of evidence for how climate change could have played a direct role in the appearance of the COVID-19 pandemic-causing virus.

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Nektar lifted by Merck alliance for bempeg, new trial funding

pharmaphorum

Nektar Therapeutics is waiting on multiple data readouts for its lead drug bempegaldesleukin paired with strategic partner Bristol-Myers Squibb’s checkpoint inhibitor Opdivo, but that hasn’t stopped it signing up to test the drug with rival Keytruda from Merck & Co. . Merck will pair Keytruda (pembrolizumab) with bempegaldesleukin (NKTR-214) – known as bempeg for short – in a phase 2/3 trial involving patients with squamous cell carcinoma of the head and neck (SCCHN) that if positive could s

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New recommendations aim to eliminate racial bias in myeloma trials

Scienmag

Recommendations underscore importance of diverse representation in clinical trials to improve efficacy of treatments available to U.S. patient population Credit: Dana-Farber Cancer Institute Researchers from Dana-Farber Cancer Institute, the U.S. Food and Drug Administration (FDA) and the American Association for Cancer Research (AACR) are releasing recommendations designed to address the under-representation of African Americans in […].

Trials 98
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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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Foresite Capital Jumps Back Into SPAC Frenzy With Second Shell Company

BioSpace

The new company, FS Development II, announced this week it raised $175 million in an upsized offering at $10 per share. The shares will be listed on the Nasdaq under the ticker symbol FSII.

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Songbirds’ reproductive success reduced by natural gas compressor noise

Scienmag

Novel research reveals bluebirds, tree swallows seemingly ignore noise at first; pay later Credit: Julian Avery, Penn State Some songbirds are not dissuaded by constant, loud noise emitted by natural gas pipeline compressors and will establish nests nearby. The number of eggs they lay is unaffected by the din, but their reproductive success ultimately is […].

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No cooling off for pharma digital transformation in 2021

pharmaphorum

COVID-19 has already proved to be a digital accelerant for the pharmaceutical industry, sparking new ideas into life and lighting a fire underneath existing plans that had, in retrospect, yet to burn brightly. After a year in which the need for digital transformation in pharma reached white heat levels, the sector mustn’t cool off in 2021 and revert to business-as-usual.

Medicine 107
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New crystalline ice form

Scienmag

Scientists elucidate crystal structure for exotic ice XIX Credit: Uni Innsbruck Ice is a very versatile material. In snowflakes or ice cubes, the oxygen atoms are arranged hexagonally. This ice form is called ice one (ice I). “Strictly speaking, however, these are not actually perfect crystals, but disordered systems in which the water molecules are […].

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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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COVID-19 collaborations could ‘unlock’ the potential of the UK’s life sciences sector

Pharma Times

New report recommends continuing collaborations across the life sciences sector

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Improving stroke treatment with a modified therapeutic molecule

Scienmag

A research team from INRS has improved the protective effect of a molecule against ischemic stroke Credit: Christian Fleury (INRS) A research team from the Institut national de la recherche scientifique (INRS) has improved the protective effect of a molecule against ischemic stroke, which is caused by an interruption of blood flow to the brain. […].

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Avacta: Rapid COVID-19 antigen test shows ‘very good sensitivity’ and generates ‘no false positive’ results

BioPharma Reporter

Avacta says data for its SARS-CoV-2 rapid antigen test from ongoing clinical studies in Europe and the UK show excellent performance of the test in identifying patients with an infectious viral load and no false positive results.

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Study suggests link between DNA and marriage satisfaction in newlyweds

Scienmag

Variation in a specific gene could be related to traits that are beneficial to bonding and relationship satisfaction in the first years of a marriage Credit: Russell Cothren FAYETTEVILLE, Ark. -Variation in a specific gene could be related to traits that are beneficial to bonding and relationship satisfaction in the first years of a marriage, […].

DNA 94
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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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On-demand capabilities help drug developers in a pinch

Outsourcing Pharma

With demand for fast-tracking therapies, vaccines and other products increasing, companies like Azzur Group offer the ability to add capabilities quickly.

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Petroleum engineers of Samara Polytech developed a unique test facility

Scienmag

It is designed to simulate reservoir conditions Credit: @SamaraPolytech The original facility developed at Samara Polytech will help to explore the earth’s interior. Under laboratory conditions the mechanism recreates the physical parameters (for example, pressure and temperature) of a deposit located at different depths. With its help, it is possible to accurately determine the mechanical […].

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Strategies to Help College Graduates Find Jobs During the COVID-19 Pandemic

BioSpace

As we leave the winter of 2020-21 behind, let’s learn more about the strategies to help college graduates secure employment during COVID-19.

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Evox raises £69.2m to advance exosome-based therapeutics pipeline

Pharma Times

Series C financing will also be used for the development of Evox's DeliverEX exosome drug platform

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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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NKarta Therapeutics’ NKT Cells Elicit Better Response than CAR-T Cells Alone

BioSpace

NKarta Therapeutics is using engineered chimeric antigen receptor natural killer T cells (CAR-NKT cells) for allogeneic therapy, showing substantial benefits both in vitro and in vivo, according to James Trager, CSO, speaking Wednesday at the virtual CAR-TCR Summit – Europe.

In-Vivo 109
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Stents or bypass surgery more effective for stable patients with high-risk cardiac anatomy

Scienmag

Location of blockages in a patient’s heart is a key consideration in selecting the right treatment, University of Alberta cardiologists find Credit: Jordan Carson A recent study by University of Alberta cardiologists at the Canadian VIGOUR Centre shows that a particular group of patients with stable ischemic heart disease have better outcomes with percutaneous coronary […].

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Astellas Delivers Positive Phase III Results Against Severe Menopausal Hot Flashes

BioSpace

Moderate to severe vasomotor symptoms (VMS), also known as hot flashes, have long been a problem by people facing menopause.

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Relationship Advice: What Patients Want HCPs to Know About Satisfaction

pharmaphorum

What aspects of a patient’s treatment matter most? For many, healthcare providers (HCPs) make a significant impact on how a person feels about their overall care plan; a positive HCP-patient relationship can help a person feel in control of their health and more prepared for the journey ahead, while a less than ideal HCP-patient relationship can lead to unanswered questions and increased anxiety.

Doctors 75
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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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Research Roundup: Five Genes Associated with Lewy Body Dementia and More

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

Gene 98
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Irregular sleep schedules connected to bad moods and depression, study shows

Scienmag

The more variation in wake-up time and sleep time, the worse mood and more chance of depression symptoms in study of first-year medical residents An irregular sleep schedule can increase a person’s risk of depression over the long term as much as getting fewer hours of sleep overall, or staying up late most nights, a […].

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Novartis’ CAR T Reimbursement Strategy Finds Sweet Spot Between Value and Price

BioSpace

Novartis managed to bridge the gap between evidence of efficacy and value in this space with a variety of value-based pricing plans developed with regional payers.

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Researchers design more secure mobile contact tracing

Scienmag

For public health officials, contact tracing remains critical to managing the spread of the coronavirus — particularly as it appears that variants of the virus could be more transmissible. The need for widespread contact tracing at the start of the pandemic led tech giants Apple and Google to announce a plan to turn iOS and […].

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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.