Wed.Sep 16, 2020

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Lilly offers first evidence that its antibody drug may help treat COVID-19

Bio Pharma Dive

The results, from a mid-stage study of Lilly's drug, suggest treatment helped lower virus levels, but the degree to which patients benefited remains unclear.

Antibody 321
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iBio’s FastPharming® Platform Produces Decoy Therapeutic to Bind to SARS-CoV-2

BioSpace

Recently licensed from Planet Biotechnology, the candidate is a recombinant protein made from human angiotensin converting enzyme 2 (ACE2) fused to a human immunoglobulin G Fc fragment.

Licensing 144
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Arrowhead shares soar on liver disease data from four patients

Bio Pharma Dive

Encouraged by the early study results, Arrowhead plans to ask regulators to streamline its clinical trials, which could pressure rivals Vertex and Dicerna.

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UPMC Researchers Isolate Tiny Antibody That Neutralizes SARS-CoV-2 Virus

BioSpace

The researchers used this antibody, which is 10-times smaller than a full-sized antibody and the smallest isolated biological molecule to date, to develop a potential therapeutic and prophylactic agent against the virus termed “Ab8.

Antibody 129
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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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Cigna rebrands health services division, including Express Scripts, as Evernorth

Bio Pharma Dive

The change, which has been in the works since before the pandemic, is the next step in integrating the companies' business since their merger in 2018.

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Eli Lilly’s Antibody Therapy Against COVID-19 Reduced Hospitalization Rates

BioSpace

Eli Lilly and Company announced interim proof-of-concept data from its BLAZE-1 Phase II clinical trial of LY-COV555, its neutralizing antibody therapy for COVID-19.

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More Trending

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NIH Raises Concerns About Potential Safety Issues Associated with AstraZeneca Vaccine

BioSpace

The National Institutes of Health is raising concern about the safety of AstraZeneca’s coronavirus vaccine, even as the U.S. FDA is weighing whether or not to resume testing in the United States following a global pause in the trial for safety reasons.

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Trial backs Lilly’s Olumiant plus remdesivir as combo COVID-19 therapy

pharmaphorum

Adding Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) and Gilead Sciences’ remdesivir reduces recovery time in COVID-19 patients compared to remdesivir alone, says a new trial. The ACTT-2 trial, funded by the US government and run by the National Institute for Allergy and Infectious Diseases (NIAID), involved COVID-19 patients who had been hospitalised because of severe symptoms.

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Unity Bio Cuts 30% of Staff, Restructures to Focus on Ophthalmology and Neurology

BioSpace

UNITY Biotechnology launched a restructuring program to focus on cellular senescence in ophthalmology and neurology. As part of the plan, it is decreasing its workforce by about 30% to optimize capital.

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Germany grants BioNTech, CureVac $745m to advance Covid-19 vaccine work

BioPharma Reporter

To accelerate Covid-19 vaccine development, as well as upscale domestic manufacturing capabilities, the German government has announced a â750m (US$890m) fund to support the vaccine programs of three German developers, BioNTech, CureVac and IDT Biologika.

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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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Shine bright in 2020!

Pharma Times

The deadline for entering the 2020 PharmaTimes Communications Awards, Sales Awards and Marketer of the Year competitions has been extended to Friday October 2 after a last-minute spike in enquiries

Sales 101
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Inhale, Exhale: Living with Severe Asthma and Severe Eosinophilic Asthma

pharmaphorum

Head of “Living With”, Mariel Metcalfe, discusses the nature of severe asthma and severe eosinophilic asthma, and presents some key findings from recent patient research conducted in Europe, USA and Japan. The science behind the condition. Most people know that asthma is a chronic long-term respiratory condition in which the lung’s airways become inflamed and narrowed, making it difficult to breathe.

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This Is How Kraft Heinz Plans to Cut Costs by $2 Billion by 2024

XTalks

Kraft Heinz, the maker of the Heinz ketchup and Oscar Meyer, said in an investor’s call Tuesday it will cut costs by $2 billion and seek to increase sales under a five-year turnaround plan. The US food giant said it plans to accomplish these goals with a new operating model focused on procurement, manufacturing and logistics. “I am extremely confident that unlocking the power of scale with agility, combined with our new operating model, will return Kraft Heinz to consistent and sustainable growt

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Regeneron tests COVID-19 antibody therapy in UK’s RECOVERY trial

pharmaphorum

Regeneron’s COVID-19 antibody cocktail has been added to the UK’s RECOVERY trial, one of the largest of its kind in the world that is testing several potential coronavirus therapies at the same time. The phase 3 open-label trial will test the cocktail in patients hospitalised with COVID-19 and will compare the effects of adding the antibody cocktail REGN-COV2 to the usual standard-of-care versus standard-of-care on its own.

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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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A new species of spider

Scienmag

University of Bayreuth researcher discovers new species of spider during a research stay in the highlands of Colombia Credit: Photo: Charlotte Hopfe. During a research stay in the highlands of Colombia conducted as part of her doctorate, Charlotte Hopfe, PhD student under the supervision of Prof. Dr. Thomas Scheibel at the Biomaterials research group at […].

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CPhI: cell and gene therapy capacity shortages on the horizon

BioPharma Reporter

CPhIâs Annual Report 2020 predicts impending cell and gene capacity shortages for the US market, and possible mAb production growth in China.

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New smart drug delivery system may help treatment for neurological disorders

Scienmag

Drug delivery technology is aimed at helping people with spinal cord and other nervous system disorders Credit: KiBum Lee, Letao Yang and Brian M. Conley A Rutgers-led team has created a smart drug delivery system that reduces inflammation in damaged nervous tissues and may help treat spinal cord injuries and other neurological disorders. The system, […].

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An Experimental Drug Protects Covid-19 Patients, Eli Lilly Claims

NY Times

A so-called monoclonal antibody lowered blood levels of the coronavirus and prevented hospitalizations. The research has not yet been vetted by independent experts.

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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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Scientists identify gene family key to unlocking vertebrate evolution

Scienmag

Credit: David Jandzik New University of Colorado Boulder-led research finds that the traits that make vertebrates distinct from invertebrates were made possible by the emergence of a new set of genes 500 million years ago, documenting an important episode in evolution where new genes played a significant role in the evolution of novel traits in […].

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BioNTech, CureVac claim bulk of Germany’s €750m COVID-19 vaccines fund

pharmaphorum

In May, Germany pledged to provide up to €750 million ($889 million) in funding to support vaccines against COVID-19, and the main recipients have now been revealed – BioNTech, CureVac and IDT Biologika – which are all German biotechs. Mainz-based BioNTech’s vaccine programme – partnered with Pfizer and China’s Shanghai Fosun Pharma – is in line for the largest share of the pot, getting €375 million, while Tübingen firm CureVac will get €252 million.

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Tailored education system to benefit kidney transplant patients

Scienmag

Researchers find their computer-tailored education system, ‘Your Path to Transplant’ increases knowledge and readiness to pursue kidney transplant Credit: TREC (LOS ANGELES) – Patients with chronic kidney disease and end-stage renal disease have to go to a dialysis center for hours at a time, several times a week for the rest of their lives.

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NICE unites with global health leaders to highlight evidence-based healthcare

Pharma Times

World Evidence-based Healthcare Day takes place on 20 October

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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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Researchers demonstrate record speed with advanced spectroscopy technique

Scienmag

Fast, sensitive dual-comb spectroscopy could be used for fast measurements of fast and non-repeatable events Credit: David R. Carlson, National Institute of Standards and Technology and the University of Colorado in Boulder WASHINGTON — Researchers have developed an advanced spectrometer that can acquire data with exceptionally high speed. The new spectrometer could be useful for […].

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Prepping for COVID-19’s Next Wave: Is the Glass Half Full or Half Empty?

BioSpace

With both autumn and flu season fast approaching, nearly everyone is wondering whether we will endure another round of illnesses that will rival that of last spring.

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Researchers discover effective pathway to convert CO2 into ethylene

Scienmag

Credit: Yu Huang and William A. Goddard III A research team from Caltech and the UCLA Samueli School of Engineering has demonstrated a promising way to efficiently convert carbon dioxide into ethylene — an important chemical used to produce plastics, solvents, cosmetics and other important products globally. The scientists developed nanoscale copper wires with specially […].

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New Artificial Pancreas Offers Hope for Children with Poorly Controlled Type 1 Diabetes

BioSpace

The study, led by U.S. researchers, showed that the novel system was safe and effective for managing blood glucose in children as young as 6 years old.

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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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EDF, NASA, DRI, Google announce web application to transform water management in the West

Scienmag

OpenET will provide easily accessible satellite-based water data to help build a resilient future for agriculture Credit: OpenET (SACRAMENTO, CA — Sept. 15, 2020) The Environmental Defense Fund (EDF), NASA, the Desert Research Institute (DRI), and Google announced plans today to develop a new web application called OpenET to enable western U.S. farmers and water […].

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AI presents obstacles and opportunities in pharma: Iqvia

Outsourcing Pharma

A leader from Iqvia will present an overview of artificial intelligence, machine learning and other technology during this yearâs CPhI Festival of Pharma.

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New gene implicated in neuron diseases

Scienmag

A defective protein quality control system leads to motor neuron death, as seen in disorders such as ALS Credit: Courtesy Scripps Research JUPITER, FL — Failures in a quality control system that protects protein-building fidelity in cells can lead to motor neuron degeneration and related diseases, according to a new study from an international team […].

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CPhI shifts from real-world to digital realm

Outsourcing Pharma

In the face of the COVID-19 pandemic, CPhI Festival of Pharma organizers have shifted the event online but kept the industry content.

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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.