Fri.Sep 11, 2020

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NIH starts broad set of studies testing blood thinners against COVID-19

Bio Pharma Dive

The trials, which involve Bristol Myers and Pfizer's Eliquis as well as other anticoagulants, follow mounting evidence of blood clotting in COVID-19 patients.

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Ex-Allergan CEO Saunders pops up again in ‘blank cheque’ company

pharmaphorum

Brent Saunders has been out of the limelight for a few months since departing Allergan after its takeover by AbbVie, but now he is back in a leading role at Vesper Healthcare Acquisition, set up to acquire assets in the healthcare sector. Delaware-incorporated Vesper has filed a with a $400 million initial public offering (IPO) and plans to list on the Nasdaq under the symbol VSRU, with Goldman Sachs and JP Morgan acting as bookrunners.

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Poll: Trust in Fauci and the CDC is Declining Ahead of the November Election

BioSpace

Six months into a global pandemic and public trust is waning in its support for public health officials in charge of the nation’s response to the novel coronavirus, according to a new poll.

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Is a lack of real-time data holding trials back?

pharmaphorum

It’s 2020 and the digital revolution is well on its way. Yet, for clinical trials worldwide, real-time access to data is not the norm – and that lack can create a cascading set of issues affecting every aspect of a study. Critical decisions are too often being made in a digital data vacuum. At best, processes are not as efficient as they could be; at worst, serious problems may go undetected for weeks or even months.

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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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Untangling the Body’s Smart Sensors: What RNA Binding Proteins Can Tell Us About Gene Regulation

BioSpace

Can you imagine organizing more than 10 terabytes of data into a useful network of information, like creating Google maps from scratch? I certainly can’t, but Eclipse BioInnovations, a San Diego-based biotech start-up, is aiming to do just that for RNA therapeutics.

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Diseases Don’t Discriminate, So Why Aren’t Clinical Trials More Diverse?

XTalks

COVID-19 isn’t one tragedy, but many. An underreported consequence of the pandemic is the outsized harm done to communities of color. In New York City — an early COVID-19 hotspot, and one of the most diverse communities in the world — 92 black residents died per 100,000 people. For white New Yorkers, the rate was less than half that, at 45 per 100,000 people.

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Delivering COVID-19 vaccines safely will be the ‘mission of the century’ for air cargo industry

BioPharma Reporter

Transporting a COVID-19 vaccine to 7.8 billion people around the world would fill 8,000 jumbo jets â illustrating the enormity of the distribution challenge. The International Air Transport Association (IATA) warns of potential capacity constraints, saying planning must begin now.

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AstraZeneca CEO: COVID-19 Vaccine Could Still Be Ready by End of 2020

BioSpace

Despite a temporary pause on its COVID-19 vaccine trial, AstraZeneca Chief Executive Officer Pascal Soriot said the preventative drug could still be available for commercial use by the end of the year, or in early 2021 barring any other setback.

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AI could drive health systems in lower-income countries – report

pharmaphorum

Health systems in lower-income countries could overtake those in richer countries with AI-enabled technologies, according to a report from Novartis Foundation and Microsoft. Technologies such as mobile phone trading platforms, e-banking, e-commerce, and even blockchain applications have often been adopted more quickly and comprehensively in low- and middle-income countries than in high-income countries, the report found.

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Vertex's CF Blockbuster Trikafta Effective in Kids 6 to 11 Years of Age

BioSpace

Based on the positive results, the company plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter and other regulatory agencies around the world afterward.

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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 hits back at Novartis with new data for MS drug Ocrevus

pharmaphorum

Roche has hit back at Novartis’ newly-approved multiple sclerosis drug Kesimpta, with new data from its already-marketed blockbuster Ocrevus. Ocrevus (ocrelizumab) was approved in 2017 for relapsing and primary progressive forms of MS and is seen as one of the most successful drug launches in pharma history, generating sales of $3.79 billion in 2019 with more growth predicted this year.

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Looking Back on a Successful Summer for Plant-Based Burgers

XTalks

Looking back on what could be the most unprecedented summer for the food and beverage industry, two companies that skipped the summer break were Impossible Foods and Beyond Meat. Both plant-based meat giants have been competing for the number one spot, trading big announcements back and forth all summer long. Whether it was international deals, retail partner announcements, or direct sales channel launches, the one common thread for both companies was expansion.

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Shedding light on coral reefs

Scienmag

New research quantifies light availability on coral reef ecosystems Credit: Eric Hochberg Earlier this year, Bermuda Institute of Ocean Sciences (BIOS) senior scientist and coral reef ecologist Eric Hochberg published a paper in the journal Coral Reefs that put numbers to a widely accepted concept in reef science: that materials in seawater (such as phytoplankton, […].

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Investors Pump $30 Million into Orasis Pharmaceuticals’ Series C Financing Round

BioSpace

Orasis Pharmaceuticals has closed on $30 million dollars in Series C financing that will propel its corrective eye drop candidate for presbyopia symptoms, CSF-1, through Phase III clinical trials.

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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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Feeding off fusion or the immortalization of tumor cells

Scienmag

Credit: ©Knoblich lab/IMBA Worldwide, cancer is the second leading cause of death – in 2018 alone, it claimed approximately 9.6 million lives, or one in six deaths. The development of cancer is incredibly complex and is controlled by an interplay of various factors – only recently, it became clear that the majority of human cancers […].

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NICE backs Portola's Ondexxya

Pharma Times

The drug's use has, however, been restricted to reversing anticoagulation from apixaban or rivaroxaban in adults with life threatening or uncontrolled bleeding in the gastrointestinal tract

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Mental Health to Play a Role in the Defense Strategy for Elizabeth Holmes

BioSpace

Elizabeth Holmes, the founder and former chief executive officer of failed diagnostics company Theranos, will be examined by a psychologist and psychiatrist ahead of her looming trial for fraud.

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Researchers develop rapid test for ovarian cancer detection

Scienmag

The CA125 antigen, a plasma membrane glycoprotein found in the tissues of the female reproductive tract, is commonly used for the detection of ovarian cancer but works poorly on its own in identifying early stage cancers. The cancer specificity can be improved significantly when CA125 detection is combined with targeting aberrant sugar structures in the […].

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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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Biotech IPOs: Intra-Cellular Therapies, 10x Genomics and Spero Therapeutics

BioSpace

It was a busy week for biopharma, biotech and medical device initial public offerings (IPOs). Here’s a look.

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NIHR, UKRI fund eight new coronavirus research projects

Pharma Times

The projects are investigating different aspects of virus transmission in the hope that findings will better inform policy decisions on prevention and containment

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Research Roundup: Why COVID-19 Is More Severe in the Elderly and Men and More

BioSpace

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

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Poor home hygiene contributing to antibiotic resistance, warn global hygiene experts

Scienmag

According to the Global Hygiene Council’s (GHC) public health experts, following a risk-based approach to home hygiene is essential to help curb the growing threat of antibiotic resistance. Credit: The Global Hygiene Council According to the Global Hygiene Council’s (GHC) public health experts, following a risk-based approach to home hygiene is essential to help curb […].

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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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Research backs use of liquid biopsy for personalised cancer care

Pharma Times

The blood test reliably picks up mutations in breast cancer and matches women to different targeted treatments, researchers said

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New immunotherapy to beat cancer

Scienmag

Cancer immunotherapy is the manipulation of the immune responses naturally present in the human body to fight cancer. Often, these immune responses are blocked by cells or molecules that prevent them from killing cancer cells, and the tumour is able to establish itself and grow. In 2004, Sophie Lucas, researcher at the University of Louvain […].

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Biopharma Update on the Novel Coronavirus: September 11

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 11, 2020.

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Taste buds may play role in fostering obesity in offspring

Scienmag

ITHACA, N.Y. – Cornell food scientists show in animal studies that a mother’s high-fat diet may lead to more sweet-taste receptors and a greater attraction to unhealthy food in their offspring – resulting in poor feeding behavior, obesity in adulthood. The researchers’ findings were published July 31 in Scientific Reports. Maternal exposure to a high-fat […].

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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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El proyecto de dos estudiantes ofrece nuevas esperanzas para tratar la ELA

NY Times

Los ensayos clínicos de varios tratamientos experimentales muestran nuevos avances y la posibilidad de que la parálisis del trastorno pueda ser frenada.

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Researchers identify role of protein in development of new hearing hair cells

Scienmag

Finding could lead to future treatments for hearing loss Credit: University of Maryland School of Medicine Researchers at the University of Maryland School of Medicine (UMSOM) have conducted a study that has determined the role that a critical protein plays in the development of hair cells. These hair cells are vital for hearing. Some of […].

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Traveling For Business Vs. Vacation

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Antibody responses in COVID-19 patients could guide vaccine design

Scienmag

Credit: NIAID, 2020 A comprehensive analysis of antibody responses in coronavirus disease 2019 (COVID-19) patients could inform the development of an effective vaccine, according to a study published September 10 in the open-access journal PLOS Pathogens by Chao Wu and Rui Huang of Nanjing University Medical School, and colleagues. The results show that the neutralizing […].

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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.