Wed.Oct 14, 2020

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Roche, aiming to make better gene therapies, turns to an emerging startup

Bio Pharma Dive

The Swiss pharma is the third large drugmaker to partner with Harvard spinout Dyno Therapeutics, a small biotech aiming to improve gene therapy technology.

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Treatment for Histoplasmosis

Pharma Mirror

Histoplasmosis is an inflammatory lung infection that usually occurs when a human has had contact with bird or bat droppings. Histoplasmosis is similar in symptoms to COVID-19, such as shortness of breath, fever, chest pain, and coughing. Some people who are at high-risk for histoplasmosis may also be concerned that they have contracted COVID-19. Though.

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Vertex faces first notable setback as it pushes beyond cystic fibrosis

Bio Pharma Dive

Safety signals in a mid-stage study led Vertex to stop work on one of its experimental drugs for the inherited disorder alpha-1 antitrypsin deficiency.

Drugs 332
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Eli Lilly Acquires Disarm Therapeutics in an Effort to Solve Axonal Degeneration

BioSpace

Eli Lilly is betting on a new approach to axonal degeneration, announcing a definitive agreement to acquire Disarm Therapeutics, a privately-held biotech company committed to solving this mystery.

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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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FDA approves Regeneron antibody drug as first Ebola virus treatment

Bio Pharma Dive

Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19.

Antibody 248
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BlueCloud and VirTrial Collaborate to Launch the First Global Training and Certification Program for Telemedicine Best Practices

VirTrial

AUSTIN, TEXAS (PRWEB) OCTOBER 14, 2020. BlueCloud® by HealthCarePoint (HCP) and VirTrial today announced a global collaboration that will enable international investigator sites to become VirTrial technology competent and ready for the benefit of Sponsors, CROs, Universities, regulatory agencies and other industry stakeholders, and ultimately patients.

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Can Dogs Identify COVID-19 Positive People?

XTalks

There are various ways to detect and diagnose COVID-19, including PCR-based tests and antigen diagnostics. But in some parts of the world, dogs are being used to sniff out COVID-19 positive patients. In Australia, a springer spaniel named Floki is being studied by scientists at the University of Adelaide. They are training the canine to detect signs of coronavirus infection in human sweat, with aims of using dogs to screen people for COVID-19.

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An alternative to animal experiments

Scienmag

New applications for organoids from human intestinal tissue Credit: E. Rath / TUM The human intestine is vital for both digestion and absorbing nutrients as well as drugs. For any type of research that involves intestines, scientists require research models that reflect the physiological situation inside human beings with the highest possible accuracy.

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Coronavirus re-infection case confirmed in the US

pharmaphorum

There is growing evidence that the coronavirus may be able to re-infect patients, and a new instance of a second infection has been confirmed in the US. . It is the fifth confirmed reinfection worldwide after at least four other cases were confirmed in Belgium, the Netherlands, Hong Kong and Ecuador. The latest case was recorded in the Lancet Infectious Diseases journal and involved a 25 year-old man with no known immune disorders or underlying conditions.

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Are corals genetically equipped to survive climate change?

Scienmag

Credit: This figure appears in the publication in Molecular Biology and Evolution. In 1998, ocean temperatures soared, and the world experienced its first significant coral bleaching event. From the Great Barrier Reef to Indonesia to Central America, corals turned white and ghostly. Many of them died. And this was just a hint as to what […].

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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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Vertex Abandons VX-814 Program for Treating Rare Liver Disease

BioSpace

Vertex Pharmaceuticals announced that after early data on its Phase II trial of VX-814 in Alpha-1 antitrypsin deficiency (AATD), it is halting the trial and ending development of the drug.

Trials 90
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Strategic interventions in dairy production in developing countries can help meet growing global demand for milk

Scienmag

Dairy production in developing countries highlighted in November issue of the Journal of Dairy Science® Credit: Adesogan, A.T. and G.E. Dahl. 2020. MILK Symposium Introduction: Dairy production in developing countries. J. Dairy Sci. 103:9677-9680. [link] Philadelphia, October 15, 2020 – Low dairy consumption is common among low- and middle-income countries (LMICs); however, with the demand […].

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A Year After Parntering with iota, Astellas Snaps Up the Company

BioSpace

Astellas Pharma is building on a 2019 collaborative relationship and snapping up California-based iota Biosciences and that company’s bioelectronics technology in order to accelerate its Rx+ business.

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Is English the lingua franca of science? Not for everyone

Scienmag

For many non-English speakers, language is a hindrance to full participation in science Credit: Photo courtesy of Valeria Ramírez-Castañeda English has become the de facto language of science: International conferences are held in English, the world’s top scientific journals are in English and academics in non-English speaking countries get promoted based on their publications in […].

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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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Clear COVID health information essential for return to normal healthcare – report

pharmaphorum

A lack of clear information on COVID risk is stopping people with long-term conditions accessing the care they need – and could be storing up problems for the future. People living with long-term health conditions have been missing vital tests and monitoring because they fear contracting the novel coronavirus. A survey carried out by the Patient Information Forum (PIF), and supported by Norgine, this summer found that almost one in three respondents had delayed accessing care during the pandemic

Research 105
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Cows prefer “live” co-moo-nication, study reveals

Scienmag

If you’ve ever wondered how to relax a cow, this one’s for you Credit: © Institute of Animal Welfare Science, Vetmeduni Vienna After months of technology-based communication enforced by COVID-19, many of us are missing a “live” human voice. But we’re not the only ones — a new study reveals that cows also prefer a […].

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Phase III? What Phase III? Russia Approves Second COVID-19 Vaccine After 100 Person Trial

BioSpace

Putin touts efficacy and safety of new vaccine without the data to back him up.

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COVID-19 recovery at home possible for most patients

Scienmag

Cedars-Sinai emergency department researchers confirm the safety of home discharge for low-risk patients with COVID-19 Credit: Photo by Cedars-Sinai LOS ANGELES (Oct. 12, 2020) — A new study shows that the vast majority of patients who visited the Ruth and Harry Roman Emergency Department at Cedars-Sinai with suspected COVID-19 (novel coronavirus) symptoms, and who were […].

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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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The Race for a COVID-19 Vaccine Continues to Heat Up as Case Numbers Rise

BioSpace

Several biopharmaceutical companies have made headway as of late in the race to develop a vaccine for COVID-19, which is responsible for the current global pandemic.

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Improving health care autonomy for young adults with autism

Scienmag

MU researcher helps adolescents with autism transition to adult health care Credit: MU School of Health Professions COLUMBIA, Mo. — Independence has always been a driving force in Nancy Cheak-Zamora’s life. Now an associate professor at the University of Missouri School of Health Professions, she grew up undiagnosed with dyslexia, a learning disorder that can […].

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3 Covid-19 Trials Have Been Paused for Safety. That’s a Good Thing.

NY Times

Experts were comforted that companies are following safety precautions. They pointed out that pauses in vaccine trials are common, but pauses in treatment trials like Eli Lilly’s are rare.

Trials 75
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Legal Team for Elizabeth Holmes Fails in Bid to Dismiss Criminal Charges

BioSpace

This week, the judge overseeing her trial denied all efforts from her legal team to dismiss more than a dozen criminal charges against the Theranos founder.

Trials 69
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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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Mapping out rest stops for migrating birds

Scienmag

New metric can help determine when birds fly over a site or stop to refuel or rest Credit: Colorado State University/ Kyle Horton Each spring, billions of land birds — thrushes, warblers, orioles, tanagers, and more — migrate through the night, navigating the coast of the Gulf of Mexico. Even greater numbers migrate in the […].

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Pros and Cons of the Common Types of COVID-19 Tests

BioSpace

While COVID-19 tests have been crucial in identifying and tracking cases of infection and disease-related morbidity and mortality, they aren’t without their potential drawbacks.

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Bone Therapeutics showcases allogeneic cell therapy data

Pharma Times

Data demonstrated a 90% successful lumbar vertebrae fusion rate at 24 months

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UMaine researcher: How leaves reflect light reveals evolutionary history of seed plants

Scienmag

The way leaves reflect light can illuminate the evolutionary history of seed plants, according to an international team of scientists led by a University of Maine researcher. Plant reflectance spectra, or the light profile leaves reflect across different wavelengths, capture the change and diversification of seed plants as a result of evolution, according to Dudu […].

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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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Current FDA COVID-19 advice and actions

Outsourcing Pharma

The federal government continues to offer life-sciences professionals advice and resources as they pursue treatments to help fight the COVID-19 virus.

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UNLV and University of Rochester physicists observe room-temperature superconductivity

Scienmag

The discovery, reported in the journal Nature, opens door for reimagining the energy grid, technology, society Credit: Josh Hawkins/UNLV Photo Services Physicists from the University of Nevada, Las Vegas and the University of Rochester have made a breakthrough in the long sought-after quest for a room-temperature superconductor, what they call the “holy grail” of energy […].

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Lilly's COVID-19 antibody trial on hold over safety concerns

BioPharma Reporter

Enrollment is temporarily on hold in the ACTIV-3 clinical trial, which is evaluating Lilly's investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients. The pause was recommended by the study's independent Data and Safety Monitoring Board (DSMB).

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Restoring 30% of the world’s ecosystems in priority areas could stave off more than 70% of projected extinctions and absorb nearly half of the carbon built up in the atmosphere since the Industrial Revolution

Scienmag

As world focuses on dual crises of climate change and biodiversity loss, landmark report is the first of its kind to pinpoint the ecosystems that should be restored for the biggest climate and biodiversity benefits-at the lowest cost London (14 October 2020)–Returning specific ecosystems in all continents worldwide that have been replaced by farming to […].

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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.