Thu.Aug 27, 2020

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CanSino, Canada abandon plans for a coronavirus vaccine trial

Bio Pharma Dive

Canada was set to help CanSino produce its experimental shot as part of a deal to run what would've been the country's first coronavirus vaccine study.

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NIH Awards EcoHealth Alliance $7.5 Million Grant Despite Political Furor

BioSpace

EcoHealth had already developed a partnership with a WIV laboratory in Wuhan, China, under a five-year NIH grant. It was expected to run through 2024 but was canceled in April.

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Foundation Medicine wins FDA OK for pan-tumor test as liquid biopsy market heats up

Bio Pharma Dive

The approval for the FoundationOne Liquid CDx follows the agency's nod earlier this month for Guardant Health's next-generation sequencing diagnostic.

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New Breast Cancer Drug Shows Promise in Halting Disease Progression

BioSpace

According to data from Phase I clinical trials, a new breast cancer drug developed by researchers at the University of Illinois Chicago can potentially stop disease progression without toxicity.

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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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With latest data, a gene therapy for a deadly brain disease inches closer to market

Bio Pharma Dive

The results keep Bluebird Bio on track to seek approval of the experimental treatment, known as eli-cel, in Europe later this year and in the U.S. in 2021.

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Abbott Wins $750 Million Contract with U.S. Government for Rapid COVID-19 Test

BioSpace

One day after Abbott secured Emergency Use Authorization for its $5 coronavirus test, the White House awarded the company a $750 million contract to deliver 150 million Abbott BinaxNOW COVID-19 Ag Card Point of Care (POC) SARS-CoV-2 diagnostic tests.

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Study: Type 2 Diabetes Treatments May Be More Effective When Combined

BioSpace

A new study published in the August 26 edition of Science Advances shows that the effectiveness of a two-pronged Type 2 diabetes treatment improves when drugs are linked by a heat-sensitive tether.

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COVID-19 is causing a renaissance in the UK biotech sector, we must ensure it lasts

pharmaphorum

Despite the UK’s world class research output and the many start-ups successfully spinning out from its academic institutions, in recent years UK biotech companies have struggled to access the capital they need to scale up and make their mark on the industry. The COVID-19 pandemic has brought about a radical transformation, with investors now eager to fund companies involved in the fight against the virus.

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Scancell receives funding for COVID-19 vaccine development

Pharma Times

It is hoped that the vaccine will generate protection not only against SARS-CoV-2, but also against new strains of coronavirus that may arise in the future

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Moderna’s COVID vaccine works in older people, according to new data

pharmaphorum

Moderna has said that its coronavirus vaccine stimulated an immune response in older people in phase 1 trials, suggesting that the jab is effective in the age groups most susceptible to COVID-19. An analysis of the latest data from a phase 1 trial showed that in 20 older adults given the vaccine – ten between the ages of 56 and 70 and ten aged 71 and older – the vaccine produced neutralising antibodies and T-cells in comparable levels to those aged 18 to 55-years-old.

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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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Research Roundup: COVID-19 Nasal Vaccine 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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Industry group says FDA botched COVID-19 convalescent plasma guidance

pharmaphorum

Already under fire for what some view as a premature authorisation of convalescent plasma for COVID-19, the FDA is now being accused of a blunder that could render current supplies unusable. Bioindustry association MichBio says the FDA’s labelling requirements for COVID-19 convalescent plasma (CCP) – which were published alongside the emergency use authorisation – could lead to “hundreds, if not thousands, of in-date, ready to transfuse CCP units across the country being rendered unusable.”.

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Biopharma Update on the Novel Coronavirus: August 28

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 28, 2020.

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Garden Gourmet’s Plant-Based Tuna Exploits Market ‘White Space’

XTalks

Nestlé has announced the launch of a plant-based alternative to one of the most popular types of seafood: tuna. It’s their first move towards growing the plant-based market for seafood. This seafood alternative can be used in a wide range of dishes, which include salads, sandwiches, food bowls, pizzas and more. The texture is flaky and rich in flavor making it a favorable add-on to meals.

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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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Older adults’s faced mental health issues during the pandemic

Scienmag

IU research shows seniors felt greater depression and loneliness during the COVID-19 pandemic Credit: Indiana University Older adults experienced greater depression and loneliness during the COVID-19 pandemic, according to a new study by Indiana University researchers, and relationship strength (perceived closeness to network members) moderated the relationship between loneliness and depression The study, published in […].

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Kidney cancer charity slams NICE rejection of Keytruda/Inlyta

Pharma Times

NICE says the combination's cost-effectiveness estimate is higher than what is considered acceptable for NHS use

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Songbirds reduce reproduction to help survive drought

Scienmag

Credit: Photo by Thomas Martin MISSOULA – With climate change heating the globe, drought more frequently impacts the reproduction and survival of many animal species. New research from the University of Montana suggests tropical songbirds in both the Old and New Worlds reduce reproduction during severe droughts, and this – somewhat surprisingly – may actually […].

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Moderna says its COVID-19 vaccine shows promise in elderly patients

The Pharma Data

DoD photo. Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . The company has already tested the treatment on 10 adults between the ages of 56-70, and 10 over 71. Each patient was given two 100 microgram doses of the vaccine 28 days apart.

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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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Phase 1 human trials suggest UIC-developed breast cancer drug is safe, effective

Scienmag

Results published in Breast Cancer Research and Treatment Credit: UIC A new type of breast cancer drug developed by researchers at the University of Illinois Chicago can help halt progression of disease and is not toxic, according to phase 1 clinical trials. The drug is specifically designed for women whose cancer has stopped responding to […].

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SubjectWell eyes diversity in COVID-19 vaccine trials

BioPharma Reporter

The clinical trials marketplace company reportedly is connecting sites with 10,000 patients a month, with 40% of them from non-white groups.

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An improved wearable, stretchable gas sensor using nanocomposites

Scienmag

Credit: Cheng Lab, Penn State A stretchable, wearable gas sensor for environmental sensing has been developed and tested by researchers at Penn State, Northeastern University and five universities in China. The sensor combines a newly developed laser-induced graphene foam material with a unique form of molybdenum disulfide and reduced-graphene oxide nanocomposites.

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UK backs push to take pan-coronavirus vaccine toward the clinic

BioPharma Reporter

UK government provides Â1.9 million ($2.5 million) to move pan-coronavirus synthetic DNA vaccine toward human testing.

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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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Conditional approval for Hansa's kidney transplant drug

Pharma Times

Idefirix is an immunosuppressant that reduces the level of donor specific antibodies, thus enabling transplantation

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Avoid Career Burnout with These Easy Ideas

BioSpace

We all have stress, but sometimes the pressures of work tend to leach into other areas of our lives. This can cause an upheaval in your entire existence and may leave you feeling on-edge at the office and detached at home.

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A.I. tool promises faster, more accurate Alzheimer’s diagnosis

Scienmag

Stevens researchers use explainable A.I. to address trustability of A.I. systems in the medical field By detecting subtle differences in the way that Alzheimer’s sufferers use language, researchers at Stevens Institute of Technology have developed an A.I. algorithm that promises to accurately diagnose Alzheimer’s without the need for expensive scans or in-person testing.

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W2O acquires health policy consulting firm Discern Health

pharmaphorum

W2O has bought US health economics and outcomes research company Discern Health, marking its sixth acquisition in less than a year. The move will give Discern Health access to healthcare communications agency W2O ’s proprietary data models and tools, as well as its 1,400-person-strong multidisciplinary team – including data analysts, scientific strategists, branding experts, communications specialists and creatives.

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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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Black children with cancer three times less likely to receive proton radiotherapy than White children

Scienmag

Retrospective analysis highlights racial disparities that exist in clinical trials for a cancer therapy that may reduce long-term adverse effects A deep concern among pediatric oncologists has been confirmed by the data: Black children enrolled in national clinical trials have been found to be three times less likely to receive proton radiotherapy than their white […].

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GSK moves further ahead in BCMA with EU okay for Blenrep

pharmaphorum

GlaxoSmithKline has approval on both sides of the Atlantic for its multiple myeloma drug Blenrep, after getting the nod from the European Commission. Blenrep (belantamab mafodotin) becomes the first BCMA-targeted drug for myeloma to be approved in the EU, and according to its label can be used to treat the blood cancer in adult patients who have received at least four prior therapies.

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Moderna’s COVID-19 vaccine trial; Freenome secures $270 M; CRISPR treats obesity in mice; Breast cancer research updates

Delveinsight

Moderna’s COVID-19 vaccine triggers an immune response in older adults. Moderna showed robust phase 1 results for its COVID-19 vaccine in adults up to 55 last month. It is now following up with data from a small group of older adults, and they look positive. The phase 1 study that is being run by the National Institute of Allergy and Infectious Diseases tests three dose levels of the vaccine, mRNA-1273, given in two injections a month apart in 120 adults.

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WE Communications launches scientific engagement service

pharmaphorum

PR agency WE Communications has set up a new scientific engagement and medical education offering and recruited Terry Bradley and Ben Fisher to lead it. The duo, who are based in the UK, will be directors at WE Communications and tasked with driving new business for the service and supporting the agency’s clients at a country, EMEA and global level.

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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.