Tue.Oct 13, 2020

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J&J halts studies of coronavirus vaccine due to participant's illness

Bio Pharma Dive

The company did not disclose details, nor could it confirm whether the participant had received its shot. But J&J is now the second vaccine developer, along with AstraZeneca, to suspend testing for a safety review.

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Relief Therapeutics and NeuroRx Release Promising Data for Potential COVID-19 Treatment

BioSpace

Relief Therapeutics and NeuroRx released results on Tuesday from their open-label prospective study looking into RLF-100 (aviptadil) as a potential treatment for COVID-19 and respiratory failure.

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There is value to patients when independent sites offer clinical trials

Bio Pharma Dive

We observe that the COVID-19 crisis shines a light on the benefits to patients and industry stakeholders of bringing clinical trials closer to patients' homes.

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Innovation boosts R&D outlook despite COVID difficulties – report

pharmaphorum

Ayming Group’s second annual International Innovation Barometer (IIB) has said that the international outlook for R&D is “remarkably promising” despite strong headwinds caused by COVID-19. The report reveals that R&D departments are being empowered by the creation of ‘innovation ecosystems’, new funding methods, and the deployment of technology.

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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 puts Voyager study on hold in latest gene therapy speed bump

Bio Pharma Dive

The biotech won't be able to start human testing of an experimental Huntington's disease treatment until regulators see more manufacturing data.

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CDC Finalizes COVID-19 Vaccine Distribution Plan as Vaccine Authorization Nears

BioSpace

With multiple COVID-19 vaccines in development, the CDC is confident that any vaccines the FDA authorizes or approves will be safe because they are based on the FDA’s usual stringent protocols. The greater question, after a vaccine is approved, is how it will be distributed.

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Roche to launch high-volume SARS-CoV-2 antigen test

BioPharma Reporter

Roche plans to launch its high-volume Elecsys SARS-CoV-2 Antigen test at the end of 2020 in markets accepting the CE mark; while the company will file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).

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COVID-19: Challenges, Innovation, and What’s Ahead in 2021

Pharma Marketing Network

Below is a Q&A with Mark Bard, Co-Founder of The DHC Group, who offers his insights on the challenges COVID-19 has brought to pharma, as well as what innovation is taking place due to this full shift to digital and what lies ahead in the future. What is the most challenging aspect of COVID-19 for the industry? Mark Bard: I think the most challenging aspect of the current situation is the inability of anyone – patient, physician, payor, or pharma – to truly predict how long it will take for v

Sales 105
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New patent for Astrazeneca Ab drug BYDUREON

Drug Patent Watch

Annual Drug Patent Expirations for BYDUREON Bydureon is a drug marketed by Astrazeneca Ab and is included in two NDAs. It is available from one supplier. There are thirty patents…. The post New patent for Astrazeneca Ab drug BYDUREON appeared first on DrugPatentWatch - Make Better Decisions.

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Scientists develop detector for investigating the sun

Scienmag

Credit: Egor Stadnichuk et al./Journal of Instrumentation Researchers from MIPT have developed a prototype detector of solar particles. The device is capable of picking up protons at kinetic energies between 10 and 100 megaelectronvolts, and electrons at 1-10 MeV. This covers most of the high-energy particle flux coming from the sun. The new detector can […].

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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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New CEO Mortazavi takes UK biotech e-therapeutics into gene silencing

pharmaphorum

UK biotech e-therapeutics has a new CEO, with executive chairman and former Silence Therapeutics chief Ali Mortazavi chosen to spearhead the next stage in the company’s development into gene silencing and other areas. Since it was founded in 2001 the company has become one of the country’s best known biotechs thanks to its approach to designing drugs based around network biology. e-therapeutics aims to design drugs that work across several targets that drive complex diseases and its remit has ch

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The Great Barrier Reef has lost half its corals

Scienmag

Credit: Andreas Dietzel. A new study of the Great Barrier Reef shows populations of its small, medium and large corals have all declined in the past three decades. Lead author Dr Andy Dietzel, from the ARC Centre of Excellence for Coral Reef Studies (CoralCoE), says while there are numerous studies over centuries on the changes […].

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First COVID-19 patient treated in Noxopharm study

Outsourcing Pharma

The clinical-stage drug development company has kicked off testing the experimental anticancer drug Veyonda on severe patients in a Phase I trial.

Trials 105
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Plant sciences student receives national honor

Scienmag

The GCSAA Mendenhall Award Recognizes Academic Excellence Credit: Image courtesy UTIA. KNOXVILLE, Tenn. – The Golf Course Superintendents Association of America has presented the Mendenhall Award, the organization’s highest academic honor for undergraduate students, to Brinkley Mull, a senior in the Department of Plant Sciences at the UT Herbert College of Agriculture.

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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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Wasp Venom Shows Potential Against Antibiotic-Resistant Bacteria

BioSpace

Scientists at the University of Pennsylvania hope to use powerful antimicrobial molecules found in the venom of the Vespula lewisii (Korean Yellow-jacket wasp) against the antibiotic-resistant bacteria that cause sepsis and tuberculosis.

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Controlling the speed of enzyme motors brings biomedical applications of nanorobots closer

Scienmag

Recent advances in this field have made micro- and nanomotors promising devices for solving many biomedical problems Credit: CNIC/ IBEC A study by scientists at the Centro Nacional de Investigaciones Cardiovasculares (CNIC), the Universidad Complutense (UCM), Universidad de Girona (UdG), and the Institute for Bioengineering of Catalonia (IBEC), working together with other international centers, has […].

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RPS calls for prevention of counterfeit medicines in UK’s supply chain

Pharma Times

In a letter to Health Secretary Matt Hancock the RPS called for urgent action

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Physics professor recognized for pioneering research

Scienmag

Physicist, cancer researcher named fellow of International Association of Advanced Materials Credit: The University of Texas at Arlington The International Association of Advanced Materials (IAAM) has selected a physicist and renowned cancer researcher at The University of Texas at Arlington as a fellow in recognition of his original and significant research in the fields of […].

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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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Sanofi’s Dupixent reduces severe asthma attacks in children

Pharma Times

Biologic therapy hit primary and all key secondary endpoints in phase III

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Genomic study of 6000 NCI-MATCH cancer patients leads to new clinical trial benchmarks

Scienmag

NCI-MATCH precision medicine trial makes major contributions to the use of tumor gene testing to select treatment for patients; new data has broad relevance in medicine and provides a roadmap for future precision medicine trials Credit: ECOG-ACRIN Cancer Research Group Five years ago, the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and National Cancer Institute (NCI), part […].

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Bavencio, Imbruvica among latest SMC decisions

Pharma Times

The committee accepted a number of drugs through the PACE process

Drugs 123
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Scientists author papers in Nature Astronomy chronicling legacy of Spitzer space telescope

Scienmag

Review papers provide an inventory of the greatest discoveries of the past decade and suggest targets for the next generation telescope Credit: Courtesy of Northern Arizona University NASA’s Spitzer Space Telescope, designed to study the early universe in infrared light, was the first telescope to see light from a planet outside our solar system.

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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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Aimmune Becomes Point Pharmaceutical Business for Nestlé

BioSpace

In August, Nestlé gobbled up Aimmune in a $2.6 billion deal, and now the food allergy-focused company will serve as the point pharmaceutical business for Nestlé Health Science.

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UC Davis creates new college program for students with intellectual disabilities

Scienmag

The fully integrated program is the first of its kind in California Credit: UC Davis Health The UC Davis MIND Institute and the UC Davis Office of Diversity, Equity and Inclusion have received a $2.1 million grant from the U.S. Department of Education to create an inclusive, four-year college program for students with intellectual disabilities. […].

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EdiGene Gets $67 Million Infusion to Bring Gene Editing to the Clinic

BioSpace

The Beijing-based biotech will use the Series B funds to further their hematopoietic disease and cancer therapies pipeline and expand team.

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To make mini-organs grow faster, give them a squeeze

Scienmag

Study finds that compressing cells, and crowding their contents, can coax them to grow and divide Credit: Yiwei Li The closer people are physically to one another, the higher the chance for exchange, of things like ideas, information, and even infection. Now researchers at MIT and Boston Children’s Hospital have found that, even in the […].

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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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Dyno Therapeutics Strikes AAV Deal with Roche Worth up to $1.8 Billion

BioSpace

Dyno will be responsible for the design of the novel AAV capsids that are expected to have improved functional properties for gene therapy. Roche and its subsidiary Spark Therapeutics will take the capsids and conduct preclinical studies with hopes of taking them into the clinic, and eventually t.

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Proactivity and partnership pay off for nursing homes in a pandemic, study suggests

Scienmag

Advance planning, universal testing and connection with a medical center kept COVID-19 activity low in three facilities in new study Credit: University of Michigan Seven months ago, the nation first heard of a surge of COVID-19 deaths in a Washington nursing home – an early warning sign of how the coronavirus could rip through such […].

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New patent for Astrazeneca Ab drug BYDUREON PEN

Drug Patent Watch

Annual Drug Patent Expirations for BYDUREON+PEN Bydureon Pen is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are twenty-nine…. The post New patent for Astrazeneca Ab drug BYDUREON PEN appeared first on DrugPatentWatch - Make Better Decisions.

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Canaan Closes $800 Million VC Fund for Life Sciences and Technology

BioSpace

Venture capital firm Canaan Partners closed on a new fund, it’s twelfth, raising $800 million to invest.

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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.