Fri.Mar 12, 2021

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The top drugs that could be impacted by an obscure provision in the pandemic relief law

Bio Pharma Dive

Elimination of the so-called penny rule in Medicaid could force drugmakers to pay larger rebates on a number of top medicines, including some HIV, diabetes and anti-inflammatory drugs.

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Avance Clinical Client Atossa Therapeutics Announces Final Results from Phase 1 Clinical Study Showing Safety and Tolerability of AT-301 Nasal Spray Being Developed for COVID-19

Pharma Mirror

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical congratulated Atossa Therapeutics on the announcement of their Phase 1 final results for the AT-301 nasal spray being developed for COVID-19. Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVI

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EU probes low platelet safety issue with COVID-19 shots

pharmaphorum

EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. The experts have also recommended a safety update on the label of Oxford University/AstraZeneca’s COVID-19 vaccine, which has been linked to anaphylactic reactions, in what has turned out to be a concerning week for vaccine safety.

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Breast cancer: The risks of brominated flame retardants

Scienmag

Brominated flame retardants may lead to early mammary gland development Credit: Isabelle Plante (INRS) Brominated flame retardants (BFRs) are found in furniture, electronics, and kitchenware to slow the spread of flames in the event of a fire. However, it has been shown that these molecules may lead to early mammary gland development, which is linked […].

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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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Cambridge Sleep Sciences’ device is trialled in Parkinson’s

pharmaphorum

Sleep disturbances are a common feature for people with Parkinson’s disease, and a device developed to help people with insomnia is now being trialled to see if it can improve their sleep quality. . The SleepHub device – developed by Barkby group company Cambridge Sleep Sciences – is on the face of it a box and speakers that plays relaxing noises to help you fall asleep more easily, but is underpinned by a sound wave technology that its developer claims prompt the brain into the activity pattern

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Natural “brake” against malignant neuroblastoma

Scienmag

Credit: Photo: Sabine Taschner-Mandl, PhD, and Tamara Weiss, PhD Copyright: St. Anna Children’s Cancer Research Institute Image: Immunofluorescence image of Schwann cells (magenta) and neuroblastoma cells (green) Copyright: Weiss T, Taschner-Mandl S et al.,… A factor that turns malignant tumors into benign ones? – That is exactly what scientists at St.

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Scientists sketch aged star system using over a century of observations

Scienmag

Credit: Credit: NASA’s Goddard Space Flight Center/Chris Smith (USRA/GESTAR) Astronomers have painted their best picture yet of an RV Tauri variable, a rare type of stellar binary where two stars – one approaching the end of its life – orbit within a sprawling disk of dust. Their 130-year dataset spans the widest range of light […].

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Life sciences must become cloud-first to seize the science of tomorrow

pharmaphorum

If the power of the life sciences industry to innovate and collaborate were ever in doubt, the speed at which vaccines for COVID-19 were discovered, developed, trialled, approved and manufactured have confirmed just how dynamic the industry can be. And that dynamism, innovation and collaboration are all qualities that the industry must continue to nurture as it faces the challenge of developing new medicines, treatments and services for the future.

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Accurate aging of wild animals thanks to first epigenetic clock for bats

Scienmag

UMD-led research identifies age-related changes to DNA and reveals longevity-related differences between bat species Credit: G. Wilkinson, G. Jones, S. Puechmaille, M. Tschapka A new study led by University of Maryland and UCLA researchers found that DNA from tissue samples can be used to accurately predict the age of bats in the wild. The study […].

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Protected: Customer engagement and pharma’s field force future

pharmaphorum

This content is password protected. To view it please enter your password below: Password: The post Protected: Customer engagement and pharma’s field force future appeared first on.

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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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How to spot deepfakes? Look at light reflection in the eyes

Scienmag

University at Buffalo deepfake spotting tool proves 94% effective with portrait-like photos, according to study Credit: Credit: www.thispersondoesnotexist.com and the University at Buffalo. BUFFALO, N.Y. – University at Buffalo computer scientists have developed a tool that automatically identifies deepfake photos by analyzing light reflections in the eyes.

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How To Improve Your Study- Startup in Clinical Trials?

Cloudbyz

Study startups (SSUs) define the process flow starting from the first point of contact with the sponsor to screening and recruiting process of subjects by study team. Researchers usually work with a SSU workflow so that the entire process can flow smoothly. While speed and efficiency are much-needed to improve study-startup, these are not just the only parameters to consider.

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RNA editing protein ADAR1 protects telomeres and supports proliferation in cancer cells

Scienmag

Isoform preserves telomere stability by preventing accumulation of R-loops, emerging as a new cancer cell vulnerability that could be therapeutically targeted. Credit: The Wistar Institute PHILADELPHIA — (March 12, 2021) — Scientists at The Wistar Institute identified a new function of ADAR1, a protein responsible for RNA editing, discovering that the ADAR1p110 isoform regulates genome […].

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New real-world evidence for Pfizer/BioNTech COVID-19 vaccine

Pharma Times

Evidence demonstrates lower incidence rates of COVID-19 in fully vaccinated individuals

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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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Oil in the ocean photooxides within hours to days, new study finds

Scienmag

Study provides new details on the fate of spilled oil in the marine environment, effectiveness of chemical dispersants Credit: MODIS on NASA’s AQUA satellite, 9 May 2010 @ 190848 UTC. Downlink and processed at the UM Rosenstiel School’s Center for Southeastern Tropical Advanced Remote Sensing (CSTARS) MIAMI–A new study lead by scientists at the University […].

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NHS England breast cancer wait times are ‘deeply worrying’

Pharma Times

All waiting time targets for breast cancer were missed in January

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Lee and collaborators studying use of 311 non-emergency issue-reporting system

Scienmag

Myeong Lee, Assistant Professor, Information Sciences and Technology, is working to understand how people use the 311 non-emergency issue-reporting system during the COVID-19 pandemic. Specifically, Lee and his collaborators aim to understand how local governments support people’s different uses of the system during the COVID-19 pandemic and how the different performance metrics of local governments […].

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Fred Figa, Who Helped Expose a Drug’s Dangers, Is Dead at 65

NY Times

He was the first hospital official to question the use of an unregulated vitamin injection linked to the deaths of 38 infants. He died of coronavirus complications.

Drugs 59
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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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Deborah Watkins Bruner to receive Fagin Distinguished Researcher Award

Scienmag

PHILADELPHIA (March 12, 2021) – The biennial award honors the best scholarly qualities that Dr. Fagin, the School’s third Dean, exemplified. It is given to a Penn Nursing faculty member, or a graduate from the School’s doctoral program, who has made a distinguished contribution to nursing scholarship. Dr. Bruner will deliver the lecture ‘Inspiration, Innovation […].

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Goodbye PharmacyCheckerBlog: Hello PolicyPrescription.com

Pharmacy Checkers

With nostalgia, I’m announcing that PharmacyCheckerBlog will no longer be updated with new posts effective today. If you’re looking for similar news, analysis, and editorial efforts, check out PolicyPrescription.com. Over 20 years ago, pharmacies in Canada began selling prescription drugs to Americans over the Internet. PharmacyChecker.com opened its virtual doors in 2003 to provide consumers, mostly in America, with information that helps them find the most affordable and safe prescription drug

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Experts recreate a mechanical Cosmos for the world’s first computer

Scienmag

Researchers at UCL have solved a major piece of the puzzle that makes up the ancient Greek astronomical calculator known as the Antikythera Mechanism, a hand-powered mechanical device that was used to predict astronomical events. Known to many as the world’s first analogue computer, the Antikythera Mechanism is the most complex piece of engineering to […].

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Why Your Personal Brand Will Get You To Your Clinical Research Goals

Clinical Trial Gurus

Your personal brand can either take you far or take you nowhere. One of the ways to work on your personal brand is by strengthening your online presence on platforms such as LinkedIn. Ashley presents out other ways to build your personal brand and offers examples of subtle yet effective ways to grow professionally.

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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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Virtual Film Festival Mathematics — Computer Science

Scienmag

Online film screenings The 8th Film Festival for Mathematics – Computer Science that was planned for November 2020 unfortunately had to be canceled. Since it is not currently possible to tell whether cinemas will open, we will be digitally screening a selection of films in March. Following each film, the director and in some cases […].

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Amar Urhekar joins Ashfield Health as global president

pharmaphorum

Former McCann Health veteran Amar Urhekar has joined Ashfield Health network as global president. Following a healthcare communications career spanning over two decades of leadership in five countries, Amar Urhekar takes the helm as global president of the more than 1,450-strong network that has rebranded from Ashfield Healthcare Communications to Ashfield Health.

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Immuno-PET can give physicians early insight into tumor response to targeted therapy

Scienmag

Credit: Image created by Patricia Pereira, PhD, Research Associate at Memorial Sloan Kettering Cancer Center Reston, VA–Immuno-positron emission tomography (PET) imaging can provide early insight into a tumor’s response to targeted therapy, allowing physicians to select the most effective treatment for patients who have cancer. The new research was published in the March issue of […].

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New ways to treat COVID: the pharmaphorum podcast

pharmaphorum

In episode 31 of the pharmaphorum podcast, Deep Dive editor George Underwood speaks to RedHill biopharma’s chief business officer Guy Goldberg about the potential for new COVID-19 therapeutics to help fight the pandemic and treat patients in the years to come. Prior to joining RedHill, Guy served as senior vice president of business operations at New Jersey specialty injectable drug development company Eagle Pharmaceuticals and he has also served as a member of the investment team at ProQuest In

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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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MRI scans more precisely define and detect some abnormalities in unborn babies

Scienmag

MRI scanning can more precisely define and detect head, neck, thoracic, abdominal and spinal malformations in unborn babies, finds a large multidisciplinary study led by King’s College London with Evelina London Children’s Hospital, Great Ormond Street Hospital and UCL. In the study, published today in Lancet Child and Adolescent Health, the team of researchers and […].

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BCMA Targeted Therapies Summit

pharmaphorum

Built with thought leaders from Seattle Genetics , Precision Biosciences and Kite Pharma , the inaugural industry-focused BCMA Targeted Therapies Summit will share the field’s cutting-edge and aggressive scientific advances of BCMA therapies within multiple myeloma. This summit is the first of its kind, uniting thought leaders in BCMA therapeutics drug development to discuss their challenges and future directions, with the aim to o vercome key obstacles when designing a clinical trial, addressin

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New machine learning model could remove bias from social network connections

Scienmag

UNIVERSITY PARK, Pa. — Did you ever wonder how social networking applications like Facebook and LinkedIn make recommendations on the people you should friend or pages you should follow? Behind the scenes are machine learning models that classify nodes based on the data they contain about users — for example, their level of education, location […].

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Sanofi/Translate start clinical trial of mRNA COVID shot

pharmaphorum

Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals despite its background in vaccines. While Pfizer/BioNTech and Moderna have been able to produce mRNA vaccines in a matter of months Sanofi is considerably behind with its collaboration with Translate Bio for COVID-19.

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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.