Fri.May 07, 2021

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Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine

Bio Pharma Dive

The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.

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Pharma’s paid media fails

World of DTC Marketing

WTF? The Washington Post reported last year that health and pharmaceutical companies spent almost $1 billion on just Facebook mobile ads in 2019. A complete waste of money, time and effort. Unlike a traditional TV or radio ad, Facebook’s ad categories help those companies target their drug ads at users who likely suffer from a specific illness the drug treats.

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Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4 billion Market Demand

Pharma Mirror

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023. Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR).

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UK ‘planning to widen AstraZeneca COVID jab restrictions’

pharmaphorum

Reports are emerging that the UK may join other countries in imposing restrictions on the use of AstraZeneca’s COVID-19 vaccine in younger people, after a fresh look at the risks and benefits of the shot. . The Joint Committee on Vaccination and Immunisation (JCVI) said last month that it is preferable for adults aged under 30 with no underlying conditions to be offered an alternative to the AZ/Oxford University adenovirus-based vaccine where available.

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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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AZ' Tagrisso first to win MHRA approval under Project Orbis

Pharma Times

Decision brings the innovative treatment to early-stage lung cancer patients, helping to address unmet need in this setting

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After a Decade Without Executions, South Carolina’s Solution: Bring Out the Firing Squad

NY Times

State lawmakers have voted to add the firing squad as an alternative to the electric chair or lethal injection, with the drugs used for capital punishment in short supply.

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More Trending

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Bobbitt promoted to strategy director role at The Bloc

pharmaphorum

Antoinette Bobbitt has been promoted to executive vice president, strategy director at independent US creative agency, The Bloc. As EVP, Strategy Director, Antoinette will be responsible for ensuring that the agency’s talent, planning methodology, and tools are aligned with the Bloc’s vision of building exceptional customer experiences. She will oversee the strategy for several clients, and she’ll manage a team that works across all business units in order to ensure The Bloc’s competitive differ

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Archaeologists pinpoint population for the Greater Angkor region

Scienmag

Study designed at the University of Oregon provided a foundation that drew new information from lidar imagery, machine learning, archaeological and historical data Credit: Photo by Alison Carter EUGENE, Ore. — May 7, 2021 — Long-running archaeological research, boosted by airborne lidar sensing and machine-learning algorithms, finds that Cambodia’s Greater Angkor region was home to […].

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Small Pharma stock market launch funds DMT-based depression drug trial

pharmaphorum

UK-based Small Pharma has launched on the Toronto’s TSX Venture Exchange, raising 58 million Canadian dollars (around £34m) to develop medicines based on N,N-dimethyltriptylene (DMT) to treat depression. Small Pharma is following the trend for development of psychedelic medicines, a field where research has been suppressed for years because of legal restrictions on use of these compounds in many countries.

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New antibody rationally designed for better tumor inhibition

Scienmag

Credit: Hefei Institutes of Physical Science (HFIPS) Recently, Prof. XIE Can from the High Magnetic Field Laboratory of the Hefei Institutes of Physical Science (HFIPS), in a collaboration with Prof. YAN Xiyun’s lab from the Institute of Biophysics, reported the structural basis of mAb AA98’s inhibition on CD146-mediated endothelial cells (EC) activation and designed higher […].

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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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Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351 Variant Shared by Protein Vaccine Maker

XTalks

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 variant. Novavax published the latest results from a Phase IIb clinical trial conducted in South Africa evaluating the safety and efficacy of NVX-CoV2373, appearing in the NEJM ’s May 6, 2021 issue.

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Scrap for cash before coins

Scienmag

Researchers including Göttingen University show Bronze Age witnessed revolution in small change across Europe Credit: N Ialongo How did people living in the Bronze Age manage their finances before money became widespread? Researchers from the Universities of Göttingen and Rome have discovered that bronze scrap found in hoards in Europe circulated as a currency.

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W.H.O. Approves China’s Sinopharm Vaccine for Emergency Use

NY Times

Sinopharm is the first Chinese shot to be classified as safe and effective by the World Health Organization, allowing the vaccine to be more widely distributed to poor and middle-income nations.

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WVU researchers study the effects of vaping during pregnancy

Scienmag

Credit: West Virginia University Spurred by unproven assumptions that vaping is safer than smoking cigarettes, a team at West Virginia University is conducting a three-year study on the effects of vaping during pregnancy. It is estimated that half of all women who smoke prior to becoming pregnant will continue to smoke during and after the […].

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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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Pfizer Seeks Full FDA Approval for Its Covid-19 Vaccine

NY Times

The vaccine has been used under an emergency authorization since December. A decision by the Food and Drug Administration could take months.

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New study determines cystic fibrosis therapy is safe and effective for young children

Scienmag

Children two to five years of age can benefit from lumacaftor/ivacaftor treatment for up to 120 weeks Credit: Children’s Hospital Colorado Children ages two to five who have the most common form of cystic fibrosis (CF), caused by two copies of the F508 gene mutation, have not had any modulator treatments available to them until […].

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Pfizer Seeks Full F.D.A. Approval for Its Covid Vaccine

NY Times

The vaccine has been used under an emergency authorization since December. A decision by the Food and Drug Administration could take months.

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Rare genetic disease caused by mutations in protein that controls RNA metabolism

Scienmag

Credit: UPMC PITTSBURGH, May 7, 2021 – In a paper published today in Nature Communications, an international group of collaborators led by researchers at UPMC Children’s Hospital of Pittsburgh have identified a genetic cause of a rare neurological disorder marked by developmental delay and loss of coordination, or ataxia. The disorder, scientists found, is caused […].

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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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Vectura, Inspira team up to develop inhaled COVID-19 drug

Pharma Times

The deal will see Vectura test Inspira's inhaled IPX formulation candidates

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The first hydroxide conductivity in anion conducting polymer thin films

Scienmag

Researchers from Japan Advanced Institute of Science and Technology (JAIST) have successfully established a new humidity in situ measurements for anion conducting polymer thin films Credit: Yuki Nagao from JAIST Ishikawa, Japan – As decarbonization progresses rapidly in the world, fuel cells offer potentially higher electrical efficiency than conventional power-generating systems.

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Sanofi and Stanford Medicine collaborate on immunology research

BioPharma Reporter

Sanofi and Stanford University School of Medicine have established a three-year research collaboration: focusing on autoimmune diseases and inflammatory conditions.

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Turning a pancreatic cancer cell’s addiction into a death sentence

Scienmag

Credit: Visual Services, UHN (Toronto, Friday, May 7, 2021) — Probing the unique biology of human pancreatic cancer cells in a laboratory has yielded unexpected insights of a weakness that can be used against the cells to kill them. Led by Princess Margaret Cancer Centre (PM) Scientist Dr. Marianne Koritzinsky, researchers showed that about half […].

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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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UK launch for progressive multiple sclerosis mega-trial

Pharma Times

It is hoped that the multi-armed Octopus trial will rapidly speed up development of new treatments

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Distinct cell-to-cell communication processes controlled differently

Scienmag

Credit: Tohoku University Cells talk to each other to coordinate nutrition, waste removal, energy use, and, in some cases, disease progression. The cells that line the surfaces of organs or specific tissues, called epithelial cells, appear to speak two different languages – one for either side of the cell, according to a new study by […].

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Communications Awards winner shares insight into the competition

Pharma Times

Lucinda Sandon-Allum of Langland and winner in the 2020 Aspiring Communications Manager of the Year shares her competition highlights.

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Alzheimer Europe calls for people with dementia and carers to be prioritized for vaccine

Scienmag

Alzheimer Europe calls for prioritisation of people with dementia and carers in COVID-19 vaccination programs across Europe Credit: Alzheimer Europe Luxembourg, 7 May 2021 – In a new position statement, Alzheimer Europe has issued a call for prioritisation of people with dementia and their carers in national COVID-19 vaccination strategies, urging governments to recognise 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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Imfinzi, tremelimumab combo boosts survival in lung cancer

Pharma Times

The POSEIDON trial is the first Phase III study to demonstrate an overall survival benefit with tremelimumab

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The AGA Research Foundation awards 45 researchers with over $2.5 million in research funding

Scienmag

The Foundation introduced new awards in the 2021 awards cycle addressing diversity of GI investigators and the need for GI-specific COVID-19 research Credit: American Gastroenterological Association Bethesda, MD (May 7, 2021) — The American Gastroenterological Association (AGA) is excited to announce the 45 researchers inducted into the 2021 class of AGA Research Foundation Awards Program […].

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Is Non-Dairy Ice Cream with an Olive Oil Base the Next Big Trend?

XTalks

We have all heard of non-dairy and 100 percent vegan ice cream made of coconut, soy and almond milks, but for the first time, Wildgood has introduced vegan ice cream made with extra virgin olive oil. The company delivers its extra virgin olive oil-based non-dairy ice cream directly to consumers’ doors nationwide. Although some may think that ice cream with an oil base would be high in calories, Wildgood has developed an ice cream that is 20 percent lower in calories compared to other non-d

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Latest peer-reviewed research: Immediate global ivermectin use will end COVID-19 pandemic

Scienmag

WASHINGTON, D.C. – Peer reviewed by medical experts that included three U.S. government senior scientists and published in the American Journal of Therapeutics, the research is the most comprehensive review of the available data taken from clinical, in vitro, animal, and real-world studies. Led by the Front Line COVID-19 Critical Care Alliance (FLCCC), a group […].

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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.