Fri.Feb 11, 2022

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FDA delays review of Pfizer's COVID-19 vaccine for young children in surprise shift

Bio Pharma Dive

The FDA pushed back plans to expedite review of the shot in children under 5, seeking more data on a third dose. An advisory meeting scheduled for next week has been postponed as a result.

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Does Pfizer have a conscience?

World of DTC Marketing

Pfizer has held a vaccine monopoly, blocking low-income countries from accessing its novel technology, while enriching shareholders at levels advocates for vaccine equity label “obscene.” The corporation is making as much as $1 million in profits every hour from vaccine sales, according to Oxfam, and its executives boast that revenues will expand exponentially in 2022. ( The Atlantic ).

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US buys up supply of new Lilly antibody meant to work versus omicron

Bio Pharma Dive

Distribution of Lilly's earlier antibody treatments was halted as testing showed them ineffective against omicron. Bebtelovimab appears able to neutralize the variant, and was authorized by the FDA on Friday.

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Empowering rare disease patient advocacy organisations with data

pharmaphorum

Komodo Health’s president and co-founder, Web Sun, tells us about his company’s new partnership with the Chan Zuckerberg Initiative (CZI) to improve early diagnosis and advance research of rare diseases by providing CZI’s Rare as One Network healthcare data and software. Though 7,000 rare diseases exist that affect 400 million people globally, a lack of understanding of these diseases can cause a delay in diagnosis and, in turn, treatment.

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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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ProQR eye drug comes up short in key study, surprising company and investors

Bio Pharma Dive

The biotech's treatment did not improve vision in the Phase 2/3 trial, a significant setback that sent shares down by 75%.

Drugs 278
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Ipsen plans sale of consumer health business for €350m

pharmaphorum

Ipsen has started exclusive negotiations that could see its global consumer health business sold to fellow French pharma company Mayoly Spindler later this year. If consummated, the deal would bring in around €350 million for Ipsen , leaving the company as a specialty pharma pure-play in cancer, rare diseases and neuroscience and ending its strategy of adopting a combined prescription and over-the-counter (OTC) medicines business model.

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Cellular tornadoes sculpt our organs

Scienmag

How are the different shapes of our organs and tissues generated? To answer this question, a team from the University of Geneva (UNIGE), Switzerland, forced muscle cells to spontaneously reproduce simple shapes in vitro. By confining them on adhesion discs, the biochemists and physicists observed that the cells rapidly self-organise by aligning themselves in the same […].

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Two cases of ‘eye bleeding’ Lassa fever found in UK

Pharma Times

Rare viral haemorrhagic disease similar to Ebola surface in the East of England

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How personal commonalities foster closeness of political views

Scienmag

We naturally feel close to people who are similar to us, who share our interests or partake in related activities, for instance. This natural feeling of closeness can be funnelled to reduce political differences and increase consensus on conflictual political topics. That is a discovery made by an international team of researchers led by Dr […].

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F.D.A Delays Review of Pfizer’s Covid Vaccine for Children Under 5

NY Times

The agency will wait for data on whether three doses of Pfizer-BioNTech’s Covid vaccine are effective in young children after new, disappointing data.

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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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Boosting the immune defense: Interleukin-2 promotes fate decisions in CD8 T cells for long- or short-term immune protection

Scienmag

BIRMINGHAM, Ala. – The immune system is a complex network of cells and proteins with a simple job. Defend the body against infection. To do that, the cells must recognize and destroy infecting viruses or bacteria. In addition, the system also has to keep a record of each pathogen it has defeated, so it can […].

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Clear Connections for Equitable Medication Access

Drug Channels

Today’s guest post comes from John Beardsley, Senior Vice President of Corporate Strategy at CoverMyMeds. John discusses some of the findings in CoverMyMeds’ recently published report on medication access. He describes patient-centric, data-driven solutions to help patients access, afford, and adhere to their therapies. To learn more, download CoverMyMeds’ 2022 Medication Access Report.

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Diabetes, metabolic syndrome in mice treated with novel class of compounds

Scienmag

A study in mice — led by researchers at Washington University School of Medicine in St. Louis — shows that a new class of compounds the scientists developed can improve multiple aspects of metabolic syndrome. An increasingly common group of conditions that often occur together, metabolic syndrome includes type 2 diabetes, high cholesterol, fat buildup […].

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New adventure: PharmaVentures moves to London for growth strategy boost

Pharma Times

Transaction advisory company heads to the big smoke as part of its expansion plans

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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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Machine learning outperforms clinical experts in classifying hip fractures

Scienmag

A new machine learning process designed to identify and classify hip fractures has been shown to outperform human clinicians. Credit: University of Bath A new machine learning process designed to identify and classify hip fractures has been shown to outperform human clinicians. Two convolutional neural networks (CNNs) developed at the University of Bath were able […].

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F.D.A. Clears Monoclonal Antibody Drug From Eli Lilly

NY Times

The federal government has ordered 600,000 doses of the monoclonal antibody treatment, which is meant for high-risk Covid patients early in their illness.

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Researchers find new clues in the brain linking pain and food

Scienmag

It has long been known that there is an association between food and pain, as people with chronic pain often struggle with their weight. Researchers at the Del Monte Institute for Neuroscience may have found an explanation in a new study that suggests that circuitry in the brain responsible for motivation and pleasure is impacted […].

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¿Vacunar a los niños pequeños o esperar?

NY Times

No está claro si tres dosis de la vacuna Pfizer-BioNTech protegerán adecuadamente a los niños. Pero es posible que la FDA autorice las primeras dos dosis de cualquier manera.

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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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Extreme climate fluctuation drives south African domestic migration

Scienmag

Using a modified network modeling approach, the team looked specifically at water availability, temperature extremes, and migrants’ socioeconomic statuses during two migration periods in South Africa. They found that, in many cases, residents were likely to leave areas struggling with climate instability, and regions with more reliable climates were more likely to attract migrants.

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Virtual Get-Togethers Keep the Good Vibes Flowing at Intouch

Intouch Solutions

At Intouch, we know how important it is that employees feel valued and supported. From great health insurance coverage to the three weeks of vacation when you start, to the adoption-assistance benefits, tuition reimbursement and student loan pay-down programs, monthly tech stipends, and a lot more , there can be no doubt that employee satisfaction matters here.

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Nanopores feel the heat

Scienmag

Osaka, Japan – Scientists from SANKEN (the Institute of Scientific and Industrial Research) at Osaka University measured the thermal effects of ionic flow through a nanopore using a thermocouple. They found that, under most conditions, both the current and heating power varied with applied voltage as predicted by Ohm’s law. This work may lead to […].

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Ex-CoverMyMeds CEO Scantland launches new digital health project

pharmaphorum

Five years after selling CoverMyMeds to McKesson for $1.4 billion, the company’s CEO Matt Scantland has returned to the digital health sector with a new startup – AndHealth – that aims to help patients reverse chronic diseases. The new company has emerged onto the scene with $57 million in new funding from tech investor Francisco Partners – backed by the American Medical Association’s venture capital arm Health 2047, Kirkland & Ellis and Twofold Ventures – and a mobile app produc

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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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CSU Energy Institute researchers receive $1.5 million for methane emissions-reduction project

Scienmag

Colorado State University leaders in natural gas engine design and optimization are among a handful of teams nationwide innovating new technologies for reducing greenhouse gas emissions in oil, gas and coal industries. Credit: Allison Vitt/CSU Energy Institute Colorado State University leaders in natural gas engine design and optimization are among a handful of teams nationwide […].

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Fulcrum Therapeutics® Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BioTech 365

Fulcrum Therapeutics® Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Fulcrum Therapeutics® Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) CAMBRIDGE, Mass., Feb. 11, 2022 (GLOBE NEWSWIRE) — Fulcrum Therapeutics, Inc.

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How El Niño and drought affected the Trans-Atlantic Slave Trade

Scienmag

El Niño, an oceanic phenomenon that affects worldwide weather patterns, significantly affected the number of enslaved Africans transported from West Africa to the Americas between the mid-1600s and mid-1800s, according to a study from the University of California, Davis. Credit: UC Davis El Niño, an oceanic phenomenon that affects worldwide weather patterns, significantly affected the […].

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Which pharmaceutical drugs have the most drug patents in Poland?

Drug Patent Watch

This chart shows the drugs with the most patents in Poland. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Poland? appeared first on DrugPatentWatch - Make Better Decisions.

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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.

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UTSA faculty elected senior members of the National Academy of Inventors

Scienmag

The National Academy of Inventors (NAI) has named 83 academic inventors to its 2022 class of NAI Senior Members. Credit: The University of Texas at San Antonio The National Academy of Inventors (NAI) has named 83 academic inventors to its 2022 class of NAI Senior Members. Among these are UTSA faculty members Amanda Fernandez, Thomas Forsthuber and Eugene John.

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Regenxbio expands MPS I gene therapy trial after first look at data

pharmaphorum

Data from the first patients enrolled into Regenxbio’s trial of its gene therapy for rare inherited disease mucopolysaccharidosis type I (MPS I) – also known as Hurler syndrome – has shown the first signs of clinical activity. The results come from five patients enrolled in the biotech’s ingoing phase 1/2 study of RGX-111 – which uses an adeno-associated viral vector (AAV9) to deliver a gene coding for an enzyme that is deficient in MPS I patients – plus a single subject from an earl

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Vaccine hesitancy and vaccine refusal: the long-term development in Germany

Scienmag

Vaccine hesitancy and opposition to vaccinations were already a much-discussed topic before the pandemic. However, little is known about long-term trends due to a lack of data. Claudia Diehl and Christian Hunkler have now investigated this development. Based on the KiGGS cohort longitudinal study on the health of children, adolescents and young adults in Germany […].

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Sanofi unveils new corporate brand and logo – unites the company under one purpose and a single identity

The Pharma Data

Sanofi unveiled a new bold and unifying corporate brand that supports the modernization and transformation the company launched in December 2019. Over the last 50 years, Sanofi has grown into a diverse, global healthcare leader, with a rich heritage of patient-centric scientific discovery. This history includes the first treatments for many rare diseases and the establishment of standards of care in diabetes and cardiovascular disease.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.