Sun.Aug 16, 2020

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Working in pharma

World of DTC Marketing

Here is a copy of a talk I recently gave via Zoom to my European colleagues. Those of you who know me know that I am a frequent contributor to Hedley Rees books as well as the author of a blog that gets close to 100,000 reads a month. I have been and continue to be critical of the pharma industry but it’s not out of spite or hate. I am critical because I love this industry.

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Unity Bio’s Pain Drug Flunks Phase II Arthritis Trial

BioSpace

UNITY Biotechnology reported that the 12-week results from its Phase II study of UBX0101 in moderate-to-severe painful osteoarthritis (OA) of the knee failed to show improvement over placebo.

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Swittons Introduces Smart IoT Devices for Pharmaceutical Lab Digital Transformation Initiatives

pharmaphorum

Swittons , a P360 company, has announced a new line of Internet of Things (IoT) enabled smart devices built specifically for pharmaceutical labs. The fully customizable devices align with strategic Lab of the Future (LoTF) initiatives and help automate various laboratory workflows between people and existing digital lab equipment, systems and solutions.

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FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder

BioSpace

The U.S. Food and Drug Administration approved Genentech’s Enspryng (satralizumab-mwge) as a subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder.

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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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EU places firm order for AZ/Oxford Uni’s ChAdOx1 COVID-19 vaccine

pharmaphorum

The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million. ChAdOx1 – which is in large-scale phase 2/3 trials – was licensed by AZ in April and renamed AZD1222, and should be ready for first deliveries before the end of the year.

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Sanofi Acquires Principia Biopharma in $3.6 Billion Deal

BioSpace

Under terms of the deal, Sanofi will acquire all of the outstanding shares of Principia for $100 per share in cash, which represents an aggregate equity value of approximately $3.68 billion.

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BMS Licenses IL-12 from Dragonfly in $475 Million Deal

BioSpace

Bristol Myers Squibb plunked down $475 million for the exclusive license to Dragonfly Therapeutics’ interleukin-12 (IL-12) investigational immunotherapy program.

Licensing 120
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Scientists further cowpea research–boosting canopy CO2 assimilation, water-use efficiency

Scienmag

Credit: RIPE team Crops grow dense canopies that consist of several layers of leaves–the upper layers with younger sun leaves and the lower layers with older shaded leaves that may have difficulty intercepting sunlight trickling down from the top layers. In a recent study published in Food and Energy Security, scientists from Realizing Increased Photosynthetic […].

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Operation Warp Speed Selects McKesson for COVID-19 Vaccine Distribution

BioSpace

“Today’s announcement puts another building block in place as the Nation moves toward a safe and effective COVID-19 vaccine,” stated Robert Redfield, director of the U.S. Centers for Disease Control and Prevention.

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Half of parents report butting heads with child’s grandparent over parenting

Scienmag

Blame, shame and disagreements between parents and grandparents over parenting choices like discipline, meals and TV time can strain relationships Credit: C.S. Mott Children’s Hospital National Poll on Children’s Health at Michigan Medicine. ANN ARBOR, Mich. — Cookies for breakfast, staying up late and maybe a little more TV than usual.

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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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Biotech Startup Codagenix Plans Human Trials for COVID-19 Vaccine

BioSpace

The 11-person team at Codagenix may be tiny, but it has big plans for the company’s new COVID-19 vaccine.

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Gender parity & heart failure research: Female authors could mean more female participants

Scienmag

Analysis lead by Penn Medicine identified gender disparities in authorship of heart failure guideline citations and clinical trials PHILADELPHIA– While about a quarter of physicians and researchers working in advanced heart failure (HF) and transplant cardiology are women, representation of women leading HF research remains limited, according to new research led by Penn Medicine.

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In the Midst of Pandemic, Top HHS and CDC Officials Resign

BioSpace

In the midst of an international pandemic, three high-profile public health officials are leaving government service.

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Diagnostic Accuracy of Symptoms, Physical Signs, and Laboratory Tests for Giant Cell Arteritis

JAMA Internal Medicine

This systematic review and meta-analysis evaluate the diagnostic accuracy of symptoms, physical signs, and laboratory tests in patients with suspected giant cell arteritis.

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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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FDA Action Alert: Bristol Myers Squibb/Juno, Seattle Genetics, BioMarin and Tricida

BioSpace

With a busy August on the U.S. Food and Drug Administration’s schedule, this week is no exception. Here’s a look at some of what’s on the agency’s calendar.

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Assessment of COVID-19 Hospitalizations by Race/Ethnicity in 12 States

JAMA Internal Medicine

This cohort study uses data from a COVID-19 tracking project to assess the prevalence of COVID-19 infection by race/ethnicity in 12 US states.

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Biopharma Update on the Novel Coronavirus: August 17

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 17, 2020.

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Effects of nutrient pollution in marine ecosystems are compounded by human activity

Scienmag

Review highlights that negative effects of nutrients from human activities in marine ecosystems are exacerbated by other factors such as climate change Excessive nutrients, such as nitrogen and phosphorus, have devastating effects on coastal marine ecosystems by causing algal blooms that deplete oxygen in the water, killing marine life. Such nutrients can enter the sea […].

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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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FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

The Pharma Data

Basel, 17 August 2020. First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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Healx uses AI to find drugs for Angelman Syndrome

pharmaphorum

The UK-based AI technology company Healx has begun a partnership with the Foundation for Angelman Syndrome Therapeutics (FAST), focusing on developing new therapies for the rare neurogenetic disorder. The latest project will focus on quickly identifying and progressing novel treatments for Angelman syndrome, which is caused by several genetic mutations.

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The medical school trying to become anti-racist

The Pharma Data

Image copyright. Eva Larkai. Image caption. Eva Larkai, a fourth-year medical student, led the student group demanding change. A major British medical school is leading the drive to eliminate what it calls “inherent racism” in the way doctors are trained in the UK. The University of Bristol Medical School says urgent action is needed to examine why teaching predominantly focuses on how illnesses affect white people above all other sections of the population.

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New Guidelines for Phage Preparation Can Accelerate Lifesaving Treatment

Scienmag

The goal: Bring lab therapeutics to patients’ bedsides in half the current time frame. Credit: SDSU When clinicians resort to phage therapy for patients who don’t respond to antibiotics, the patients are usually very ill and time is of the essence. But the average time for labs to produce therapeutic phages is more than a […].

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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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Clinical Catch-Up: August 10-14

BioSpace

It was a very busy week for clinical trial updates. Here’s a look.

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Nitrate supplementation could help breathing and lung clearance in the elderly

Scienmag

New research published today in The Journal of Physiology shows that nitrate improves function in the diaphragm, the muscle involved in coughing and breathing, by improving power. The study done in old mice, if replicated in humans, could provide a strategy for helping elderly people clear the lungs more effectively and avoid infection. Previous studies […].

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Eppendorf Research 8-Channels Micropipette 0.5-10 ul

BioTech 365

EUR 159,90Scadenza: sabato ago-29-2020 22:54:12 CESTCompralo Subito per soli: EUR 159,90Compralo Subito | Aggiungi all’elenco degli oggetti che osservi Biotech365 : Eppendorf Research 8-Channels Micropipette 0.

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Coronavirus: Public Health England 'to be replaced'

The Pharma Data

Image copyright. PA Media. Public Health England is to be replaced by a new agency that will specifically deal with protecting the country from pandemics, according to a report. The Sunday Telegraph claims Health Secretary Matt Hancock will this week announce a new body modelled on Germany’s Robert Koch Institute. Ministers have reportedly been unhappy with the way PHE has responded to the coronavirus crisis.

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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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EPPENDORF 5415D Micro centrifuga FUNZIONA laboratorio Università

BioTech 365

EUR 545,00Scadenza: lunedì ago-17-2020 23:27:40 CESTCompralo Subito per soli: EUR 545,00Compralo Subito | Aggiungi all’elenco degli oggetti che osservi Biotech365 : EPPENDORF 5415D Micro centrifuga FUNZIONA laboratorio Università BioMarketplace You want to propose your products or a Biotech Company, a … Continue reading →

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Coronavirus: Test for Covid-19 T cells immunity developed

The Pharma Data

Image copyright. Indoor Biotechnologies. Image caption. Dr James Hindley says T cells can create more antibodies if a person is exposed to the virus again. A company in Cardiff has developed a test for coronavirus T cells – which can potentially provide longer-term immunity to the virus than antibodies. The body develops T cells when fighting an infection and they can create more antibodies if a person is exposed again.

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Arvelle Announces Partnership with Durbin Across Europe

BioTech 365

Arvelle Announces Partnership with Durbin Across Europe Zug, Switzerland, 17 August 2020 – Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, is pleased to announce a collaboration with Durbin Group (Durbin), … Continue reading →

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Kiadis collaborates with premier Dutch institutions to apply K-NK-cell technology for the development of a novel COVID-19 therapy

BioTech 365

Initiates new COVID-19 research and development program (K-NK-ID101) Expands the application of Kiadis’ K-NK technology into infectious diseases Announces collaboration with five premier Dutch institutions: Viroclinics-DDL; Harbour BioMed Netherlands; Sanquin Bloedvoorziening; Erasmus Medical Center; and the Utrecht University, each contributing … Continue reading →

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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.