Mon.May 09, 2022

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Clay Siegall, founding Seagen CEO, takes leave amid domestic violence accusation

Bio Pharma Dive

The company's board is investigating the allegation, which Siegall, who has led Seattle's largest biotech for 24 years, denied. Chief Medical Officer and former Merck executive Roger Dansey was named interim CEO.

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As pharma dives deeper into digital, ad fraud is getting worse

World of DTC Marketing

Short on Time? Adalytics r eported that for nine months, billions of ad auctions for space on Gannett’s USA Today website resulted in brands unknowingly getting stuck with their ads running on other Gannett sites — often remote community sites. Ads from who-knows-how-many companies ran in the wrong places for nine months. Not a single brand noticed this, and not a single media buyer noticed the fraud.

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J&J ends hepatitis B, HPV vaccine work with Bavarian Nordic

Bio Pharma Dive

The companies' hepatitis B program never reached clinical testing, while J&J said it would no longer develop an HPV vaccine because of the "widespread uptake" of effective shots from other companies.

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SparkRx: The first digital therapeutic for adolescents

pharmaphorum

Mental health issues among teens and young adults have risen dramatically over the past decade. Jessica Lake, chief science officer at Limbix, tells us about SparkRx, a digital therapeutics app aimed to help treat adolescent depression. . SparkRx is designed to decrease depression in individuals aged 13 to 22 by providing a multi-week programme based on cognitive behavioural therapy (CBT) and behavioural activation protocols.

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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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Traditional and bespoke registries

Bio Pharma Dive

In order to truly understand the lived experience of a patient with a given condition or disease, several types of real-world data sources should be analyzed.

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Game used to track symptoms in children with cancer

pharmaphorum

A study has shown that a mobile game can be used to gather symptom data from children undergoing treatment for cancer, and potentially might also be used to provide personalised management of their care. That is the conclusion of a small US study looking at the role of Color Me Healthy, a gaming app developed through a collaboration between children, game designers and clinical staff.

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Developing vaccines against Epstein-Barr virus

BioPharma Reporter

Last week the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, launched a clinical trial to investigate a preventative vaccine for Epstein-Barr virus (EBV). Itâs part of growing efforts to create a vaccine against the virus.

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New patent expiration for Purdue Pharma drug TARGINIQ

Drug Patent Watch

Annual Drug Patent Expirations for TARGINIQ Targiniq is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are fifteen patents protecting this drug. Drug patent…. The post New patent expiration for Purdue Pharma drug TARGINIQ appeared first on DrugPatentWatch - Make Better Decisions.

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Digital divide: Data highlights internet inequities in Chicago

Scienmag

In 2021, the Infrastructure Investment and Jobs Act authorized $65 billion to expand broadband access and adoption, and address disparities highlighted by the COVID pandemic and the shift to remote work, school and health care. But to invest that funding most effectively for improving digital equity in the United States, new and deep data at […].

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TFF: Phase I study of inhalable COVID-19 drug shows promise

Outsourcing Pharma

The thin-film freezing specialist reports positive safety and pharmacokinetic data coming out of the Phase I trial of its niclosamide inhalation powder.

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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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Effects of breastfeeding on maternal mental health

Scienmag

A new systemic review of the literature examines the effects of breastfeeding on maternal mental health to inform breastfeeding recommendations. The results of this study are published in the peer-reviewed Journal of Women’s Health. Click here to read the article now. Credit: Mary Ann Liebert, Inc., publishers A new systemic review of the literature examines […].

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AbbVie and Cerebras Systems partner to accelerate AI research

Pharma Times

Link up between AbbVie and Cerebras Systems boosts AI platforms, while radically reducing energy consumption

Research 101
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High-performance hysteresis-free perovskite transistors

Scienmag

Robot vacuums, a major household appliance that make life easier, are convenient but they often stumble on door thresholds that are not even very high. A similar threshold voltage exists in a transistor through which current flows. As long as the voltage exceeds the threshold voltage, the output impedance of the transistor is sharply lowered […].

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Evotenix receives patent for gene synthesis method

Pharma Times

Vital patent for Evotenix is anticipated to enable a new generation of DNA synthesis platforms

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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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Getting sticky with it: Phospholipid found to play a key role in epithelial cell adhesion

Scienmag

In multicellular organisms, body cells adhere to each other to form tissues that perform various physiological functions. Epithelial cells form our skin and lining surfaces, such as the gut and other ducts, and protect our internal organs. To maintain the integrity of an organism and function properly, it is important for these cells to remain […].

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Nykode vaccine shows its worth in cervical cancer trial

pharmaphorum

Adding Nykode Therapeutics’ VB10.16 vaccine to treatment with Roche’s cancer immunotherapy Tecentriq resulted in disease control in two-thirds of patients with advanced cervical cancer. The combination of vaccine and checkpoint inhibitor had an overall response rate of 21% in the phase 2 VB C-02 trial involving 39 patients with HPV16-positive cervical cancer, including two complete responses and six partial responses with six months follow-up, said the Norwegian biotech.

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More difficult than expected for glaciers to recover from climate warming

Scienmag

Ice shelves are floating extensions of glaciers. If Greenland’s second largest ice shelf breaks up, it may not recover unless Earth’s future climate cools considerably. This is the result of a new study, published in Nature Communications. Credit: Photo: Martin Jakobsson Ice shelves are floating extensions of glaciers. If Greenland’s second largest ice shelf breaks […].

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Cardiovascular patient recruitment: Traditional vs. Digital methods

Clairnes

The post Cardiovascular patient recruitment: Traditional vs. Digital methods appeared first on Clinical Trial Recruitment & Management Services.

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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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Strategy overcomes EZH2 inhibitor resistance in SMARCB1 mutated cancer

Scienmag

(Memphis, Tenn.—May 9, 2022) Inhibitors of the protein EZH2 are effective against cancers with SMARCB1 mutations such as rhabdoid tumors in children. However, these drugs are subject to treatment resistance. Scientists at St. Jude Children’s Research Hospital have identified a novel drug target that may help overcome resistance to EZH2 inhibitors. A paper on the […].

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Informa Connect’s Hub and Specialty Pharmacy Models East

Drug Channels

Informa Connect’s Hub and Specialty Pharmacy Models East. Delivered as a Hybrid Event. June 28-30, 2022 | Sheraton Parsippany | Parsippany, NJ www.informaconnect.com/hub-specialty-pharmacy. Drug Channels readers will save 10% off the current registration rate when they use code 22DC10*. This important event convenes key stakeholders including manufacturers, specialty pharmacies, hub providers and more for unrivaled collaboration to leverage innovation and optimize access.

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Food insecurity risk related to diabetes later in life

Scienmag

SPOKANE, Wash. – Young adults who were at risk of food insecurity had increased incidence of diabetes 10 years later, according to a Washington State University study. While previous research has associated food insecurity with a range of health issues including diabetes, obesity and hypertension, this study showed a connection over time, suggesting a causal […].

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Ex-Sanofi CEO backs first European biomanufacturing SPAC

pharmaphorum

A new “black cheque” company that claims to be the first in Europe devoted to biomanufacturing has been set up by a team of investors, including former Sanofi chief executive Gerard le Fur. The new company – dubbed eureKING – plans to raise €150 million ($158 million) that will be used to buy up companies that operate in the European contract development and manufacturing organisation (CDMO) category.

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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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Crystal study may resolve DNA mystery

Scienmag

HOUSTON – (May 9, 2022) – When cells reproduce, the internal mechanisms that copy DNA get it right nearly every time. Rice University bioscientists have uncovered a tiny detail that helps understand how the process could go wrong. Credit: Yang Gao Lab/Rice University HOUSTON – (May 9, 2022) – When cells reproduce, the internal mechanisms […].

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Myovant Sciences and Pfizer Provide Update on Supplemental New Drug Application (sNDA) for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis

The Pharma Data

Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for MYFEMBREE ® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis.

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Stopping lung damage before it turns deadly

Scienmag

LA JOLLA, CA—If you’ve ever struggled to breathe, you’ve had a moment of hypoxia—a lack of oxygen. Hypoxia can have long-term effects. In fact, doctors describe hypoxia as an “initial insult.” Credit: La Jolla Institute for Immunology LA JOLLA, CA—If you’ve ever struggled to breathe, you’ve had a moment of hypoxia—a lack of oxygen.

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WHO delivers 20 ambulances to Ukraine

The Pharma Data

To support emergency health needs in Ukraine, World Health Organization (WHO) today gave 20 all-terrain ambulances able to function in even the most damaged and inaccessible areas to the Ministry of Health of Ukraine. “We bring not just supplies but support based on your needs. Today we are handing to you 20 ambulances, along with generators and blood refrigerators to hospitals wherever they are needed.” said Dr Tedros Adhanom Ghebreyesus, the WHO Director-General handing over the keys to

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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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Timing of ocean plankton blooms to shift with global warming

Scienmag

Global warming is directly impacting the ocean’s net primary production (NPP) at the base of the food web as well as the seasonal timing of plankton blooms, according to a new study, published in the journal Nature Climate Change. Credit: Institute for Basic Science Global warming is directly impacting the ocean’s net primary production (NPP) at […].

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Recurring brain tumor growth is halted with new drug

The Pharma Data

When a non-metastatic brain tumor – a meningioma – recurs after surgery and radiation treatment, a patient is out of options. No drugs are approved for these aggressive tumors, which occur in up to 20% of cases and can lead to patient disability or even death. But now Northwestern Medicine scientists, in an international collaboration with scientists at the University of California, San Francisco and the University of Hong Kong, have identified a drug that inhibits growth of the most

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Gatling receives funding for planning and training for digitization of materials

Scienmag

Benjamin Gatling, Assistant Professor, English, received funding from the University of California Los Angeles (UCLA) for: “Planning and training for the digitization of materials from the folklore archive of the Rudaki Institute of Language and Literature in Dushanbe, Tajikistan.” This project will result in a survey, inventory, and sample digitization of items from the folklore archive […].

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Oxurion craters as failed trial cuts its pipeline down to one

pharmaphorum

Shares in Belgian biotech Oxurion are taking a hammering this morning after it reported that one of its drugs for diabetic eye disease had failed a phase 2 trial and will be terminated. The decision affects THR-687, a pan RGD integrin antagonist for the treatment of diabetic macular oedema (DME), and leaves Oxurion with a single clinical-stage candidate – plasma kallikrein (PKal) inhibitor THR-149 – which is in phase 2 for the same indication.

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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.