Tue.May 17, 2022

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Scientists home in on cause of Duchenne gene therapy side effect

Bio Pharma Dive

An unusual collaboration among gene therapy developers suggests certain mutations could be behind "peculiar" side effects experienced by several patients treated in clinical trials.

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A new era of pharma marketing?

World of DTC Marketing

Just 13% of people trust the pharma companies they interact with. 68% say the interactions feel transactional. Only a third agree that organizations know their communication preferences. Communication and transparency are vital to building trust, which necessitates a shift away from traditional DTC marketing. If pharma is going to leap to a new era of marketing, they have to get to know their audiences.

Marketing 214
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Gilead, having resolved manufacturing issues, forges ahead with HIV drug

Bio Pharma Dive

The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

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Crown Bioscience and MBL Enter Joint Venture to Provide Advanced Preclinical Services for Japanese Customers

Pharma Mirror

California, Crown Bioscience and Medical & Biological Laboratories (MBL), JSR Life Sciences companies, today announced the formation of a joint venture, to further expand the provision of Crown Bioscience’s preclinical services to Japanese customers. The new entity named “Crown Bioscience & MBL”, is a long-term strategic partnership that is expected to accelerate growth for both companies.

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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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Ultragenyx strikes deal with struggling Abeona for rare disease gene therapy

Bio Pharma Dive

The treatment, which is designed to treat Sanfilippo syndrome, could become Ultragenyx's first gene therapy to reach market in the U.S., according to the biotech's CEO.

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How Heart Attack Survivors Can Improve Lifestyle Factors with a Text Messaging Program

XTalks

Results of an Australian study published in the American Heart Association’s flagship, peer-reviewed journal Circulation show that a text messaging program designed to remind, support and motivate heart attack survivors to take their medication helped them improve their weight and eat more fruits and vegetables but interestingly, did not improve medication adherence.

More Trending

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Pringles Scorchin’ Line Expands with New Limited-Edition Flavors

XTalks

The Pringles Scorchin’ team has partnered with First We Feast’s internet phenomenon Hot Ones to release new limited-edition flavors that pack a deliciously fiery burn. The Kellogg Company-owned brand worked with the Emmy-nominated talk show to create three new Pringles Scorchin’ flavors to deliver a spicy heat that builds over time. . The three new limited-edition Pringles Scorchin’ Hot Ones are inspired by Hot One wing sauce.

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New patent for Ironwood Pharms drug ZURAMPIC

Drug Patent Watch

Annual Drug Patent Expirations for ZURAMPIC Zurampic is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug. This drug…. The post New patent for Ironwood Pharms drug ZURAMPIC appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 95
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MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer treatment

Pharma Times

Authorisation of the treatment is based on results from the phase 3 trial

Marketing 141
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Fourth Edition of Landmark Glycobiology textbook now available in print and online

Scienmag

May 17, 2022 Credit: Dr. Lorenzo Casalino in the Amaro Laboratory (University of California San Diego) May 17, 2022 Cold Spring Harbor, NY — Glycans (saccharides or carbohydrates) are widely distributed in all living life-forms, and Glycobiology is the study of their structure, biosynthesis, biology, and evolution. It is a rapidly growing field, relevant to […].

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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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The State of Specialty Pharmacy 2022: Reflections, Trends, and Photos from #Asembia22

Drug Channels

Two weeks ago, Paula and I had the pleasure of attending Asembia’s 2022 Specialty Pharmacy Summit at the wonderful Wynn Las Vegas. Below, I violate Vegas code and tell you what happened there. I offer reflections on my keynote session with Scott Gottlieb, share my experiences during the featured session, and highlight three crucial specialty industry trends.

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CABBI team develops automated platform for plasmid production

Scienmag

Plasmids have extensive use in basic and applied biology. These small, circular DNA molecules are used by scientists to introduce new genes into a target organism. Well known for their applications in the production of therapeutic proteins like insulin, plasmids are broadly used in the large-scale production of many bioproducts. Credit: CABBI Plasmids have extensive […].

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COVID-19 vaccine study focuses on young and immunosuppressed

Pharma Times

Team at Imperial College London will expand MELODY study to include immunosuppressed young people

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Rice chemists skew the odds to prevent cancer

Scienmag

HOUSTON – (May 17, 2022) – The path to cancer prevention is long and arduous for legions of researchers, but new work by Rice University scientists shows that there may be shortcuts. Credit: Rice University HOUSTON – (May 17, 2022) – The path to cancer prevention is long and arduous for legions of researchers, but […].

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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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Do pharmaceutical businesses need to rethink what their graduate schemes offer?

pharmaphorum

As the world and the UK continues its march out of the pandemic’s shadow, the pharmaceutical and life sciences sector has been squarely in the spotlight. In the UK, the Government has often said that we are indebted to the astonishing power of life sciences, especially in the pandemic’s context. The Government has identified the development of a pipeline of highly skilled talent as a key component in the UK economy’s continued growth.

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Scientists use machine learning models to help identify long COVID patients

Scienmag

CHAPEL HILL, NC – Clinical scientists used machine learning (ML) models to explore de-identified electronic health record (EHR) data in the National COVID Cohort Collaborative (N3C), a National Institutes of Health-funded national clinical database, to help discern characteristics of people with long-COVID and factors that may help identify such patients using data from medical records. […].

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Adding value through coaching

pharmaphorum

Strategic coaching is bringing rewards across pharma as the industry adjusts to post-pandemic practices and challenges. Field forces are being realigned, business development re-focussed and digital channels maximised in a new era of sales and engagement. Coaching is now playing a pivotal role in driving better practice and sales performance and it is having an added benefit of boosting employee satisfaction, according to experts.

Sales 72
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Concussion symptoms in children may have multiple underlying causes

Scienmag

Different types of brain damage caused by a concussion may lead to similar symptoms in children, according to research led by McGill University. A new way of studying concussions could help develop future treatments. While most children fully recover after a concussion, some will have lasting symptoms. The findings published in eLife help explain the […].

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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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BenevolentAI, AstraZeneca AI-based drug discovery collaboration achieves third milestone

pharmaphorum

BenevolentAI has discovered a second novel target for idiopathic pulmonary fibrosis (IPF), which AstraZeneca has added to its drug development portfolio, resulting in a milestone payment to the London-based research firm. This is the third novel target from the duo’s collaboration identified using the Benevolent Platform across two disease areas – IPF and chronic kidney disease – and subsequently validated and selected for portfolio entry by AstraZeneca.

Drugs 69
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Henry Ford cardiologist to perform a live heart procedure at International Medical Education event

Scienmag

DETROIT (May 17, 2022) – For the third straight year, Henry Ford Hospital interventional cardiologist Khaldoon Alaswad, M.D. will perform a live heart procedure as part of an international interactive medical education event, with proceeds benefiting hospitals in Ukraine. Credit: Henry Ford Health DETROIT (May 17, 2022) – For the third straight year, Henry Ford […].

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Targeting the Uneven Burden of Kidney Disease on Black Americans

NY Times

New treatments aim for a gene variant causing the illness in people of sub-Saharan African descent. Some experts worry that focus will neglect other factors.

Gene 73
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Algorithms empower metalens design

Scienmag

Compact and lightweight metasurfaces — which use specifically designed and patterned nanostructures on a flat surface to focus, shape and control light — are a promising technology for wearable applications, especially virtual and augmented reality systems. Today, research teams painstakingly design the specific pattern of nanostructures on the surface to achieve the desired function of […].

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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 Research Coordinators: Unsung Heroes at the Heart of Trials

Imperical Blog

Health care heroes are everywhere, from surgeons in war zones to pediatric nurses in suburban offices. In trials, clinical research coordinators (CRCs) are priceless members of every trial team. From study startup to study closeout, CRCs make the trial happen. While the principal investigator is… The post Clinical Research Coordinators: Unsung Heroes at the Heart of Trials appeared first on Imperial Clinical Research Services Blog.

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Reliable diagnostics at the tip of your finger

Scienmag

Biomarkers are components that may be present in biological samples and are related to specific diseases. Therefore, doctors can analyze biological samples from a patient to check their health condition or to monitor the progress of a specific therapy. Typically, these samples need to be purified and diluted before the analysis, and current medical diagnostic […].

Doctors 84
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AbbVie and Cugene partner to tackle autoimmune diseases

pharmaphorum

AbbVie and Cugene have teamed up to research autoimmune diseases and cancer in an exclusive worldwide agreement. The Chicago-based pharma firm, AbbVie, received the option to license worldwide rights to Cugene’s CUG252 – a clinical-stage and potential best-in-class Treg-selective IL-2 mutein. It’s hoped that adding this drug to its portfolio will further boost AbbVie’s commitment to developing novel therapies in immunology.

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Vine removal technique foils devastating grape disease

Scienmag

ITHACA, N.Y. – Removing not only a diseased grapevine but the two vines on either side of it can reduce the incidence of leafroll disease, a long-standing bane of vineyards around the world, Cornell University researchers have found. Leafroll disease, a virus spread by mealybugs, damages grapevines, reduces yield and alters grape quality – all […].

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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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Medical Informatics and Rare Disease: a bridge between two worlds

pharmaphorum

In this webinar, sponsored by IQVIA, speakers from The Medical Informatics Group at the University Hospital Frankfurt and the Collaboration on Rare Diseases in Medical Informatics project, Germany will discuss the potential of medical informatics in rare disease research and treatment. They will also provide insight into current problems, future challenges and new ideas across the bridge between rare diseases and medical informatics.

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Scientists see signs of traumatic brain injury in headbutting muskox

Scienmag

Scientists at the Icahn School of Medicine at Mount Sinai saw for the first time hallmarks of concussions and other head trauma in the brains of deceased headbutting animals—muskoxen and bighorn sheep. The results published in the journal Acta Neuropathologica may contradict the commonly-held belief that ramming animals do not suffer brain injuries and support […].

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Regulatory Compliance Coverage & Reference between FDA 21 CFR Part 11 and EU Annex 11

Cloudbyz

Until recently, clinical trials have been performed in a mostly paper-based processes. Advancements in technology, surge in remote work and digitization of the processes is driving the clinical research industry and consequently, there is increased use of electronic records and electronic signatures to support these processes. Though the regulations around electronic records and signatures, such as FDA 21 CFR part 11 and EU Annex 11 , have been published for a long time, their application has am

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Friendly fungi announce themselves to their hosts

Scienmag

For many years after discovering a diverse population of sometimes dangerous microbes constantly living in our intestines, scientists described the situation as a form of living with the enemy. But when it comes to commensal populations of the fungus Candida albicans, the dreaded invader may be better seen as a helpful friend arriving with gifts. […].

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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.