Pharmaceutical Technology

SEPTEMBER 22, 2022

It is the year 2030. You have just received the results from your whole genome sequencing test, offered through your public health provider, and discovered that you have a 75% chance of developing a rare form of cancer. But you are not panicking; your genomic data was automatically uploaded, with your permission, to your electronic health record (EHR), which is fully secured with blockchain technology.

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Genome Genomics Clinical Trials Clinical Trials 342

Bio Pharma Dive

SEPTEMBER 22, 2022

The French drugmaker terminated a nearly decade-old deal that helped Allogene emerge as the sector's largest "off-the-shelf" cell therapy developer.

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Development 211

Pharmaceutical Technology

SEPTEMBER 22, 2022

GSK has signed an exclusive licence agreement with Spero Therapeutics for the latter’s tebipenem pivoxil hydrobromide (tebipenem HBr) treatment for complicated urinary tract infections (cUTI). A late-stage asset of Spero, tebipenem HBr is being developed as the first oral carbapenem antibiotic to treat cUTIs, including pyelonephritis, which are caused by specific bacteria.

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Bacteria Marketing Trials Clinical Development 147

Bio Pharma Dive

SEPTEMBER 22, 2022

The British drugmaker is investing in Spero Therapeutics and acquiring most of the rights to an oral antibiotic the FDA previously rejected, but could approve if it succeeds in a new Phase 3 trial.

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Trials 200

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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

Clinical Research

Pharmaceutical Technology

SEPTEMBER 22, 2022

Avrobio has received rare pediatric disease designation from the US Food and Drug Administration (FDA) for its investigational gene therapy, AVR-RD-04, designed to treat cystinosis. AVR-RD-04 works by genetically modify a patient's hematopoietic stem cells (HSCs) to express the gene that encodes the cystinosin protein. Cystinosis patients have a high deficiency of this protein.

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Gene Therapy Gene Protein Licensing 147

Bio Pharma Dive

SEPTEMBER 22, 2022

The approval is another example of so-called tissue-agnostic indications, which are based on a cancer’s genetic signature rather than where it is in the body.

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Gene Genetics Drugs 183

Bio Pharma Dive

SEPTEMBER 22, 2022

The deal results from a strategic review Sesen, formerly known as Eleven Biotherapeutics, undertook after the FDA rejected its top drug last year.

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Drugs 177

Pharmaceutical Technology

SEPTEMBER 22, 2022

Amarin is going full steam ahead with its plans for global expansion of its cardiovascular drug Vazkepa (Vascepa/icosapent ethyl). Last week, at the HC Wainwright Investment Conference, Amarin’s CEO, Karim Mikhail, spoke of the company’s plans to widen the scope of the drug. After establishing Vazkepa’s role in the American cardiovascular therapeutic landscape, Amarin aims to widen the drug’s scope to the European Union (EU) and beyond.

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FDA Approval Marketing Drugs Production 130

Bio Pharma Dive

SEPTEMBER 22, 2022

The grant is one of the Novo Nordisk Foundation’s largest and will fund a 12-year research collaboration to construct a quantum computer dedicated to the life sciences.

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Life Science Research 152

Pharmaceutical Technology

SEPTEMBER 22, 2022

Abpro has entered a strategic collaboration with Celltrion for the global development and commercialisation of the former's antibody therapy, a t-cell engager known as ABP 102. The cancer molecule will be developed for treating patients with HER2+ cancer, including gastric, pancreatic and breast cancer. Under the deal, Celltrion will make payments totalling up to $1.75bn to Abpro.

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Bio Pharma Dive

SEPTEMBER 22, 2022

The Swiss company is evaluating “all available options” following the ruling, which could lead to the launch of copycat versions of its MS drug Gilenya.

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Sales Drugs 152

NPR Health - Shots

SEPTEMBER 22, 2022

Volunteers for the trial put an arm over a box with hundreds of mosquitoes carrying a genetically modified malaria parasite. Here's why they did it that way — and why the trial holds promise.

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Trials Genetics Vaccination Vaccine 145

Bio Pharma Dive

SEPTEMBER 22, 2022

The drug, Pedmark, has been in development for more than two decades and was previously rejected twice by U.S. regulators.

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Drugs Regulation Development 141

STAT News

SEPTEMBER 22, 2022

The National Institutes of Health on Thursday announced more than $600 million in fresh funding for an expansive and ongoing push to unravel the mysteries of the human brain, bankrolling efforts to create a detailed map of the whole brain, and devise new ways to target therapeutics and other molecules to specific brain cell populations. Scientists across the country are involved, from teams at the Salk Institute to Duke University to the Broad Institute of MIT and Harvard, among other places.

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Genome Project Genome Genomics Scientist 138

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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.

Clinical Supply

Rethinking Clinical Trials

SEPTEMBER 22, 2022

The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 15th Annual Conference on the Science of Dissemination and Implementation in Health in Washington, DC. The workshop, “Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems.

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Trials Clinical Trials Clinical Trials Research 100

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 22, 2022

The Indian Institute of Science (IISc), Centre for BioSystems Science and Engineering, has designed a new method to deliver a vaccine candidate for tuberculosis (TB). The research involves using spherical vesicles secreted by bacteria coated on gold nanoparticles which can then be delivered to the immune cells. This, according to the researchers, can potentially trigger […].

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Vaccination Vaccine Research Bacteria 100

Rethinking Clinical Trials

SEPTEMBER 22, 2022

                                           . Speaker. Tor Biering-Sørensen, MD, PhD, MPH. Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. Department of Biomedical Sciences. Faculty of Health and Medical Sciences.

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Trials Cardiology Vaccination Vaccine 130

STAT News

SEPTEMBER 22, 2022

Over the last six years, a venture capital team run out of pharmaceutical giant Bayer invested roughly $1.5 billion into small biotech startups. Now, it’s ramping up. The firm plans to invest a nearly identical pot of money — this time, $1.3 billion — in half the time.

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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.

Clinical Trials

NPR Health - Shots

SEPTEMBER 22, 2022

Even after their babies died, hospital bills kept coming. These parents of fragile, very sick infants faced exorbitant bills — though they had insurance. "The process was just so heartless," one says.

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STAT News

SEPTEMBER 22, 2022

Envision Healthcare, the large chain of outpatient surgery centers and physician staffing services for hospitals, is on the cusp of bankruptcy and likely will run out of cash by the end of next year. Moody’s Investors Service on Wednesday downgraded Envision’s debt to its lowest possible junk-level rating, one that indicates the debt is “typically in default, with little prospect for recovery of principal and interest.

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pharmaphorum

SEPTEMBER 22, 2022

BeiGene’s BTK inhibitor Brukinsa (zanubrutinib) has become the first drug in the class to be recommended for routine NHS use in England and Wales to treat Waldenström macroglobulinaemia (WM) – a rare form of non-Hodgkin lymphoma (NHL). The final appraisal document from health technology assessment (HTA) agency NICE says that Brukinsa can be used to treat WM in adults who have had at least one prior treatment, and only if bendamustine plus rituximab therapy is also suitable.

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Medicine Drugs Marketing Production 98

STAT News

SEPTEMBER 22, 2022

The amazing images of the Cartwheel Galaxy captured by the James Webb Space Telescope this summer, and before them the spectacular images from the Hubble telescope, have amazed and inspired many people worldwide, who now look to NASA as a trusted federal agency. It hasn’t always enjoyed such strong support. After the Challenger disaster , in which the space shuttle with seven crew members aboard exploded after liftoff, NASA was beset by questions about its decision-making and faced a sign

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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.

Clinical Supply

Drug Discovery World

SEPTEMBER 22, 2022

A new bioreactor platform that aims to support the cell and gene therapy (CGT) sector from process development to commercial manufacturing has been launched. The Quantum Flex Cell Expansion System has been created by medical technology company Terumo Blood and Cell Technologies (Terumo BCT). Using the system, developers can complete early process development on the same platform as manufacturing.

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STAT News

SEPTEMBER 22, 2022

This story has been excerpted from the STAT Report , “STAT’s guide to blockchain in health care.” N ot long ago, blockchain technology captured the imagination — and the wallets — of financial services firms that sought a “first-mover” advantage by integrating it into their outdated management systems.

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Compliance 98

pharmaphorum

SEPTEMBER 22, 2022

Alexandre Le Vert, CEO and co-founder of Osivax, discusses the company’s breakthrough vaccine technology, oligoDOM, and how it’s driving the development of new influenza and SARS-CoV-2 vaccines that attack T-cells, providing a long-lasting effect. Currently, available vaccines for influenza and COVID-19 require yearly administration due to their makeup, as they target the outer layer of the virus.

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Vaccination Vaccine Antibody Clinical Trials 97

STAT News

SEPTEMBER 22, 2022

Hello, everyone, and how are you today? A dank cloudy cover greeted us this morning, but we are ignoring the gloom by keeping busy. After all, there is much to be done. There are deadlines to meet, a variety of reading material to digest, and calls to make. We trust you can relate. So please join us as we fortify ourselves with more cups of stimulation — we are back to blueberry cobbler — and get started.

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Drug Trials Trials Drugs 98

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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.

Clinical Trials

XTalks

SEPTEMBER 22, 2022

Scientists at the University of Manchester in the UK have developed a test for Parkinson’s disease using information from a woman’s unique sense of smell that can detect the condition. Perth, Scotland-based Joy Milne noticed that her now late husband Les, a former physician, smelled differently when he came home from work one day. She recalls that he had an unpleasant musky yeast-like scent on him, which was very different from his usual musky smell that she loved.

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Scientist Development Research Nurses 96

Pharma Times

SEPTEMBER 22, 2022

Data shows participants achieved greater treatment satisfaction when switching to icodec

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BioPharma Reporter

SEPTEMBER 22, 2022

San Francisco based Cellares is partnering with Lexington, Massachusetts headquartered iVexSol to accelerate and improve the quality of viral vector manufacturing and transduction.

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Manufacturing Development 52

ECRG Media's Clinical Research Podcast

SEPTEMBER 22, 2022

If you would like to ask questions during the Live, please sub on youtube! Send in a voice message: [link] If you would like to ask questions during the Live, please sub on youtube!

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Clinical Research Research 52

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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.

Clinical Trials