Fri.Dec 09, 2022

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Biotech layoffs claim more jobs at Sensei, Instil, TherapeuticsMD

Bio Pharma Dive

Cell therapy Instil Bio will cut 60% of its staff and Sensei Bio will reduce its headcount by 40%. TherapeuticsMD, meanwhile, is laying off all its employees days after announcing a deal to sell off its drug portfolio.

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EC grants marketing authorisation for Takeda’s dengue vaccine

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for Takeda ’s Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) to prevent dengue in people aged four years and above. This development comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency provided a positive recommendation in October this year.

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Gilead buys into multiple myeloma cell therapy with Arcellx deal

Bio Pharma Dive

The company is paying Arcellx $225 million, on top of a $100 million equity investment, for rights to a CAR-T therapy that’s currently in mid-stage testing as a treatment for the blood cancer.

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We make clinical research easy.

Deltaclinical

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols. We have specialists with knowledge of all study phases and can deliver an optimized configuration of operations such as: Administrative tasks Data processing (eCRF) Quality control Training study nurse (Pre-)screening calls Preparing (home) visits Conducting

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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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Pharvaris, pushing through trial pause, sees shares surge with new study results

Bio Pharma Dive

Though the FDA halted testing of the biotech’s pill for hereditary angioedema in August, enough patients were already enrolled to accrue results that sent shares soaring.

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We make clinical research easy.

Deltaclinical

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols. We have specialists with knowledge of all study phases and can deliver an optimized configuration of operations such as: Administrative tasks.

More Trending

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We make clinical research easy.

Deltaclinical

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols. We have specialists with knowledge of all study phases and can deliver an optimized configuration of operations such as: Administrative tasks.

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CPHI Frankfurt returns to pre-pandemic strength as pharma industry booms again

Pharma Mirror

In-person visitor numbers rebound sharply, with record C-Suite attendance and the largest ever online presence Amsterdam – The global pharma industry was out in full force at CPHI Frankfurt in November with 40,405 executives from 167 countries visiting the 2022 edition of the world-leading pharma industry tradeshow, a huge 75% increase over the number of attendees in 2021.

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We make clinical research easy.

Deltaclinical

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols. We have specialists with knowledge of all study phases and can deliver an optimized configuration of operations such as: Administrative tasks.

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Olympus to Join Government Project to Verify Dissemination of Endoscopic AI Diagnosis in Vietnam

Pharma Mirror

Participating in the Ministry of Internal Affairs and Communications of Japan project to conduct a survey study for international expansion of AI diagnosis support system and education for doctors in Vietnam TOKYO: Olympus Corporation (Olympus), a global medtech company committed to making people’s lives healthier, safer and more fulfilling, today announced their part in a project in cooperation with the Ministry of Internal Affairs and Communications of Japan (MIC), entitled, “Surve

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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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IN FOCUS: Solvias

Pharmaceutical Technology

Rankings 2022. M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Pharmaceutical Technology Excellence Rankings – The Verdict. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings.

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Opinion: Artificial intelligence: crossing the border between health care and tech

STAT News

There’s been significant investment in companies creating artificial intelligence (AI) applications for health and health care over the last decade. But while there have been successes, notably in the area of medical imaging, the industry is known more for not yet living up to its potential — think IBM Watson. The slow pace of AI adoption in health care stems from the fact that health AI sits on the border between two large industries, health care and tech.

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Vertex and Entrada partner for EEV therapeutics development

Pharmaceutical Technology

Vertex Pharmaceuticals has entered into an international partnership with Entrada Therapeutics to discover and develop intracellular Endosomal Escape Vehicle (EEV) therapeutics to treat myotonic dystrophy type 1 (DM1). . The alliance includes ENTR-701, a programme of Entrada for DM1. An EEV-conjugated phosphorodiamidate morpholino oligomer, ENTR-701 is currently in the late stage of preclinical development.

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Why vaccine hesitancy persists in China — and what they're doing about it

NPR Health - Shots

The reluctance of many citizens — especially the elderly — to get vaccinated is a problem for a government facing intense pressure to roll back strict COVID policies.

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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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Expanding the arsenal of drugs for use against COVID-19

Medical Xpress

The ongoing COVID-19 pandemic, caused by the SARS-CoV-2 virus, has been devastating the entire world. While the vaccination program is advancing, drug treatments for COVID-19 are still highly important for those who become infected.

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Because of Wisconsin's abortion ban, one mother gave up trying for another child

NPR Health - Shots

Kristen Petranek has a history of miscarriages – and she has diabetes, which makes pregnancy risky. She fears that if something goes wrong, her state's law may inhibit doctors from helping her.

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How a viral toxin may exacerbate severe COVID-19

Medical Xpress

A new study in the journal Nature Communications reveals how a viral toxin produced by the SARS-CoV-2 virus may contribute to severe COVID-19 infections.

Research 135
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STAT+: 5 ways health tech companies can make their products more equitable

STAT News

Disparities along racial and socioeconomic lines have long persisted in health care. But it’s only somewhat recently that the health care industry’s often glitzy gatherings have started grappling with health equity, as the pandemic both widened health inequities and also demonstrated the potential of technology to tackle them. Companies selling sleek and convenient digital health services like virtual doctors’ visits or apps to manage diabetes often struggle to get them into

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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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New treatment for moderate to severe atopic dermatitis shows promising long-term results

Medical Xpress

Patients with moderate to severe atopic dermatitis who participated in a clinical trial of rocatinlimab—a novel, patient-tailored monoclonal antibody therapy—showed promising results both while taking the drug and up to 20 weeks after the therapy was stopped, Mount Sinai researchers reported in The Lancet.

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STAT+: Up and down the ladder: The latest comings and goings

STAT News

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Prostate cancer risk prediction algorithm could help targeted testing for men at greatest risk

Medical Xpress

Cambridge scientists have created a comprehensive tool for predicting an individual's risk of developing prostate cancer, which they say could help ensure that those men at greatest risk will receive the appropriate testing while reducing unnecessary—and potentially invasive—testing for those at very low risk.

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Ballerina, firefighter, hygienist? Why dentistry needs to start its pipeline with young kids

STAT News

Dentistry has a diversity problem, and medical and dental experts say the best way to fix it is to start the pipeline early in Black and brown communities. “We can’t wait until someone graduates from undergrad to try to recruit an African American or Hispanic dentist,” Gillian Barclay, vice president of global public health at Colgate-Palmolive, said at the Milken Institute Future of Health Summit on Wednesday.

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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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Researchers find missing piece of the asthma puzzle

Medical Xpress

An inflammatory molecule called LIGHT, appears to be the cause of life-threatening airway damage in patients with severe asthma. According to the new research from scientists at La Jolla Institute for Immunology (LJI), therapeutics to stop LIGHT (which is related to tumor necrosis factor) could reverse airway and lung damage in patients—and potentially offer a long-term treatment for asthma.

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STAT+: Why a tone-deaf Regeneron executive deserved to be booed over Alzheimer’s drug remarks

STAT News

File this under “What was he thinking?” The otherwise staid Milken Institute summit on health care grew unexpectedly heated on Thursday when George Yancopoulos, the Regeneron Pharmaceuticals president and chief scientific officer, drew boos from the crowd as he became cantankerous and talked over the panel moderator, who had expressed concern about access to high-priced Alzheimer’s medicines.

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What are the best ways to participate in research studies?

Antidote

Participating in a clinical research study can have many benefits. From offering specialized care to providing participants with potential new treatment options, finding the right clinical trial can lead to positive outcomes for today’s patients and unlock breakthroughs for those diagnosed in the future.

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STAT+: Pharmalittle: Medicare willing to reevaluate coverage of Alzheimer’s drugs; judge tosses shingles-vaccine lawsuits against Merck

STAT News

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda, so far, appears to be rather modest. We plan to promenade extensively with the official mascot, tidy up around the castle, check in on the Pharmalot ancestors, and have a listening party with Mrs.

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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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New customizable, strontium-filled scaffold could improve dental implant healing

Medical Xpress

A team of University at Buffalo researchers has developed a new strontium-loaded scaffold that can be personalized to fit any size dental implant and could help improve healing and tissue attachment in patients.

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Autolus announces primary endpoint met in FELIX trial, prices public offering

pharmaphorum

Autolus Therapeutic Plc. (Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd., has announced that the pivotal phase 2 FELIX clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukaemia (ALL) patients has met its primary endpoint of overall remission rate (ORR) at interim analysis.

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Epigenetic emergency switch improves defense against infections

Medical Xpress

During infections, the hematopoietic system switches from normal to emergency mode. This improves the defense against pathogens. Scientists at the German Cancer Research Center have now found an epigenetic switch in blood stem cells and progenitor cells of mice that can trigger the switch from one mode to the other.

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AZ writes the 'next chapter' in Enhertu's saga with head-to-head win versus Roche's Kadcyla

Fierce Pharma

AZ writes the 'next chapter' in Enhertu's saga with head-to-head win versus Roche's Kadcyla. fkansteiner. Fri, 12/09/2022 - 09:22.

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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.