Wed.Dec 28, 2022

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Gilead Sciences to buy all rights of GS-1811 from Jounce

Pharmaceutical Technology

Gilead Sciences and Jounce Therapeutics have amended their current license agreement for first-in-class immunotherapy, GS-1811 (formerly JTX-1811). The initial license agreement was signed in 2020. The amended agreement will allow Gilead Sciences to acquire all the remaining rights for GS-1811 from Jounce Therapeutics. Certain operational obligations of the companies that are related to GS-1811 have also been terminated as part of the transaction.

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It's not too late to get a COVID booster — especially for older adults

NPR Health - Shots

Public health officials want more Americans to get the latest COVID vaccine booster. Only 35% of people over 65 have gotten the shot, though 75% of COVID deaths are among people in this age group.

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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

This year, the predicted flurry of merger and acquisition (M&A) activity might not have materialised. However, as we near the end of the year, there were some big moves. M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline.

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How a scrappy African start-up could forever change the world of vaccines

NPR Health - Shots

Afrigen is the linchpin of global project to use mRNA technology to empower low-resource countries to make their own vaccines against killer diseases from TB to HIV. What will it take to succeed?

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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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Study could pave way for new antiviral, as China grapples with Covid wave

STAT News

When Eric Xu fell sick and tested positive with Covid this month, he took pills of his own invention.  Paxlovid, the primary oral antiviral available in the U.S., is in short supply in China. But Xu, a prominent biochemist at the Chinese Academy of Sciences, had helped devise his own in 2021 and, as the drug’s inventor, could legally take it even as it went through clinical trials.

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Monitoring heart measures via smartwatches shows COVID booster vaccine is safe

Medical Xpress

In a first-of-its-kind study, researchers at Tel Aviv University equipped close to 5,000 Israelis with smartwatches and monitored their physiological parameters over two years. Of those monitored, 2,038 received the booster dose of the coronavirus vaccine, allowing the researchers to objectively compare measures before and after the participants took the vaccine, and confirm the safety of the vaccine.

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'Might' or 'might not': Three-year-olds do not deploy possibility concepts in decision-making

Medical Xpress

Developmental stages in children at young ages happen rapidly, considering the comparatively more leisurely changes that young people experience when they're older; many parents will relate—often with haunted, shell-shocked expressions—that the differences between a two-year-old and a three-year-old are vast and challenging. Cognitive psychologists at Harvard University recently conducted a study exploring whether young children develop the ability to consider alternative possibilities when plan

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STAT+: The FDA’s ‘breakthrough’ program for medical devices keeps gaining steam

STAT News

For medical devices in the Breakthrough Devices Program, 2022 has been a breakout year. The Food and Drug Administration is on track to top its previous records, offering expedited regulatory consideration — and if medical device companies have their way, a streamlined path to insurance coverage — to dozens of novel tools.

Drugs 98
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Alveolar macrophages help CD8+ T cells go (anti-)viral

Medical Xpress

The human immune system is a highly complex network of cells, signals, and responses that is tightly regulated to ensure that the body can fight off infection without damaging its own tissues. Now, researchers from Japan report a new way in which the immune system protects lung tissue from viral infections.

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Opinion: How value-based payments to clinicians can help close equity gaps

STAT News

The U.S. health system has been evolving over the past decade to focus on the quality and value of care. Until recently, though, value-based payment models have not explicitly addressed longstanding racial and ethnic inequities in care. This month, Blue Cross Blue Shield of Massachusetts, the not-for-profit health plan I lead, introduced a value-based payment model that will reward clinicians for closing equity gaps, starting with areas including colorectal cancer screening, blood pressure contr

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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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Model provides insight into how autism arises

Medical Xpress

The development of autism may now become easier to understand, thanks to an explanatory model presented in a thesis from University of Gothenburg. This model provides new insights into how various risk factors give rise to autism and why there is such great variability between individuals.

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STAT’s most memorable photos of 2022

STAT News

Reflecting back on our favorite photographs from 2022, we are struck by how many portraits were in our selection. This year, more than others, the strength of individuals was at the center of our visual journalism. Our photographers have pictured medical students fighting for racial justice; harm reduction workers and crisis line volunteers; and patients, families, and researchers fighting to find life-saving cures.

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New technique improves high-intensity focused ultrasound treatment for brain disorders

Medical Xpress

UT Southwestern physicians have developed an improved targeting method, four-tract tractography, to personalize MRI-guided, high-intensity focused ultrasound (HIFU) used at UTSW to treat medication refractory tremor in essential tremor and tremor-dominant Parkinson's disease. Results of the clinical cases utilizing this approach, published in Brain Communications, suggest that it enables more precise targeting of the brain, decreases treatment times, reduces side effects and improves treatment r

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STAT+: Drug companies set sights on new Covid medicines to boost depleted arsenal

STAT News

It was not that long ago that the medical community had a small arsenal of new drugs to prevent and treat COVID-19 in people most susceptible to severe disease. But the arrival of new variants, as well as the loss of two treatments for immunocompromised people, has amped up the urgency to develop a stronger generation of medicines. Some biotech companies are looking to rebuild and expand the war chest, including British pharmaceutical giant AstraZeneca and several smaller Massachusetts firms.

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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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New study highlights role of drug and alcohol use in serious crashes

Medical Xpress

Each year, many people look forward to ringing in the new year with family and friends. However, some celebrations include the combination of alcohol and late-night driving—which can lead to fatal accidents.

Drugs 98
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FDA slaps partial hold on Biogen, InnoCare MS drug

pharmaphorum

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. The US regulator has placed oral BTK inhibitor orelabrutinib on partial clinical hold, meaning new patients cannot be enrolled into clinical trials and patients treated with the drug for 70 days or less must discontinue treatment.

Drugs 74
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'Adaptive leadership' led to successful COVID-19 response in Alaskan capital

Medical Xpress

To date, Juneau, Alaska has the highest vaccination rates, among the lowest coronavirus cases, and among the fewest deaths among other boroughs (counties) in Alaska. Now, a research team that studied Juneau's early response to the pandemic has identified a number of factors that helped the Alaskan capital mitigate COVID-19's impact on residents.

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The U.S. will require travelers from China to take COVID tests

NPR Health - Shots

The U.S. will require travelers from China to take COVID tests from Jan. 5. CDC officials have also expressed concerns about new variants originating from China, which is experiencing a surge.

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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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Rheumatologist recommends patients receive pneumococcal vaccine

Medical Xpress

Patients with rheumatoid arthritis, lupus, and other rheumatic conditions are more at risk for complications and death from pneumonia, meningitis, and other bacterial infections, yet most have not been vaccinated against infection.

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Benefits of Artificial Intelligence for Clinical Research Will Require Human Touch Along the Way

ACRP blog

The clinical research enterprise may be barreling toward a future in which artificial intelligence (AI) will play a major role in decreasing workloads and increasing efficiencies for study professionals, but a whole lot of traditional human touch will be needed along the way, one industry observer said as part of some big picture predictions for 2023.

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AI improves colorectal cancer screening in Lynch syndrome

Medical Xpress

People with Lynch syndrome have a higher hereditary risk of colon cancer. Despite regular endoscopic surveillance, it remains elevated in those affected. Researchers at the National Center for Hereditary Tumor Diseases (NZET) at Bonn University Hospital (UKB) have now found that artificial intelligence (AI) can improve the effectiveness of colonoscopy in the presence of Lynch syndrome.

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Exploring the Digital Therapeutics Landscape

Pharmaceutical Commerce

Observations from recent digital health events and a glimpse of what’s ahead—from Milan to Boca Raton.

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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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Screening catches only one in seven cancers: Report

Medical Xpress

Only 14% of cancers diagnosed in the United States are diagnosed after the patient had a recommended screening test, according to a report released Dec. 14 by NORC at the University of Chicago.

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New patent for Azurity drug ZONISADE

Drug Patent Watch

Annual Drug Patent Expirations for ZONISADE Zonisade is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There is one patent protecting…. The post New patent for Azurity drug ZONISADE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Nerve pathway discovered: Good and bad feelings for brain stem serotonin

Medical Xpress

New insights into the opposing actions of serotonin-producing nerve fibers in mice could lead to drugs for treating addiction and major depression.

Drugs 98
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Congress delivers festive PIE to patients, speeding access to therapies

pharmaphorum

After years of preparation, the US Congress passed the Pre-approval Information Exchange (PIE) Act just ahead of the Christmas break, legislation that will allow medical payers and the FDA to review new treatments concurrently. The act – which still needs to be signed into law by President Joe Biden – could shave months or even years off the time it takes for novel treatments to be available to patients, according to its sponsors.

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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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Role of pyrethroid derivatives in autophagy and apoptosis crosstalk signaling and potential risk for malignancies

Medical Xpress

Pyrethroids are extensively used insecticides by virtue of insecticidal activity potential in Asia, especially India, and in different nations worldwide to counter mosquitoes and insects for household or agricultural needs. The continuous widespread and uncontrolled use of pyrethroids and its derivatives have influenced multiple deleterious effects resulting in a potential risk factor causing damage to organ systems.

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UCB's bimekizumab finally back on the FDA's review list after May rejection

Fierce Pharma

UCB's bimekizumab finally back on the FDA's review list after May rejection. zbecker. Wed, 12/28/2022 - 11:17.

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China Covid pivot sparks jitters worldwide

Medical Xpress

Beijing's sudden pivot away from containing COVID-19 has caused jitters around the world, with the United States saying it may restrict travel from China following its decision to end mandatory quarantine for overseas arrivals.

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New tentative approval for Amneal Pharms drug saxagliptin

Drug Patent Watch

[![saxagliptin structure]([link] Saxagliptin is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this compound. There are…. The post New tentative approval for Amneal Pharms drug saxagliptin appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 40
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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.