Tue.Sep 20, 2022

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Vesalius Therapeutics, a buzzy, Flagship-backed startup, cuts jobs six months after public launch

Bio Pharma Dive

When the company debuted in March, it announced plans to hire 200 employees over two years. Now, it’s laid off nearly half its staff in a year when the biotech sector has experienced a sharp market downturn.

Marketing 278
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The New COVID Subvariant BA.4.6 Is Spreading. Here’s What We Know

AuroBlog - Aurous Healthcare Clinical Trials blog

BA.4.6, a subvariant of the Omicron COVID variant which has been quickly gaining traction in the US, is now confirmed to be spreading in the UK. The latest briefing document on COVID variants from the UK Health Security Agency (UKHSA) noted that during the week beginning August 14, BA.4.6 accounted for 3.3 percent of samples […].

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J&J opens new research hub near San Francisco

Bio Pharma Dive

The roughly 200,000-square-foot facility will house about 400 employees and more than double the size of the drugmaker’s presence in San Francisco.

Research 286
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September 20, 2022: Application Period Opens for Postdoctoral Fellowship in Ethics and Regulatory Aspects of Pragmatic Trials

Rethinking Clinical Trials

The Johns Hopkins Berman Institute of Bioethics this week opened the application period for its 2023-2024 postdoctoral fellowships, including a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. From the announcement: The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials.

Trials 246
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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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Rocket gives struggling gene therapy company a lifeline after SPAC merger

Bio Pharma Dive

Rocket is acquiring Renovacor at a roughly 75% discount to its public debut price last year, when it became one of dozens of biotechs to merge with a blank check company, or SPAC.

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Genfit agrees to acquire biopharma firm Versantis for $109m

Pharmaceutical Technology

Genfit has signed an exclusivity agreement for the acquisition of all the share capital and voting rights of Versantis, a Switzerland-based clinical-stage biotechnology firm, in a deal totalling $109m (Sfr105m). Versantis focuses on unmet liver ailment needs. Its key asset, VS-01, is a first-in-class liposomal-based treatment product candidate. This product is being analysed clinically as a first-line therapy for acute-on-chronic liver failure (ACLF) and urea cycle disorder (UCD).

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EC grants approval for Roche’s Vabysmo to treat two retinal conditions

Pharmaceutical Technology

The European Commission (EC) has granted approval for Roche's Vabysmo (faricimab) to treat two retinal conditions, neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME) associated visual impairment. . This latest approval is based on findings from four Phase III clinical trials in the two indications, which enrolled a total of 3,220 subjects.

Trials 130
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J&J tried to block lawsuits from 40,000 cancer patients. A court wants answers

NPR Health - Shots

Critics say a legal maneuver by one of the world's wealthiest corporations could set a precedent, allowing non-bankrupt companies and rich individuals to avoid liability for wrongdoing.

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Leading clinical packaging companies in contract marketing

Pharmaceutical Technology

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research.

Packaging 100
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Daily 'breath training' can work as well as medicine to reduce high blood pressure

NPR Health - Shots

Research finds five to 10 minutes daily of a type of strength training for muscles used in breathing can help anyone reduce or prevent high blood pressure. The training can also help elite athletes.

Medicine 141
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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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Leading commercial dose (non-sterile) companies in contract marketing

Pharmaceutical Technology

The production of commercial dose non-sterile products such as tablets, capsules, ointments, creams, and powders is rising due to their growing global demand, attributed to increasing demand for anti-ageing products, hereditary factors, genetic mutations, exposure to harmful radiation, and rising geriatric population. Contract marketing companies support pharmaceutical companies in creating, improving, and maintaining their brand, as well as reducing risk, and ensuring better product placement i

Marketing 130
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How Biden's declaring the pandemic 'over' complicates efforts to fight COVID

NPR Health - Shots

Biden's comments — made as officials try to convince Americans to get a new booster shot and the White House seeks $22 billion in new COVID funding — were "unfortunate," several epidemiologists said.

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Epic hits a crossroads, judge rules on UnitedHealth’s Change bid, & Meta faces health data pressure

STAT News

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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The clock is ticking for U.N. goals to end poverty — and it doesn't look promising

NPR Health - Shots

Can we end poverty, provide food for all and otherwise make Earth a better place by 2030? By all accounts, the answer is no. So then what's the point of the Sustainable Development Goals?

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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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STAT+: Minimal compliance, or meaningful change? Epic faces a crossroads as new rules put pressure on health data sharing

STAT News

In the business of selling record-keeping software to hospitals, Epic Systems is breaking away from the pack. The Wisconsin-based company’s contracts now account for nearly half the nation’s hospital beds, and in recent months it has jumped out to a commanding lead over No. 2 Oracle Cerner, taking away dozens of customers. More than 253 million Americans, or 77% of the population, are estimated to now have data in the company’s software.

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Many children are regularly exposed to gun violence. Here's how to help them heal

NPR Health - Shots

Children who are regularly exposed to gun violence can struggle with feelings of hopelessness and anxiety. There's a lot communities and after-school programs can do to help.

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Hope for lupus sufferers with Feinstein Institutes-led phase 2 trial

pharmaphorum

Findings from the litifilimab trial, undertaken by Northwell Health’s Division of Rheumatology and The Feinstein Institutes for Medical Research, have been published in the New England Journal of Medicine and show promise for those who have been diagnosed with systemic lupus erythematosus (SLE). Sponsored by Biogen Inc., data from the phase 2 LILAC (Part A) clinical trial published this month shows that the experimental lupus therapy could reduce disease activity in the joints of patients, globa

Trials 111
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A new study asks: Are we harming blood donors by taking blood from them?

STAT News

One question has plagued the field of blood donation for as long as there have been transfusions: Are we harming blood donors by taking blood from them? Our iron stores are largely self-conserved: Our bodies recycle iron from old red blood cells to make new red blood cells. Iron that’s in use doesn’t tend to exit the body unless a person loses blood, whether through menstruation, bleeding from trauma, illness — or through donation.

Research 105
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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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Single IRB Approach Can Deliver More Efficient Clinical Trials

ACRP blog

Leveraged wisely by those who understand when and how to best use it, single institutional review board (IRB) review for multisite studies can be employed by clinical trial practitioners to garner faster approvals for clinical studies of vital drugs and other treatments, says Barbara E. Bierer, MD, director of the Regulatory Foundations, Ethics, and the Law Program for Harvard Catalyst, the Harvard Clinical and Translational Science Center.

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STAT+: New CRISPR startup, drawing big-name backers, seeks to fix diseases caused by large DNA errors

STAT News

A new CRISPR startup — backed by some big names in venture capital — is planning to develop gene-editing treatments that can insert a genetic sequence of any length, at any location in the DNA strand, according to industry insiders and documents. The biotech is called Tome Biosciences, and it hopes to write the next chapter in genomic medicines.

DNA 98
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How working-class Black men in Pittsburgh pioneered emergency medicine

NPR Health - Shots

Freedom House was Pittsburgh's first professional ambulance service, and likely the first anywhere. The first paramedics were a group of Black men from the city's historic Hill District.

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Coors, Mondelez, and other big food companies want to sell CBD-filled food and drinks. The FDA is staunchly opposed

STAT News

WASHINGTON — Major food makers are ready to cash in on selling CBD-filled foods and drinks. But the Food and Drug Administration isn’t having it. Technically all products containing CBD, or cannabidiol, are illegal under FDA’s rules — regardless of whether they’re a dietary supplement sold at the Vitamin Shoppe or a CBD seltzer from Whole Foods.

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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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Why your bad boss will probably lose the remote-work wars

NPR Health - Shots

Since 2020, office workers have waged an epic battle to work remotely. They're mostly winning.

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Poxviruses, outbreaks, and Ebola: A Q&A with a retiring CDC expert on bad bugs

STAT News

In the last week of August, one of the world’s foremost poxvirus experts retired from the Centers for Disease Control and Prevention. To outside eyes, the timing of Inger Damon’s departure could be seen as odd or unfortunate, given that after years of relative obscurity, poxviruses are at the center of the world’s infectious diseases radar, thanks to the ongoing monkeypox outbreak.

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Family Dollar recalls Colgate products that were improperly stored

NPR Health - Shots

Family Dollar says it is not aware of any complaints from customers nor any reports of illnesses related to the recall.

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Opinion: Preventive services can improve Americans’ health, but they are now on trial

STAT News

Twelve years after the Affordable Care Act was enacted, it appears to be here to stay, fully integrated into the nation’s health care system, extending coverage to more than 30 million Americans and protecting coverage against pre-existing conditions. The Supreme Court has ruled three times that the law is constitutional, and neither political party seems interested in overhauling it.

Trials 98
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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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CGT Catapult begins virtual reality training to help ensure future workforce needs

BioPharma Reporter

A new pilot training model, one using augmented reality (AR) and virtual reality (VR) to support learning, is aimed at individuals looking to boost their knowledge and skills so they can continue to progress the area of Advanced Therapy Medicinal Product (ATMP) development.

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STAT+: UnitedHealth bid for Change Healthcare may proceed, judge rules

STAT News

A federal judge on Monday shot down the U.S. Justice Department’s legal challenge to UnitedHealth Group’s $13 billion acquisition of the technology company Change Healthcare.  Judge Carl Nichols’ one-page order denying the government’s bid to stop the merger stipulated that UnitedHealth divest Change’s claims editing subsidiary, ClaimsXten, to TPG Capital.

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Keyword Coverage: Comparing Top SEO Tools

Intouch Solutions

When you’re looking at keywords, how do you know if you’re seeing everything that’s out there? Sadly, you probably aren’t. No tool is perfect. But which one is best? Tylor Hermanson, VP, SEO, EVERSANA INTOUCH recently conducted an investigation of four top SEO tools, and his article on the work appeared in Search Engine Land. “ The by-no-means-definitive keyword size showdown ” compared GSC, Ahrefs, Semrush, and Moz, and their keyword coverage for domains in t

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Opinion: Hospital financing in black and white

STAT News

During our training as doctors, we have rotated through safety-net hospitals, elite academic medical centers, and private clinics. The resources for patient care and comfort were sumptuous in some facilities, spartan in others. The differences were often night and day or, as we quantified in a later analysis, black and white: we cared for far more white patients at highly resourced facilities and many more Black patients and other patients of color at those with fewer resources.

Doctors 98
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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.