Sat.Nov 05, 2022 - Fri.Nov 11, 2022

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AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments

Fierce Pharma

AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments. aliu. Thu, 11/10/2022 - 09:02.

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Firefly, Sprinter Team Up to Close the Loop on Virtual Primary Care

MedCity News

Sprinter Health is integrating its at-home clinical and diagnostic services into Firefly Health’s virtual primary care model. Firefly’s members will be able to receive common medical services from Sprinter clinicians in their homes — such as vital checks, blood draws, electrocardiograms, diabetic eye exams and diabetic foot screenings.

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Trending Sources

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SirsiDynix CloudSource+ Now Offering Get It Now From CCC

Copyright Clearance Center

November 7, 2022, LEHI, Utah — CloudSource+ , the newest content solution for open access materials from SirsiDynix , has integrated with Get It Now from CCC (Copyright Clearance Center) to provide immediate purchase and delivery of full-text articles to unsubscribed journals. Get It Now is used by hundreds of academic libraries around the world to help expand their virtual collections.

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Device Measures Hemoglobin More Accurately in Dark Skin

Medgadget

Researchers at the University of Texas at Arlington, in collaboration with Shani Biotechnologies, a local firm, have created a point-of-care device that can accurately measure hemoglobin levels and perform pulse oximetry in individuals with dark skin. At present, methods to determine hemoglobin levels at the point of care, such as pulse oximetry, are inaccurate in individuals with higher levels of melanin in their skin, and there is a clear need to develop alternatives that work for everyone.

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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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Moderna’s Spikevax carries higher risk of myocarditis than Pfizer's Comirnaty, study says

Fierce Pharma

Moderna’s Spikevax carries higher risk of myocarditis than Pfizer's Comirnaty, study says. zbecker. Tue, 11/08/2022 - 11:03.

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Report: Health Insurance Is Influencing Americans’ Job Choices

MedCity News

More than 31% of people with employer-sponsored insurance stuck with a job they disliked for the company’s health insurance, a Forbes Advisor survey found. Another 8% of respondents left a job they liked to seek better coverage.

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More Trending

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The legacy of Glen de Vries: Our last interview with the pioneering entrepreneur

PharmaVoice

Recorded just weeks before his passing, our sit-down interview with the legendary medical sciences entrepreneur showcased his passion for pushing the industry toward its next frontier.

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Sanofi, GSK crash the COVID-19 vaccine party late with a world-first nod for their next-gen booster

Fierce Pharma

Sanofi, GSK crash the COVID-19 vaccine party late with a world-first nod for their next-gen booster. fkansteiner. Thu, 11/10/2022 - 14:09.

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What Healthcare Insights Can We Gain from Space Exploration? [Sponsored]

MedCity News

In an interview, the deputy director and chief innovation officer of Translational Research Institute for Space Health, headquartered at Baylor College of Medicine, described some of the group’s work, adapting known tech for space applications and using space-based insights to improve healthcare at home.

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First human trials of lab-grown red blood cells start in UK

pharmaphorum

Blood cells grown in a laboratory have been given to people for the first time in a clinical trial being carried out by researchers in the UK, in the hope that plentiful supplies of rare blood groups can be manufactured to order. A team from the universities of Bristol and Cambridge, NHS trusts and NHS Blood and Transplant (NHSBT) have started giving small quantities of the lab-grown red blood cells – a couple of teaspoons full – to two healthy volunteers to see if they are safe.

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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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Can gene therapies for haemophilia defend their high price tags?

Pharmaceutical Technology

Despite their potential multi-million-dollar sticker price, if haemophilia treatments by BioMarin and CSL Behring prove durable, they could help patients save money compared to current treatments, experts note. On November 2, the Institute for Clinical and Economic Review (ICER) released its updated evidence aimed at measuring the clinical effectiveness and cost of the two haemophilia gene therapies.

Safety 111
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GSK's CAR-T rival Blenrep fails multiple myeloma trial, endangering its accelerated approval

Fierce Pharma

GSK's CAR-T rival Blenrep fails multiple myeloma trial, endangering its accelerated approval. aliu. Mon, 11/07/2022 - 09:45.

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Consumers Need Better Communication From Their Health Plans, Survey Shows

MedCity News

More than half, or 58%, of health plan members are “overwhelmed” when it comes to managing their health plans. Insurers need to provide information in a way that’s accessible and easy to understand, the report stated.

Insurance 127
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First patients given lab-grown blood cell transfusion

European Pharmaceutical Review

Lab-grown blood cells have been transfused into a second patient in the world’s first-of-a-kind clinical trial , opening up future treatments for blood disorders such as sickle cell if found safe and effective. Stem cells from blood donors were separated and grown to produce modified red blood cells at NHS Blood and Transplant ( NHSBT ) Advanced Therapies Unit in Bristol.

Patients 113
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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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UK MHRA approves Pfizer-BioNTech’s bivalent Covid-19 booster

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 and BA.5 sub-variants. Indicated for usage as a booster in people aged 12 years and older, the modified vaccine is the second bivalent shot of the companies to obtain approval in the region.

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Troubled Clovis telegraphs bankruptcy amid FDA hardball on key cancer drug, difficulty in fundraising

Fierce Pharma

Troubled Clovis telegraphs bankruptcy amid FDA hardball on key cancer drug, difficulty in fundraising. aliu. Wed, 11/09/2022 - 11:33.

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Debunking Cloud Cost and ROI Hogwash for Healthcare

MedCity News

The hogwash started in The Wall Street Journal with a contrarian take on a recent KPMG technology report. But cloud operates in a fundamentally different paradigm from the IT infrastructure of the past, and embracing big change is rarely free or easy. But the rewards of evolving are obvious and far too great to ignore.

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Battery-Free Light-Powered Pacemaker Now a Reality

Medgadget

Researchers at the University of Arizona have developed a battery-free light-powered pacemaker that uses optogenetic stimulation of cardiomyocytes to achieve heart pacing. With conventional pacemakers, the leads of the device are anchored into the wall of the heart, using invasive hooks or screws. Small electrical shocks are then sent through the entire heart, potentially causing discomfort and pain.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Planning appeal blocks Lilly’s €400m plant in Ireland

pharmaphorum

Eli Lilly plans for a new biopharmaceutical manufacturing facility in Ireland that will be used to produce active ingredients for its biologic medicines, including its new Alzheimer’s candidate donanemab, has been blocked by a planning objection. Lilly had already secured planning approval from Limerick City and County Council for the plant at the Raheen Business Park.

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Neurotech's vision loss cell therapy implant hits primary goals in phase 3 trials

Fierce Pharma

Neurotech's vision loss cell therapy implant hits primary goals in phase 3 trials. ntaylor. Tue, 11/08/2022 - 06:28.

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Northwell, Aegis Launch Virtual Menopause Care Startup for Employers

MedCity News

Aegis Ventures launched a new startup with Northwell Holdings, the venture capital arm of Northwell Health. The New York City-based company, named Upliv, focuses on virtual menopause care. It will partner with employers to provide its services to their employees at no cost.

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flipMD by GoodRx decreases physician burnout through medical matchmaking

PharmaVoice

Using flipMD, organizations can find, vet, connect with and source practicing board-certified physicians from all specialties for contract, project-based or full-time assignments.

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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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Pandemic boost to decentralised trials is here to stay

pharmaphorum

Due to the pandemic, decentralised trial solutions made the shift from an emerging trend to a crucial element of drug development. Ben Hargreaves examines the latest research suggesting that this transition looks set to become a permanent feature of trials in the years to come. The pharmaceutical industry’s role in developing effective vaccines against COVID-19 was a major benefit to the industry.

Patients 113
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Eli Lilly ordered to pay $177M to rival Teva in migraine patent fight

Fierce Pharma

Eli Lilly ordered to pay $177M to rival Teva in migraine patent fight. zbecker. Thu, 11/10/2022 - 11:11.

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FDA Again Spurns BrainStorm’s ALS Data, This Time With Official Refusal

MedCity News

BrainStorm Cell Therapeutics’ stem cell therapy for amyotrophic lateral sclerosis received an FDA refuse-to-file letter, correspondence that informs a company its application seeking approval is incomplete. The notice means BrainStorm might need to run another clinical trial.

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EC grants approval for Sanofi-GSK’s Covid-19 booster

Pharmaceutical Technology

The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. It is indicated as a booster in people of this age group who were earlier inoculated with a Covid-19 vaccine. The latest development comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion on vaccine use.

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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.

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This plant-based gel stops bleeding in seconds — and might have potential in drug delivery

PharmaVoice

29-year-old biotech founder Joe Landolina is hoping to capitalize on major possibilities in the human health market through his startup Cresolin and just inked a research partnership with Walter Reed.

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Viatris executive charged in insider trading scheme that allegedly netted $7.2 million

Fierce Pharma

Viatris executive charged in insider trading scheme that allegedly netted $7.2 million. kdunleavy. Fri, 11/11/2022 - 11:30.

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Patient Engagement Collaboration Is an EHR’s Missing Link

MedCity News

Instead of EHR companies trying to build solutions in-house, collaborating with a patient engagement technology provider is the simplest and most cost-effective way for them to deliver the communication link demanded by today’s healthcare consumer.

Patients 116
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AstraZeneca reports 9% rise in Q3 2022 total revenue

Pharmaceutical Technology

AstraZeneca has reported an 11% rise in total revenue to $10.98bn in the third quarter (Q3) 2022 as against $9.87bn in the year-ago quarter. For the quarter ending on 30 September 2022, product sales were reported at $10.59bn from $9.7bn in Q3 last year, indicating a growth of 9%. In the third quarter of 2022, core earnings per share (EPS) were recorded to be $1.67, signifying a 55% increase while reported EPS was $1.06.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.