Sat.Dec 31, 2022 - Fri.Jan 06, 2023

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COVID-19 tracker: AstraZeneca workers who were fired for refusing vaccine file lawsuit

Fierce Pharma

COVID-19 tracker: AstraZeneca workers who were fired for refusing vaccine file lawsuit. kdunleavy. Tue, 01/03/2023 - 10:31.

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Google and DeepMind share work on medical chatbot Med-PaLM

pharmaphorum

Google and DeepMind have developed an artificial intelligence-powered chatbot tool called Med-PaLM designed to generate “safe and helpful answers” to questions posed by healthcare professionals and patients. The tool is an example of a large language model or LLM, which are designed to understand queries and generate text responses in plain language, drawing from large and complex datasets – in this case, medical research.

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Trending Sources

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Withings Unveils Urine Analysis Device That Sits in Your Toilet Bowl

MedCity News

Withings announced that it is developing a miniaturized platform that can analyze urine at home. The device, called U-Scan, sits within a toilet bowl and assesses specific biomarkers found in urine.

Medical 135
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Cell therapies might revolutionise treatment for multiple sclerosis patients

Pharmaceutical Technology

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections. However, new mechanisms of action (MoAs) are in constant development, with some of the more innovative ones utilizing cell-based therapies.

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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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Pfizer, GSK, AbbVie and many more celebrate New Year with price hikes: report

Fierce Pharma

Pfizer, GSK, AbbVie and many more celebrate New Year with price hikes: report. esagonowsky. Wed, 01/04/2023 - 10:21.

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Forks in the road lead one medical expert to a ‘game changing’ liver treatment

PharmaVoice

Durect’s chief medical officer altered his retirement plans to take a leading role at the company, which is developing a treatment for severe alcohol-associated hepatitis.

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Four Vital Optimizations Required For Digital Marketing Success

Healthcare Success

I’ve noticed that most people tend to focus on only one of four variables when optimizing their digital marketing results. That’s a shame because true optimization requires a more strategic approach that considers each of the following four factors: Consumer Demand. Campaign Management (e.g., Google Ads or Microsoft). Landing Page. Conversion Process.

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Lilly, Merck double down on peptide-targeted drug delivery, betting billions in biobucks on PeptiDream pacts

Fierce Pharma

Lilly, Merck double down on peptide-targeted drug delivery, betting billions in biobucks on PeptiDream pacts. ntaylor. Tue, 01/03/2023 - 08:31.

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Point-Of-Care Biosensor to Detect Oral Cancer

Medgadget

Researchers at the University of Florida have created a point-of-care biosensor that can rapidly detect a biomarker for oral cancer. The device uses test strips, such as those used in blood glucose tests, to spot cell proliferation regulating inhibitor of protein phosphatase 2A (CIP2A), a protein biomarker that can reveal the presence of oral cancer.

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Drug Approvals in 2022: A Recap of Notable FDA Regulatory Decisions

MedCity News

Fewer new drugs won FDA approvals in 2022 compared to previous years, but some of the products that passed regulatory muster are indicative of trends expected to continue into 2023. For example, more gene and cell therapies are on track to face regulatory decisions in the coming year.

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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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UK partners with BioNTech on clinical trials of mRNA cancer therapies

pharmaphorum

The UK has formed an partnership with German biotech BioNTech to provide up to 10,000 patients with access to personalised cancer therapies, in another example of the country embracing the mRNA technologies that underpinned COVID-19 vaccines. The cancer immunotherapies will mainly be provided in the context of clinical trials over the alliance, which extends out to 2030, but also covers supply of commercial therapies if approved in the interim.

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Moderna makes its first-ever acquisition, buying Japanese DNA manufacturer OriCiro for $85M

Fierce Pharma

Moderna makes its first-ever acquisition, buying Japanese DNA manufacturer OriCiro for $85M. mbayer. Wed, 01/04/2023 - 06:37.

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Bioprinted Eye Tissue to Study Retinal Diseases

Medgadget

Researchers at the National Eye Institute, which is part of the National Institutes of Health, have created a method to 3D bioprint eye tissue that forms the outer blood-retina barrier. This tissue supports the photoreceptors in the retina and is implicated in the initiation of age-related macular degeneration. The outer blood-retina barrier is the interface of the retina and the choroid, including Bruch’s membrane and the choriocapillaris.

Ethics 107
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How Much of a Risk Is a Potential Class-action Lawsuit against CommonSpirit?

MedCity News

CommonSpirit Health is facing a proposed class-action lawsuit over a ransomware attack it suffered last fall that exposed 623,774 patients’ personal data. However, hospitals’ data breach lawsuits usually never make it court, a legal expert said.

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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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Technology as a New Evolution in Fighting Disease

PharmaTech

Advancing the use of AI to understand the whole of a disease can reveal drug development insights that lead to drug discovery breakthroughs.

Leads 122
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Unicycive's pivotal trial of rival to Takeda kidney drug hits main goal, clearing path to FDA filing

Fierce Pharma

Unicycive's pivotal trial of rival to Takeda kidney drug hits main goal, clearing path to FDA filing. ntaylor. Tue, 01/03/2023 - 03:20.

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Newron says pivotal treatment-resistant schizophrenia trial is a go

pharmaphorum

Encouraged by new data, Newron Pharmaceuticals has said it will start a registration study of would-be blockbuster evenamide in treatment-resistant schizophrenia (TRS) later this year. The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months.

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Timely Referrals to Hospice Can Help Patients with Advanced Lung Disease Breathe Easier

MedCity News

There’s a lingering misperception among many patients, loved ones, and even healthcare professionals that hospice care is useful only in a patient’s last days or weeks of life.

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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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How To Run Outstanding Marketing Events for Senior Living Communities

Clear Pivot

Warmth, hospitality, and friendliness are all crucial for senior living communities. In fact, your success as a business depends on it. These qualities are all easy to communicate with face-to-face interactions, so make sure you're taking advantage of one of the most effective ways to get them: events.

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With Leqembi approval in Alzheimer's disease, Eisai and Biogen plot 'meticulous' launch

Fierce Pharma

With Leqembi approval in Alzheimer's disease, Eisai and Biogen plot 'meticulous' launch. fkansteiner. Fri, 01/06/2023 - 12:44.

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State of Financing Deals and Go-to-Market Strategy in Biotech: Q&A with Timothy Moore and Jack Mycka, Indegene

PharmExec

A chat with with Indegene's Timothy Moore, Senior Vice President, Emerging Biotech and Key Accounts and Jack Mycka, Vice President, Enterprise Medical Solutions and Emerging Biotech.

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Leaning In: How eCOA can Help Advance Mental Health Research

MedCity News

Electronic Clinical Outcomes Assessment and digital health tools were well-suited to accommodate the rapid rise of virtual and telehealth shifts during the Covid-19 pandemic and there is no going back. The adoption of eCOA technology in mental healthcare research can make pivotal advancements in mental health patient care.

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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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Research Fronts 2022 highlights hot and emerging fields, including vaccine hesitancy, ‘mega-fires’ and asteroids [Report]

Clarivate

To highlight fast-moving and emerging specialty areas of science, Clarivate has once again partnered with the Chinese Academy of Science (CAS) on a special report on the hottest fields in science, including data on the regions and institutions producing the work. The latest annual edition, Research Fronts 2022, marks the 9th collaboration between Clarivate and the CAS.

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Particulates, label issues prompt separate recalls for Pfizer's Hospira and Accord

Fierce Pharma

Particulates, label issues prompt separate recalls for Pfizer's Hospira and Accord. zbecker. Wed, 01/04/2023 - 11:35.

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The end-of-life care conundrum

pharmaphorum

Research advises against aggressive cancer treatment at the end-of-life stages of the disease. At the same time, the pharmaceutical industry is creating a greater number of oncology treatments that could provide breakthroughs for patients where none previously existed. Ben Hargreaves examines why there is no easy answer to the question of when palliative care is the right option for patients.

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Technology Will Be Critical To Move Healthcare Organizations Forward in 2023

MedCity News

with the right technology, healthcare organizations in the year ahead can become more efficient, make quality care accessible to more people, reduce their recruiting and hiring costs, prevent mistakes, and deliver better outcomes for themselves, their workers and their patients.

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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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Capsida Biotherapeutics and Prevail to develop CNS gene therapies

Pharmaceutical Technology

Capsida Biotherapeutics and Eli Lilly and Company ’s wholly owned subsidiary Prevail Therapeutics have announced a partnership for the development of non-invasive gene therapies for central nervous system (CNS) diseases. Under the multi-year strategic partnership, Prevail will detect and advance capsids, which are clinically translatable, along with its cargo to develop the transformative genetic medicines by using Capsida’s novel adeno-associated virus (AAV) engineering platform.

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Bluebird scores $95M nest egg after selling second FDA priority review voucher to BMS

Fierce Pharma

Bluebird scores $95M nest egg after selling second FDA priority review voucher to BMS. fkansteiner. Fri, 01/06/2023 - 08:42.

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Geron finally gets close to a product approval with imetelstat

pharmaphorum

More than 30 years after it was first formed, Geron is on the cusp of bringing its first product to market, after imetelstat hit the mark in a phase 3 trial in patients with myelodysplastic syndromes (MDS). The Foster City, California-based biotech said today that its IMerge trial of imetelstat – vying to become the first telomerase inhibitor to reach the market – hit its objectives in patients with lower risk MDS, a rare group of bone marrow cancers.

Safety 98
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10 Key Medtech Themes for 2023

MedCity News

We expect 2023 to be a pivotal year for the industry, as the accelerated acceptance of virtual care and demographic trends, such as an aging population, increasing chronic illnesses and healthcare worker shortages, sustain demand for medtech-enabled solutions.

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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.