Fri.Mar 15, 2024

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Madrigal, FDA approval in hand, outlines plan to sell MASH drug

BioPharma Drive: Drug Pricing

The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.

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Driving efficiency across upstream bioprocess workflow

Drug Target Review

The discovery and development phases of biotherapeutic drugs leverage multiple technologies and processes across upstream and downstream stages of the bioprocess workflow. Advancements in cell line development (CLD), including screening and selection of final clones, scale up, automation and digitalisation have enabled precision and enhanced productivity.

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New research suggests that our universe has no dark matter

Science Daily: Pharmacology News

A new study challenges the current model of the universe by showing that, in fact, it has no room for dark matter.

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Waterborne Parasite That Can Kill Dogs Is Spreading to U.S. West

Drugs.com

FRIDAY, March 15, 2024 -- A parasite that can kill dogs has been found in a portion of the Colorado River that runs through Southern California.Heterobilharzia americana is a flatworm usually referred as liver fluke. It has never been reported.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Drug Discovery Industry Roundup with Barry Bunin — March 15, 2024

Collaborative Drug

“Long Covid ‘Brain Fog’ May Be Due to Leaky Blood-Brain Barrier Ozempic Taking off in China? Is Exercise More Effective For Women than Men?

Drugs 101
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Uncooked Morel Mushrooms Proved Fatal for Montana Diners

Drugs.com

FRIDAY, March 15, 2024 -- A salmon-and-mushroom sushi roll proved deadly for two restaurant patrons in Montana last year, and experts are sounding the alarm on the dangers of undercooked morel mushrooms. A total of 51 patrons at an unnamed.

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More Trending

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Pooch Power: 'Relax' Brainwaves Begin When Folks Play With Dogs

Drugs.com

FRIDAY, March 15, 2024 -- Playing fetch or grooming Fido isn't just good for your precious pooch — it also benefits your brain.Such interactions appear to strengthen brain waves associated with rest and relaxation, South Korean researchers report.

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Recap of CDD User Group Meeting – Berlin 2024

Collaborative Drug

CDD User Group Meeting in Berlin. Contributions from experts at Bayer Co.Lab, PROTEROS biostructures GmbH, Refoxy Pharma, PROSION Therapeutics, Schrödinger.

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Step Away From the 'Go Barefoot Everywhere' TikTok Trend, Experts Say

Drugs.com

FRIDAY, March 15, 2024 -- Attention, America: ignore the "experts" on TikTok and put your shoes on.Barefootin' is risky business, according to Dr. Sari Priesand, a foot specialist at Michigan Medicine-University of Michigan in Ann Arbor."Keep the.

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FDA panel backs broader use of J&J, Bristol Myers cell therapies for myeloma

BioPharma Drive: Drug Pricing

A majority of experts believed that the factors that may have led to an increased risk of early death in testing of Carvykti and Abecma aren’t as likely to occur outside of a clinical trial.

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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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'Space Headaches' Can Hit Astronauts, Study Finds

Drugs.com

FRIDAY, March 15, 2024 -- Astronauts who have never had headaches may develop migraines and other tension-type headaches for the first time when they go into space.A side effect of zero gravity, these headaches start with motion sickness as.

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Longitudinal gut fungal alterations and potential fungal biomarkers for the progression of primary liver disease

SCIENMAG: Medicine & Health

Science China Life Sciences recently reported on the research results of Lanjuan Li’s team from Zhejiang university. Recent advances in microbiome research have revealed complex changes in gut microecology across various disease states, highlighting their profound impact on disease progression.

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FDA Approves First Drug for Common, Serious Liver Disease

Drugs.com

FRIDAY, March 15, 2024 -- Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday.The condition is.

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The Four Key Factors to Evaluate When Insourcing vs. Outsourcing Patient Support Programs

Drug Channels

Today’s guest post comes from Josh Marsh, Vice President and General Manager of Sonexus™ Access and Patient Support at Cardinal Health. Josh discusses factors that drive manufacturers to insource versus outsource patient support services. He shares data from a Cardinal Health survey of biopharmaceutical companies and offers four factors to consider when evaluating your patient support program.

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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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Eating Healthy Slows 'Aging Clock,' Helping to Shield Your Brain From Dementia

Drugs.com

FRIDAY, March 15, 2024 -- Scientists have long noticed that folks who eat healthy have healthier brains as they age, including lowered odds for dementia.Now, researchers believe they know why: Regimens like the heart-healthy Mediterranean or DASH.

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Newly discovered receptor influences gut development in fruit flies

SCIENMAG: Medicine & Health

Adhesion GPCRs belong to the large family of G protein-coupled receptors (GPCRs). There are about 700 variants in humans, which are responsible for sensory impressions, hormonal cycles, controlling the cardiovascular system and more. GPCRs translate stimuli that hit a cell from outside into an intracellular biochemical signal. Credit: Photo: Dr.

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Living in Poor Neighborhoods Ups Risks for Dementia, Early Aging

Drugs.com

FRIDAY, March 15, 2024 -- Doctors looking to help their patients head off dementia may want to ask for their address.An international team of researchers has linked accelerated brain aging and a higher risk of thinking declines to living in a.

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Bristol Myers cell therapy wins first-of-its-kind approval

BioPharma Drive: Drug Pricing

Sold as Breyanzi, the therapy is now cleared for use in certain adults with hard-to-treat forms of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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FDA Approves First Drug for Common, Serious Liver Disease, Rezdiffra

Drugs.com

FRIDAY, March 15, 2024 -- Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday. The condition is.

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Shaping the Future: Eli Lilly's Role in the Weight Management Revolution

DrugBank

The weight loss industry has emerged as a major hub for innovative research, groundbreaking treatments, and economic opportunity. According to Grand View Research , the global weight loss and weight management market size was valued at $142.5 billion in 2022 and is projected to grow at a compound annual growth rate of 9.94% from 2023 to 2030. Many drug discovery and repurposing initiatives are shifting focus to capturing a share of this market in light of Eli Lilly and the Novo Nordisk success.

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New tentative approval for Zydus Pharms drug empagliflozin;linagliptin;metformin hydrochloride

Drug Patent Watch

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.

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FDA revises early Alzheimer’s draft guidance, adds considerations for surrogate endpoints

Agency IQ

BY AMANDA CONTI Given the progressive nature of Alzheimer’s disease (AD), developing treatments for early-stage populations is crucial. FDA has now issued a second revision to its draft guidance on developing drugs for this population. The guidance walks through appropriate outcomes—including surrogate endpoints—but emphasizes the importance of getting agency input.

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New tentative approval for Sandoz Inc drug rifaximin

Drug Patent Watch

Rifaximin is the generic ingredient in one branded drug marketed by Salix Pharms and is included in one NDA. There are twenty-nine patents protecting this compound.

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California publishes draft regulations for landmark plastic pollution reduction act

Agency IQ

BY WALKER LIVINGSTON, ESQ CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. The newly released draft regulations, statement of reason and regulatory impact assessment all point to the wide-reaching implications that the rule will have for a variety of industries across the state.

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MRI May Predict Who'll Respond Best to Schizophrenia Treatment

Drugs.com

FRIDAY, March 15, 2024 -- Specialized brain scans may accurately predict whether a psychotic patient will go on to develop treatment-resistant schizophrenia, Dutch researchers report.The scan — called a neuromelanin-sensitive MRI, or NM-MRI for.

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FDA drafts ‘select updates’ to guidance on medical device cybersecurity, addressing statutory requirements

Agency IQ

BY LAURA DIANGELO, MPH In late 2023, the FDA finalized a long-awaited guidance on medical device cybersecurity – but also promised updates to that final guidance which would address certain statutory requirements. Today, the agency published a draft version of those “select updates,” which delineate how the FDA will interpret key statutory definitions and provide expectations for documentation and for bringing existing devices into compliance.

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Perficient Included in Forrester Trends Report: Rethink Enterprise Applications Governance

Perficient: Drug Development

Perficient, a leader in digital transformation, has been included as a company interviewed in Forrester’s recent report, “ Rethink Enterprise Applications Governance : Refocus Applications Governance And High-Performance IT Exploiting New Technologies To Win, Serve, And Retain Customers.” This comprehensive report explores the evolving landscape of enterprise applications governance, shedding light on the transformative potential of new technologies such as AI and cloud computi

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CORE-MD research showcases possibilities of patient-reported outcomes in high-risk device clinical investigations

Agency IQ

BY COREY JASEPH, MS, RAC The latest webinar from the CORE-MD consortium presented the group’s research into how patient-reported outcome measures have been used in clinical evaluations of high-risk medical devices. Researchers reported their findings from systematic literature reviews and a Delphi study of the use of different patient-reported outcome measures – and how patients thought these tools could be made better.

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Women in STEM with Dr Petra Dieterich

Drug Target Review

Could you explain how you got into STEM? As a child, I loved creative play, drawing, painting, crafting, and logic problems. Later on at school, Chemistry, Biology, and Art were my favourite subjects. Especially in chemistry, I loved the idea of studying something to understand it and then using that knowledge to make new molecules. Can you describe your personal journey that got you to where you are now?

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ECHA unveils 6-month plan to evaluate universal PFAS restriction proposal

Agency IQ

BY SCOTT STEPHENS, MPA ECHA announced the steps it will take over the next six months to evaluate the proposed universal restriction on “forever chemicals.” The unprecedented volume of comments received during last year’s public consultation means EU regulators have had to resort to exceptional measures in the REACH restriction procedure as they seek to maintain transparency, objectivity and a high level of quality.

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New patent for Springworks drug OGSIVEO

Drug Patent Watch

Annual Drug Patent Expirations for OGSIVEO Ogsiveo is a drug marketed by Springworks and is included in one NDA. It is available from one supplier.

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Oncology Market Outlook 2024

Fierce BioTech

Oncology Market Outlook 2024 This paper assesses the current state of the oncology market, reviewing key expectations for 2024. It addresses CAR-T therapies, KRAS, radiopharmaceuticals, & targeted protein degradation. jpiatt Fri, 03/15/2024 - 13:46 This paper assesses the current state of the oncology market, reviewing key expectations for 2024.

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Using Snowflake and Databricks Together

Perficient: Drug Development

This is not another comparison between Databricks and Snowflake ; they’re not hard to find. This is a practical guide about using Databricks and Snowflake together in your organization. Many companies have both products implemented. Sometimes, there is a discrepancy between the two as far as the data being stored, creating new data silos. The Databricks users would like to access data that is only in Snowflake and vice versa.