Mon.Oct 23, 2023

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With FDA rejection to treat hives disorder, Sanofi and Regeneron's Dupixent suffers rare setback

Fierce Pharma

Regeneron and Sanofi are anxious to bring Dupixent as an answer for chronic spontaneous urticaria (CSU), a severe inflammatory condition that causes hives and deep swelling on or under the skin.

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2.3M People Would Gain Coverage If Remaining 10 States Expanded Medicaid

MedCity News

If the remaining 10 states expanded Medicaid, uninsured rates would greatly drop for women of reproductive age, non-Hispanic Black adults and young adults, a new Urban Institute report found.

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Trending Sources

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With $385M settlement, Indivior closes out long-running Suboxone antitrust case

Fierce Pharma

With a $385 million settlement, Suboxone maker Indivior is moving to wrap up years of antitrust litigation tied to its opioid addiction treatment. | The deal follows previous settlements worth $102 million and $30 million with two other claimant groups.

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Forget Fair-Weather Healthcare: Disruptors of This Industry Are Already in It

MedCity News

Companies built for other businesses are attempting to offroad their skills into a brand new field. These fairweather healthcare players are unprepared for the terrain. Meanwhile, the true disruptors of this industry are already in it.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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EU authorities fine Boehringer, others for operating drug-ingredient 'cartel'

Fierce Pharma

Five pharmaceutical companies, including the global player Boehringer Ingelheim, have landed in hot water for running a "cartel" to dominate the market for a specific drug ingredient in Europe. | Authorities said the companies agreed to set minimum prices, allocated business and more. Boehringer Ingelheim was hit with the largest fine among the group.

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Heard at HLTH 2023: Execs Share Progress on Digital Health for Pharma, Hospitals, and Behavioral Health Care Coordination [Sponsored]

MedCity News

In the second part of the Heard at HLTH series, executives from BrightInsight, Iodine Software, Intelligent Medical Objects, Carrum Health, Clarify Health and Trayt Health shared new developments across their businesses and perspectives on value-based care at the HLTH 2023 event.

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More Trending

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Abivax Adds $236M to Show Its Anti-Inflammatory Med Can Stand Apart in Crowded Field

MedCity News

Abivax pulled off stock market deals in the U.S. and Europe that infuse the biotech with capital to continue clinical development of a small molecule for inflammation that’s differentiated from biologic therapies. In other biotech IPO news, Cargo Therapeutics and Invea Therapeutics both filed paperwork to go public.

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An ‘inverse vaccine’ takes aim at autoimmune diseases

PharmaVoice

Backed by Pfizer, Anokion’s innovative approach to treating celiac, MS and more is showing early promise where others failed.

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LLMs Can Perpetuate Harmful Ideas About Race-Based Medicine, Study Shows

MedCity News

A new study led by Stanford researchers tested four commercially available LLMs and found that they all could potentially cause harm by breeding inaccurate, racist information. For example, all models tried to justify race-based medicine when asked questions about calculating patients’ kidney function and lung capacity — two areas where race-based medicine practices used to be common but have since been scientifically refuted.

Medicine 105
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ESMO 2023: Janssen reveals data for intravesical delivery system

European Pharmaceutical Review

An intravesical drug delivery system designed to provide sustained local release of gemcitabine into the bladder, has enabled 77 percent of bladder cancer patients (23 out of 30) to achieve a complete response (CR) in the Cohort 2 of the Phase IIb SunRISe-1 study. TAR-200 is indicated for Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) CIS (carcinoma in situ)-positive in individuals who are ineligible for, or decline radical cystectomy.

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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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Roche to Pay $7.1B to Get Contender in Tight Inflammatory Bowel Disease Race

MedCity News

Roche’s Telavant acquisition comes as the Roivant Sciences subsidiary prepares its main asset for Phase 3 testing in ulcerative colitis. The antibody drug candidate blocks a novel target for inflammation and fibrosis that’s also the focus of clinical-stage programs of other big pharma companies.

Pharma 105
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How to approach die plate adhesion during tableting

European Pharmaceutical Review

In tablet compression, there are a range of factors which contribute to a successful production run. 1 In pharmaceutical manufacturing, the high level of final product quality is the major driver. Tablets should be defect-free and compliant to good manufacturing practice (GMP) aspects and final-user requirements. The most common defects in tableting are classified as visual or functional 2 : visual issues compromise tablet quality without affecting its functionality, something which functional i

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Weight Loss Startup Calibrate Is Changing Hands

MedCity News

Weight loss company Calibrate — which sells a program combining GLP-1 drugs with personalized metabolic health coaching — announced a legal restructuring of its business. The startup, which had two major rounds of layoffs this year, has struggled in recent months amid GLP-1 drug shortages and mounting user complaints.

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FlyPharma Conference Europe 2023 shares industry collaboration initiatives and explores the future of pharma logistics

PharmaTimes

On 10 to 11 October 2023, the seventh FlyPharma Conference Europe successfully concluded in Vienna, Austria - News - PharmaTimes

Pharma 107
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Execs Weigh In on the Gaps in Suicide Prevention

MedCity News

There are several gaps in suicide prevention, including a lack of screening and access to care. During a recent panel discussion at HLTH 2023, execs detailed what gaps need to be filled.

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AstraZeneca granted licence for Nanoform’s AI technology

PharmaTimes

STARMAP will accelerate the selection of AZ’s best molecule candidates - News - PharmaTimes

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Roche to gain rights to novel antibody for IBD

European Pharmaceutical Review

As part of an acquisition agreement of over $7 billion, Roche will gain rights to a novel TL1A directed antibody for inflammatory bowel disease (IBD). Roche has agreed to acquire Telavant Holdings, Inc. (Telavant), a Roivant company, owned by Roivant Sciences Ltd. and Pfizer Inc for $7.1 billion. Roche will also pay a near-term milestone payment of $150 million.

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Suction Cup Delivers Drugs Through Cheek

Medgadget

Researchers at ETH Zurich in Switzerland have developed an alternative to injections as a way to deliver large drugs, such as peptides, minimally invasively into the blood stream. The suction cup created by these researchers is inspired by octopus suckers, and it affixes to the mucosal lining of the inside of the cheek. The cup stays in place because a vacuum is drawn when the patient presses it onto their cheek lining.

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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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FDA Clears Pfizer’s Meningococcal Disease Treatment

PharmExec

Penbraya indicated as the first and only vaccine for the prevention of the five most common serogroups in adolescents.

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Enhanced mRNA Vaccine May Work Intranasally.

Medgadget

Researchers at MIT have developed an enhanced mRNA vaccine system that can elicit a greater immune response at lower doses. The vaccine technology is so potent that it may be useful for intranasal COVID-19 vaccines. This would have the benefit of localized immunity in the nasal mucus membranes that could kill the SARS-CoV-2 virus before it enters the body.

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AstraZeneca granted license for Nanoform’s AI technology

PharmaTimes

STARMAP will accelerate the selection of AZ’s best molecule candidates - News - PharmaTimes

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ESMO 2023: MSD’s Welireg leads HIF-2? inhibitors in RCC despite unclear OS

Pharmaceutical Technology

At ESMO 2023, interim results from the Phase III LITESPARK-005 trial evaluating MSD’s Welireg (belzutifan) as a treatment for patients with previously treated advanced clear cell renal cell carcinoma (RCC) were presented.

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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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CCC Hires Ian Palmer as Vice President, Marketing

Copyright Clearance Center

Oct. 23, 2023 – Danvers, Mass. – CCC , a pioneer in voluntary collective licensing that advances copyright, accelerates knowledge, and powers innovation, announces Ian Palmer as Vice President, Marketing, responsible for leading the company’s international marketing communications strategy and driving global brand awareness for CCC information solutions.

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MedTechVets Breakfast Panel Recap, 2023 MedTech Conference

MedTechVets

October 23rd, 2023– On October 10th, MedTechVets hosted a Breakfast Networking Panel titled, “Veteran Impact on MedTech” at The MedTech Conference in Anaheim, California. Over 250 attendees registered for our breakfast panel. The room was packed full of people interested in learning how Veterans add purpose to the MedTech Industry.

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Indivior relieves Suboxone hangover with $385m deal

pharmaphorum

Indivior relieves Suboxone hangover with $385m deal Phil.

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What is quantum computing and what does it mean for business?

Pharmaceutical Technology

What is quantum computing and what does it mean for business. Quantum computing has emerged from a hype cycle with continued investment.

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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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ESMO: Trials end 20-year hiatus in cervical cancer therapy

pharmaphorum

ESMO: Trials end 20-year hiatus in cervical cancer therapy Phil.

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Simplify Your Salesforce Integration with SPOTIO for Enhanced Sales Performance

Spotio

In today’s interconnected world, seamless communication and collaboration among software systems have become the foundation of operational success. At SPOTIO, we’re committed to simplifying and supercharging your Salesforce CRM (SFDC) integration process. Our native, bi-directional integration with SFDC is the key to streamlining operations, eradicating data entry redundancy, and maximizing efficiency.

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Manufacturing issues delay lebrikizumab’s entry to the atopic dermatitis market

Pharmaceutical Technology

On 2 October, Eli Lilly announced that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the biologic license application (BLA) for its anti-interleukin (IL)-13 biologic lebrikizumab for the treatment of adults and adolescents (12 and older) with moderate-to-severe atopic dermatitis (AD).

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Harnessing Omnichannel, AI, and beyond: Reimagining Scientific Publications

pharmaphorum

Bringing together industry panellists to share insights and lessons learned from their own professional lives on successful transformation with AI and omnichannel, and the hurdles that can occur along the way.

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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.