Thu.Nov 16, 2023

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Bristol Myers' $4.1B Turning Point buy yields FDA approval for lung cancer drug Augtyro

Fierce Pharma

Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. | Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market.

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U.K. Is First to Approve a CRISPR-Based Therapy, Covering Two Blood Disorders

MedCity News

Casgevy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is now approved in the United Kingdom for treating the blood disorders sickle cell disease and beta thalassemia. It’s the first regulatory approval in the world for a CRISPR-based therapy.

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Trending Sources

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Pharma is racing to oncology's first line, causing a rethink of early-stage disease treatment

Fierce Pharma

Timothy Yap, Ph.D., used to see patients nearing the end of their cancer journey in his phase 1 department at the University of Texas' MD Anderson Cancer Center. | Cancer drugs are getting better thanks to innovation, driven by the data and regulatory forces like Project FrontRunner.

Pharma 270
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AstraZeneca showed the pandemic isn’t over for immunocompromised patients. What’s next?

PharmaVoice

Dr. Paul Moss, a hematology expert in the U.K., conducted a study with AstraZeneca showing the alarming extent to which immunocompromised patients are burdened with COVID-19.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Micron nets nearly $24M from Gates Foundation to pioneer needle-free vaccine tech in low- and middle-income countries

Fierce Pharma

Micron nets nearly $24M from Gates Foundation to pioneer needle-free vaccine tech in low- and middle-income countries fkansteiner Thu, 11/16/2023 - 11:08

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The Women’s Edge and The Boston Globe Again Name CCC to Top 100 Women-Led Businesses in Massachusetts List

Copyright Clearance Center

November 16, 2023 – Danvers, Mass. – The Women’s Edge , a nonprofit that supports female business leaders, in partnership with The Boston Globe , has announced CCC , a pioneer in voluntary collective licensing, advancing copyright, accelerating knowledge, and powering innovation, was named to its annual Top 100 Women-Led Businesses in Massachusetts list.

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More Trending

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Why Healthcare is the Perfect Place For AI to Shine

MedCity News

In reality, the healthcare sector is, in many ways, the ideal place for AI to be used. After all, it’s one of the few industries with access to a treasure trove of precisely the kind of high-quality data with which AI operates best.

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Vertex, CRISPR gain 'historic' nod in UK for exa-cel. But will cost watchdogs embrace the gene-editing therapy?

Fierce Pharma

Vertex, CRISPR gain 'historic' nod in UK for exa-cel. But will cost watchdogs embrace the gene-editing therapy?

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We’re at a Turning Point for Alzheimer’s Disease Research

MedCity News

Medical science has made significant strides in the development of advanced treatments over the past decade. However, the majority of FDA-approved treatments for Alzheimer’s focus on the management of symptoms or delayed progression of the disease.

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'The Top Line': Exploring Alzheimer’s breakthroughs, Leqembi's potential and what comes next

Fierce Pharma

This episode of "The Top Line" is dedicated to Alzheimer’s disease, exploring the latest treatments and what lies ahead. | This episode of "The Top Line" is dedicated to Alzheimer’s disease, spotlighting the latest treatments and what lies ahead. Fierce Pharma's Fraiser Kansteiner discusses Leqembi's full approval with Eisai's Alexander Scott.

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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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MedCity Pivot Podcast: Health Equity in Opioid Addiction Treatment With Dr. Brian Clear

MedCity News

Dr. Brian Clear, an addiction treatment physician and chief medical officer of Bicycle Health, believes that telemedicine is one way to improve access and reduce the inequities inherence in addiction treatment. The other is education.

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The Changing Role of Diagnostic Labs in Personalized Oncology Care

Fierce Pharma

By Yuri Fesko, MD | Our latest white paper, delves deep into the symbiotic relationship between diagnostic labs, pharmaceutical companies, and healthcare providers in the era of precision medicine.

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How Digital Twins Drive Sustainability in Clinical Supply Planning

PharmExec

Emerging technologies like digital twins offer supply chain efficiency solutions, allowing the industry to integrate sustainable practices while ensuring patient safety.

Safety 105
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Which Tech Solutions Are Actually Having a Positive Impact on the Workforce Crisis?

MedCity News

Knowing that many tech solutions end up being not as effective as health systems would have hoped, two health system executives gave examples of tools they believe have made a significant impact on staffing issues at their organizations. One is a wearable patch that continuously monitors inpatients’ vital signs, and one is a platform that allows providers to fill open shifts with local nurses.

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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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First CRISPR-based gene-editing therapy authorised

European Pharmaceutical Review

Casgevy (exagamglogene autotemcel), also known as exa-cel, is the first treatment to be licensed that uses CRISPR. It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia.

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Navigating the Challenges of HIPAA Compliance in the Digital Age

MedCity News

Navigating the complexities of HIPAA compliance requires a multifaceted strategy that combines efficient processes, continuous training, technological innovation, and proactive engagement with regulatory bodies. While meeting compliance benchmarks is non-negotiable, the ultimate goal should be to provide high-quality, patient-centric care.

Training 101
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World’s first CRISPR-based gene therapy approved for sickle cell anaemia

Pharmaceutical Technology

Vertex and CRISPR's Casgevy has received conditional approval in the UK for treating sickle cell and transfusion-dependent beta-thalassemia.

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Bristol Myers Squibb Wins FDA Approval for Lung Cancer Drug From $4B Deal

MedCity News

FDA approval of Bristol Myers Squibb’s Augtyro covers treatment of patients whose non-small cell lung cancer is driven by the rare ROS1 mutation. The molecule comes from BMS’s 2022 acquisition of Turning Point Therapeutics.

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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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Regional inequalities threatening Europe’s biosimilars market

European Pharmaceutical Review

While Europe has historically been a pioneer in the adoption of biosimilars, a new report by the global initiative Act4Biosimilars has revealed differences country by country, including disparities between Eastern and Western Europe. This is based on research from a report published in April this year by IQVIA. [Act4Biosimilars’ Regional Deep Dive Report Europe] noted that biosimilar adoption levels vary significantly across Europe” Act4Biosimilars shared that their Deep Dive Report

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Talkspace Offers Free Telemental Health Services to NYC Teens

MedCity News

New York City teens ages 13 to 17 will soon be able to access Talkspace therapists through phone, video or text for free. They will also be able to use Talkspace’s self-guided content.

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Express Scripts to Launch New Network Option With Simpler Drug Pricing Structure

PharmExec

Express Scripts has announced plans to offer to a new pharmacy network cost-based pricing option for prescription medications and pharmacy services.

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Twist Bioscience Launches Gene Synthesis Service

PharmaTech

Twist Bioscience now offers its Express Genes rapid gene synthesis service at its Wilsonville, Ore. manufacturing facility.

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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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Xphozah wins orphan drug designation for paediatric hyperphosphatemia

Pharmaceutical Technology

Ardelyx scores another FDA win after Xphyozah was approved by the FDA in October as an add-on therapy for chronic kidney disease patients.

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Ask The Chefs: cOAlition S’s “Towards Responsible Publishing”

Copyright Clearance Center

We asked the Chefs to weigh in with their thoughts on the new "Towards Responsible Publishing" manifesto from cOAlition S.

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FDA approves study of Versameb’s mRNA therapy in urinary incontinence

Pharmaceutical Technology

The mRNA therapy may help to accelerate the regeneration of the urinary sphincter muscle, treating women with stress urinary incontinence.

FDA 97
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Reaching New Global ‘Frontiers’ In Life Sciences

Eversana Intouch

Last week, Frontiers Health, the premier global digital health innovation event, was held in Rome, Italy. The annual event assembled nearly 1,000 attendees from over 40+ countries across the healthcare ecosystem to learn, network and explore industry challenges, strategic trends and solutions in life sciences and healthcare. While Frontiers Health has always been a flagship event for EVERSANA INTOUCH and our clients to attend each year, this year’s event was significant as we were proud to co-ho

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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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Glox Therapeutics secures £4.3m seed funding to combat AMR

PharmaTimes

The bacteriocin development programme will first target pseudomonas aeruginosa - News - PharmaTimes

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Kite and Arcellx expand strategic collaboration

Pharmaceutical Technology

Kite has expanded its existing partnership with Arcellx for the latter’s CART-ddBCMA candidate to include lymphomas.

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Single-use bioprocessing market to value $84.14bn by 2032

European Pharmaceutical Review

The global single-use bioprocessing market is expected to value estimated $84.14 billion by 2032, according to Towards Healthcare. This is due to rising demand for personalised medicines, rising investment in R&D, and adoption of decentralised clinical trials. The organisation’s report asserted that growth of the market is being driven by numerous factors including the greater demand for biologics, the expanding biopharmaceutical industry, and the numerous advantages that single-use bioproce

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LifeArc and UKDRI invest £14.5m into neurodegeneration research

PharmaTimes

The funding will be used to develop new diagnostic tests, treatments and devices - News - PharmaTimes

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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.