Wed.May 31, 2023

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ASCO: Novartis pressures Lilly with Kisqali, targeting $3B opportunity in early breast cancer

Fierce Pharma

Adding Kisqali to endocrine therapy after surgery reduced the risk of invasive tumor recurrence or death by 25% in certain early-stage breast cancers.

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XtalPi announces $250m AI drug discovery collaboration with Eli Lilly

Pharmaceutical Technology

XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. XtalPi will receive $250m in upfront and milestone payments. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.

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FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy

Fierce Pharma

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02

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ChatGPT in Healthcare – The Promise and the Danger

MedCity News

AI-generated information can be considered akin to obtaining a second or even third opinion regarding one’s health – it makes up part of what needs to be known, but it’s not the entire story.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Former Novartis execs cleared of Greek bribery charges after yearslong investigation

Fierce Pharma

After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. | After an investigation that dates back to 2017, four former Novartis executives and a Greek politician were cleared of bribery charges. But 15 doctors were charged for their alleged involvement.

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Health Inequity Has Been Reduced to a ‘Checklist of Unmet Social Needs,’ Exec Says

MedCity News

Health equity strategies need to take factors like racism and lack of power into account, said Dr. Shreya Kangovi, executive director of the Penn Center for Community Health Workers. She made these comments last week at the MedCity INVEST conference in Chicago.

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Big Pharma inventory management trends revealed

European Pharmaceutical Review

The inventory position of 28 major pharmaceutical manufacturers in 2022 has been revealed in an annual report. Analysis explored the impact of macro-trends on inventory management from corporate reports of Big Pharma companies including Merck, AstraZeneca and Pfizer. It investigated how excessive inventories are affecting the industry and what factors could influence inventory growth in 2023.

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AbbVie's Rinvoq passes midstage test in systemic lupus erythematosus, heads into phase 3

Fierce Pharma

AbbVie's Rinvoq passes midstage test in systemic lupus erythematosus, heads into phase 3 esagonowsky Wed, 05/31/2023 - 09:39

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Sanofi MS Drug Shines in Phase 2, Paving Way for a Pivotal Test Next Year

MedCity News

Frexalimab, a Sanofi drug candidate with roots at Dartmouth’s medical school, has met the main goal of its Phase 2 test. The encouraging data for this program come as different experimental Sanofi MS drug nears its one-year anniversary under FDA clinical hold.

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NICE gives thumbs-up to Pfizer's migraine drug—but with lots of restrictions

Fierce Pharma

NICE gives thumbs-up to Pfizer's migraine drug—but with lots of restrictions kdunleavy Wed, 05/31/2023 - 09:43

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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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Strive Health Rakes In $166M for Value-based Kidney Care

MedCity News

Strive Health’s $166 million funding round was led by NEA and included participation from CVS Health Ventures, CapitalG, Echo Ventures, Town Hall Ventures, Ascension Ventures and Redpoint. In total, the company has raised more than $400 million.

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Stealth and Pharmanovia partner for commercialisation of elamipretide

Pharmaceutical Technology

Stealth BioTherapeutics has made an exclusive licensing agreement with Pharmanovia for the commercialisation of its elamipretide to treat Barth syndrome. Pharmanovia will hold exclusive rights for the commercialisation of elamipretide in the EU, other European countries including Switzerland, Norway, Iceland and the UK, and the Middle East and northern Africa region.

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Making Healthcare Access More Shoppable to Build Enduring Relationships with Patients [Sponsored]

MedCity News

A recent webinar sponsored by DexCare explored how the consumerization trend is shifting expectations for health consumers and how companies are enlisting AI tools such as machine learning and Chat GPT to improve the patient experience. Register to access the recording.

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CRISPR-based microbial gene therapy delivers promise

European Pharmaceutical Review

The novel CRISPR-Cas therapeutic selectively targets antibiotic-resistant E. coli which can cause life-threatening bloodstream infections” Positive interim results from a Phase I trial have demonstrated that the first CRISPR-armed phage microbial gene therapy can reduce Escherichia coli ( E. coli ) levels in the GI tract. “With the combined killing effects of bacteriophages and CRISPR-Cas technology, SNIPR001 has demonstrated the ability to target and eliminate antibiotic-resistant E

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Woman of the Week: Mirati Therapeutics’ Laurie Stelzer

PharmaVoice

With the recent approval of Krazati, the biotech veteran is guiding Mirati into its next phase as a commercial-based organization.

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Clinicians Offer Snapshot from Day in the Life of Delivering Care at Teladoc Health [Sponsored]

MedCity News

In a series of interviews, two Teladoc Health physicians and a therapist offered a window into a day in the life of delivering virtual care.

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Workflow of the Future: Sustainable Business Models

Copyright Clearance Center

The post Workflow of the Future: Sustainable Business Models appeared first on Copyright Clearance Center.

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Healthcare Moves: A Monthly Summary of Hires and Layoffs

MedCity News

Here is a selection of recent executive hires, exits, promotions and layoffs occurring across the healthcare industry.

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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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3 Ways Longevity Positively Impacts Medical Equipment Sales Careers

MedReps

When it comes to medical equipment sales careers, longevity is one thing that can make you more successful than your counterparts. Sure, you may feel the need to switch up your specialties or employers based on the ongoing trends in the field, but this may cause more detriments to your career. As it turns out, selling medical equipment and spending years both in the field and working for the same employer comes with many benefits, including these three. 1) You Know the Products Well Medical equi

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Amgen’s Otezla shows promise in psoriatic arthritis

PharmaTimes

The inflammatory form of arthritis is estimated to affect nearly 38 million people worldwide

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University of Sydney will use AI to boost cancer drug research

Pharmaceutical Technology

The University of Sydney and Australian company Pharos Therapeutics have reached an agreement to leverage artificial intelligence (AI) to progress drug discoveries for the treatment of cancer and rare diseases. The university and Pharos have drawn up a memorandum of understanding (MoU) to use AI technology to identify potential compounds for the rapid development of treatments.

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Roller Compaction: New Trends, Challenges and Solutions

PharmaTech

When developing a tablet or capsule formulation, three widely used technologies are often considered to produce solid dosage forms: direct compression, wet granulation and dry granulation (including roller compaction). This article discusses why roller compaction is a robust option.

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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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Demystifying the 5G standard essential patent landscape: Phase 4

Clarivate

A new report [1] from Clarivate patent experts provides an update on 5G standards-essential patent declarations. In our Demystifying the 5G standard essential patent landscape : Phase 3 report published in March 2022, we presented the statistics of patents declared as essential to 5G standards as of December 31, 2021. We present statistics in a new report that captures new declarations, new 5G standards, new patent applications and new grants within the patent families.

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Direct Compression of Probiotics with PROSOLV® EASTtab Nutra

PharmaTech

Although probiotics are mostly administered in the form of capsules, there are some advantages of tablets in terms of production effort, cost efficiency and stability of the probiotic bacteria.

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ZNA-1041 by F. Hoffmann-La Roche for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

ZNA-1041 is under clinical development by F. Hoffmann-La Roche and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how ZNA-1041’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Nexcella Begins Production of CAR-T Cell Therapy Engineering Batches at US Manufacturing Site

PharmaTech

The start of production of US engineering batches of NXC-201, a CAR-T cell therapy candidate in early clinical development, is the first step in transferring Nexcella’s existing manufacturing process to the United States.

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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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ISPOR 2023: A Focus on Quality

Prognos Health

Todd Somsel , Commercial Lead, RWD Marketplace The acceptance and application of real-world evidence (RWE) by stakeholders across the healthcare industry continues its rapid pace of growth. And as these stakeholders are presented with more and more RWE from pharmaceutical manufacturers, they are asking tough questions to better understand whether to use this evidence when making critical decisions that impact the health of patients.

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MedCity Moves Podcast: Recent Hires, Layoffs & an Interview with Lara Khouri, COO of Children’s Hospital Los Angeles

MedCity News

In this month’s episode, we dive into some of the recent executive appointments occurring in the healthcare sector, as well as layoffs affecting the industry. We also hear from Lara Khouri, the new COO of Children’s Hospital Los Angeles, about her passion for pediatric healthcare.

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Fishawack Health Deepens Key Capabilities and Builds an Integrated Delivery Model Under New Chief Marketing and Creative Officer

PM360

Leading global commercialization partner Fishawack Health (FH) has announced the integration of key capabilities within its Marketing division to seamlessly deliver connected customer experiences built on data-driven insights. Tenured agency executive Ryan Mason has been promoted to Chief Marketing and Creative Officer and will unite creative, brand, and engagement strategy and media and analytics teams.

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BBT-401 by Bridge Biotherapeutics for Ulcerative Colitis: Likelihood of Approval

Pharmaceutical Technology

BBT-401 is under clinical development by Bridge Biotherapeutics and currently in Phase II for Ulcerative Colitis. According to GlobalData, Phase II drugs for Ulcerative Colitis have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how BBT-401’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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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.