Fri.Oct 27, 2023

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Sanofi CEO Hudson's new 'Play to Win' pivot sends stock plunging

Fierce Pharma

Sanofi acolytes are none too happy with the latest chapter of CEO Paul Hudson’s "Play to Win" strategy. | Sanofi acolytes are none too happy with the latest chapter of CEO Paul Hudson’s "Play to Win" strategy. After unveiling the pivot alongside third-quarter earnings Friday, Sanofi’s stock plunged nearly 20%, with one analyst group suggesting the plan came “at the wrong time.

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Beyond the Bedside: Strengthening Patient-Physician Bonds Through Virtual Care

MedCity News

While some people question how virtual care can be effective without physical touch, it is clear that in-person appointments are not frequently delivering on developing a comprehensive understanding of a patient’s need and holistic health.

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Trending Sources

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Eli Lilly enters crowded ulcerative colitis market with delayed FDA approval for Omvoh

Fierce Pharma

Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too. | Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too.

Marketing 245
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How Tech Changes to Clinical Trials Help Both Patients and Biopharma Firms

MedCity News

Technology is transforming how clinical trials are run. A panel during MedCity News’ INVEST Digital Health conference discussed the tech trends shaping the design and execution of drug studies.

Biopharma 118
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Santhera, Catalyst score FDA nod for Duchenne drug. Can they gain more indications for Agamree?

Fierce Pharma

With the FDA approval of Agamree (vamorolone) to treat Duchenne | Thursday’s FDA approval of Santhera’s Agamree (vamorolone) to treat Duchenne muscular dystrophy (DMD) is just a start. The Swiss company is anxious to see how many disorders the first-in-class corticosteroid can treat.

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How Cedars-Sinai, Evernorth & More Are Deploying AI Responsibly

MedCity News

While the dawn of a new AI age is certainly exciting, healthcare leaders are still concerned that the industry lacks a comprehensive framework to regulate these new tools. In the absence of these guidelines, healthcare executives are creating their own governance strategies to deploy AI responsibly, executives said during a panel discussion on Thursday at MedCity News’ INVEST Digital Health conference in Dallas.

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The Challenges of Providing Healthcare in Rural Areas

MedCity News

The lack of proper healthcare infrastructure, human resources, equipment, and funding can reduce the quality of care in rural hospitals and clinics. It’s crucial to improve the rural healthcare delivery models and provide quality care to the residents.

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Specialty injectables maker Exela issues recall after particles turn up in 3 different drugs

Fierce Pharma

Rogue particles turning up in drugs has caused a plethora of recalls in recent years, most recently affecting pharma giants Pfizer and GSK. | Exela is working with the FDA to recall three separate medications—injectable sodium bicarbonate, midazolam and the nutrition additive Elcys—after inspections of leftover samples flagged silicone matter in some vials.

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The 2023 Red Jacket honorees

PharmaVoice

This year's inductees to the PharmaVoice 100 "hall of fame" are leaders who have been at the forefront — and will stay at the forefront — of industry change.

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GSK's Jemperli prolongs life in endometrial cancer trial. Will FDA label expansion come next?

Fierce Pharma

After a quick FDA approval in a subgroup of endometrial cancer patients, GSK is trumpeting a win for its Jemperli that might help the PD-1 inhibitor expand to a broader population. | After a quick FDA approval in a subgroup of endometrial cancer patients, GSK is trumpeting a win for its Jemperli that might help the PD-1 inhibitor expand to a broader population.

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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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Who Won INVEST Digital Health Pitch Perfect 2023?

MedCity News

Femtech was the theme of the INVEST Digital Health Pitch Perfect contest in Dallas this week. Seven companies presented their approaches to addressing women’s health.

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Look out, Eylea: Roche's Vabysmo wins new use in retinal vein occlusion

Fierce Pharma

The market battle between Roche’s Vabysmo and Regeneron and Bayer’s Eylea just cranked up a notch. | The fast-growing blockbuster previously showed non-inferiority to Regeneron and Bayer's Eylea in the condition. This approval will expand the showdown between the two rival drugs.

Marketing 164
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3 Tips That Could Reduce Friction in Payer-Provider Relationships

MedCity News

During a panel at MedCity News’ INVEST Digital Health conference, three executives representing a provider, a payer and a technology vendor shared their thoughts on how to heal the rocky relationship between hospitals and health plans. For instance, one leader encouraged payers and providers not to be afraid to give up some control, and another urged them to build comprehensive risk models.

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Sustainable biosimilar competition in Europe: can it be achieved?

European Pharmaceutical Review

According to The Biosimilar Medicines Group, part of Medicines for Europe, a new report by IQVIA indicates there is a window of opportunity for the EU to foster future-proof biosimilar competition. This publication has come in wake of the EU actively reviewing its Pharmaceutical Legislation. Julie Marechal-Jamil, Director Biosimilar Policy & Science at Medicines for Europe stated the report identified “many policy shortcomings that must be addressed now to deliver access to medicines in the

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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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MedCity Pivot Podcast: A Conversation with CommonSpirit Health’s Population Health Innovation Lead

MedCity News

Season 4 launches with a focus on health equity and a conversation with Dr. Alisahah Jackson, system vice president of population health innovation and policy at CommonSpirit Health.

Leads 102
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Red Jacket: Ken Getz, a champion of clinical trials

PharmaVoice

Ken Getz has spent his career improving clinical research for the benefit of patients, the life sciences industry and other R&D stakeholders.

Patients 104
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New Bill could enhance UK clinical trial regulation

European Pharmaceutical Review

A report published by the Policy Exchange has highlighted how The Future Clinical Trials Bill could improve the UK’s approach to the establishment and regulation of clinical trials. The new Bill is part of a range of proposed policies for implementation under the new legislative programme that will be set out in the final session of this Parliament.

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UK NICE recommends use of AbbVie’s Parkinson’s treatment 

Pharmaceutical Technology

The UK NICE has recommended the use of AbbVie’s foslevodopa–foscarbidopa (Produodopa) for the treatment of advanced Parkinson’s disease.

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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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Parkinson’s UK awards over £1.8m for nine research projects

PharmaTimes

Around 145,000 people in the UK are living with Parkinson’s disease - News - PharmaTimes

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(CST-2032 + nadolol) by CuraSen Therapeutics for Dementia: Likelihood of Approval

Pharmaceutical Technology

(CST-2032 + nadolol) is under clinical development by CuraSen Therapeutics and currently in Phase II for Dementia.

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Regulators develop five principles for machine learning-enabled medical devices  

PharmaTimes

The new principles will remove the regulatory burden for MLMD manufacturers - News - PharmaTimes

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(CST-2032 + nadolol) by CuraSen Therapeutics for Dementia: Likelihood of Approval

Pharmaceutical Technology

(CST-2032 + nadolol) is under clinical development by CuraSen Therapeutics and currently in Phase II for Dementia.

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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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RSV Designations Reached All Time High in 2022, Data Shows

PharmExec

Surge acted as a precursor for the RSV-marketed drug landscape in 2023, says GlobalData.

Marketing 105
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Sanofi will exit consumer health and boost R&D investment

pharmaphorum

Sanofi will exit consumer health and boost R&D investment Phil.

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Generating Pharma’s AI: Q&A With Masanori Ito, Senior Director, Head of Enterprise Insights and Digital Solutions, Digital, Analytics, and Technology at Astellas

PharmExec

Ito discusses how data-driven AI can be utilized by the pharma industry.

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How Companies Can Support Veterans

MedTechVets

October 27th, 2023– How can companies support veterans? The simple answer–hire veterans. The military has equipped Veterans with skills that are highly valued in the corporate world. Leadership, work ethic, adaptability, versatility, mission-oriented minds, problem-solving skills, loyalty, relationship-building skills, and a self-starter attitude are just a few of the areas where Veterans excel.

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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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Red Jacket: Dr. Jeremy Levin, a transformational leader

PharmaVoice

A consummate life sciences executive who has led with boldness and devotion, Dr. Jeremy Levin considers himself a participant as well as a leader.

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Lilly finally gets FDA OK for ulcerative colitis drug Omvoh

pharmaphorum

Lilly finally gets FDA OK for ulcerative colitis drug Omvoh Phil.

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The Impact of Quality Data on Healthcare Recruitment and Staffing Strategies

Scott’s Directories

In the ever-evolving realm of healthcare, the success of recruitment and staffing strategies hinges on the quality of data at one’s disposal. The Alberta physicians directory emerges as a pivotal resource, especially when navigating the intricate healthcare landscape from High Valley in the north to Cardston in the south and Grand Prairie in the west to Vermillion in the east.

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Early result backs Regeneron’s deafness gene therapy

pharmaphorum

Early result backs Regeneron’s deafness gene therapy Phil.

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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.