Tue.Apr 02, 2024

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Eli Lilly's popular diabetes drug Mounjaro to face continued supply squeeze through April, FDA says

Fierce Pharma

Amid steadily increasing demand for Eli Lilly’s popular diabetes med Mounjaro, it appears patients on multiple dose strengths may have to wait even longer than anticipated to re-up on supply. | Four dose strengths are now expected to be in short supply through April, according to the FDA. The agency previously expected the squeeze to let up at the end of March.

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How to Help Physicians Generate More Revenue and Make Their Patients Healthier

MedCity News

Interest in using GLP-1 drugs to reduce obesity combined with a desire by physicians to become less dependent on insurance-based reimbursement after the recent Change Healthcare cyberattack is building. The post How to Help Physicians Generate More Revenue and Make Their Patients Healthier appeared first on MedCity News.

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Acorda inks $185M asset sale to Merz, files for bankruptcy after years of disappointing sales

Fierce Pharma

After years of struggling with hurdles such as generic competition and significantly lower-than-expected sales of its top meds, Acorda Therapeutics is hanging up the gloves with a $185 million deal | Merz Therapeutics, in a "stalking horse bid," agreed to pick up Acorda's Parkinson's disease med Inbrija and multiple sclerosis drug Amprya ahead of a court auction.

Sales 268
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Insurer Advocacy Orgs Slam Final MA, Part D Rate Announcement

MedCity News

America’s Health Insurance Plans, the Better Medicare Alliance and the Association for Community Affiliated Plans all came out against CMS’ final 2025 Medicare Advantage and Part D rate announcement. The post Insurer Advocacy Orgs Slam Final MA, Part D Rate Announcement appeared first on MedCity News.

Insurance 115
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Teva, Viatris revive patent challenge on J&J's long-acting schizophrenia blockbuster Invega Sustenna

Fierce Pharma

After incurring a loss in New Jersey federal court in 2021, Teva and Viatris have successfully resurrected challenges to the last remaining U.S. | After incurring a loss in New Jersey federal court in 2021, Teva and Viatris have successfully resurrected challenges to the last remaining U.S. patent on a lucrative Johnson & Johnson schizophrenia drug.

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‘Cliff’ Countdown: Balancing Internal and External Growth

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, explores the two major strategies big pharma companies are employing amid current macro challenges and efforts to offset looming patent losses to blockbuster brands.

Pharma 104

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Ipsen Joins the ADC Chase, Licensing Phase 1-Ready Asset for Novel Cancer Target

MedCity News

Ipsen is acquiring global rights to a Sutro Biopharma antibody drug conjugate for a target that is not yet hit by any FDA-approved drugs. Merck is among the companies pursuing this target, but Sutro claims its ADC could be first and best in this class. The post Ipsen Joins the ADC Chase, Licensing Phase 1-Ready Asset for Novel Cancer Target appeared first on MedCity News.

Biopharma 100
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What does the future of specialist distribution look like?

Fierce Pharma

Joining us on this episode of The Top Line is Jeff Beck, Chief Development Officer at BioCare. | The patient journey is evolving. How will specialty distribution keep up? Hear insights from BioCare’s Jeff Beck on new product archetypes, expanded data capabilities, understanding site economics and delivering seamless product access and service.

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Overcoming the Fear Factor in Adopting Virtual Reality in Nursing Education

MedCity News

There are some lingering misconceptions around the use of VR that are likely to give instructors pause when considering whether to add a VR component to the nursing curriculum. This article addresses five common misconceptions about immersive VR simulations. The post Overcoming the Fear Factor in Adopting Virtual Reality in Nursing Education appeared first on MedCity News.

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EP monographs allow rFC for water testing

European Pharmaceutical Review

Revised versions of two widely used European Pharmacopoeia (EP) monographs now allow the use of recombinant factor C (rFC) for testing of pharmaceutical waters. The revised monographs – Water for injections (0169) and Purified water (0008) – mean that users can select the rFC test described in Ph. Eur. 2.6.32 directly when testing pharmaceutical waters.

Ethics 94
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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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ICR collaboration forms national NHS patient database registry for Lynch syndrome patients

PharmaTimes

The genetic condition affects one in 279 people in England and significantly increases cancer risk

Patients 123
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Endotoxin testing: the international regulatory landscape

European Pharmaceutical Review

Animal welfare is a crucial consideration in the adoption of alternative methods like recombinant Factor C (rFC) and recombinant Cascade Reagents (rCR) for bacterial endotoxin testing (BET). These methods aim to impede animal suffering by reducing dependence on horseshoe crab blood. At Roche, we see it as our ethical and environmental responsibility to support the use of alternative methods that prioritise animal welfare while ensuring the safety of our patients and the quality of our products.

Ethics 90
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Ipsen licenses Sutro ADC in $900m deal

pharmaphorum

Ipsen has expanded its oncology pipeline by licensing rights to an antibody-drug conjugate (ADC) for solid tumours from Sutro Biopharma, its first drug in the category. The deal, which has a top-end value of $900 million including $90 million in near-term payments, focuses on STRO-003, a preclinical-stage ADC targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1).

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Lonza appoints new Chief Executive

European Pharmaceutical Review

Wolfgang Wienand has been chosen to succeed Albert Baehny as the CEO of Lonza. Wienand will join the contract development and manufacturing organisation (CDMO) in the summer of 2024. He has been CEO of the Swiss CDMO Siegfried Holding AG since 2019. Baehny has held his Chief Executive Officer ad interim role since October 2023 and will support Wienand through the transition period.

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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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The Growing Future of Drug Manufacturing

PharmaTech

With an ever-growing market driving technological advances, there is always work to be done in drug manufacturing.

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Acorda filed for bankruptcy, and Merz is eyeing its assets

pharmaphorum

Acorda Therapeutics has filed for bankruptcy protection, hoping to keep operating while it tries to arrange the sale of its main assets to a US subsidiary of Germany’s Merz. The announcement made last night US time sparked a run on Acorda's shares, down almost 62% at the time of writing. The news emerged shortly after Acorda cancelled its fourth-quarter results conference call, which was scheduled to take place yesterday.

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The Power of Patient Adherence Tools to Improve the Patient Journey

Pharmaceutical Commerce

Why manufacturers should leverage technology to address low adherence rates.

Patients 110
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AZ, Daiichi Sankyo file Dato-DXd for second indication

pharmaphorum

AstraZeneca and Daiichi Sankyo file for approval of datopotamab deruxtecan (Dato-DXd) for second indication in breast cancer.

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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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Researchers reveal people with Parkinson’s more likely to experience delirium in hospital

PharmaTimes

Two out of three people with the neurodegenerative condition experienced delirium in hospital

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Bristol Myers Squibb’s Director of Business Operations for MSAT, Carl Allenspach, Highlights Collaboration and Interactive Exchange at INTERPHEX

PharmaTech

Carl Allenspach, director of business operations, manufacturing, science, and technology organization at Bristol Myers Squibb discusses the interactive and collaborative important of INTERPHEX.

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Providence Spins Out New Patient Engagement Startup With $20M in Funding

MedCity News

Providence spun out its fourth digital health startup: Praia Health, a platform designed to build stronger relationships with patients by personalizing their healthcare journeys and connecting them to relevant resources and services. The startup also announced the closing of a $20 million Series A funding round led by Frist Cressey Ventures. The post Providence Spins Out New Patient Engagement Startup With $20M in Funding appeared first on MedCity News.

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A dementia-focused VC digs past anti-amyloid for neuroscience diamonds in the rough

PharmaVoice

Even as new drugs like Eisai and Biogen’s Leqembi make a splash in Alzheimer’s, VCs like the Dementia Discovery Fund have invested in the next wave of therapies.

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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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Pharma Pulse 4/2/24: Tackling Barriers to Adopting BYOD, Lonely Men with HIV More Likely to Smoke & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharma 105
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Share Your Insights on the Changing Healthcare Landscape

MedCity News

Do you advise self-insured employers? Your insights will offer leading, innovative points of view that can guide employers and peers. Join us for this year’s survey! The post Share Your Insights on the Changing Healthcare Landscape appeared first on MedCity News.

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Redx joins C4X in delisting from AIM due to liquidity issues

pharmaphorum

Redx Pharma has decided it would be better off in private hands than publicly listed on the UK AIM, and has started the process of exiting the exchange

Pharma 57
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Dual Shaft Mixers Line

PharmaTech

The ROSS line of Dual Shaft Mixers are robust, versatile systems with enough power to batch dispersions, suspensions, and emulsions with viscosities up to several hundred thousand centipoise.

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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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Key Trends Shaping the Future of Drug Development

PharmExec

In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, discusses upcoming advancements in the drug pipeline and trends shaping the future of drug development.

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Focusing on Effectiveness for CAPAs

PharmaTech

Compliance can be greatly improved by concentrating on the basic elements of CAPA investigations, advises Kate Rice, global quality systems manager, Nelson Laboratories, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

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Effective Strategies for Selling to MRO Companies

Spotio

Think about the equipment you need to do your job… A computer to find leads, update CRM software, and send emails. A cell phone to call prospects and capture lead information in the field. A vehicle to get you to and from sales meetings. The truth is, most of us take our tools for granted. We assume they’ll always be there, exactly when we need them.

Sales 52
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May I Present the Neoantigen

PharmaTech

Experts believe it is likely cancer cells are more common in the body than previously thought, but typically caught early and removed in the body’s cancer-immune cycle. When the system is in good working order (and protecting us), dead cancer cells release neoantigens.

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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.