Thu.Oct 19, 2023

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BMS, Halozyme score with subcutaneous version of Opdivo

Fierce Pharma

Months after ditching an auto-injected version of Opdivo (nivolumab), Bristol Myers Squibb has found success with a more traditional way to administer its oncology blockbuster—with a syringe and vi | Months after ditching an auto-injected version of Opdivo, Bristol Myers Squibb has found success with a more traditional way to administer its oncology blockbuster—with a syringe and vial.

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Actor and epilepsy advocate Greg Grunberg wants the world to ‘talk about it’

PharmaVoice

The actor of “Heroes” and “Star Wars: The Force Awakens” fame is starring in another role as a patient advocate for people with epilepsy.

Patients 138
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Takeda’s stem cell treatment Alofisel flunks phase 3 trial in Crohn's complication

Fierce Pharma

After trimming an early-stage Crohn’s disease candidate from i | After trimming an early-stage Crohn’s disease candidate from its pipeline this year, Takeda is dealing with the failure of another of its therapies in a related indication. Alofisel (daradstrocel), a stem cell therapy designed to treat one of the most debilitating complications of Crohn’s—complex perianal fistulas (CPF)—has come up short in a phase 3 trial.

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Exo Is On a Mission to Put an Ultrasound Machine In Every Care Provider’s Pocket

MedCity News

With its new handheld ultrasound device, Exo is seeking to take point-of-care ultrasound beyond just the emergency medicine field — into areas like urgent care, primary care and the home. Kurt Hammond, Exo’s chief commercial officer, said that the device sets itself apart from other handheld ultrasound devices, such as those sold by GE, Philips and Butterfly Network, because its AI does a better job of making the ultrasound process quick and easy for providers.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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PTC inks Royalty deal worth up to $1.5B on Genentech-partnered SMA drug Evrydsi

Fierce Pharma

Amid a cost-cutting drive and a looming commercial threat in Europe, PTC Ther | PTC will hold on to 19% of its royalty interest in the Genentech drug with the option to sell the rest down the line. The company licensed the med to Genentech in 2011.

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Survey: Managing Costs, Mental Health Are Employers’ Top Health Priorities

MedCity News

When asked to list their top health and wellbeing priorities over the next three years, 69% of employers said managing their health plan’s costs and budgeting, while 63% said enhancing mental health programs, a new survey shows.

More Trending

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Hospitals Need to Cultivate a Culture of Informed Awareness [Sponsored]

MedCity News

In an upcoming webinar, learn how informed awareness can help hospitals overcome their most challenging operational challenges to simultaneously improve efficiency, staff engagement and satisfaction, quality of care, and profitability.

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EU, UK authorities crack down on fake versions of Novo Nordisk's Ozempic

Fierce Pharma

As Novo Nordisk works to get a handle on sales of illicit semaglutide, British and European drug authorities are warning that they've discovered falsified Ozempic pens on their home turf. | Novo Nordisk's hugely popular diabetes and weight-loss meds have attracted their share of counterfeits. Now, British and European drug authorities are warning that they've discovered falsified Ozempic pens on their home turf.

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There Is an STI Epidemic in the United States. We Need CPT Codes for At-Home Diagnostics Now

MedCity News

The CDC calls for increased access to sexual health services and prioritization of STI screening and treatment, an all-hands attempt to turn the surge. So why hasn’t the American Medical Association (AMA),approved CPT codes for at-home STI testing and linkage to care services?

Medical 101
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ESMO: In showdown with Merck's Keytruda, BMS' Opdivo delivers competitive perioperative lung cancer data

Fierce Pharma

In the race for leadership in the treatment of early-stage non-small cell lung cancer (NSCLC), Bristol Myers Squibb has put up trial data that look competitive to those from Merck’s Keytruda. | In the race for leadership in the treatment of early-stage non-small cell lung cancer, Bristol Myers Squibb has put up trial data that look competitive to those from Merck’s Keytruda.

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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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Base-Editing Biotech Beam Restructures, Narrowing Pipeline & Cutting 20% of Staff

MedCity News

Sickle cell disease is among the Beam Therapeutics programs spared, and here the company needs to show differentiation from genetic medicines under FDA review from Vertex Pharmaceuticals and Bluebird Bio. Meanwhile, Beam aims to find partners for its research in allogeneic cancer cell therapies and hepatitis B.

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With new study results, Johnson & Johnson can tout Tremfya's efficacy across all skin tones

Fierce Pharma

The first biologic to win approval to treat moderate to severe psoriasis was Astellas’ now-discontinued Amevive (alefacept) in 2003, paving the way for significant progress in the disease space. | The VISIBLE trial is the first large-scale psoriasis study in only people of color, J&J said. The company hopes that its study model can set an example for inclusive research.

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Medicaid Startups: Beware of the Healthcare Dabblers When Looking for Investors, Expert Says

MedCity News

Investors who dabble in healthcare are a “red flag,” and startups in the Medicaid space should avoid these investors, said Adaeze Enekwechi, operating partner of Welsh, Carson, Anderson and Stowe, during a panel discussion at HLTH 2023.

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With COVID windfall in rearview mirror, Roche starts to flesh out blood cancer ambitions

Fierce Pharma

After a boom during the pandemic, sales from COVID-19 drugs are now nonexistent at Roche. But the Swiss pharma’s blood cancer portfolio is enjoying a rejuvenation. | After a boom during the pandemic, sales from COVID-19 drugs are now nonexistent at Roche. But the Swiss pharma’s blood cancer portfolio is enjoying a rejuvenation.

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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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Inside Memorial Hermann’s New Menopause Care Partnership with Midi Health

MedCity News

Memorial Hermann Health System in Houston struck a new partnership with Midi Health, a virtual care clinic focused exclusively on women who are navigating menopause. The health system’s two main goals for the partnership are to provide another point of access for its patients to manage their health at home and to gather data to inform decisions about which services it should offer to meet women’s healthcare needs.

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Counterfeit diabetes pens identified in EU and UK

European Pharmaceutical Review

According to the European Medicines Agency (EMA), pre-filled pens falsely labelled as the type 2 diabetes medicine Ozempic ( semaglutide , 1mg, solution for injection) have been identified at wholesalers in the EU and the UK. The pens, with labels in German, originated from wholesalers in Austria and Germany. There are differences in the appearance between the falsified pen and the original pen.

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Sensor Monitors Transplanted Organs for Signs of Rejection

Medgadget

Researchers at Northwestern University have developed a sensor that can monitor transplanted organs for signs of rejection. Patients who receive transplants require immunosuppressive medication to ensure that their body does not reject the transplanted tissue, but this can still happen, sometimes years after the initial transplant. Current methods to monitor for immune rejection involve taking biopsies or monitoring blood markers, but these techniques are invasive and blood markers may not show

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EC expands Takeda’s Adcetris label for advanced Hodgkin lymphoma treatment

Pharmaceutical Technology

Adcetris/AVD is already approved as a first-line treatment for patients with CD30+ Stage IV Hodgkin lymphoma.

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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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miRNA Therapy Slows Cancer Growth

Medgadget

Scientists at Purdue University have developed a microRNA therapy designed to slow tumor growth. The technology takes advantage of the tendency of several cancer types to express an excess of surface receptors that bind folate (vitamin B9) and draw it into the cell interior. By attaching the microRNA strand to a folate molecule, the researchers could target it to cancer cells.

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Drug Solutions Podcast: Digital Transformation in the Biopharma Industry

PharmaTech

In this episode of the Drug Solutions Podcast, industry experts discuss the challenges and advantages of the digitalization trend in the biopharma industry, with particular emphasis on the impacts to biomanufacturing.

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Lateral Flow Test for Gingivitis

Medgadget

Researchers at the University of Cincinnati have developed a lateral flow assay that can detect bacterial toxins from Porphyromonas gingivalis , the causative bacteria for gingivitis. The technology could make it easier and faster to identify early-stage gingivitis, which can lead to periodontitis and eventual tooth loss, as well as contributing to a variety of other diseases such as stroke and heart disease.

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WHO releases key regulatory considerations on AI for health

PharmaTimes

The considerations will help to develop new or existing guidance on AI - News - PharmaTimes

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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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Ball Changes Shape with Breath for Mental Health Management

Medgadget

Researchers at the University of Bath in the United Kingdom have developed a shape-shifting ball that can inflate and deflate in response to someone’s breath. The idea is an advancement of many techniques designed to help people de-stress and manage their mental health, which all focus on awareness of the breath. For instance, mindfulness meditation often requires people to focus on their own breath, which can help to reduce anxiety and stress, but maintaining this focus is difficult.

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Gilead’s Biktarvy reinforced as a treatment option for HIV

PharmaTimes

HIV affects approximately 39 million people worldwide and can lead to AIDS - News - PharmaTimes

Leads 98
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Pfizer sets Paxlovid price at nearly $1,400 per course

pharmaphorum

Pfizer sets Paxlovid price at nearly $1,400 per course Phil.

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Drug repurposing, real world data and AI/ML: perspectives and opportunities

Clarivate

De-novo drug discovery and development pipelines are time-consuming and costly. It can take up to 17 years and cost more than $2 billion dollars from the discovery of a new drug until it reaches the market. Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects).

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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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Lilly makes another ADC play, buying Mablink

pharmaphorum

Lilly makes another ADC play, buying Mablink Phil.

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How do Design Review meetings work with Vault EDC?

Veeva

In a traditional EDC build process, sponsors don’t see the case report forms (CRFs) until user acceptance testing (UAT), which occurs late in the process after the forms and associated edit checks are complete. Veeva’s Agile Design process changes that by introducing interactive and collaborative “Design Review” meetings at the start. The goal is to establish agreement (much like user acceptance) on the forms before the advanced rules and edit checks are configured, minimizing the amount of rewo

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Trust the Data: Mastering the Craft of Evidence-Driven Medical Sales

Contrarian Sales Techniques

You've probably heard me talk about my job in medical sales a lot, right? Well, there's this super cool shift happening in the industry, and I thought you might find it interesting. It's all about using solid evidence and data to make our sales pitches. Think of it like showing your cards in a game, but instead of cards, it's all the cool facts and figures that back up what we're saying.

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CCC Hires Duncan Campbell as Executive Director

Copyright Clearance Center

DANVERS, Mass.–(BUSINESS WIRE)–CCC, a pioneer in voluntary collective licensing and leading information solutions provider, announces Duncan Campbell has joined its Client.

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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.