Thu.Oct 26, 2023

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Novartis claims ex-staffer jumped to Takeda with 'thousands' of sensitive files

Fierce Pharma

Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. | Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. Now, the Swiss pharma giant wants a peek at Takeda’s business records to find out whether its confidential information has been used improperly.

Pharma 267
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Why VCs Aren’t Interested in Point Solutions

MedCity News

It’s difficult for employers to work with multiple point solutions that target very specific populations, investors said during a panel discussion. Instead, many investors are more interested in platform-based solutions that support more people.

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Trending Sources

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Eisai, Biogen's injectable Leqembi clears toxic protein in Alzheimer's disease. What about safety?

Fierce Pharma

With concerns growing over the burden Leqembi could impose on healthcare infrastructure, Eisai and Biogen have trotted out data for an under-the-skin version of the Alzheimer’s disease drug that ma | Eisai and Biogen have trotted out data for a subcutaneous version of the Alzheimer’s disease drug Leqembi. The self-injected version showed an encouraging efficacy result but a seemingly increased risk of ARIA, which analysts said shouldn't be too much of a concern.

Safety 257
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Why Telehealth is Vital for Addressing the Children’s Mental Health Crisis Affecting Emergency Departments Nationwide

MedCity News

In a recent call for action, leading medical bodies agree that telehealth is integral to providing accessible and equitable mental health care for children.

Leads 117
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bristol Myers' incoming CEO plots turnaround for struggling new launches

Fierce Pharma

On outgoing chief executive Giovanni Caforio’s last earnings call, Bristol Myers Squibb had some tough questions to answer about a roster of underperforming new products. | On outgoing chief executive Giovanni Caforio’s last earnings call, Bristol Myers Squibb had some tough questions to answer about a roster of underperforming new products. But according to CEO-elect Chris Boerner, it’s a question of “when, not if” those drugs rise to meet expectations.

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Avalere Health CEO Jon Koch Discusses the Organization’s Rebrand

PM360

Last week, Fishawack Health announced it was changing its name to Avalere Health and unifying all of its various companies under that single brand, which includes Hive and Pollen Health, Dudnyk, 2e, closerlook, StoneArch, Skysis, Fire and Rain, PAI, and PRMA Consulting. The notion of operating the company under a more integrated and unified brand was something PM360 first spoke about with CEO Jon Koch when he arrived in that role just over two years ago.

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What are the 4 Pillars of Cancer Care?

MedCity News

Although the definition is evolving, truly personalized cancer care might be thought of as having four major pillars: interrogation of the cancer, predictive testing, inherited genes, and patient lifestyle, values and goals.

Patients 103
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Takeda takes $770M in write-downs after Alofisel flop, Exkivity withdrawal decision

Fierce Pharma

After one Takeda drug flunked a phase 3 trial and as the company pulls another from the market, the drugmaker is taking some hefty impairment charges. | The write-downs were attributed to stem cell Alofisel's recent flunk in a phase 3 trial in Crohn's disease fistulas, plus the withdrawal of cancer med Exkivity worldwide. Takeda also cut its profit forecast for the year by a sizable amount.

Marketing 201
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DCT Opportunities in Clinical Research

PharmExec

A discussion of the biggest digital trends in clinical research, how COVID-19 impacted digital use for sponsors/CROs, what the future of DCT services looks like, and more.

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'The Top Line': A look at the FDA's Aduhelm approval and the potential for regulatory bias

Fierce Pharma

In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. | In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection.

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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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Payers Can Use the “People, Process and Technology” Framework to Improve Encounters and Revenue Capture

MedCity News

Improving encounter processing and reporting can safeguard and maximize revenue and operating margins providing the financial resources for payers to continue providing members with quality, life-enhancing healthcare.

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Generative AI and how we can harness its power in clinical development

Fierce Pharma

By Thomas Pietsch, Global Head of Scientific Data Technology and AI, Parexel International | AI holds unlimited potential to change today’s clinical development paradigm. Explore three broad areas where it could be especially useful today.

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Digital Medicines Sector Draws Lessons From Pear Therapeutics’ Demise

MedCity News

Digital therapeutics have shown how therapy can be delivered effectively through a digital interface, but the bankruptcy of Pear Therapeutics raised questions about whether these technologies can be commercially successful. A panel at the MedCity News INVEST Digital Health conference discussed the promise and pitfalls of these emerging technologies.

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AstraZeneca’s commitment to lung cancer and improving patient outcomes

Fierce Pharma

In this episode of The Top Line, Dr. Arun Krishna, AstraZeneca Vice President and Head of Lung Cancer Franchise at the company’s U.S. | In this episode, AstraZeneca’s Dr. Arun Krishna talks about the end-to-end work being carried out by AZ’s oncology unit, including the role of the Lung Ambition Alliance.

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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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Antibody-drug conjugates: paving the future of oncology clinical development

European Pharmaceutical Review

Antibody-drug conjugates (ADCs), such as datopotamab deruxtecan (Dato-DXd) and trastuzumab deruxtecan, have demonstrated compelling evidence of efficacy in oncology across numerous diseases in recent months. In August 2023, Biswajit Podder, PhD, Oncology and Hematology Analyst at GlobalData shared that HER2-positive breast cancer “seems to be a major focus” in ADC drug development.

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Fierce Pharma Asia—Merck inks $4B Daiichi tie-up, trims Kelun deal; AstraZeneca's ADC letdown

Fierce Pharma

In a busy week for the antibody-drug conjugate (ADC) field, Merck signed a three-drug deal with Daiichi Sankyo but abandoned two preclinical assets from Kelun-Biotech. | In a busy week for the antibody-drug conjugate (ADC) field, Merck signed a three-drug deal with Daiichi Sankyo but abandoned two preclinical assets from Kelun-Biotech. Meanwhile, AstraZeneca and Daiichi's TROP2 ADC disappointed in a lung cancer trial.

Pharma 130
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The Importance of Having the Biopharma Industry Join the Journey to Net-Zero Emissions

Pharmaceutical Commerce

How setting action-based goals and cultivating partnerships will help overcome challenges associated with implementing a sustainable GHG strategy.

Biopharma 105
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Device Vibrates DNA for Highly Sensitive Detection

Medgadget

Researchers at the University of Massachusetts Amherst have developed a new method of detecting very small amounts of DNA. The breakthrough could allow clinicians to spot genetic markers of disease at the point-of-care, as the approach does not require conventional laboratory analysis, which is usually time-consuming and costly. In fact, the approach has led to a 100-fold increase in DNA detection sensitivity, with no corresponding increase in cost.

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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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How gene therapies can transform sickle cell disease treatment

Pharmaceutical Technology

The potential for using gene therapies to treat sickle cell disease is high, but their durability and high price point invite scrutiny.

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Microfluidic System Incorporates Eight Organ Tissues for Drug Testing

Medgadget

Researchers at Northwestern University have developed a sophisticated microfluidic system that incorporates tissue from up to eight different organ systems. The technology is unprecedented in allowing researchers to study complex interactions between different organs during disease. Moreover, it also allows for more comprehensive drug testing that investigates the effects of drug candidates on multiple organ systems at once.

Media 90
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NHS virtual wards to treat heart failure patients at home

PharmaTimes

Thousands of patients with heart failure are set to benefit from the expansion - News - PharmaTimes

Patients 114
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European Commission bolsters defences against critical medicine shortages

Pharmaceutical Technology

The EC announced new initiatives to tackle critical medicine shortages in winter, introducing more flexibility to strengthen supplies.

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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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FDA Approves Novel Therapy for Rare Form of Blood Cancers

PharmaTech

The treatment has received Priority Review designation, as well as FDA Breakthrough Therapy designation and Orphan Drug designation.

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Pfizer and BioNTech post early win for combination Covid-19/flu vaccine 

Pharmaceutical Technology

A pivotal Phase III trial will be initiated in the coming months to further evaluate the lead formulations of the combination vaccine.

Leads 96
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Bayer and PCF launch darolutamide challenge awards for prostate cancer

PharmaTimes

The two projects will be awarded $1m each to support their clinical investigations - News - PharmaTimes

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NICE recommends first Parkinson’s treatment

European Pharmaceutical Review

The National Institute for Health and Care Excellence (NICE) has recommended AbbVie’s foslevodopa–foscarbidopa (Produodopa) as a treatment option for advanced Parkinson’s. The treatment is administered by an infusion pump over 24 hours. A benefit of the device is its small size, in addition to its portability and the fact it can be refilled at home.

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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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COVID, flu combo jab from Pfizer/BioNTech heads for phase 3

pharmaphorum

COVID, flu combo jab from Pfizer/BioNTech heads for phase 3 Phil.

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10 Best Sales Coaching Tools For Field Sales Managers

Spotio

Field sales managers have a lot of responsibilities. They have to devise sales strategies, cut and assign territories, motivate their reps, analyze sales metrics, generate reports for company leadership teams… The list goes on and on. Unfortunately, these responsibilities take time and effort, which means most field sales managers don’t have the resources they need to coach their reps effectively.

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Career Changes for Nurses: New Opportunities for Your Skills and Experience

Rep-Lite

Nursing is a noble profession that demands unwavering dedication, empathy, and a unique blend of technical and interpersonal skills. Yet, it’s not uncommon for nurses to seek a change, a new adventure in their professional lives. So, why do nurses make career changes? What are the benefits of a career changes for nurses? What is the most common career change for nurses?

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Market Access Veteran Ellen Cappellino Joins Klick Health

PM360

Klick Health announced that admired market access professional Ellen Cappellino has joined the agency to further build out its value, access, and reimbursement capabilities and help transform the healthcare experience for patients. As Executive Director Value, Access, and Reimbursement, Cappellino is working cross-functionally, harnessing Klick’s industry-leading clinical, creative, and analytics, to demonstrate the benefits and optimal places in treatment for therapies.

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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.