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Latest Ozempic results 'move the needle' for treating patients with diabetes, chronic kidney disease: Novo exec

Fierce Pharma

While it’s hard to overstate the success Novo Nordisk’s GLP-1 franchise has already achieved, the company’s latest deep dive into semaglutide data in chronic kidney disease (CKD) could help set a n | Early Friday, Novo shared full, positive results from the FLOW trial assessing the ability of once-weekly semaglutide 1.0 mg to help combat major kidney outcomes such as kidney failure, loss of kidney function and death from kidney or cardiovascular causes in people with Type 2 diabetes and chronic

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Why Allegheny Health Network Created Its Own Chat-GPT For Employees

MedCity News

Allegheny Health Network rolled out a large language model designed exclusively for use by its staff members. You can think of the tool as the health system’s own version of Chat-GPT, said Ashis Barad, AHN’s chief digital and information officer. The post Why Allegheny Health Network Created Its Own Chat-GPT For Employees appeared first on MedCity News.

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Why Healthcare Data Is Vital for Employers

MedCity News

Employers need healthcare data in order to make decisions, but the data isn’t always easy to get, experts said on a panel at MedCity INVEST. The post Why Healthcare Data Is Vital for Employers appeared first on MedCity News.

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Introducing the Clarivate Academic AI Platform

Clarivate

We have released the first version of the Clarivate Academic AI Platform, serving our suite of AI-powered Research Assistants. Discover how it is going to help address the needs of students, researchers and librarians for trusted AI. At Clarivate TM , we understand the transformative power of artificial intelligence (AI) in the academic realm and the imperative to introduce AI thoughtfully and responsibly into research, teaching and learning environments.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Cytokinetics eyes go-it-alone strategy for aficamten

pharmaphorum

Cytokinetics has been a top biotech takeover candidate for some time, thanks to blockbuster speculation about its lead drug aficamten, but a $1 billion-plus set of financing deals shows it is prepared to go to market on its own.

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Researchers combine herpes virus with cancer vaccine to treat brain cancer in children

PharmaTimes

High-grade gliomas are rare, malignant tumours which account for up to 12% of all childhood brain tumours

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Biogen Agrees to Acquire HI-BIO for $1.15 Billion

Pharmaceutical Commerce

The deal features felzartamab, an investigational anti-CD38 monoclonal antibody, whose clinical outcomes have shown potential to tackle various immune-mediated diseases.

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Why AlphaFold 3 is stirring up so much buzz in pharma

PharmaVoice

The “Nobel Prize-worthy invention” could be worth hundreds of billions commercially — and have a deep impact on drug R&D.

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GSK’s twice-yearly asthma drug clears two phase 3 trials

pharmaphorum

GSK’s follow-up to its severe asthma therapy Nucala has shown its value in a pair of phase 3 trials, reducing exacerbations compared to placebo with dosing once every six months. The company says new IL-5 inhibitor depemokimab (formerly GSK3511294) has the potential to become the first ultra-long-acting biologic for severe asthma with a six-monthly dosing schedule.

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ASCO: Bristol Myers unveils I-O triplet data in melanoma as Iovance touts ‘paradigm-changing’ combo result

Fierce Pharma

Over the years, melanoma has become a popular testing ground for researchers to explore new immuno-oncology approaches. | With prior approvals in melanoma, Bristol Myers Squibb and Iovance are now showcasing early clinical data for their novel combinations in small first-line melanoma trials.

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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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The Powerful Hospice Lessons of Jimmy Carter  

MedCity News

Carter entered hospice care in his home, more than a year ago, and has set an inspirational example of how to live your last days on Earth with hope, meaning, and vigor. The post The Powerful Hospice Lessons of Jimmy Carter appeared first on MedCity News.

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The Power of Grip: A Journey from Adversity to Success in the Consumer Goods Industry

Scott Burrows

In the world of motivational speaking, stories of triumph over adversity are not uncommon. But for me, the narrative goes beyond inspiration—it’s about embodying the very principles of vision, mindset, and grit that have shaped my journey. At the age of 19, a car accident left me with a broken neck and a daunting diagnosis of quadriplegia. But from the confines of a wheelchair, I refused to let my circumstances define me.

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Final report says UK infected blood scandal “should have been avoided”  

Pharmaceutical Technology

Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.

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Tony Blair Institute weighs in on use of NHS patient data

pharmaphorum

A think tank set up by former UK Prime Minister Tony Blair has called for the formation of a public-private trust that could oversee the sharing of anonymised patient data with trusted researchers.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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AstraZeneca, on fast track of growth, sets revenue target at $80B by 2030

Fierce Pharma

A decade ago, with AstraZeneca in decline and some investors urging the drugmaker to sell out to Pfizer, new CEO Pascal Soriot presented an audacious plan to hike revenue to $45 billion by 2023. | After AstraZeneca achieved Pascal Soriot's ambitious $45-billion-by-2023 revenue goal, the CEO is thinking big again. On Tuesday morning, AZ unveiled its new plan to swell its revenue to $80 billion by 2030.

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Tax Challenges for Healthcare Accounting Teams Bring Opportunity for Innovation

MedCity News

A good outsourced partner can work alongside in-house accountants and stay on top of the moving target of healthcare accounting regulations, addressing tax risks and identifying cost-saving opportunities. The post Tax Challenges for Healthcare Accounting Teams Bring Opportunity for Innovation appeared first on MedCity News.

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Bristol Myers Squibb Plans 10-Year Strategy to Expand Access to Medications

PharmaTech

The company is collaborating with the Access to Oncology Medicines Coalition to expand patient access to immuno-oncology therapy Opdivo.

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Asymchem Takes Ownership of Former Pfizer Manufacturing Facilities

Pharmaceutical Commerce

The CDMO will run the active pharmaceutical ingredient pilot plant in Sandwich, UK, along with development laboratories.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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FDA competition seeks digital endpoints for Parkinson’s

pharmaphorum

FDA is asking artificial intelligence teams to develop a digital endpoint tool to study freezing of gait, a symptom of Parkinson’s that can have a serious impact on patients.

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Otsuka pulls plug on Alzheimer's agitation drug after 2nd failed trial

Fierce Pharma

Otsuka Pharmaceutical is packing up an Alzheimer’s disease med after a phase 3 study failed to move the needle on m | Otsuka Pharmaceutical is packing up an Alzheimer’s disease med after a phase 3 study failed to move the needle on measures of agitation associated with dementia.

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5 Things to Know About How NIH’s SEED Can Help Life Science Startups Grow

MedCity News

The NIH’s SEED office formed to help startups leverage government’s funding programs. Chris Sasiela, director of the SEED office, discussed these programs during the MedCity News INVEST Conference in Chicago. The post 5 Things to Know About How NIH’s SEED Can Help Life Science Startups Grow appeared first on MedCity News.

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Merck’s MilliporeSigma agrees to acquire Mirus Bio for $600m

Pharmaceutical Technology

Merck KGaA’s MilliporeSigma has entered a definitive agreement for the acquisition of Mirus Bio in a deal totaling $600m (€500m).

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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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Development of novel water-soluble inks for 3D-printed polypills

European Pharmaceutical Review

A paper has reported a multi-material ink-jet 3D printing (MM-IJ3DP)-based method that could enable tailored drug release profiles of personalised pharmaceutical tablets during manufacturing. While biocompatible water-soluble polymers as excipients, have “been recently explored to produce gels [they have not been investigated] as a water-soluble excipient”, according to the paper.

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ASCO: AffyImmune claims a first with CAR-T for solid tumours

pharmaphorum

AffyImmune Therapeutics has recorded what it says is the first documented complete response in a patient with a solid tumour treated with CAR-T therapy. The case comes from a phase 1 study of its ICAM-1 targeting CAR-T autologous candidate AIC100 in patients with relapsed/refractory poorly differentiated thyroid cancer (PDTC) and anaplastic thyroid cancer (ATC), which will be reported at the ASCO congress next week.

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New NIH findings on talc use and ovarian cancer pose challenge to J&J's high-stakes defense

Fierce Pharma

The more than 53,000 women in the U.S. | The more than 53,000 women in the U.S. who have filed injury lawsuits against Johnson & Johnson have added ammunition for their claims as new research indicates there is an association between long-term use of talcum-based powders and an increased risk of developing ovarian cancer.

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4 Things Digital Health Investors Need To Get Off Their Chest

MedCity News

During a panel at MedCity News’ INVEST conference, venture capitalists shared some of their takes on today’s healthcare funding landscape — including their thoughts on AI and the industry’s slower investment pace. The post 4 Things Digital Health Investors Need To Get Off Their Chest appeared first on MedCity News.

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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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AstraZeneca and Nona Biosciences sign agreement for monoclonal antibody

Pharmaceutical Technology

AstraZeneca has entered into a worldwide licence and option agreement with Nona Biosciences for a preclinical monoclonal antibody.

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King’s Doctoral Training Centre to investigate MS symptom management

PharmaTimes

The lifelong autoimmune disease affects more than 150,000 people living in the UK

Doctors 101
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Novavax investor withdraws proxy fight after Sanofi deal

pharmaphorum

Shah Capital Management has withdrawn a proxy campaign against the re-election of director at vaccines firm Novavax in the wake of its $1.2 billion alliance with Sanofi. The top-three investor in Novavax – which has been steadily raising its stake in the company in recent weeks and now holds around 7.9% – said it welcomed the Sanofi deal but warned that “does not mean our engagement is at an end” and it still believes Novavax would benefit from a stockholder on its board of directors.

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J&J faces allegations it used 'fraudulent maneuvers' to avoid compensating talc plaintiffs

Fierce Pharma

As Johnson & Johnson sorts through a mountain of litigation claiming its talcum-based powders caused users to develop cancers, the company has now been slapped with a related but different | Women represented by six law firms who previously filed lawsuits against J&J over talc claims have filed a proposed class action lawsuit in U.S. federal court in New Jersey.

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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.