Fierce Pharma

APRIL 22, 2024

Sanofi will pay $100 million—or approximately $25,000 each—to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that its heartburn medicine Zantac (rani | Sanofi will pay approximately $25,000 per person to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that its heartburn medicine Zantac (ranitidine) can cause cancer, Bloomberg reported.

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Medicine 252

MedCity News

APRIL 22, 2024

The Commonwealth Fund recently launched the National Task Force on the Future Role of Employers in the U.S. Health System. In 2025, the task force will release a blueprint of actionable recommendations on how employers can improve their coverage. The post Why the Commonwealth Fund Created a Task Force for Employer-Sponsored Insurance appeared first on MedCity News.

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Insurance 111

Fierce Pharma

APRIL 22, 2024

After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S. | After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S. approval in the cancer immunotherapy Anktiva.

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FDA 248

MedCity News

APRIL 22, 2024

In this episode, we’re joined by John Auerbach, senior vice president of federal health at consulting firm ICF. He discusses rising preeclampsia rates and how stakeholders need to act. The post MedCity FemFwd: What Needs To Happen to Improve Preeclampsia Rates? appeared first on MedCity News.

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Consulting 107

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Fierce Pharma

APRIL 22, 2024

The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S. | The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S. Supreme Court shot down the company’s attempt to challenge an appeals court decision invalidating several of the drug’s patents in 2023.

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Prospecting Pharmaceutical 239

MedCity News

APRIL 22, 2024

Hospital readmissions have a two-fold impact. They not only drive up the cost of care, but they also create a glut of surplus patients in hospitals waiting to be discharged to a limited number of beds at a partner skilled nursing facility. The post Hospital Discharge Backlogs Impacting Patient Outcomes appeared first on MedCity News.

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Patients 107

MedCity News

APRIL 22, 2024

Real-world analysis can provide insights into how factors largely out of rural residents’ control impact health outcomes and access to medical care. The post How Real-World Data Is Helping Close the Rural-Urban Health Divide appeared first on MedCity News.

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Medical 104

Pharmaceutical Technology

APRIL 22, 2024

Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.

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Patients 103

MedCity News

APRIL 22, 2024

The diagnostics/medical device track focuses on cardiology this year. The post Which Medtech Startups Will Take Part in the MedCity INVEST Pitch Perfect Contest? appeared first on MedCity News.

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Medical 104

Pharmaceutical Technology

APRIL 22, 2024

Discover how Avidity Biosciences' patented polynucleic acid molecule conjugate targets the DUX4 gene to combat FSHD. Learn more about this groundbreaking approach in gene therapy.

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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.

Safety

MedCity News

APRIL 22, 2024

The key is having a holistic approach that identifies the top two or three critical issues and tailors the primary care solution to address those needs. The post Delivering the Right Approach for Virtual Primary Care: 3 Key Insights appeared first on MedCity News.

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Pharmaceutical Technology

APRIL 22, 2024

Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.

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Pharmaceutical Patients 96

MedCity News

APRIL 22, 2024

Two Japanese pharmaceutical companies and a bank are teaming up to form a joint venture to advance therapeutic discoveries from academia. The focus will be innovation from universities in Japan. The post Takeda, Astellas & Sumitomo Mitsui Form Joint Venture to Lift Japanese Innovation From ‘Valley of Death’ appeared first on MedCity News.

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Pharmaceutical Biopharma Pharma 98

PharmaVoice

APRIL 22, 2024

The fast-acting medication is one of a few new approaches being tested for the crippling condition.

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Medical 128

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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

Distribution

MedCity News

APRIL 22, 2024

Two months after a cyberattack on a UnitedHealth Group subsidiary halted payments to some doctors, medical providers say they’re still grappling with the fallout, even though UnitedHealth told shareholders on Tuesday that business is largely back to normal. The post Medical Providers Still Grappling With UnitedHealth Cyberattack: ‘More Devastating Than Covid’ appeared first on MedCity News.

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pharmaphorum

APRIL 22, 2024

Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into phase 3 trials. TGCT is a rare disease affecting the joints and tendons caused by overproduction of the protein CSF-1, which stimulates the proliferation of various cell types, inflammation, and destruction of the matrix of the joint.

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European Pharmaceutical Review

APRIL 22, 2024

The USP Microbiology Expert Committee is due to vote on the proposed Chapter <86> to approve bacterial endotoxin testing using non-animal derived reagents between 21 June and 1 July 2024. Jaap Venema , Chief Science Officer, USP shared with EPR that the chapter is helping to guide manufacturers how to the adopt these methods and provides “a path to wider adoption”.

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Manufacturing Pharmaceutical 92

Pharmaceutical Technology

APRIL 22, 2024

GS-6212 is under clinical development by Gilead Sciences and currently in Phase I for Human Immunodeficiency Virus (HIV) Infections (AIDS).

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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.

Safety

MedCity News

APRIL 22, 2024

Focusing on these areas can help healthcare organizations reduce the incidence of denials, optimize revenue cycle performance and enhance overall patient satisfaction. The post Transforming Denials Management: Insights and Best Practices for Your Organization appeared first on MedCity News.

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Management Healthcare Healthcare Patients 79

pharmaphorum

APRIL 22, 2024

Bristol-Myers Squibb has shored up manufacturing of its CAR-T therapies by reserving exclusive capacity wt contract manufacturer Cellares in $380m deal

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Manufacturing 86

Pharmaceutical Technology

APRIL 22, 2024

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Non-Small Cell Lung Cancer.

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Pharmaceutical 95

MedCity News

APRIL 22, 2024

The first FDA-approved MASH drug doesn’t treat patients with liver cirrhosis. A new Boehringer Ingelheim/Ochre Bio collaboration is researching regenerative medicines that could treat patients in this most advanced stage of the fatty liver disease. The post Boehringer Ingelheim Strikes Regenerative Med R&D Deal Spanning MASH & More Liver Diseases appeared first on MedCity News.

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Medicine FDA Patients Biopharma 74

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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.

Specialization

Pharmaceutical Technology

APRIL 22, 2024

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Renal Cell Carcinoma.

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Pharmaceutical 97

PM360

APRIL 22, 2024

An industry poised for progress will need to take the steps that reinvent copay technologies, and improve patient affordability programs. The opportunity to reshape an industry doesn’t come along every day. Two decades ago copay savings programs were once a novel idea: instant rebate cards that financially assisted millions of patients in accessing vital medications, treatments, and therapies that would otherwise be unaffordable to them.

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Manufacturing Patients Medical Engineering 69

Pharmaceutical Technology

APRIL 22, 2024

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Esophageal Cancer.

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Pharmaceutical 96

pharmaphorum

APRIL 22, 2024

Ipsen agrees $1.8 bn alliance with Skyhawk Therapeutics focused on RNA-modulating drugs for rare neurological diseases.

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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

Leads

Pharmaceutical Technology

APRIL 22, 2024

AST-001 is under clinical development by Ascentawits Pharmaceuticals and currently in Phase II for Rectal Cancer.

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Pharmaceutical 98

PharmaTimes

APRIL 22, 2024

The neurodegenerative condition currently affects more than 944,000 people living in the UK

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Pharmaceutical Technology

APRIL 22, 2024

Datopotamab deruxtecan is under clinical development by Daiichi Sankyo and currently in Phase I for Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer).

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Pharmaceutical Commerce

APRIL 22, 2024

The rationale behind transforming case management in healthcare.

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Healthcare Healthcare Management 102

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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.

Management