Trending Articles

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MeiraGTx spins Parkinson’s, obesity gene therapies into AI startup

Bio Pharma Dive

The joint venture with generative AI firm Hologen hands MeiraGTx $200 million up front as well as other financial perks — a “transformative” deal, according to the company’s CEO.

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Grand Rounds March 7, 2025: A Trial of a “Kidney Action Team” for Hospitalized Patients with Acute Kidney Injury (F. Perry Wilson, MD MSCE)

Rethinking Clinical Trials

Speaker F. Perry Wilson, MD MSCE Associate Professor of Medicine and Public Health Director, Clinical and Translational Research Accelerator Yale University New Haven, CT Slides Keywords Electronic Alerts; Acute Kidney Injury; Action Team Key Points Acute Kidney Injury (AKI), or abrupt decline in kidney function, is common, affecting about 15% of hospitalized patients.

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March 12, 2025: In This Week’s PCT Grand Rounds, Spillover as a Potential Source of Bias in Pragmatic Trials

Rethinking Clinical Trials

Sean Mann In this Friday’s PCT Grand Rounds, Sean Mann of RAND will present “Spillover Due to Constraints on Care Delivery: A Potential Source of Bias in Pragmatic Clinical Trials.” The Grand Rounds session will be held on Friday, March 14, 2025, at 1:00 pm eastern. Mann is a senior policy analyst at RAND. Join the online meeting. The post March 12, 2025: In This Week’s PCT Grand Rounds, Spillover as a Potential Source of Bias in Pragmatic Trials appeared first on Rethink

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Merck opens $1B vaccine plant in North Carolina

Bio Pharma Dive

Unveiling of the new factory comes as Merck and other pharma companies face pressure to reshore manufacturing back to the U.S.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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MeiraGTx and Hologen launch AI-backed gene therapy venture

Pharmaceutical Technology

The venture aims to advance MeiraGTxs Parkinsons gene therapy through Phase III trials with up to $430m in funding from Hologen.

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Wholemeal or Wholegrain? An Expert Explains How to Choose Your Bread.

AuroBlog - Aurous Healthcare Clinical Trials blog

(Laura Leyshon/Getty Images) If you head to the shops to buy bread, you’ll face a variety of different options. But it can be hard to work out the difference between all the types on sale. For instance, you might have a vague idea that wholemeal or wholegrain bread is healthy. But what’s the difference?

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Ono earmarks $940m to gain rare blood cancer therapy from Ionis

Pharmaceutical Technology

Ono Pharmaceuticals has secured the global rights to sapablursen, an RNA-targeting therapy by Ionis to treat polycythemia vera (PV).

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Vepdegestrant Hits Primary Endpoint in Phase III Breast Cancer Trial

XTalks

Arvinas and Pfizer have reported positive Phase III VERITAC-2 results in a trial of 624 patients across 26 countries, demonstrating that vepdegestrant (ARV-471) monotherapy significantly improves progression-free survival in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer.

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Open-source AI matches top proprietary model in solving tough medical cases

Medical Xpress

Artificial intelligence can transform medicine in a myriad of ways, including its promise to act as a trusted diagnostic aide to busy clinicians.

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Key Considerations for Generic Drug Stability Testing

Drug Patent Watch

The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? It's not just a matter of copying a formula and slapping a new label on it. Behind the scenes, generic drug manufacturers are working tirelessly to ensure that their products are safe, effective, and identical to their branded counterparts.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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2seventy bio, Bluebird’s cell therapy spinout, sells to Bristol Myers for less than $300M

Bio Pharma Dive

The deal ends 2Seventy’s short run as an independent company, during which it restructured, sold off research and lost nearly all of its market value.

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ElevateBio taps Amazon’s genAI tools to design CRISPR therapeutics

Pharmaceutical Technology

AWSs framework will speed up the analysis of ElevateBios large protein datasets, hinting at promising drug candidates.

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Advanced Biomed IPO Raises $6.56M Towards Liquid Biopsy Testing

XTalks

On March 7, 2025, Advanced Biomed Inc. raised $6.56 million in its IPO and began trading on Nasdaq under the ticker ADVB. The biotech firm, which develops semiconductor-based microfluidic technology for early cancer detection, issued 1.64 million shares at $4 each, with an option to purchase an additional 246,000 shares within 45 days. Current Share Price: Established in 2014, Advanced Biomed has developed a proprietary microfluidic platform that functions as a compact laboratory on a chip.

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Ebola-infected monkeys cured with a pill, sparking human treatment hopes

Medical Xpress

Monkeys infected with Ebola can be cured with a pill, according to a new study out Friday that could pave the way for more practical, affordable treatments in humans.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Budgeting and Contracting Best Practices for Research Sites

ACRP blog

This is a sponsored message. To grow your business, negotiate and collect fair payment for your work by understanding its true costs before budget discussions. This includes all direct and indirect costs, and typically covers: Personnel costs: salaries, overtime, training, and additional staffing if needed. Facility costs: not only facility space, maintenance, utilities, and equipment, but also any additional space or modifications needed for the study.

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FDA sets flu shot recommendations without input of outside advisers

Bio Pharma Dive

The agency formulated its advice to manufacturers after coordinating with the CDC and Defense Department. An advisory meeting that's typically held was canceled last month.

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Viking strikes $150m deal to secure supply of obesity drug

Pharmaceutical Technology

The multi-year manufacturing deal with CordenPharma will secure future supply of VK2735 if it goes to market.

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CagriSema, Novo Nordisk’s Latest Obesity Drug Offering, Disappoints Investors with Trial Results

XTalks

Novo Nordisks investigational obesity combination drug, CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg), underperformed in its latest clinical trial, leading to a dip in the companys share price. In response to the trial outcomes, Novos shares declined by approximately 8% this week. Novo shared the latest data from the Phase III REDEFINE 2 trial evaluating the drug in overweight or obese patients with type 2 diabetes.

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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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Careology and Entia join forces to transform cancer care

Pharma Times

Collaboration brings remote care to cancer patients

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Addressing supply chain challenges for biosimilar products

Drug Patent Watch

Navigating the Complex World of Biosimilar Supply Chains As the demand for biosimilars continues to grow, so do the challenges associated with their supply chains. From manufacturing and quality control to distribution and regulatory compliance, the stakes are high for pharmaceutical companies looking to bring these life-changing treatments to market.

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Mallinckrodt, Endo to combine in $7B deal

Bio Pharma Dive

The merger will give the combined entity the financial flexibility to pursue drug licensing deals and broaden its therapeutic focus, executives said on a conference call.

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Azurity acquires Covis Pharma from existing investors

Pharmaceutical Technology

Azurity Pharmaceuticals has acquired Covis Group from existing investors, making the latter a wholly owned subsidiary.

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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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Medical Device & MedTech Layoffs in 2025: A Roundup

XTalks

In 2025, as market pressures intensify and companies refocus on core strategic priorities, medical device and medtech companies have been forced to make tough decisions regarding their workforces. These developments come amid a broader nationwide trend of workforce realignment, with both private and public entities, including the FDA’s recent rehires amid mass layoffs, adapting to ongoing pressures.

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New weight-loss pill shows promising results

Pharma Times

Oxford Medical Products targets overweight individuals

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Marketing Strategies for Pharma Brands: Driving HCP Engagement

Pharma Marketing Network

Table of Contents Understanding the Importance of HCP Engagement in Pharma Marketing Key Marketing Strategies for Pharma Brands to Reach HCPs Optimizing Digital and Paid Media Strategies for Pharma Marketing Measuring Success: Tracking HCP Engagement and ROI Understanding the Importance of HCP Engagement in Pharma Marketing Engaging healthcare professionals (HCPs) effectively is a top priority for pharmaceutical brands.

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Orca Bio to seek approval of T cell transplant after positive trial data

Bio Pharma Dive

Study results showed Orca’s treatment, a purified mix of donor-derived T cells and stem cells, was safer than standard transplant in treating certain blood cancers.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Emergent signs financial investment agreement with Swiss Rockets

Pharmaceutical Technology

Emergent has entered a strategic financial investment agreement with Swiss Rockets to support the latters biotech portfolio.

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Perfuze’s Zipline Access Catheters for Stroke Interventions Cleared by FDA

XTalks

Perfuze advances stroke care with FDA 510(k) clearance for its new Zipline access catheters. Designed to support the delivery of large aspiration catheters during neurointerventional procedures, the device aims to enhance physicians ability to quickly remove blood clots from patients suffering from acute ischemic stroke a condition where every minute matters.

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Dementia drug neflamapimod shows positive phase 2b trial results

Pharma Times

CervoMed's therapy demonstrates significant improvement in patients

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Kids under eight shouldn't drink slushies, researchers warn

Medical Xpress

Children under eight should not drink slushy ice drinks containing glycerol, researchers have warned after a string of hospitalizations in the UK and Ireland.

Research 111
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time