Drug Patent Watch

MARCH 12, 2025

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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Rethinking Clinical Trials

MARCH 12, 2025

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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Bio Pharma Dive

MARCH 13, 2025

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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Pharmaceutical Technology

MARCH 10, 2025

AstraZeneca and Ionis are intensifying their competition with Alnylam by securing an EU approval for Wainzua.

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Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

Clinical Trials

XTalks

MARCH 14, 2025

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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Rethinking Clinical Trials

MARCH 10, 2025

In an article published online ahead of print , leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the importance of independent oversight by a safety office or data and safety monitoring board in pragmatic clinical trials, even for trials deemed to have minimal risk. Challenges specific to pragmatic trials include: complexity, quality, and timing of a real-world data pipeline, especially in trials with many heterogeneous sites embedding of interventions in clinical

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Pharmaceutical Technology

MARCH 14, 2025

The EMA warns of products being sold as dendritic cell therapies with little evidence, but high health risks, in the European Union.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2025

(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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XTalks

MARCH 10, 2025

Genentechs asthma drug Xolair (omalizumab) now faces its first competitive biosimilar. The FDA has approved Celltrions Omlyclo (omalizumab-igec) as an interchangeable product to Xolair. Omlyclo marks Celltrions fourth FDA approval in barely three months this year a significant milestone signaling the companys rapid advancement in the biosimilar space.

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Bio Pharma Dive

MARCH 11, 2025

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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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

Medicine

Pharmaceutical Technology

MARCH 14, 2025

AstraZenecas senior director in oncology data science outlined how the company uses AI for drug discovery at a recent talk.

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ACRP blog

MARCH 12, 2025

The benefits of diversity and inclusion in clinical research are widely recognized, yet the financial and operational costs of these efforts are often overlooked. Practical strategies are needed to identify and mitigate these hidden costs, helping organizations create effective and sustainable strategies. These will be more important than ever if current U.S.

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XTalks

MARCH 11, 2025

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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Bio Pharma Dive

MARCH 14, 2025

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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Manufacturing 274

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Pharmaceutical Technology

MARCH 12, 2025

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

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Pharma Times

MARCH 12, 2025

Phase 2a TREE study assesses safety and efficacy of leriglitazone

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XTalks

MARCH 13, 2025

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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Bio Pharma Dive

MARCH 10, 2025

While initial study results suggest Beam's technology can correct alpha-1 antitrypsin deficiency's genetic roots, shares fell by double digits.

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Genetics 274

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

Clinical Trials

Pharmaceutical Technology

MARCH 10, 2025

Roche has announced the launch of the Roche Genentech Innovation Center Boston, which will serve as the companys CVRM hub.

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Velocity Clinical Research

MARCH 10, 2025

Luke Boylan, MBChB, MBA, Principal Investigator at Velocity in North London, recently attended the Parexel Site Alliance Network event. This collaborative gathering included NHS/NIHR-affiliated sites and other commercial research organizations, providing an invaluable opportunity to discuss the evolving landscape of clinical trials in the U.K. Dr. Boylans key takeaways from the event: Regulatory Improvements: There was strong consensus from the MHRA on the need for faster regulatory approval tim

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XTalks

MARCH 13, 2025

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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Bio Pharma Dive

MARCH 13, 2025

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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Licensing Licensing Drugs 246

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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.

Clinical Trials

Pharmaceutical Technology

MARCH 14, 2025

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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Drug Patent Watch

MARCH 10, 2025

The Future of Generic Drugs: How Technology is Revolutionizing the Industry As we continue to navigate the ever-changing landscape of healthcare, one thing is clear: technology is playing an increasingly important role in shaping the future of generic drug development. From AI-powered discovery to 3D printing, the latest advancements are not only speeding up the process but also making it more efficient and cost-effective.

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XTalks

MARCH 12, 2025

Following the success of Issue 3 , which focused on the critical importance of patient diversity in clinical research, Xtalks is thrilled to announce Xtalks Clinical Edge Issue 4. This 4th edition will explore the exciting space of next-gen clinical research, unpacking novel technologies, strategies and trends that are gradually steering how the industry moves forward.

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Bio Pharma Dive

MARCH 10, 2025

Enhancing manufacturability is crucial for reducing the risks associated with scaling production.

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Manufacturing Production 246

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.

Clinical Research

Pharmaceutical Technology

MARCH 11, 2025

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

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Protein Drugs 259

Medical Xpress

MARCH 14, 2025

In Nature Neuroscience, UConn School of Medicine researchers have revealed a new scientific clue that could unlock the key cellular pathway leading to devastating neurodegenerative diseases like Alzheimer's disease, and the progressive damage to the brain's frontal and temporal lobes in frontotemporal degeneration (FTD) and the associated disease amyotrophic lateral sclerosis (ALS).

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Drug Patent Watch

MARCH 13, 2025

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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Bio Pharma Dive

MARCH 12, 2025

Funded by investors such as Flagship and General Catalyst, the AI startup claims its platform will help scientists speed up the experimentation process.

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Scientist 184

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