Worldwide Clinical Trials

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest? Rigorous procedures to ensure that drugs are effective and safe.

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Clinical Trials Clinical Trials Drugs Trials 195

Rethinking Clinical Trials

JANUARY 21, 2025

Dr. Corita Grudzen and Dr. Keith Goldfeld, principal investigators for PRIM-ER An evidence-based training program to improve the capacity of emergency department care teams to communicate with seriously ill older patients about palliative care did not lead to lower rates of hospital admission, according to the results of the PRIM-ER trial. The results were published online ahead of print in JAMA.

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Bio Pharma Dive

JANUARY 23, 2025

In an interview, the CEO discussed trying to gain support from investors hyper-focused on M&A, and competing with Pfizer and Alnylam in a closely watched commercial battle.

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Drugs 354

Pharmaceutical Technology

JANUARY 21, 2025

Innophore will launch the CavitOmiX AI tool to screen for new drugs, predict side effects, and repurpose existing molecules.

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Drugs 345

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

Medical Xpress

JANUARY 24, 2025

Researchers from Mass General Brigham and collaborating institutions have developed a non-invasive approach to manipulate cardiac tissue activity by using light to stimulate an innovative ink incorporated into bioprinted tissue. Their goal is to develop a technique that can be used to repair the heart. Their findings in preclinical models, published in Science Advances, show the transformative potential of non-invasive therapeutic methods to control electrically active tissues.

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XTalks

JANUARY 21, 2025

From non-invasive cancer diagnostics to life-saving cardiovascular implants, the latest medical devices cleared or approved by the FDA in 2024 reflect the remarkable strides in science and engineering. In this blog, we discuss some of these new medical devices of 2024 that have improved patient outcomes and enhanced quality of life worldwide. 1. TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR).

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FDA Approval Manufacturing Development RNA 105

Pharmaceutical Technology

JANUARY 21, 2025

With increasing demand for cell and gene therapies, mesenchymal stem cells (MSCs) have gained attention for their versatility and potential.

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Drug Patent Watch

JANUARY 23, 2025

Designing the Future of Biosimilars: Strategies for Success As the biosimilar market continues to grow, pharmaceutical companies are facing increasing pressure to develop high-quality, cost-effective treatments that meet the evolving needs of patients and healthcare systems. One key aspect of this journey is the clinical trial design and execution process a critical step that can make or break the success of a biosimilar product.

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Clinical Trials Clinical Trials Trials Production 87

XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. The approval makes Datroway AstraZenecas eighth new medicine since 2020, the first US approval for Daiichi Sankyo and AstraZenecas TROP2-directed ADC and the second based on their proprietary DXd technology.

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Antibody FDA Approval HR Trials 105

Bio Pharma Dive

JANUARY 24, 2025

Brenner, who has worked in the FDA’s Center for Devices and Radiological Health, will lead the agency until a permanent commissioner is confirmed.

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Radiology 245

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

JANUARY 24, 2025

The settlement ends the Sackler familys ownership of the Oxycontin developer Purdue Pharma.

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Development 278

Drug Patent Watch

JANUARY 23, 2025

The Future of Generic Drug Development: Opportunities and Challenges for Emerging Markets As the global healthcare landscape continues to evolve, emerging markets are playing an increasingly important role in shaping the future of generic drug development. With the rise of affordable healthcare initiatives and growing demand for quality medicines, emerging markets present a significant opportunity for generic drug manufacturers to expand their reach and improve access to life-saving treatments.

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Generic Drugs Marketing Development Drugs 85

XTalks

JANUARY 20, 2025

The pharma and biotech sector has witnessed impressive growth over the past decade, driven by innovations and strategic partnerships. Among these, mergers and acquisitions (M&As) have played a pivotal role in reshaping the industry landscape, enabling companies to bolster their portfolios, enhance R&D capabilities and expand their global market reach.

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Marketing Botox Life Science Pharma Companies 104

Bio Pharma Dive

JANUARY 22, 2025

The pharma expects a modest financial headwind this year from changes to Medicare prescription drug benefits under the Inflation Reduction Act.

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Drugs 237

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Pharmaceutical Technology

JANUARY 23, 2025

The FDA reported that six patients died after being injected with Tevas Copaxone or Sandozs Glatopa.

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Drugs 264

Rethinking Clinical Trials

JANUARY 22, 2025

In this Friday’s PCT Grand Rounds, Jeffrey Samet of Boston University will present “The HEALing Communities Study10 Million People, 67 Communities: A Community-Based Cluster Randomized Trial to Reduce Opioid Overdose Deaths.” The Grand Rounds session will be held on Friday, January 24, 2025, at 1:00 pm eastern. Samet is the John Noble Professor in General Internal Medicine at the Boston University Chobanian and Avedisian School of Medicine and and a professor of public health a

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Clinical Trials Clinical Trials Medicine Trials 112

Drug Channels

JANUARY 22, 2025

For 2025, the three largest pharmacy benefit managers (PBMs)Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)have again each excluded hundreds of drugs from their standard formularies. You can find our updated counting below. As youll see below, the combination of formulary exclusion and private labels is creating an increasingly confusing and crowded biosimilar marketplace.

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Pharmacy Drugs Production Marketing 98

Bio Pharma Dive

JANUARY 22, 2025

CEO Joaquin Duato said the company is positioned for sustained growth in coming years even as competition batters Stelara, one of its top-sellers.

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Sales 214

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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

JANUARY 24, 2025

The FDA rejected the companys initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.

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Drugs Trials 255

Medical Xpress

JANUARY 18, 2025

Like many rare diseases, fibrolamellar hepatocellular carcinoma (FLC) mounts a ferocious attack against an unlucky fewin this case, children, adolescents, and young adults. Because its symptoms can vary from person to person, it's often missed or misdiagnosed until it has metastasized and becomes lethal. Moreover, drug therapies for common liver cancers are not just useless for FLC patients but actually harmful.

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Clinical Trials Clinical Trials Trials Drugs 93

Drug Patent Watch

JANUARY 22, 2025

The Unseen Heroes of Generic Drug Manufacturing: Good Manufacturing Practice (GMP) As we navigate the complex world of generic drug manufacturing, it's easy to overlook the unsung heroes that ensure the quality and safety of these life-saving medications. I'm talking about Good Manufacturing Practice (GMP), a set of guidelines that govern the production, testing, and packaging of generic drugs.

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Generic Drugs Manufacturing Drugs Production 94

Bio Pharma Dive

JANUARY 24, 2025

An experimental drug called amycretin showed signs it could be more potent than Eli Lilly’s rival Zepbound, though analysts cautioned certain aspects of the study may have inflated its performance.

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Drugs 182

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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

JANUARY 20, 2025

Moderna is set to receive $590m in funding from the HHS to expedite the development of mRNA-based pandemic influenza vaccines.

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Development Vaccination Vaccine 257

Medical Xpress

JANUARY 18, 2025

Researchers at Baylor College of Medicine and collaborating institutions have improved our understanding of how rotavirus, the most common cause of acute gastroenteritis in children, makes people sick. The study published in Science Advances is among the first to show that the rotavirus protein NSP4 is both necessary and sufficient for multiple aspects of rotavirus infection by disrupting calcium signaling not only within infected cells but also in nearby uninfected cells.

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Protein Medicine Research 84

Pharma Times

JANUARY 22, 2025

Europes first biomarker trial seeks to prevent Crohns Disease onset

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Trials 172

Bio Pharma Dive

JANUARY 23, 2025

The China-based cancer drug developer’s offering will fund testing of medicines for several blood malignancies — one of which is part of an alliance with Takeda.

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Medicine Development Drugs 182

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

XTalks

JANUARY 24, 2025

The FDA has updated the labeling for glatiramer acetate , used for the treatment of multiple sclerosis (MS), to include a boxed warning about the risk of the allergic reaction anaphylaxis. The drug is marketed by Teva Pharmaceuticals as Copaxone and Sandoz sells a generic version of it under the name Glatopa. According to the FDA, cases of anaphylaxis which can be life-threatening in severe cases and if not treated in a timely or effective manner have been reported in patients treated with gla

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Drugs FDA Approval Life Science Marketing 66

Pharmaceutical Technology

JANUARY 24, 2025

The funds will support the development of Ascentages pipeline, including its lead candidate olverembatinib to treat blood cancer.

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Development 162

ACRP blog

JANUARY 22, 2025

Independent investigators play a vital role in advancing translational “bench to bedside” research to improve human health. Setting up an investigator-initiated research program (IIRP) can encourage and support these investigators while fostering an institutions high-quality research and compliance. The Hackensack Meridian Health (HMH) Research Institutes IIRP uses a structured, integrated team approach to support independent investigators.

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Research Nurses Compliance Clinical Trials 64

Bio Pharma Dive

JANUARY 22, 2025

The biotech said it has dosed the first participant in a Phase 3 study of its in vivo gene editing treatment. Elsewhere, the FDA imposed a hold on Atara and lifted another on Amylyx.

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Gene Editing In-Vivo Gene Drugs 182

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