Tue.Jan 21, 2025

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Continuous Innovation with WorldwideEdge™ — A World of a Difference in Bioanalytic Operations

Worldwide Clinical Trials

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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January 21, 2025: In PRIM-ER Trial, Palliative Care Training in Emergency Departments Did Not Reduce Hospital Admissions

Rethinking Clinical Trials

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.

Trials 157
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NVIDIA champions Innophore partnership to model drug dynamics with AI

Pharmaceutical Technology

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

Drugs 345
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Moderna gets $590M from US government for bird flu vaccine

Bio Pharma Dive

Moderna has been testing an mRNA candidate for influenza viruses like the H5 and H7 strains that are seen as pandemic threats. Others, including GSK and Pfizer, are also at work on similar shots.

Vaccine 307
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Bridging Innovation & Patient Care: The Growing Role of AI

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

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!

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Streamlining mesenchymal stem cell (MSC) expansion

Pharmaceutical Technology

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

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Top 30 New Medical Devices of 2024

XTalks

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).

More Trending

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Datroway’s Approval in Breast Cancer Solidifies Daiichi Sankyo’s Leadership in ADCs

XTalks

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.

Antibody 105
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Sionna, Odyssey join queue of biotechs testing investors’ IPO interest

Bio Pharma Dive

The startups are the fourth and fifth drugmakers to file for initial public offerings since late December — the most notable burst of activity in more than three months.

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AI’s potential in the women’s health exciting, says Gates Foundation leader

Pharmaceutical Technology

Panellists at the World Economic Forum 2025 Davos meeting discussed how artificial intelligence (AI) could help close the gap in womens health research.

Research 147
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A New Approach to Assess and Manage Study Coordinator Workload

ACRP blog

Historically, the vital task of assigning study coordinators to clinical trials has relied on a research leaders experience and intuition. The realities of todays challenging studieswith increasing complexity and tightening budgetsdemand an accurate assessment of the level of support required for each trial. This is an essential step in maintaining quality while avoiding staff burnout.

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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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Junshi partners LEO Pharma for toripalimab distribution in Europe

Pharmaceutical Technology

Junshi Biosciences and TopAlliance are set to enter a collaboration with LEO Pharma to distribute and market toripalimab in Europe.

Marketing 147
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AlzeCure’s NeuroRestore ACD856 to be presented at AD/PD 2025

Pharma Times

Preclinical data highlights potential in treating Alzheimer's disease

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J&Js Lazcluze/Rybrevant combination obtains European approval to treat NSCLC 

Pharmaceutical Technology

The Lazcluze plus Rybrevant combination could challenge AstraZenecas standard-of-care Tagrisso in non-small cell lung cancer (NSCLC).

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Data Quality in AI-Powered Pharmacovigilance Systems

Drug Patent Watch

The Hidden Threat to AI-Powered Pharmacovigilance Systems: Data Quality As the pharmaceutical industry continues to adopt AI-powered pharmacovigilance systems, one critical factor is often overlooked: data quality. While AI can process vast amounts of data quickly and accurately, it's only as good as the data it's fed. Inaccurate, incomplete, or inconsistent data can lead to flawed insights, incorrect conclusions, and ultimately, compromised patient safety.

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

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CEPI provides $6.2m to push first mRNA-based Rift Valley fever vaccine into trial

Pharmaceutical Technology

Afrigen Biologics has secured a $6.2m grant from CEPI to develop the first mRNA-based vaccine against Rift Valley fever.

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EC approves lazertinib in combination with amivantamab for NSCLC patients

Pharma Times

Combination therapy shows superior survival benefit over standard treatment

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Health Canada gives Takeda’s mCRC capsules market authorisation

Pharmaceutical Technology

Health Canada has granted market authorisation to Takeda Canada for FRUZAQLA capsules to treat adults with mCRC.

Marketing 147
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What will 2025 hold for biopharma?

Bio Pharma Dive

What does 2025 hold for pharma? Find out the top drugs, companies and therapy areas for the year ahead.

Drugs 130
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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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FDA review designations: tracking 40 years of innovation

Pharmaceutical Technology

This rising trend mirrors the evolution of the pharmaceutical industry in terms of investment and utilisation of novel technologies.

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Risk Management Strategies for Generic Drug Development

Drug Patent Watch

Navigating the Complex World of Generic Drug Development: Risk Management Strategies to Know As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. But with the ever-changing landscape of pharmaceutical regulations and patent laws, it's more crucial than ever to have a solid risk management strategy in place.

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EC approves GSK’s Jemperli-chemo combo for endometrial cancer

Pharmaceutical Technology

The EC has approved GSK's Jemperli (dostarlimab) combined with chemotherapy for primary advanced or recurrent endometrial cancer in adults.

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Digital Advertising in Clinical Trials: The Real Secret Sauce

Imperical Blog

Ive spent my entire adult life immersed in media, marketing, and advertising, long enough to remember the days before digital advertising in clinical trials took over. For patient recruitment, sponsors and CROs had little more to rely on than local newspapers and radio stations. They… The post Digital Advertising in Clinical Trials: The Real Secret Sauce appeared first on Imperial Clinical Research Services Blog.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Could OTC Cialis for erectile dysfunction reach the US?

pharmaphorum

Sanofi's consumer healthcare unit Opella could finally be able to bring an OTC PDE-5 inhibitor for erectile dysfunction to the US market

Marketing 105
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Bridgewest merges portfolio Australian CDMOs

Outsourcing Pharma

Australian CDMOs, BioCina and NovaCina, have merged in a move to pool their biologic and small molecule production expertise and infrastructure.

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Two more biotechs join IPO waiting list

pharmaphorum

Odyssey and Sionna have filed to carry out IPOs on the Nasdaq, following after Metsera and Maze which filed earlier in January

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Novo Nordisk reports positive results for high-dose Wegovy formulation

Outsourcing Pharma

Results from Novo Nordisk's STEP UP trial show that a high-dose formulation of Wegovy can significantly increase the weight loss effects the drug is known for.

Trials 69
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Large study points to benefits - and risks - of GLP-1 drugs

pharmaphorum

The largest observational study of GLP-1 weight-loss drugs suggests their benefits could be wide-ranging, but there are some risks to consider.

Drugs 96
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Analysis: Medicare Part D Enrollees Who Reach the $2,000 OOP Spending Cap to Save an Average of $2,474 Nationally

Pharmaceutical Commerce

The latest AARP report concludes that plan members who hit this amount are expected to see savings, even when premiums are considered.

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EU approves endometrial, lung cancer drugs from GSK and J&J

pharmaphorum

GSK and J&J have claimed pivotal approvals for growth-phase oncology therapies Jemperli and Rybrevant in the EU

Drugs 73
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A Qualthera Deep Dive

Pharmaceutical Commerce

In the fourth part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, discusses the origins of the compounding pharmacy, including what it seeks to accomplish.

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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