Tue.Jan 07, 2025

article thumbnail

ALS drugs from Denali, Calico come up short, marking more failures for Healey trial

Bio Pharma Dive

Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, bringing the tally of failed drugs in the innovative “Healey platform trial” to seven.

article thumbnail

Open-World Games Like Zelda Can Boost Your Mental Health, Study Says

AuroBlog - Aurous Healthcare Clinical Trials blog

Still from Breath of the Wild. (Nintendo) Many modern video games fall into the open-world category, giving players vast, detailed worlds to explore and a new study shows these expansive digital playgrounds have benefits for our mental health.

Research 168
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Metsera reveals study data supporting long-acting obesity shot

Bio Pharma Dive

The startup, which has already raised more than half a billion dollars, released Phase 2 results that could position its drug as a future threat to weight loss medicines from Novo Nordisk and Eli Lilly.

Medicine 263
article thumbnail

Variant Bio and Novo Nordisk to identify targets for metabolic disease treatment

Pharmaceutical Technology

Variant has entered a multi-year research partnership with Novo Nordisk to identify new targets to treat metabolic conditions.

Research 147
article thumbnail

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

article thumbnail

Vertex, startup Orna to partner on gene editing research

Bio Pharma Dive

The three-year partnership is another example of Vertex’s interest in improving on Casgevy, its CRISPR medicine for sickle cell and beta thalassemia.

article thumbnail

FDA accepts Sentynl’s Menkes disease therapy NDA for priority review

Pharmaceutical Technology

The FDA has accepted for filing and priority review Sentynl Therapeutics CUTX-101 NDA for the treatment of Menkes disease.

147
147

More Trending

article thumbnail

WuXi Biologics to sell Ireland-based vaccine site to MSD for $500m

Pharmaceutical Technology

The transaction is expected to close in the first half of 2025, subject to the satisfaction of customary closing conditions.

article thumbnail

J&J says cancer drug combination showed survival benefit over Tagrisso

Bio Pharma Dive

Results from a study called Mariposa found a regimen of Rybrevant and Lazcluze helped patients with a common form of advanced lung cancer live longer.

Drugs 111
article thumbnail

Candid Therapeutics signs $925m T cell engager deal with WuXi Biologics

Pharmaceutical Technology

Candid plans to conduct first-in-human studies in 2026 as it continues its T-cell engager deal drive.

147
147
article thumbnail

Verona says COPD drug is off to a flying start

pharmaphorum

Verona Pharma's plans to transform COPD treatment with recently approved Ohtuvayre look like they are on course, given early sales figures.

Sales 105
article thumbnail

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

article thumbnail

FDA grants ODD to Tempest’s hepatocellular carcinoma treatment

Pharmaceutical Technology

The FDA has granted ODD to Tempest's amezalpat (TPST-1120), for individuals with hepatocellular carcinoma (HCC).

147
147
article thumbnail

Novartis gene therapy set to enhance SMA treatment

Pharma Times

OAV101 IT expands potential for type II SMA patients

article thumbnail

Acelyrin stock plunges after positive Phase II data readout in thyroid eye disease

Pharmaceutical Technology

Acelyrin plans to initiate two Phase III studies this quarter, which will enrol up to 350 patients with thyroid eye disease (TED).

130
130
article thumbnail

US reports its first fatal case of H5N1 bird flu

pharmaphorum

A man in Louisiana has become the first recorded fatality in the US attributed to the H5N1 strain of bird flu.

93
article thumbnail

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

article thumbnail

COVID-19: The global clinical trial landscape in 2024

Pharmaceutical Technology

The landscape of pandemic response has been transformed, with new standards being set for clinical excellence. A new report looks at emerging therapies, trial insights, and the innovations shaping the future of global healthcare.

article thumbnail

GSK bags breakthrough status for bone cancer drug

pharmaphorum

GSK has claimed its second breakthrough designation from the FDA for B7-H3-targeted ADC, this time in osteosarcoma.

Drugs 91
article thumbnail

Merck unveils new cyber-physical trust platform at CES 2025

Pharma Times

M-Trust set to improve product safety and counterfeiting solutions

article thumbnail

Denali Therapeutics’ ALS drug fails to improve function and survival in phase 2/3 trial

Outsourcing Pharma

Denali Therapeutics' DNL343 fails to slow ALS progression in phase 2/3 trial but shows safety and offers insights for future analysis.

Trials 88
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Top 10 Largest MedTech Mergers and Acquisitions of the Decade

XTalks

The medical device and medtech industry has undergone significant mergers and acquisitions over the past decade. These strategic deals have reshaped the competitive landscape, spurred innovation and enabled companies to diversify their product offerings, expand into new markets and enhance operational efficiencies. This list highlights the top 10 largest mergers and acquisitions among companies in the medical device, medtech and diagnostics sector from the past decade.

article thumbnail

FDA issues first guidance on AI in medicine development

pharmaphorum

The FDA has placed the credibility of AI's 'context of use' in pharma development at the heart of its first guidance in this area

article thumbnail

Eli Lilly’s Zepbound Approved as First Treatment for Obstructive Sleep Apnea

XTalks

Eli Lillys obesity drug Zepbound (tirzepatide) has become the first approved medication for obstructive sleep apnea (OSA). At the end of December, the US Food and Drug Administration (FDA) approved Zepbound for the treatment of moderate to severe OSA in adults with obesity, for use in combination with a reduced-calorie diet and increased physical activity.

article thumbnail

How GenAI will transform life sciences in 2025

pharmaphorum

The life sciences industry is in a position to help humanity, perhaps more than ever, with the introduction of generative AI (GenAI).

article thumbnail

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.

article thumbnail

Top Pharma Marketing News and Trends for 2025: Insights for Industry Leaders

Pharma Marketing Network

Table of Contents Sr# Headings 1 Introduction: Why Pharma Marketing Matters 2 Digital Dominance in Pharma Marketing 3 Personalization: The Future of Engagement 4 Regulatory Updates Impacting Pharma Ads Introduction: Why Pharma Marketing Matters The world of pharmaceutical marketing is evolving rapidly, and staying informed is no longer optional for executives.

article thumbnail

Merck Purchases WuXi Vaccine Plant in Ireland for $520 Million

Pharmaceutical Commerce

The deal is expected to be finalized by the first half of this year.

article thumbnail

Marketing in Pharma: Top Strategies for Executive Success

Pharma Marketing Network

Table of Contents Sr# Headings 1 Introduction: The Importance of Marketing in Pharma 2 Digital Strategies Redefining Pharma Marketing 3 Building Trust Through Patient-Centric Campaigns 4 Navigating Compliance While Innovating Introduction: The Importance of Marketing in Pharma Marketing in pharma has never been more critical. In todays rapidly evolving landscape, executives must navigate a complex mix of innovation, regulation, and competition to remain relevant.

article thumbnail

Velocity Contributes to ACRP Whitepaper on Responsible AI Oversight

Velocity Clinical Research

Velocitys team contributed to the new Association of Clinical Research Professionals (ACRP) comprehensive whitepaper, titled ‘Responsible Oversight of Artificial Intelligence for Clinical Research Professionals.’ The development of our VISION technology has coincided with the proliferation of AI and large language models (LLMs). For recruitment purposes, these tools have improved patient-trial matching, automated outreach, and enabled the creation of more granular potential participa

article thumbnail

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

article thumbnail

Rebranding Big Pharma: Strategies to Build Trust and Connection

Pharma Marketing Network

Table of Contents Sr# Headings 1 Introduction: Big Pharma and Public Perception 2 Transparency: The First Step to Trust 3 Humanizing Big Pharma Through Patient-Centric Marketing 4 The Role of Community and Corporate Responsibility Introduction: Big Pharma and Public Perception The term Big Pharma often stirs strong emotions, conjuring both respect for its life-saving innovations and skepticism over perceived corporate motives.

article thumbnail

The great ISO IDMP implementation challenge: Are companies finally ready?

pharmaphorum

Large pharma companies now generally have good awareness of the value of IDMP-based product data standardisation as part of wider process digitalisation ambitions.

article thumbnail

A Visit with Christina Brennan, the 2025 ACRP Board of Trustees Chair

ACRP blog

As Christina Brennan, MD, MBA, CCRC, begins her volunteer duties as the 2025 Chair of the Association Board of Trustees (ABoT) for ACRP, she took time to answer some questions about her experience in the clinical research enterprise, some of the challenges and opportunities facing it, and how ACRP can be of service to its members and stakeholders. Q: Can you give us the quick highlights along your career roadmap to serving as the 2025 Chair of the ABoT that you believe will help you achieve your

article thumbnail

3 ways AI and patient-centred support can improve medication adherence

pharmaphorum

3 ways AI and patient-centred support can improve medication adherence Nicole.

52
article thumbnail

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.