Rethinking Clinical Trials

JANUARY 8, 2025

In this Friday’s PCT Grand Rounds, Heather Schacht Reisinger and Dana Dailey of the University of Iowa will present “FM-TIPS Community Engagement Methods for Recruitment.” The Grand Rounds session will be held on Friday, January 10, 2025, at 1:00 pm eastern. FM-TIPS, an NIH Collaboratory Trial, is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among pati

Trials 183

Trials Clinical Trials Clinical Trials Medicine 183

Bio Pharma Dive

JANUARY 8, 2025

The regulator is requiring labeling that warns of Guillan-Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.

Regulation 354

Regulation 354

XTalks

JANUARY 8, 2025

The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for integrating artificial intelligence (AI) into regulatory decisions for drug and biological product development. It targets sponsors, manufacturers and stakeholders, aiming to enhance the credibility of AI models in generating data for evaluating safety, effectiveness and quality.

Development 105

Development Drugs Compliance Clinical Trials 105

Bio Pharma Dive

JANUARY 8, 2025

Alongside plans to spin out a new company, the Belgian drugmaker said it will cut some 300 positions, or about 40% of its current workforce.

Research 284

Research 284

Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group

Let’s face it—most ethics and compliance training programs aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, captivating, and maybe even enjoyable! Join learning design expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training. We'll explore innovative strategies to bring traditionally dry topics to life, making them resonate with learners and drive tangible change.

Compliance

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 8, 2025

(SDI Productions/E+/Getty Images) The right therapy can dramatically boost the self-healing capabilities of the human heart after heart failure, a new study has found giving the vital organ regenerative powers even beyond those of a healthy heart.

Production 242

Production Development Clinical Trials Clinical Trials 242

Bio Pharma Dive

JANUARY 8, 2025

Maze fits the mold of biotechs that have pulled off successful offerings recently: The seven-year old startup, which raised about $500 million privately, has a drug in Phase 2 testing.

Drugs 167

Drugs 167

Pharmaceutical Technology

JANUARY 8, 2025

GSK has gained US FDA breakthrough therapy designation for GSK'227 to treat adults with relapsed or refractory osteosarcoma.

162

162

Pharma Times

JANUARY 8, 2025

Investment to support RNA therapeutics for epilepsy and neurological disorders

RNA 144

RNA 144

Pharmaceutical Technology

JANUARY 8, 2025

As part of the agreement, Sanofi will provide Alloy with upfront license fees and near-term preclinical milestone payments up to $27.5m.

Licensing 147

Licensing Licensing Development Drugs 147

Bio Pharma Dive

JANUARY 8, 2025

The Arch-backed startup begins life with several assets acquired from Denali Therapeutics. Elsewhere, Jasper got a negative reaction to data for its hives drug and Stoke finalized Phase 3 trial plans.

Drugs 111

Drugs Trials 111

Advertisement

Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

Trials

Pharmaceutical Technology

JANUARY 8, 2025

With clinical trials facing multiple challenges, digital solutions could provide the answer. We identify the key trends to watch in 2025.

Clinical Trials 147

Clinical Trials Clinical Trials Trials 147

pharmaphorum

JANUARY 8, 2025

Rybrevant plus Lazcluze extended median OS by more than a year compared to Tagrisso in the MARIPOSA trial in treatment-naive, EGFR-mutated NSCLC

Trials 105

Trials 105

Pharmaceutical Technology

JANUARY 8, 2025

Araris will use its linker technology to generate multi-warhead ADCs for undisclosed targets provided by Chugai.

Research 147

Research 147

pharmaphorum

JANUARY 8, 2025

Clarivate has revealed 11 drugs due to launch in 2025 that could top $1 billion in annual sales or be clinical 'game changers' in the next five years.

Drugs 105

Drugs Sales 105

Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk

In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?

Compliance

Pharmaceutical Technology

JANUARY 8, 2025

Actuate Therapeutics has gained OMPD from the EMA for elraglusib aimed at treating pancreatic ductal adenocarcinoma (PDAC).

147

147

Velocity Clinical Research

JANUARY 8, 2025

Congratulations to Paul Evans for being named one of the Top 50 Healthcare Technology CEOs of 2024! With Pauls leadership, Velocity continues to redefine how clinical trials are conducted leveraging VISION technology, centralization, and global site integration to accelerate drug development. His recognition by The Healthcare Technology Report is a nod to his vision and impact on the industry.

Clinical Trials 52

Clinical Trials Clinical Trials Clinical Research Trials 52

Pharmaceutical Technology

JANUARY 8, 2025

Orna will receive a $65m upfront payment and is eligible to receive potential milestone payments and royalties.

Gene Therapy 147

Gene Therapy Gene 147

pharmaphorum

JANUARY 8, 2025

Novo Nordisk almost doubles the scale of its R&D alliance with AI specialist Valo Health, which now spans 20 programmes and a value of up to $4.6bn.

98

98

Advertisement

Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.

Life Science

Pharmaceutical Technology

JANUARY 8, 2025

Sickle cell patient advocacy groups in the US are calling for greater education on the disease and increasing awareness of blood therapy.

130

130

pharmaphorum

JANUARY 8, 2025

Belgian biotech Galapagos is mixing things up again via a plan to split in two, separating its drug development and cell therapy operations.

Drugs 98

Drugs Development 98

Drug Patent Watch

JANUARY 8, 2025

A robust patent strategy can make or break a company’s success. With billions of dollars invested in research and development, protecting your intellectual property is not just importantit’s essential. This comprehensive guide will walk you through the intricacies of optimizing your drug patent strategy, ensuring that your innovations are safeguarded and your market position is strengthened.

Drugs 52

Drugs Licensing Licensing Marketing 52

pharmaphorum

JANUARY 8, 2025

With the Federal Reserve poised to implement interest rate cuts (albeit fewer than earlier forecasts assumed) and FTC leadership turnover anticipated, there may be broader shifts in how capital is both sourced and used in the biopharma industry.

97

97

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

Pharma Times

JANUARY 8, 2025

New FDA-approved schizophrenia treatment shows promise in clinical trials

FDA Approval 73

FDA Approval Clinical Trials Clinical Trials Trials 73

pharmaphorum

JANUARY 8, 2025

Our round-up of recent biotech financings includes a big round for Aviceda, with Orbis, Alebund, XyloCor, and PrimeGene also raising additional cash.

Drugs 96

Drugs 96

Crucial Data Soutions

JANUARY 8, 2025

RENO, NV, UNITED STATES, January 8, 2025 /EINPresswire.com/ — Crucial Data Solutions (CDS), a leader in eClinical technology and a. The post Crucial Data Solutions Begins 2025 with AI Breakthroughs and Leadership Momentum appeared first on Crucial Data Solutions.

52

52

pharmaphorum

JANUARY 8, 2025

Access to cells for CGT is closer than you think Nicole.

94

94

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 Commerce

JANUARY 8, 2025

What is the value in US adults addressing these risks, and how do social determinants of health play a role?

52

52

CTTI (Clinical Trials Transformation Initiative)

JANUARY 8, 2025

Oracle Exec Maps Data Integration Strategy for Modern Clinical Trials in 2025 and Beyond The post Oracle Exec Maps Data Integration Strategy for Modern Clinical Trials in 2025 and Beyond appeared first on CTTI.

Clinical Trials 40

Clinical Trials Clinical Trials Trials 40

Pharmaceutical Commerce

JANUARY 8, 2025

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jon Kostas, executive director, Association for Prescription Psychedelics (APP), addresses the importance of stopping the spread of misinformation when it comes to psychedelics.

52

52

Pharmaceutical Technology

JANUARY 8, 2025

China's National Medical Products Administration has granted expanded approval to MSD's GARDASIL for use in males aged nine to 26 years.

Vaccine 147

Vaccine Vaccination Production 147

Advertisement

Clinical Supply