Worldwide Clinical Trials

JANUARY 6, 2025

Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential? BioA plays a pivotal role in therapeutic development, facilitating progress in our understanding and treatment of complicated diseases through PK/PD, immunogenicit

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Bio Pharma Dive

JANUARY 6, 2025

The startup is developing a kind of macrocyles, which share strengths of both small molecules and biologics, as oral medicines against “validated blockbuster biologic targets.

Medicine 301

Medicine Development 301

Rethinking Clinical Trials

JANUARY 6, 2025

In an upcoming session of the VA Spotlight on Pain Management Cyberseminars series curated by the Pain Management Collaboratory (PMC), Julie Fritz and Dan Rhon will present “Supporting Whole Person Pain Management in the Military Health System.” The session will be held on Tuesday, January 7, from 11:00 am to 12:00 pm eastern. Improving care for persons with chronic musculoskeletal pain is a priority in the Military Health System.

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Clinical Trials Clinical Trials Trials Research 173

Bio Pharma Dive

JANUARY 6, 2025

Esperion CEO Sheldon Koenig reflects on personal challenges and advancing innovative heart therapies.

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Pharma Companies 176

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

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 6, 2025

Artificial intelligence (AI) and machine learning (ML) are poised to redefine the landscape of critical care medicine, offering innovative solutions to the challenges faced in intensive care units (ICUs). ICUs are high-stakes environments where every decision can mean the difference between life and death.

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Bio Pharma Dive

JANUARY 6, 2025

By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.

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Regulation Drugs 157

Pharmaceutical Technology

JANUARY 6, 2025

The US FDA has granted ODD to NMD Pharmas oral lead development programme, NMD670, designed to treat Charcot-Marie-Tooth disease (CMT).

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Development 130

Bio Pharma Dive

JANUARY 6, 2025

The stage is set for JPM 2025—don't miss expert reactions following 2025’s principal catalyst event!

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Pharmaceutical Technology

JANUARY 6, 2025

Orbis Medicines has raised 90m ($94m) in Series A funding to advance the development of its next-generation orally dosable macrocycle drugs.

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Development Medicine Drugs 130

Worldwide Clinical Trials

JANUARY 6, 2025

With 20-25% of the global population affected by metabolic problems, finding effective treatments is crucial for cardiovascular and metabolic (CVM) conditions. Traditional study designs feature predetermined sample sizes, assessments, and analyses that must remain in place over long treatment durations. Although formal protocol amendments are possible, this process is time-consuming and complex.

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Trials Clinical Trials Clinical Trials Research 130

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Pharmaceutical Technology

JANUARY 6, 2025

Amgens bispecific T-cell engager (BiTE) led to an ORR of 41% in patients with extensive-stage small cell lung cancer.

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Pharma Times

JANUARY 6, 2025

EpiSwitch PSE shows promise in reducing unnecessary procedures

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Pharmaceutical Technology

JANUARY 6, 2025

The decision follows a positive recommendation received from the Committee for Medicinal Products for Human Use (CHMP) in November 2024.

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pharmaphorum

JANUARY 6, 2025

Novo Nordisk has asked the FDA to block compounders from making versions of its older, once-daily GLP-1 agonist liraglutide.

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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 6, 2025

The China NMPA has approved GSKs Nucala (mepolizumab) as an add-on treatment along with intranasal corticosteroids to treat CRSwNP.

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XTalks

JANUARY 6, 2025

In a groundbreaking move for pediatric medicine, the US Food and Drug Administration (FDA) has approved Ryoncil (remestemcel-L) , the first mesenchymal stromal cell (MSC) therapy ever approved in the US. Mesoblasts Ryoncil is now available for children aged two months and older with steroid-refractory acute graft-versus-host disease (SR-aGVHD). Acute graft versus host disease (aGVHD) occurs when donor immune cells attack the recipients tissues after an allogeneic (donor) bone marrow transplant.

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FDA Approval Immune Response Medicine Trials 100

Pharmaceutical Technology

JANUARY 6, 2025

The Abu Dhabi Stem Cells Center (ADSCC) has developed clinical-grade induced pluripotent stem cells (iPSCs) that meet GMP protocols.

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Development 130

pharmaphorum

JANUARY 6, 2025

MSD has expanded its presence in Ireland with an agreement to buy a vaccines manufacturing facility from WuXi Biologics in Dundalk.

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Vaccine Vaccination Manufacturing 99

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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 6, 2025

The heart failure market is expected to grow at a 9.6% CAGR from $13.5bn in 2022 to $33.7bn in 2032 in the 7MM.

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Marketing 130

XTalks

JANUARY 6, 2025

Just before the end of 2024, Novo Nordisk nabbed US Food and Drug Administration (FDA) approval for its awaited hemophilia drug Alhemo (concizumab-mtci). Alhemo is approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors.

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FDA Approval Antibody Drugs Clinical Trials 99

pharmaphorum

JANUARY 6, 2025

US biotech NeOnc Technologies has applied to list on the Nasdaq as it advances a portfolio of drugs to treat diseases affecting the CNS.

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Drugs 99

Pharmaceutical Commerce

JANUARY 6, 2025

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jon Kostas, executive director, Association for Prescription Psychedelics (APP), provides a peek into what the association has set out to accomplish.

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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

pharmaphorum

JANUARY 6, 2025

More community hubs and changes to the NHS App are at the core of the UK government's new elective reform plan.

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XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation. This approval marks a significant milestone for Vertex Pharmaceuticals, making Alyftrek their fifth CFTR modulator to secure FDA approval, offering hope

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Gene Therapy Protein Genetic Disease Gene 75

pharmaphorum

JANUARY 6, 2025

The NHS is dealing with a major rise in influenza cases, with the number of hospitalised patients quadrupling to around 5,000 ahead of the New Year.

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Velocity Clinical Research

JANUARY 6, 2025

Robert Cupelo, MD, Principal Investigator in Syracuse, NY, shares his firsthand insights into the evolving landscape of Alzheimer’s treatment. Nearly two years after the FDA’s approval of lecanemab (Leqembi), and with the subsequent approval of donanemab (Kisunla), researchers are making crucial steps forward in the fight against disease progression and for disease prevention.

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Clinical Research Research 52

Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

ACRP blog

JANUARY 6, 2025

This is sponsored content. While the U.S. Department of Justice (DOJ) continues to prioritize its investigation of fraud and misconduct within the clinical research space, the Office of Research Integrity in the U.S. Department of Health and Human Services recently released its Final Rule on regulations governing Public Health Service Policies on Research Misconduct, which takes effect January 1, 2025.

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Compliance Clinical Trials Clinical Trials Clinical Research 59

Pharmaceutical Commerce

JANUARY 6, 2025

The moveone that meets industry standardsconfirms the Cryoport companys commitment to providing quality and safety in the cold chain solutions space.

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Production 59

XTalks

JANUARY 6, 2025

Just before the end of 2024, Novo Nordisk nabbed US Food and Drug Administration (FDA) approval for its awaited hemophilia drug Alhemo (concizumab-mtci). Alhemo is approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors.

FDA Approval 52

FDA Approval Antibody Drugs Clinical Trials 52

Pharmaceutical Commerce

JANUARY 6, 2025

The latest news for pharma industry insiders.

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