Drug Patent Watch

DECEMBER 17, 2024

Flexibility has become more than just a buzzword it’s a necessity. Contract Development and Manufacturing Organizations (CDMOs) are at the forefront of this shift, playing a crucial role in bringing innovative therapies to market. But what exactly makes flexibility so important for CDMOs, and how can they cultivate this essential trait? Let’s dive into the world of pharmaceutical outsourcing and explore why adaptability is the key to success.

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Manufacturing Production Development Big Data 69

Imperical Blog

DECEMBER 18, 2024

Our blog team reviewed our 2024 clinical study blogs, and we selected these six worth re-reading. Check them out! 1. Sustainability in Business: Transparency and Keeping Score ESG: Environmental, social, and governance are factors that influence commercial success. Discover how Imperial achieved a sustainability rating… The post 6 Clinical Study Blogs Not to Miss appeared first on Imperial Clinical Research Services Blog.

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Drug Patent Watch

DECEMBER 16, 2024

When it comes to researching and navigating the complex world of drug patents, inventors and researchers often turn to various tools to find relevant information. Google Patents, with its user-friendly interface and vast database, might seem like an ideal resource. However, there are several reasons why relying solely on Google Patents can be risky, especially in the context of pharmaceutical patents.

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Drugs Marketing Research Manufacturing 52

Fierce Pharma

DECEMBER 17, 2024

Its not a new question, but it is one that is gaining increased traction: Is there a link between Novo Nordisks diabetes superstar Ozempic and blindness? | After the recent release of two independent studies from the University of Southern Denmark suggested the use of Ozempic increases patients' chances of developing a rare eye disorder, the Danish Medicines Agency has asked European officials to investigate.

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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

Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. The coming year is expected to be no different. As we look to 2025, Advarra thought leaders have compiled predictions and perspectives on key topics shaping the industry. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, an

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Bio Pharma Dive

DECEMBER 17, 2024

Phase 2 results in inflammatory bowel disease hinted the therapy could be more potent than similar medicines from Merck and Roche, each of which were acquired in multibillion-dollar deals.

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Medicine Drugs 232

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 18, 2024

People with missing teeth may be able to grow new ones, say Japanese dentists testing a pioneering drug they hope will offer an alternative to dentures and implants.

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Clinical Trials Clinical Trials Drugs Trials 154

Worldwide Clinical Trials

DECEMBER 19, 2024

At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing. While the agenda remained the same across both events, the conversations revealed key regional distinctions and global perspectives on how genetic testing, ethics, and operational challenges are ad

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Bio Pharma Dive

DECEMBER 20, 2024

Novo shares lost nearly a quarter of their value after an experimental combination treatment called cagrisema fell short of the bar set by executives.

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Trials Drugs 179

Pharmaceutical Technology

DECEMBER 20, 2024

The US Food and Drug Administration (FDA) has stood by an earlier decision confirming that the tirzepatide shortage is over.

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Drugs 162

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AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 15, 2024

The human body can survive without food for some time before starvation risks causing significant harm to the body.

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Rethinking Clinical Trials

DECEMBER 18, 2024

Speaker Gbenga Ogedegbe, MD, MPH, FACP Dr. Adolph & Margaret Berger Professor of Population Health NYU Grossman School of Medicine Director, Institute for Excellence in Health Equity (IEHE) NYU Langone Health Slides Keywords Hypertension; Racial Disparities; Case Management; Telemonitoring Key Points There are significant racial disparities when it comes to stroke outcomes in the U.S., with Black and Hispanic populations experiencing poorer outcomes than Caucasian

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Nurses Clinical Trials Clinical Trials Trials 100

Bio Pharma Dive

DECEMBER 19, 2024

The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.

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Pharmaceutical Technology

DECEMBER 20, 2024

Astellas Pharma and Sangamo have signed a licence agreement for neurotropic adeno-associated virus (AAV) capsid, STAC-BBB.

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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

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 16, 2024

Children with attention deficit hyperactivity disorder ( ADHD) do not have a behavioural disorder, nor are they lazy, or lacking in manners and boundaries. Their brains mature in a different way, with different patterns of neurological activity and a number of neurochemical differences. For this reason, ADHD is considered to be a neurodevelopmental disorder.

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Clinical Trials Clinical Trials Trials 142

Pharma Mirror

DECEMBER 16, 2024

CPHI Milan the worlds largest pharma event hosted last month in Milan saw a new record attendance of 59,000 pharma executives buoyed by returning confidence and increased deal-making on site. The post Pharma prepares for CDMO growth in 2025 as CPHI Milan reports record attendance appeared first on Pharma Mirror Magazine.

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Bio Pharma Dive

DECEMBER 17, 2024

An FDA approval of Merck’s drug clesrovimab by June would give physicians another option for protecting newborns from respiratory syncytial virus.

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Pharmaceutical Technology

DECEMBER 18, 2024

Abera and Orexo have entered a partnership to develop and test the powder formulations of the formers vaccine candidates.

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Vaccination Vaccine Development 165

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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

Rethinking Clinical Trials

DECEMBER 17, 2024

December 8, 2024 : The NIH Pragmatic Trials Collaboratory hosted a workshop at AcademyHealth's 17th Annual Conference on the Science of Dissemination and Implementation in Health. The workshop introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus on methods relevant to health services researchers.

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Medical Xpress

DECEMBER 20, 2024

UAB research has characterized in detail how polymer-based commercial tea bags release millions of nanoplastics and microplastics when infused. The study shows for the first time the capacity of these particles to be absorbed by human intestinal cells, and are thus able to reach the bloodstream and spread throughout the body.

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Research 109

Bio Pharma Dive

DECEMBER 16, 2024

The company is scrapping two drugs aimed at targets called TIGIT and LAG-3, both of which were in the middle of Phase 3 testing.

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Drugs 173

Pharmaceutical Technology

DECEMBER 20, 2024

The US FDA has approved Ionis' TRYNGOLZA (olezarsen) as an adjunct to diet for reducing triglyceride levels in the adult population with FCS

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FDA Approval 147

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

Fierce Pharma

DECEMBER 17, 2024

Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the companys attempt to gain approval of its subcutaneous version of lung cancer drug R | The FDA has sent complete response letters to Johnson & Johnson and AstraZeneca, rejecting J&J's application for subcutaneous Rybrevant and AZ's bid for a full approval of Andexxa.

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Manufacturing Drugs 121

Rethinking Clinical Trials

DECEMBER 16, 2024

A new study snapshot and updated ethics and regulatory documentation are now available for the I CAN DO Surgical ACP trial. As part of the study’s transition from the planning phase to the implementation phase this fall, the investigators reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. Read the updated ethics and regulatory documentation See the study snapshot I CAN DO Surgical ACP, an NIH Collaboratory Trial, is testing a system-based ap

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Clinical Trials Clinical Trials Trials 130

Bio Pharma Dive

DECEMBER 18, 2024

News of Merck’s licensing of Hansoh’s preclinical medicine pressured shares in Viking and other obesity drug developers seen as likely buyout targets.

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Pharmaceutical Technology

DECEMBER 20, 2024

Palleon and Henlius Biotech have entered into a licence agreement and partnership for the formers E-602 to treat autoimmune diseases.

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XTalks

DECEMBER 18, 2024

The US Food and Drug Administration (FDA) has granted approval to Checkpoint Therapeutics PD-L1 inhibitor Unloxcyt (cosibelimab-ipdl) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients who cannot be cured with surgery or radiation therapy. The approval marks the first product approval for the Massachusetts-based biotech and the first approved anti-programmed death-ligand 1 (PD-L1) treatment for advanced cSCC. cSCC is the second most common fo

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FDA Approval Antibody Immune Response Marketing 95

pharmaphorum

DECEMBER 19, 2024

At its third attempt, Mesoblast has secured FDA approval for the first-ever mesenchymal stem cell (MSC) therapy, Ryoncil for acute GvHD in children.

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FDA Approval 96

Bio Pharma Dive

DECEMBER 19, 2024

An startup formed by KdT Ventures intends to test the drug, which was once licensed to Merck and evaluated in multiple metabolic disorders, for an unspecified rare conditon.

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Pharmaceutical Technology

DECEMBER 20, 2024

The UK's DHSC has announced its anticipated 2025 headline payback rate for new medicines under the 20242028 VPAG.

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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.

Clinical Trials