XTalks

DECEMBER 9, 2024

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions. This guidance focuses on improved accountability, earlier confirmatory studies and greater clarity on novel endpoints.

Clinical Trials 88

Clinical Trials Clinical Trials Compliance Trials 88

Pharmaceutical Technology

DECEMBER 9, 2024

Shares in WuXi AppTec, one of those implicated in the Chinese biotech blacklisting legislation, surged following the omission.

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Bio Pharma Dive

DECEMBER 9, 2024

Drugs 218

Drugs 218

Pharmaceutical Technology

DECEMBER 9, 2024

Citryll has secured an oversubscribed Series B funding round, raising 85m ($89.8m) to advance the clinical development of CIT-013.

Development 261

Development Antibody Clinical Development 261

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

Bio Pharma Dive

DECEMBER 9, 2024

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201

Pharmaceutical Technology

DECEMBER 9, 2024

The breakthrough designation for Daiichi Sankyo comes after early pooled results from two ongoing trials finding the drug was well tolerated.

Trials 147

Trials Drugs 147

Pharmaceutical Technology

DECEMBER 9, 2024

Novo Holdings, the investment arm of the Novo Nordisk Foundation, has gained approval from the EC for its acquisition of Catalent.

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147

Bio Pharma Dive

DECEMBER 9, 2024

Research 129

Research Drugs 129

Pharmaceutical Technology

DECEMBER 9, 2024

The US FDA has granted priority review to AstraZeneca's sBLA for Imfinzi (durvalumab) for muscle-invasive bladder cancer (MIBC) treatment.

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147

Bio Pharma Dive

DECEMBER 9, 2024

Gene Therapy 129

Gene Therapy Gene 129

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Clinical Supply

Pharmaceutical Technology

DECEMBER 9, 2024

How to increase efficiency and flexibility in buffer production for biopharmaceutical manufacturing? ZETA presents an innovative solution that saves space and reduces costs. Learn more about the future of buffer production!

Manufacturing 130

Manufacturing Production 130

Pharma Times

DECEMBER 9, 2024

Trial results lead to new treatment option for lung cancer

Trials 120

Trials 120

Pharmaceutical Technology

DECEMBER 9, 2024

Image Analysis Group is a winner in the Innovation category in the 2024 Pharmaceutical Technology Excellence Awards.

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130

Bio Pharma Dive

DECEMBER 9, 2024

Marketing 100

Marketing 100

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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

DECEMBER 9, 2024

ZETA provides the best-in-class services and customised solutions to specific problems of its customers.

Engineer 100

Engineer 100

Bio Pharma Dive

DECEMBER 9, 2024

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100

Pharma Times

DECEMBER 9, 2024

promising pre-clinical data on preventing cytokine release syndrome

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95

Drug Patent Watch

DECEMBER 9, 2024

In the vast realm of pharmaceutical research and development, there’s a fascinating intersection between ancient wisdom and modern science. This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. But what exactly is pharmacognosy, and how does it relate to the complex world of drug patents?

Medicine 87

Medicine Drugs Production Development 87

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Clinical Supply

Fierce Pharma

DECEMBER 9, 2024

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84

pharmaphorum

DECEMBER 9, 2024

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80

Fierce Pharma

DECEMBER 9, 2024

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75

pharmaphorum

DECEMBER 9, 2024

Development 75

Development Drugs 75

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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

Fierce Pharma

DECEMBER 9, 2024

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74

pharmaphorum

DECEMBER 9, 2024

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74

Drug Patent Watch

DECEMBER 9, 2024

Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. The emphasis on analytical and functional testing through sophisticated technology is crucial in overcoming these challenges.

Clinical Trials 52

Clinical Trials Clinical Trials Immune Response Production 52

pharmaphorum

DECEMBER 9, 2024

Drugs 74

Drugs 74

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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

Clinical Research

Crucial Data Soutions

DECEMBER 9, 2024

December 9, 2024— Crucial Data Solutions is proud to announce that our groundbreaking innovation, TrialKit AI, has been recognized with. The post TrialKit AI: Revolutionizing Clinical Research Analytics with AI appeared first on Crucial Data Solutions.

Clinical Research 59

Clinical Research Research 59

pharmaphorum

DECEMBER 9, 2024

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ACRP blog

DECEMBER 9, 2024

This is a sponsored message. Clinical Trial Management Systems (CTMSs) are software platforms that provide clinical research sites and research study staff with the ability to manage all operational aspects of a clinical trial, both at the study protocol level and participant level. A CTMS platform can help streamline study start-up processes, provide real-time visibility into the status of a study, improve collaboration through automated workflows, and optimize financial management processes.

Clinical Trials 64

Clinical Trials Clinical Trials Clinical Research Compliance 64

Pharmaceutical Commerce

DECEMBER 9, 2024

Because of the potential for product shortages at pharmacies, the FDA has not only given industry more time for compliancebut time to catch up on boosting the supply chains interoperable efforts.

Pharmacy 52

Pharmacy Production 52

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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