Rethinking Clinical Trials

FEBRUARY 14, 2024

Dr. Jeffrey Carson In this Friday’s PCT Grand Rounds, Jeffrey Carson of Rutgers Biomedical and Health Sciences will present “Clinical Implications of the MINT Trial: p=0.07.” The Grand Rounds session will be held on Friday, February 16, 2024, at 1:00 pm eastern. Carson is provost-New Brunswick for Rutgers Biomedical and Health Sciences and the Distinguished Professor of Medicine and Richard C.

Trials 152

Trials Clinical Trials Clinical Trials Medicine 152

Bio Pharma Dive

FEBRUARY 14, 2024

Latigo Biotherapeutics has raised $135 million to develop drugs that block NaV1.8, a target shared by a Vertex therapy that just succeeded in Phase 3 testing.

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Development Drugs 298

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 14, 2024

The moment when a slithering sperm propels itself head-first into a gelatinous egg is one of sudden change. Within seconds to minutes, chemical changes in the egg’s membrane and outer coat are enacted to block any more sperm from attaching to and entering the oocyte.

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Clinical Trials Clinical Trials Clinical Research Trials 194

Bio Pharma Dive

FEBRUARY 14, 2024

The company and partner Biogen say signs from payers and doctors suggest the launch of Zurzuvae, the first oral therapy for PPD, is off to a good start.

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Doctors Doctor 300

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Clinical Supply

Pharmaceutical Technology

FEBRUARY 14, 2024

A bipartisan group of lawmakers is seeking an investigation and sanctions against WuXi given alleged connections to the Chinese military.

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Bio Pharma Dive

FEBRUARY 14, 2024

The clearance of Onivyde for first-line pancreatic adenocarcinoma triggers a $225 million payment to Merrimack, from whom Ipsen bought the drug.

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Drugs 272

Bio Pharma Dive

FEBRUARY 14, 2024

The biotech is planning to dissolve less than four years after launching with plans to license drugs and market them in China and other Asian countries.

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Licensing Licensing Marketing Drugs 164

Pharma Mirror

FEBRUARY 14, 2024

In the dynamic realm of laboratory instruments, ultra-low freezers play a pivotal role in preserving valuable samples and reagents. These sophisticated devices are crucial for various fields, ranging from medical research to pharmaceutical development. Today, we delve into the nuances of ultra-low (also called so low) freezer repair, exploring their main applications and common troubleshooting issues.

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Reagent Development Research 130

Pharmaceutical Technology

FEBRUARY 14, 2024

The US FDA has granted fast track designation to Edgewise Therapeutics’ EDG-5506 aimed at treating Duchenne muscular dystrophy.

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Rethinking Clinical Trials

FEBRUARY 14, 2024

            Speaker Cynthia Hau, MPH Statistician Boston Cooperative Studies Program Coordinating Center VA Boston Healthcare System Slides Keywords Diuretic Comparison Project, VA Health System, Patient Recruitment, VA Point of Care Program Key Points Diuretic Comparison Project (DCP) was one of the first full-scale studies for the VA Point of Care Program.

Clinical Trials 152

Clinical Trials Clinical Trials Cardiology Trials 152

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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

FEBRUARY 14, 2024

A panel at the 2024 SCOPE Summit shared their experiences of setting up and running clinical trials that are more inclusive of the LGBTQIA+ community.

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Trials Clinical Trials Clinical Trials 130

Pharma Times

FEBRUARY 14, 2024

The aggressive type of cancer accounts for 13% of all lung cancer cases worldwide

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Pharmaceutical Technology

FEBRUARY 14, 2024

The FDA has issued warning letters to two online sellers for selling unapproved versions of semaglutide and tirzepatide.

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XTalks

FEBRUARY 14, 2024

This episode features an interview with Yang Liu, PhD, founder, chairman, CEO and chief scientific officer; and Abid Ansari, MBA, Chief Financial Officer at OncoC4 , a clinical-stage biopharmaceutical company focused on developing novel treatments for cancer. This includes first-in-class immunotherapy products such as novel antibodies and CAR T-cell treatments targeting CTLA-4.

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Life Science DNA Production Clinical Trials 119

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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

Pharmaceutical Technology

FEBRUARY 14, 2024

BioAge Labs has secured $170m in an Series D funding round to progress the development of therapeutics for obesity and metabolic diseases.

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Development 130

pharmaphorum

FEBRUARY 14, 2024

Discover how artificial intelligence (AI) is revolutionising the drug development process and transforming the way FDA-approved drugs are produced, ensuring compliance and optimising the supply chain. Learn more about the future of AI in pharmaceuticals.

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Development FDA Approval Drugs Compliance 118

Pharmaceutical Technology

FEBRUARY 14, 2024

Ipsen reported that the US FDA approved the Onivyde regimen (NALIRIFOX) as a first-line treatment for metastatic pancreatic cancer.

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FDA Approval 130

Fierce Pharma

FEBRUARY 14, 2024

FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic fkansteiner Wed, 02/14/2024 - 05:10

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Sales Manufacturing 112

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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

Pharmaceutical Technology

FEBRUARY 14, 2024

Sudo Biosciences secured $30m in second round of Series B funding to further the development of TYK2 inhibitors into the clinic.

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Development 130

Fierce Pharma

FEBRUARY 14, 2024

Over the last month, for those watching HBO’s macabre “True Detective Night Country”—a TV series set in a harsh, sunless winter in a fictional Alaskan town—a continual theme is frostbite. | The FDA has approved the first medicine for severe frostbite. The U.S. regulator has signed off on Johnson & Johnson’s Aurlumyn (iloprost), an injected treatment to reduce the risk of amputation of the fingers or toes.

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FDA Approval Regulation Medicine 105

Pharmaceutical Technology

FEBRUARY 14, 2024

The partnership will focus on designing molecular glues for unspecified therapeutic targets.

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Drugs 147

BioPharma Reporter

FEBRUARY 14, 2024

Stella Vnook, a seasoned veteran in the pharmaceutical industry with extensive experience in senior leadership roles at Catalent, Merck, and Diverse Biotech, has been a prominent figure in the field, particularly in oncology, for over 25 years.

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Development 105

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Clinical Supply

Pharmaceutical Technology

FEBRUARY 14, 2024

Grifols’ Phase III AdFIrst trial met its primary endpoint and the company plans to file for approval in Q4 2024.

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FDA Approval Trials 130

pharmaphorum

FEBRUARY 14, 2024

Ipsen has won FDA approval for first-line use of its pancreatic cancer therapy Onivyde, saying it is now part of a potential new “standard-of-care” for patients

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FDA Approval 96

Fierce Pharma

FEBRUARY 14, 2024

With another quarter exceeding analysts’ expectations, Blueprint Medicines has raised its peak sales estimate for rare disease drug Ayvakit to $2 billion. | With another quarter exceeding analysts’ expectations, Blueprint Medicines has raised its peak sales estimate for rare disease drug Ayvakit to $2 billion.

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Sales Medicine Drugs 90

Pharma Times

FEBRUARY 14, 2024

The report includes five recommendations for the government to address these issues

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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

Fierce Pharma

FEBRUARY 14, 2024

Biogen’s business has been in decline thanks to fierce multiple sclerosis competition and a botched Alzheimer’s drug launch. To make matters worse, the U.S. | Biogen’s business has been in decline thanks to fierce multiple sclerosis competition and a botched Alzheimer’s drug launch. To make matters worse, the U.S. Department of Justice is looking into the company’s foreign operations.

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Sales Drugs 83

pharmaphorum

FEBRUARY 14, 2024

Eicos Sciences' Aurlumyn has become the first FDA-approved drug treatment to prevent amputations in cases of severe frostbite

FDA Approval 94

FDA Approval Drugs 94

Fierce Pharma

FEBRUARY 14, 2024

Even as Australia’s CSL continues to grow, the company’s ambitions for its kidney disease and iron deficiency outfit Vifor Pharma—now known as CSL Vifor—have become more muted. | Even as Australia’s CSL continues to grow, the company’s ambitions for its kidney disease and iron deficiency outfit Vifor Pharma—now known as CSL Vifor—have become more muted.

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ACRP blog

FEBRUARY 14, 2024

Now is the time to keep all stakeholders engaged in DEI in clinical research A Q&A with Gilead’s Stacey Bledsoe, MSN, conducted by ACRP Executive Director Susan Landis This will be a critical year for professionals throughout the clinical research enterprise to build on the momentum gained in 2023 for improving diversity, equity, and inclusion (DEI)—not just among the volunteer participants in clinical trials, but also among all other stakeholders in their design, management, and results.

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Clinical Trials Clinical Trials Clinical Research Trials 64

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Clinical Supply