Rethinking Clinical Trials

MARCH 28, 2024

Dr. Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. The Equitable Language Cheat Sheet is available on the Health Equity Core webpage and will be updated as terminology and guidance evolves.

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Trials Nurses Clinical Trials Clinical Trials 215

Bio Pharma Dive

MARCH 28, 2024

Xilio will get just over $40 million from Gilead in return for a license to its experimental IL-12 immunotherapy. The biotech is also discontinuing other work and laying off staff.

Licensing 280

Licensing Licensing Drugs 280

Pharmaceutical Technology

MARCH 28, 2024

Nanoscope Therapeutics released promising top-line results for its RESTORE trial, which is studying the gene therapy MCO-010 in patients with retinitis pigmentosa (RP).

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Gene Therapy Gene Trials 246

Bio Pharma Dive

MARCH 28, 2024

The agency gave Akebia’s drug an OK after receiving more safety data, but imposed a strict boxed warning for its use that may limit uptake.

FDA Approval 273

FDA Approval Drugs 273

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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

MARCH 28, 2024

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

Vaccination 284

Vaccination Vaccine 284

Bio Pharma Dive

MARCH 28, 2024

With Zola Therapeutics, Krieg plans to design and sell a series of cancer immunotherapies without the help of outside investors, he told BioPharma Dive.

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Drugs 177

Bio Pharma Dive

MARCH 28, 2024

Novo Nordisk’s acquisition of Cardior Pharmaceuticals is a bet on new approaches to cardiovascular disease, says Cardior head Claudia Ulbrich.

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Pharmaceutical Technology

MARCH 28, 2024

Discover how 4D Molecular Therapeutics Inc's patented variant AAV capsid proteins enhance muscle cell infectivity for gene therapy, revolutionizing treatment for genetic disorders.

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Gene Therapy Genetics Protein Gene 130

Fierce Pharma

MARCH 28, 2024

An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. | An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. suggests intelligence officials and lawmakers may have good reason to be concerned about the CDMO’s potential political ties to its home country.

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Development 129

Pharmaceutical Technology

MARCH 28, 2024

Licensing agreements for innovator drugs utilising clustered regularly interspaced short palindromic repeats (CRISPR) technologies saw oncology, immunology, and central nervous system as the top three therapy areas by total deal value with a combined $21bn over the past five years.

Licensing 130

Licensing Licensing Drugs 130

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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

BioSpace

MARCH 28, 2024

The Swiss contract manufacturer’s cash deal for Roche’s Genentech facility in Vacaville, California, is one of the world’s largest manufacturing sites for biologics—a major growth driver for Lonza and other CDMOs.

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Marketing Manufacturing 113

Pharmaceutical Technology

MARCH 28, 2024

Discover a groundbreaking patent for treating atypical teratoid/rhabdoid tumors with HydroxyUreaMethyl Acylfulvene. Learn how this method targets SMARCB1 gene alterations and enhances efficacy with radiation therapy. Explore the potential of this innovative treatment option today.

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Gene 130

BioSpace

MARCH 28, 2024

Avalo Therapeutics rolled the dice on a big pivot Wednesday, acquiring AlmataBio and focusing on the biotech’s ex-Eli Lilly hidradenitis suppurativa candidate over its existing assets.

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Pharmaceutical Technology

MARCH 28, 2024

Discover the groundbreaking patent by Pieris Pharmaceuticals Inc for novel muteins derived from human lipocalin 2, targeting Alzheimer's disease and tumor neovasculature. Explore the potential of these muteins in diagnostics, therapeutics, and research.

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Research 130

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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

Fierce Pharma

MARCH 28, 2024

Johnson & Johnson will get a do-over in its defense against more than 50,000 lawsuits that claim the company’s iconic baby powder can cause ovarian cancer. | Johnson & Johnson will get a do-over in its defense against more than 50,000 lawsuits claiming that the company’s iconic baby powder can cause ovarian cancer. A New Jersey court ruled on Wednesday that J&J can contest the scientific findings that back those cases.

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Pharmaceutical Technology

MARCH 28, 2024

Discover a groundbreaking method for treating PCOS-FAH with a CRF1 antagonist, targeting adrenal androgens to alleviate symptoms like hirsutism and infertility. Patent US11858932B2 offers new compounds and effective management strategies.

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pharmaphorum

MARCH 28, 2024

Explore the cutting-edge innovations featured at WIRED Health 2024, including insights on Alphafold, clean air technology, and Lingo. Stay informed about the latest disruptors shaping the future.

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Pharmaceutical Technology

MARCH 28, 2024

Discover the groundbreaking patent by Atea Pharmaceuticals for treating COVID-19 with purine nucleotide phosphoramidates. Learn about the compound's specific configurations and dosing regimens for optimal efficacy.

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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

BioSpace

MARCH 28, 2024

Sanders says he wants Novo Nordisk to “do the right thing” and lower the costs of Ozempic and Wegovy. But only the Inflation Reduction Act can achieve that.

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Drugs 119

Pharmaceutical Technology

MARCH 28, 2024

Discover the groundbreaking patent by Abivax SA for an antitumor pharmaceutical combination involving compound ABX196 and chemotherapeutic or immunotherapeutic agents. Revolutionizing cancer treatment for improved patient outcomes.

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BioSpace

MARCH 28, 2024

Data from a late-stage study showed that Bristol Myers Squibb’s Zeposia (ozanimod) was unable to significantly improve clinical remission in adult patients with moderate to severe active Crohn’s disease.

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Trials 111

Pharmaceutical Technology

MARCH 28, 2024

Discover how Synlogic Inc's patented genetically programmed microorganisms can modulate and treat diseases. Learn about the innovative method for producing pharmaceutical compositions using non-pathogenic bacteria to metabolize phenylalanine. Explore the potential applications in gut microbiome and tumor environments.

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Genetic Engineering Bacteria Genetics Engineer 130

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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

BioSpace

MARCH 28, 2024

Gilead Sciences’ Vemlidy on Thursday secured a label expansion from the FDA, allowing the antiviral drug’s use to treat chronic hepatitis B in pediatric patients aged six years and older.

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Pharmaceutical Technology

MARCH 28, 2024

Revolutionize cancer treatment with OSE Immunotherapeutics' patented anti-SIRPa antibodies targeting human SIRPa for enhanced T cell response and antigen presentation. Discover a comprehensive approach to treating various cancers with innovative combination therapies.

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Antibody 130

BioSpace

MARCH 28, 2024

Citing the need for more time to review a major amendment, the FDA is pushing the target action date for the investigational aldose reductase inhibitor in the treatment of classic galactosemia to Nov. 28, 2024.

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Pharmaceutical Technology

MARCH 28, 2024

Discover how Cidara Therapeutics' patented conjugates can revolutionize the treatment of viral infections, specifically influenza, with innovative compositions and methods.

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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

XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. Duvyzat, a histone deacetylase (HDAC) inhibitor that works to reduce inflammation and muscle loss, is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD.

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FDA Approval Genetics Gene Therapy Gene 105

Pharmaceutical Technology

MARCH 28, 2024

Drug shortages are worsening globally, leaving patients without access to essential medications, and healthcare providers struggling to find alternative treatments.

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Drugs 130

XTalks

MARCH 28, 2024

In recent years, the food industry has faced growing scrutiny over its environmental impact, particularly concerning the use of plastic packaging. This scrutiny has sparked significant interest and investment in alternative packaging solutions, with edible food packaging emerging as a particularly innovative and sustainable option. In this episode of the Xtalks Food Podcast, Sydney talks about the rise of edible food packaging and the technologies and types of edible packaging available.

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Packaging Packaging Production Development 105

Pharmaceutical Technology

MARCH 28, 2024

The Japanese MHLW has approved AstraZeneca's Truqap (capivasertib) plus Faslodex (fulvestrant) for treating a specific type of breast cancer.

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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Clinical Trials