Thu.Mar 28, 2024

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March 28, 2024: Health Equity Core Provides Reference for Equitable Language in Pragmatic Trials

Rethinking Clinical Trials

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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Gilead bets on Xilio cancer drug as biotech restructures

Bio Pharma Dive

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 285
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Nanoscope Therapeutics exhibits positive top-line Phase IIb results for MCO-010

Pharmaceutical Technology

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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FDA approves Akebia anemia pill, two years after rejection

Bio Pharma Dive

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.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Measles cases continue to rise in US amid lagging vaccination rates

Pharmaceutical Technology

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

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Biotech veteran Art Krieg postpones retirement to build an unorthodox drug startup

Bio Pharma Dive

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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‘The heart is back,’ says Cardior CEO, as Novo’s $1B deal boosts field

Bio Pharma Dive

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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4D Molecular Therapeutics gets grant for recombinant aav for muscle cell infectivity with heterologous peptide

Pharmaceutical Technology

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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Intelligence officials warned lawmakers WuXi AppTec furnished China with client's intellectual property: Reuters

Fierce Pharma

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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CRISPR drug licensing deals secure $21bn in top three therapy areas over five years

Pharmaceutical Technology

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.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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What Lonza’s $1.2B Buy of Roche Biologics Plant Means for CDMO Market

BioSpace

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.

Marketing 115
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Lantern Pharma gets grant for treatment of atypical teratoid/rhabdoid tumor using hydroxyureamethyl acylfulvene

Pharmaceutical Technology

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.

Gene 130
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The IRA, Medicare and the High Costs of GLP-1 Drugs Like Wegovy

BioSpace

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.

Drugs 122
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Pieris Pharmaceuticals gets grant for patent granted for novel muteins derived from human lipocalin

Pharmaceutical Technology

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.

Research 130
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Avalo Snags Former Eli Lilly Asset and $185M in Major Pipeline Pivot

BioSpace

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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Spruce Biosciences gets grant for treatment of polycystic ovary syndrome with adrenal hyperandrogenism

Pharmaceutical Technology

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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BMS’ Zeposia Fails to Meet Primary Endpoint in Phase III Crohn’s Trial

BioSpace

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.

Trials 110
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Atea Pharmaceuticals gets grant for treatment of covid-19 using purine nucleotide phosphoramidates

Pharmaceutical Technology

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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The New Age of Decentralized Clinical Trials

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.

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Highlighting the disruptors: Innovation for now and tomorrow at WIRED Health 2024, Part One

pharmaphorum

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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Abivax gets grant for antitumor pharmaceutical combination for cancer treatment

Pharmaceutical Technology

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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Gilead Wins Label Expansion for Vemlidy to Treat Hepatitis B Virus in Kids

BioSpace

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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Synlogic gets grant for genetically engineered bacteria for treating phenylketonuria

Pharmaceutical Technology

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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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Johnson & Johnson gets a new opportunity to contest science in talc litigation

Fierce Pharma

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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OSE Immunotherapeutics gets grant for anti-human SIRPA antibody for treating cancer

Pharmaceutical Technology

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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FDA Extends Review Period for Applied Therapeutics’ Govorestat by Three Months

BioSpace

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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Cidara Therapeutics gets grant for conjugates for treating viral infections

Pharmaceutical Technology

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

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Strand Therapeutics develops new class of mRNA molecules for cancer

Pharma Times

The self-replicating mRNA molecule could be used in cancer and potentially a broad range of other diseases

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Cheap drugs, inspections, and a future war in Europe – what’s driving drug shortages?

Pharmaceutical Technology

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

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Italfarmaco’s Duvyzat Wins FDA Approval as First Nonsteroidal Treatment for All Genetic Variants of DMD

XTalks

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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Japan approves AstraZeneca’s Truqap with Faslodex for breast cancer

Pharmaceutical Technology

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 New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.