Drug Target Review

AUGUST 28, 2024

Once a patient develops advanced cirrhosis/end-stage liver disease there are no specific therapies to significantly avoid major decompensations and death in the next few years. Could you describe the platform of macrophage biology and cell engineering used by Resolution Therapeutics in developing their cell therapies?

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Fierce BioTech

SEPTEMBER 5, 2024

Overcoming drug development hurdles with phase-appropriate technology transfers Discover how phase-appropriate technology transfers can help you overcome regulatory challenges, reduce costs, and accelerate your path to commercialization. Learn strategies to maximize efficiency and focus on what you do best—innovating new therapies.

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PPD

OCTOBER 17, 2024

Cell and gene therapy (CGT) studies are rapidly gaining momentum in the Asia-Pacific region, fueled by growing patient demand and a thriving ecosystem of innovation. In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches.

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Conversations in Drug Development Trends

NOVEMBER 12, 2024

By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. Below, we discuss some of these challenges in cell therapy trials.

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Drug Target Review

JULY 18, 2024

Why is detecting cancers via liquid biopsy before they become visible on imaging important for drug development, not just diagnostics? We believe liquid biopsy is very helpful for oncology drug development because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.

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Codon

FEBRUARY 13, 2024

Tom Ireland writes about the companies and technologies that are reimagining phage therapy. Soon after its publication, scientists, journalists, and investors were revisiting ‘phage therapy’ as a promising alternative to our failing antibiotics. Nearly three million drug-resistant infections occur annually in the U.S.

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DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.

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Alta Sciences

AUGUST 29, 2024

Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning.

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BioPharma Drive: Drug Pricing

SEPTEMBER 16, 2024

Applying CAR T-cell therapy in new clinical settings presents unique challenges. Worldwide Clinical Trials is at the forefront, partnering with drug development teams to map this new path forward.

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Drug Target Review

AUGUST 7, 2024

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world.

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Drug Target Review

NOVEMBER 29, 2023

Our primary focus is to design and develop RNA therapies for liver diseases. Our team of chemists then uses this information to develop novel therapies. By doing this, we get a superior understanding of which therapies will and will not work in human biology before a clinical trial.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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Drug Target Review

FEBRUARY 1, 2024

But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Historically, what has limited investor interest in funding neurological and psychiatric therapies in development?

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BioPharma Drive: Drug Pricing

JULY 16, 2024

The Merck KGaA spinout has a tau-regulating medicine it claims could be an “ideal therapy” for Alzheimer’s. The pitch has intrigued both healthcare investors and pharma venture arms.

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Broad Institute

NOVEMBER 2, 2023

Bayer and Broad Institute extend cancer therapy research collaboration By Corie Lok November 2, 2023 Breadcrumb Home Bayer and Broad Institute extend cancer therapy research collaboration Long-standing industry-academia collaboration has already resulted in three clinical oncology candidates.

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Fierce BioTech

APRIL 3, 2024

Mini-Organs, Major Breakthroughs: How Hub Organoids Are Accelerating Oncology Drug Development dwunderlin Wed, 04/03/2024 - 17:28 Tue, 05/14/2024 - 09:30 Resource Type Webinar Dr. Sylvia F. Boj Duration 60 Minutes Patient-derived organoids are viewed as the gold standard in bridging the gap between the lab and the clinic.

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FDA Law Blog: Drug Discovery

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Valentine, HPM Director.

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Drug Target Review

SEPTEMBER 1, 2023

Could you explain the fundamental distinction between autologous and allogeneic cell therapies and how they differ in terms of cell sourcing and application? Autologous immune cell therapy involves the grafting of a patient’s own immune cells. Then, cells are infused back to that same patient.” There are pros and cons to each.

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PPD

SEPTEMBER 6, 2023

Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. LEARN HOW The post How to Optimize Drug Development by Combining FSO and FSP Models appeared first on PPD Inc.

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BioPharma Drive: Drug Pricing

NOVEMBER 11, 2024

Innovation-without-borders philosophy seeks to bring forward only the most promising therapies.

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LifeSciVC

JANUARY 3, 2024

Moreover, scaffolding inhibitors demonstrated no deleterious effects on effector T cell functions or T-regulatory cell numbers, which we believe enables potential combination with CAR-T or T-cell engagers without any negative effects on those immune therapies.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). There have been challenges in gene therapy development.

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Drug Target Review

JUNE 19, 2024

The mission of Lineage Cell Therapeutics is to deliver on some of the early promises of cell therapy. Cell therapy as a concept is a wonderful idea, but many of the early efforts never generated the kind of clinical data that gets people excited and leads to new medicines. In some cases, cell therapy can be curative for the patient.

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Alta Sciences

JUNE 11, 2024

My Attendance at the 2024 Boston Society Cell and Gene Therapy Conference pmjackson Tue, 06/11/2024 - 20:49 , via Wikimedia Commons" data-entity-type="file" data-entity-uuid="c7a7fa8b-b2fe-4d84-a75e-d1ba3a4e2caf" src="[link] width="742" height="249" loading="lazy" /> Ecm85, CC BY-SA 3.0

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BioPharma Drive: Drug Pricing

JUNE 20, 2023

The deal adds to recent M&A activity as well as signals pharma’s continued interest in pills for inflammatory conditions, which are meant to approach the potency of injectable therapies.

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Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

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SCIENMAG: Medicine & Health

JUNE 14, 2023

Although effective drugs and therapies have been developed for most breast cancer subtypes, triple negative breast cancer lacks the key receptors that these drugs interact with – in other words, it’s negative for the three receptors for which […]

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FDA Law Blog: Drug Discovery

MARCH 26, 2024

Sasinowski — On March 21st, FDA announced the approval of the first nonsteroidal therapy for the treatment of Duchenne Muscular Dystrophy (DMD) (FDA press release available here ). Duvyzat (givinostat), a histone deacetylase (HDAC) inhibitor developed by Italfarmaco, S.p.A., By Charles G. Raver & James E. Valentine & Frank J.

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Alta Sciences

JULY 20, 2023

A Proactive Drug Development Solution for Your Biologics nbartlett Thu, 07/20/2023 - 15:37 HTML The process of biologic drug development, from lead molecule identification to approval, can be long and complicated. Altasciences is here to help streamline the process. Download now. Fact Sheet: Biologics/Biosimilars.

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The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

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The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. As in all nonclinical drug development programs, the goal is to identify potential safety issues in humans. Is fit-for-purpose?

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FDA Law Blog: Drug Discovery

MAY 19, 2024

aimed at identifying and characterizing the challenges in developing therapies for ultra-rare diseases and conditions that affect exceedingly small populations. By Sarah Wicks — On May 21, 2024, the EveryLife Foundation for Rare Diseases (ELF) will host a Scientific Workshop at the National Press Club in Washington, D.C.

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Fierce BioTech

OCTOBER 19, 2023

How cell and gene therapies are forcing sponsors to rethink safety and efficacy monitoring In this whitepaper, we look at how the industry is rising to the challenge, focusing on how cell and gene therapies are radically improving health outcomes and the technologies and techniques that are facilitating their development.

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Alta Sciences

APRIL 16, 2024

Inside The Altascientist: The Benefits of PCR for Your Gene Therapy Programs pmjackson Tue, 04/16/2024 - 19:04 The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines. Tags Bioanalysis Weight 15

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PPD

DECEMBER 19, 2022

PPD, Thermo Fisher Scientific ’s clinical research business, surveyed more than 150 decision-making leaders at pharmaceutical and biotech companies around the globe to collect key insights on the state of the evolving drug development industry. The opportunity to leverage new technologies in drug development (e.g.,

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Alta Sciences

MAY 15, 2023

TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY aasimakopoulos Mon, 05/15/2023 - 16:06 Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion , without, for the most part, shorter development timelines.

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