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.

Drug Development 52

Drug Development Drugs Therapies Marketing 52

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.

Drug Development 59

Drug Development Clinical Trials Drugs Vaccine 59

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.

Drug Development 74

Drug Development Clinical Trials Drugs Therapies 74

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.

Drug Development 52

Drug Development Small Molecule Clinical Trials Drugs 52

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.

Drug Development 59

Drug Development Clinical Pharmacology Clinical Trials Packaging 59

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?

Therapies 114

Therapies Disease Engineering Medical Schools 114

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.

Drug Development 52

Drug Development Treatment FDA Approval Therapies 52

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.

Therapies 52

Therapies Clinical Trials Clinical Research Trials 52

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.

Drug Development 52

Drug Development Molecular Biology Compliance Clinical Trials 52

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.

Therapies 120

Therapies DNA Virus Clinical Trials 120

LifeSciVC

JANUARY 3, 2024

There is clear precedent for such a complex-directed therapeutic approach in drug discovery. At HotSpot, we believe our proprietary Smart Allostery TM drug discovery platform affords us a unique understanding of how nature controls proteins through signaling pathways, including at the intricacies of complex formation.

Drug Development 91

Drug Development Drugs Small Molecule Disease 91

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.

Drug Development 52

Drug Development Drugs Therapies Treatment 52

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.

Drug Development 98

Drug Development Clinical Trials Drugs Clinical Research 98

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.

Drug Development 75

Drug Development Regulations Therapies Drugs 75

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.

Therapies 72

Therapies Clinical Supply Clinical Trials Molecular Biology 72

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 […]

Drug Development 87

Drug Development Drugs Therapies Science 87

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.

Therapies 52

Therapies Trials Clinical Trials Drug Development 52

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.

Therapies 102

Therapies Disease RNA Engineering 102

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. Not failed drugs, but failed studies. As soon as drug developers can begin to develop conviction, momentum increases.

Therapies 104

Therapies Drug Development Disease Clinical Development 104

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.

Therapies 105

Therapies Research Small Molecule Clinical Trials 105

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. The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases.

Drug Development 52

Drug Development Disease Therapies Engineering 52

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.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

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.

Therapies 105

Therapies Engineering Production Clinical Trials 105

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.

Therapies 98

Therapies Trials FDA Clinical Trials 98

BioPharma Drive: Drug Pricing

NOVEMBER 11, 2024

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

Drug Development 52

Drug Development Disease Therapies Drugs 52

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.

Drug Development 40

Drug Development Biosimilars Drugs Therapies 40

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.

Drug Development 95

Drug Development Therapies Drugs 95

ASPET

OCTOBER 12, 2023

To maintain cadence with looming threats in a prolonged field care environment, the broader medical countermeasure (MCM) enterprise must adopt new strategies for CBRN-addressing drug development. CBRN MCMs).

Therapies 100

Therapies Licensing Licensing FDA Approval 100

BioPharma Drive: Drug Pricing

APRIL 10, 2024

The biotech is working on a preventive therapy for the immune disorder, known as FNAIT for short, while J&J is studying its drug nipocalimab as a treatment.

Drug Development 60

Drug Development Drugs Therapies Treatment 60

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.,

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

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.

Drug Development 52

Drug Development Clinical Trials Compounding Pharmacies Laboratories 52

NIH Director's Blog: Drug Development

SEPTEMBER 27, 2022

But this “bandage” actually contains an ultra-sensitive, battery-operated sensor that’s activated when placed on the skin of mouse models used to study possible new cancer drugs. The researchers are continuing to test their sensor in more cancer models and with more therapies to extend these initial findings.

Drug Development 52

Drug Development Drugs Engineering Therapies 52

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

Therapies 52

Therapies Molecular Biology Immune Response Science 52

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.

FDA Approval 59

FDA Approval Therapies FDA Trials 59

The Pharma Data

MARCH 20, 2021

Precision imaging analytics technology known as radiomics will see increased adoption in 2021 and will be incorporated into drug development strategies and clinical trials management, according to Rose Higgins, CEO of HealthMyne.

Clinical Trials 52

Clinical Trials Drug Development Trials Drugs 52

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.

Therapies 84

Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

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.

Disease 59

Disease Therapies Drug Development FDA 59