PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

Antidote

JANUARY 3, 2023

Before becoming available to patients, every medication, therapy, and intervention must undergo a rigorous approval process: the clinical trial. Clinical trials are divided into phases that are aimed at testing the safety and efficacy of every potential new treatment before it is able to enter the market.

Clinical Trials 97

Clinical Trials Trials Therapies Treatment 97

Drugs.com

SEPTEMBER 26, 2024

25, 2024 -- A new gene therapy approved earlier this year can serve as a sustainable single-dose treatment for people with hemophilia B, newly published clinical trial data shows. THURSDAY, Sept. People with hemophilia B saw their bleeding episodes.

Therapies 116

Therapies Trials Clinical Trials Treatment 116

Antidote

AUGUST 21, 2023

Before any new treatment is able to be approved, it is required to go through the vigorous testing process known as clinical trials. These trials are aimed at determining whether or not a drug, medical device, therapy, or other type of intervention is safe and effective for the public.

Clinical Trials 98

Clinical Trials Trials Therapies Treatment 98

Drugs.com

SEPTEMBER 26, 2024

25, 2024 -- A new gene therapy approved earlier this year can serve as a sustainable single-dose treatment for people with hemophilia B, newly published clinical trial data shows.People with hemophilia B saw their bleeding episodes. THURSDAY, Sept.

Therapies 98

Therapies Trials Clinical Trials Treatment 98

Conversations in Drug Development Trends

JULY 8, 2024

By: Lisle Kingery, PhD, Therapeutic Strategy Lead, Neuroscience With depression rates at an all-time high and limited new treatments available, depression clinical trials are more important than ever. DSM-5 or other standard depression clinical outcome assessment).

Clinical Trials 52

Clinical Trials Trials Treatment Therapies 52

Antidote

FEBRUARY 22, 2024

Behind every new treatment is the incredible team of doctors, researchers, patients, and clinical trial specialists who worked on the research that made it possible.

Clinical Trials 69

Clinical Trials Trials Doctors Therapies 69

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. Operationalizing these trials requires proactive and flawless management at every stage.

Therapies 72

Therapies Clinical Supply Clinical Trials Molecular Biology 72

PPD

AUGUST 7, 2024

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

Drug Target Review

FEBRUARY 21, 2024

Stem cell transplants have saved patients’ lives time and time again, which led us to launch our own Stem Cell Transplant and Cellular Therapy Program. Regarding CAR-T cell therapy, could you highlight the promising findings that have been identified in the early stages of drug discovery, as well as potential challenges?

Therapies 64

Therapies Treatment Vaccine FDA Approval 64

Vial

JUNE 18, 2024

The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Patients underlined the need for transparency by pharma and other related companies to build trust and partnership.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Clinical Development 69

Clinical Development Production Clinical Trials Treatment 69

Antidote

AUGUST 29, 2022

In the world of medical research, experts are constantly looking for new drugs, treatments, and therapies for a variety of conditions — but the process of getting these treatments approved is only possible if they are tested through clinical trials.

Clinical Trials 98

Clinical Trials Trials Therapies Treatment 98

Drug Target Review

FEBRUARY 9, 2024

What key findings about stem cell behaviour, differentiation and integration within host tissues impact the development of stem cell therapies? Despite their potential, ADSC therapy faces several challenges in preclinical studies. Is there a certain disease or condition that you believe stem cell therapy holds the most promise for?

Therapies 105

Therapies Immune Response Clinical Trials Treatment 105

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

PLOS: DNA Science

MARCH 21, 2024

The Food and Drug Administration just announced approval of Lenmeldy (atidarsagene autotemcel), a gene therapy to treat the neurological condition metachromatic leukodystrophy (MLD). million price tag for the one-time infusion, and for the older siblings who contributed to developing the gene treatment, but were too sick to receive it.

Therapies 98

Therapies Clinical Trials DNA Trials 98

Broad Institute

JUNE 27, 2024

Science (2024) Related content New gene delivery vehicle shows promise for human brain gene therapy My Quest to Cure Prion Disease — Before It’s Too Late | Sonia Vallabh | TED Prion diseases lead to rapid neurodegeneration and death and are caused by misshapen versions of the prion protein in the brain. Credit: Neumann EN, Bertozzi TM, et al.

Disease 142

Disease Therapies Engineering Clinical Trials 142

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. Read it on our website here. Illustration by David S. Fast forward to 2023.

Therapies 120

Therapies DNA Virus Clinical Trials 120

Drug Target Review

OCTOBER 2, 2024

Cell and gene therapies (CGTs) have made significant advancements in treating oncological diseases, with therapies like CAR-T cell treatments transforming cancer care. However, cell-based therapies are intended to leverage those healthy cells via transplant to regenerate damaged tissue.

Therapies 98

Therapies Disease Engineering RNA 98

Alta Sciences

JUNE 27, 2023

Cancer Treatments, Clinical Trials, and the Motivation to Innovate nbartlett Tue, 06/27/2023 - 20:58 Getting to the Heart of Science with Michelle Newby At the heart of science are stories—stories of courage, challenges, successes, lessons, and people. Q: What was your cancer diagnosis and was treatment options were you given?

Clinical Trials 40

Clinical Trials Trials Treatment Science 40

PPD

SEPTEMBER 7, 2023

For more than 40 years, drug developers have been dedicated to advancing HIV clinical research in the quest for treatments and, ultimately, a cure. Though there has been considerable progress in treatment options, 39 million people across the globe are infected with HIV, with an estimated 1.3 million new infections in 2022.

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

Antidote

MAY 22, 2023

Participating in a clinical trial can be a worthwhile opportunity for any individual.

Clinical Trials 98

Clinical Trials Trials Therapies Treatment 98

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

Drug Target Review

JULY 3, 2023

Dr David Baram from gene therapy company EmendoBio provides a snapshot of the history of therapeutic genetic engineering, explaining the early pitfalls and reasons for recent renewed optimism.

Therapies 98

Therapies Clinical Trials DNA Engineering 98

Antidote

MAY 1, 2023

Clinical trials are crucial to advancing medical breakthroughs and bringing new therapies or treatments to market. Unfortunately, many clinical trials are not designed with a patient-centered approach. However, for research studies to be effective, it is vital that patients take part.

Clinical Trials 52

Clinical Trials Trials Therapies Treatment 52

thought leadership

JUNE 18, 2024

Over three decades of gene therapy (GT) clinical trials have yielded many innovative and promising treatments for pernicious genetic disorders but industry has shown slow development and dashed expectations.

Therapies 52

Therapies Clinical Trials Treatment Trials 52

Advarra

JUNE 13, 2024

Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their use is becoming increasingly common in clinical trials. Clinical personnel need to understand these risks and how risks are differentiated between healthy and vulnerable individuals.

Clinical Trials 52

Clinical Trials Engineering Trials Virus 52

SCIENMAG: Medicine & Health

JUNE 15, 2023

A new therapy is on the horizon for patients with metastatic colorectal cancer who have run out of treatment options. Credit: Vanderbilt University Medical Center A new therapy is on the horizon for patients with metastatic colorectal cancer who have run out of treatment options.

Treatment 83

Treatment Clinical Trials Therapies International 83

Alta Sciences

SEPTEMBER 27, 2024

Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials. Each class of immunomodulator has a defined complexity and mechanism of action.

Clinical Trials 52

Clinical Trials Trials Pharmacokinetics Small Molecule 52

Drugs.com

SEPTEMBER 26, 2024

25, 2024 -- A new gene therapy approved earlier this year can serve as a sustainable single-dose treatment for people with hemophilia B, newly published clinical trial data shows. THURSDAY, Sept. People with hemophilia B saw their bleeding episodes.

Therapies 52

Therapies Trials Clinical Trials Treatment 52

BioPharma Drive: Drug Pricing

JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

FDA 132

FDA FDA Approval Clinical Trials Therapies 132

Antidote

MARCH 17, 2023

Before any new medication, therapy, or treatment is put onto the market, it must first be approved by the Food and Drug Administration. Part of this approval process is thorough testing through clinical trials to ensure that any therapy is safe and effective before it is released to the general public.

Clinical Trials 52

Clinical Trials Trials Therapies Treatment 52

Drug Target Review

NOVEMBER 17, 2023

They do not induce ‘graft versus host’ disease when transplanted for allogeneic therapy and there appears little sign of immune rejection. Peripheral blood NK cells have been used in allogeneic cancer therapies and shown to be safe. Only three of the CAR-NK studies were for the treatment of solid tumours.

Therapies 118

Therapies Cell Biology Clinical Trials Trials 118

PPD

JUNE 29, 2023

Although several corticosteroid treatments are available as first-line treatments, drug developers continue to seek more effective therapies to improve the wellbeing of those diagnosed with atopic dermatitis. But developing treatments for atopic dermatitis is complex and competitive.

Clinical Trials 52

Clinical Trials Trials Drug Development Clinical Research 52

Drug Target Review

MARCH 7, 2024

1 Although pancreatic cancer is rarer than the abovementioned cancers, it claims over 50,000 lives each year in the United States because of a lack of effective treatments. Since then, two therapies have been approved for use in lung and breast cancer but it did not advance pancreatic cancer treatment.

Treatment 98

Treatment Therapies Clinical Trials Research 98

Fierce BioTech

NOVEMBER 17, 2024

How Does Imaging Support the Development of New Therapeutics Antibody-drug conjugates (ADCs) and radioisotope therapies (RITs) offer targeted therapies that effectively attack tumor cells while minimizing harm to surrounding healthy tissue. However, getting the design of ADC and RIT trials right is critical.

Clinical Trials 59

Clinical Trials Therapies Trials Treatment 59

Drug Target Review

JANUARY 15, 2024

Could you provide insights into the driving factors behind exploring novel treatments for cancer types? Could you provide further details on how this phenomenon could impact broader treatment outcomes? Immunotherapy has become a cornerstone of cancer therapy and significantly improved patient outcomes.

Treatment 105

Treatment Immune Response Therapies Clinical Trials 105