BioPharma Drive: Drug Pricing

JULY 17, 2023

The results come about two years after negative findings from an earlier phase of the study, and position the company to seek an approval in transthyretin amyloidosis cardiomyopathy.

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BioPharma Drive: Drug Pricing

DECEMBER 9, 2023

Study results disclosed at the American Society of Hematology meeting Saturday suggested potential for cell therapy in lupus and pointed out drug trial limitations.

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Drugs.com

SEPTEMBER 22, 2023

22, 2023 – New research suggests some newer diabetes treatments may not be as beneficial for Black patients, after earlier drug trials included small numbers of non-white people. FRIDAY, Sept. Whether the medications -- called sodium-glucose.

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Drug Discovery World

NOVEMBER 29, 2023

“The most important benefit is that we now have an accurate model that we can use to perform virtual experiments with different types of interventions, quickly and digitally.”

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Drug Discovery World

JUNE 20, 2024

Read More: UK research partners team up to accelerate MND drug discovery Drug trial targets the blood brain barrier In April, Axoltis Pharma received authorisation from ANSM, the French agency for the safety of health products, to launch the SEALS study for ALS, the most common form of MND.

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Drug Discovery World

NOVEMBER 3, 2023

First spaceflight mission for drug development lab Redwire will launch its in-space pharmaceutical manufacturing platform, PIL-BOX, onboard SpaceX’s 29th cargo resupply services mission (SpaceX-29) for NASA to the International Space Station (ISS).

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The Pharma Data

JANUARY 20, 2021

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

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Drug Discovery World

JUNE 9, 2023

FDA announces additional steps to modernise clinical trials The US Food and Drug Administration has published draft guidance with updated recommendations for good clinical practices (GCPs) to modernise the design and conduct of clinical trials.

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The Pharma Data

OCTOBER 26, 2020

based aTyr Pharma has finalized enrollment for a phase 2 trial to evaluate an investigational anti-inflammatory drug in COVID-19 patients with severe respiratory complications. San Diego, Calif.-based ATYR1923 is meant to reduce inflammation and restore the lung’s immune balance.

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The Pharma Data

DECEMBER 8, 2020

The FDA has issued a clinical hold on Bellicum Pharmaceuticals for its ongoing phase 1/2 trial evaluating CAR-T therapy BPX-601 in patients who received prior treatment for metastatic pancreatic or prostate cancer, following the death of a trial participant. The Houston, Tex.,

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Drug Discovery World

FEBRUARY 10, 2023

Clinical drug trials have made the headlines this week, as it was revealed that breast cancer still tops the bill for number of clinical studies and the shortcomings in current methods to ensure representation of patient populations in trials were exposed.

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Drug Discovery World

MAY 3, 2023

Official comments “Measuring endothelial dysfunction with the EndoPAT technology in drug trials is a cost-effective and robust method for early documentation of proof-of-concept in pulmonary, renal and vascular diseases” says Elin Rosendahl, VP Clinical Operations, Vicore Pharma.

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Drug Discovery World

FEBRUARY 20, 2023

While changes to how clinical trials are conducted and trial data is managed are likely in 2023 and going forward, and we can expect less attention on Covid-19, it is a safe bet that oncology will remain an area of focus for many companies. The post What are the top disease areas for clinical drug trials?

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Drug Discovery World

NOVEMBER 3, 2023

The post Psychedelic depression drug trial shows rapid and robust response appeared first on Drug Discovery World (DDW).

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Drug Discovery World

MAY 21, 2024

In contrast, machine learning can facilitate epitope-specific design: directing the algorithm towards favourable epitopes that elicit favourable biological responses, which may improve the prospects for the antibody in drug trials. These targets, along with many others, are universally deemed as ‘difficult-to-drug’ targets.

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Drug Discovery World

NOVEMBER 7, 2022

Receiving a genetic diagnosis is important as it allows patients to receive access to family planning, specialised IVF, and drugs trials. It can also permit targeted screening of known disease complications and access to drug studies.

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The Pharma Data

NOVEMBER 30, 2020

Sponsors of drug trials should determine what effect the use of acid-reducing agents (ARA), such as antacids, proton pump inhibitors and histamine blockers, could have on the solubility of an orally administered drug, according to a new FDA draft guidance released Monday.

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Drug Discovery World

OCTOBER 2, 2023

These advances are seen in many indications of imaging as it relates to drug trials – oncological, cardiovascular, metabolic, NASH, musculoskeletal and other. Advancements in AI 2,3,4 now allow radiologists and readers to save precious time during interpretation and post-processing while delivering more endpoint-relevant biomarkers.

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Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023.

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Drug Discovery World

MARCH 7, 2023

She founded Neuroute in 2019, with the aim of empowering patients from diverse backgrounds to participate in drug trials. Ng studied Neuroscience at University College London and Imperial College London, followed by a stint in academic research in the biotech sector.

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Advarra

AUGUST 16, 2022

That is part of the responsibility of the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Department for Health and Human Services (DHHS), prepared guidance on expedited programs for sponsors of orphan drug trials. These centers, in conjunction with the FDA and U.S.

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Conversations in Drug Development Trends

NOVEMBER 3, 2022

Looking to diversify the reach of your orphan drug trial? Reach out to learn how Worldwide Clinical Trials can help. The post What the FDA’s guidance on diversity means for rare disease sponsors appeared first on Worldwide Clinical Trials. Originally published in BioPharma Dive on October 31st, 2022.

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Advarra

MARCH 21, 2023

These products will require clinical trial data to get to market, but with significantly fewer participants required as compared to a drug trial. Class 3: Applied to products with the highest risk, or to Class 2 products that are the first in their category. Think of the intent or purpose for the intended use (e.g.,

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The Open Targets Blog

OCTOBER 31, 2023

[ Deanne Taylor , lead Principal Investigator of MTP] In the US, formal clinical trials are required to establish the safety and utility of those treatments in pediatric cancers. Despite the evidence that pediatric cancers could benefit from the same drugs used to treat adult cancers, drug trials are much rarer in children than adults. To

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Advarra

JUNE 27, 2023

Some Phase I trials are also first-in-human (FIH) studies, meaning the treatment has not previously been tested in people.

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PPD

MARCH 28, 2024

Furthermore, partnering with a CRO can bend the cost and time curve of drug trials, a critical factor for investors seeking returns on their capital. This assurance reduces executional risk and provides investors with a clear path to understanding how their investment will be used to test hypotheses efficiently.

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The Pharma Data

NOVEMBER 10, 2020

This is encouraging as a pharmacodynamic biomarker in larger trials,” Dage said. The assay is being explored for applications in clinical research, including new drug trials, based on its capability to identify patients with Alzheimer’s disease and also to predict their risk of progression.

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Codon

JANUARY 21, 2024

In some cases, I’d argue that a malaria challenge trial is safer than a typical oncology phase 1 drug trial, where you're taking people who don't have cancer and testing the safety of a drug that has maybe been tested in mice but has never been used in humans. What is your pitch for them?

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The Pharma Data

AUGUST 16, 2020

Exploring the fact that drug trials predominantly involve white, male participants, and looking at how this may lead to inaccurate and harmful prescribing for other patients. Teaching on the history of medicine, including the exploitation of people of colour in scientific research.

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Agency IQ

MARCH 29, 2024

Andrews, Oxford, the British Medical Journal Medicine products pending European Commission decision following CHMP opinion Below are the drug or biologic products for which decisions are expected to occur within the next two months, according to AgencyIQ’s review of opinions from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

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Drug Target Review

SEPTEMBER 19, 2023

Human In Silico Drug Trials Demonstrate Higher Accuracy than Animal Models in Predicting Clinical Pro-Arrhythmic Cardiotoxicity. Functional patient-derived organoid screenings identify MCLA-158 as a therapeutic EGFR × LGR5 bispecific antibody with efficacy in epithelial tumors. Nature Cancer. 2022;3(4):418-36. Frontiers in Physiology.

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Drug Discovery World

JANUARY 17, 2024

Moreover, NGS testing is being used in three main clinical circumstances, including: (i) the determination of patient eligibility for clinical trials, (ii) for guiding advanced refractory disease treatment when first line treatments have failed, and (iii) for off-label use of FDA-approved drugs.

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Drug Target Review

NOVEMBER 30, 2023

We are the only company in the world including this population in any Alzheimer’s drug trial, and we are very proud of this! Too few people know that Alzheimer’s-like characteristics develop in more than 98 percent of people with Down syndrome over age 40. COVID-19 has shown the revolutionary impact of vaccines.

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Drug Discovery World

OCTOBER 6, 2022

Before drugs make it to market they have to pass through a gauntlet of stages involved in clinical trials. As such, patient selection for clinical trials has become an increasingly critical consideration for drug trial success.

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Agency IQ

MAY 3, 2024

.: Hands-on training course Webinar/ Seminar ( OPEN ) EMA 5/14/2024 5/14/2024 From paper to digital leaflets: making patient information more inclusive Webinar/ Seminar ( OPEN ) Association of the European Self-Care Industry (AESGP) 5/14/2024 5/14/2024 Changes in the area of DiGA due to the Digital Act Webinar/ Seminar ( OPEN Germany’s Federal Institute (..)

Regulations 40

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Codon

MARCH 14, 2023

The FDA used to require animal tests before a human drug trial could proceed; they reversed that decision in January. .” When they repeated the experiment on identical mice, of the same strain and from the same vendor, those mice gained bone density. A third experiment found no effect. Each animal had a different microbiome.

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Agency IQ

AUGUST 18, 2023

We’ve seen what’s been going on with the MDR, but the main concern we’ve heard of IVDR is the performance study application process is affecting drug trials. What is going to happen with the IVDR? A big question is how many of the IVDs that used to be self-certified (most of them) plan to remain on the market?

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