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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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inhibitors and histamine blockers, could have on the solubility of an orally administered drug, according to a new FDA draft guidance released Monday.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 Target Review

OCTOBER 3, 2024

FDA no longer needs to require animal tests before human drug trials [Internet]. 1975 Aug;256(5517):495–7. Crescioli S, Kaplon H, Chenoweth A, et al. Antibodies to watch in 2024. 2024 Jan 5;16(1). www.science.org. Available from: [link] ‌Baker M. Reproducibility crisis: Blame it on the antibodies. 2015 May;521(7552):274–6.

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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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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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Agency IQ

JULY 22, 2024

Because this also includes device studies that involve drug products , for instance when diagnostics are part of a drug trial, this has complicated development of what was already a complex and ambitious EUDAMED module.

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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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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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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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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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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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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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Agency IQ

AUGUST 23, 2024

The reclassification initiative: In February 2024, CDRH announced a new initiative to review the risk-based classifications of “most” IVDs that are regulated as “high risk” (Class III) devices to see if they could be appropriately regulated in a lower risk-based category (Class II, moderate risk).

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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 (..)

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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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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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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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Alta Sciences

JULY 31, 2024

Public Health Service Syphilis Study at Tuskegee, conducted between 1932 and 1972), as well as restrictions on equitable access to clinical services that continue to the present day. A 2022 study found that sharing results from a hypertension drug trial with 15% Black participants increased Black patients' confidence in the drug's effectiveness (..)

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Agency IQ

FEBRUARY 2, 2024

This remains a major area of concern for both industry and regulators, with a March 2023 survey from EFPIA finding that the challenges with the IVDR has led to issues with IVDs used in drug trials , and particularly cancer trials. Featuring previous research and expert analysis by Corey Jaseph.

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The Pharma Data

MAY 17, 2021

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). . Covid-19 Drugmakers Take On Your Favorite TV Shows to Tackle Vaccine Hesitancy ( WSJ ). Trump tax law cut what US drugmakers owed.

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