Advarra

NOVEMBER 29, 2022

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline. Improving Communication Between FDA and Sponsors.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

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The Pharma Data

OCTOBER 22, 2020

The Company intends to use the net proceeds from this offering to support its planned New Drug Application submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem, and for working capital and general corporate purposes.

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Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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Agency IQ

AUGUST 9, 2024

FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far Last month, the FDA published a new draft guidance document on diversity action plans. The section of the guidance on enrollment goals begins on page 11 of the document. Read AgencyIQ’s extensive analysis of the draft guidance here.]

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The Pharma Data

JULY 29, 2021

Gilead presented additional lenacapavir clinical development program data at the International AIDS Society (“IAS”) 2021 Conference on HIV Science. Kite announced a purchase agreement with BioNTech SE to acquire Kite’s solid tumor neoantigen T cell receptor R&D platform and clinical manufacturing facility in Gaithersburg, Maryland.

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PPD

JULY 11, 2023

To move patient diversity forward, our experts recommend a multi-dimensional lens to understand how the intersectionality of characteristics plays a role in diversifying clinical trials. Patient diversity in clinical research requires a multi-faceted approach. Document and track reasons for screen failure.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

For drugs, the rationale should describe data and information, if any, that suggest the potential for differential safety and effectiveness across the clinically relevant population, such as possible differences in PK or PD. 510(k) submission, De Novo classification request, Premarket Approval (“PMA”) application).

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The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Presentation Topic: Clinical Trials. Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program.

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The Pharma Data

APRIL 4, 2023

Forty-seven percent of patients had a documented baseline HbA1c of <5.7%. Merck has the industry’s largest immuno-oncology clinical research program. Forty-five percent of patients had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1 and 15% had an ECOG performance status of 2.

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Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. That said, FDA has not done nothing in 2024 related to clinical trial diversity.

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