FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. . ” About Ascletis.

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Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

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The Pharma Data

MARCH 7, 2022

The topline data further characterize the long-term safety profile of fezolinetant and will inform future regulatory filings. 1 About Fezolinetant Fezolinetant is an investigational, oral nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause.

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The Pharma Data

JULY 8, 2021

The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Please see the full Prescribing Information.

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The Pharma Data

JANUARY 17, 2021

“We are very pleased that EMA has acknowledged the potential Tessa’s CD30 CAR-T therapy holds for patients with Hodgkin Lymphoma” said Jeffrey H. These results were published in Journal of Clinical Oncology ( Ramos et al., BEDMINSTER, N.J. and SINGAPORE , Jan. Buchalter , President and CEO of Tessa Therapeutics.

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The Pharma Data

DECEMBER 22, 2020

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. A2 anticipates that the successful development of its allogeneic Tmod candidate therapy will enable subsequently developed allogeneic Tmod candidates.

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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.

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Drug Target Review

OCTOBER 10, 2024

What are the risks of over-reliance on healthy donor material in early-stage research, and how can decision-makers ensure a balanced integration of diseased material to avoid potential gaps when transitioning to clinical trials? Diseased cells are likely to be more fragile or less abundant, making it difficult to obtain enough for therapy.

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The Pharma Data

DECEMBER 13, 2020

NRG1 fusions are a rare genetic mutation that are increasingly recognized as a driver of multiple tumor malignancies, and an actionable target for HER3 targeted therapy. Up to 1% of all solid tumors harbor NRG1 fusions, therefore, it is important to identify this patient population and develop therapies that can treat them. [1].

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The Pharma Data

JANUARY 12, 2021

Working alongside KSQ will facilitate smart drug discovery and development of what we hope will be transformative new therapies for patients with intractable forms of cancer.”. KSQ and Takeda can collaborate on IND-enabling activities, with clinical development led by Takeda to explore multiple modalities.

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Drug Target Review

MAY 7, 2024

Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. For instance, AI algorithms could facilitate patient-trial matching, encompassing medical records, genetic information, demographics, and personal preferences.

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Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. The first guidelines published in 1996 and known as ICH GCP E6 provided guidance on the design, conduct, and reporting of clinical trials.

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The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly.

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The Pharma Data

JANUARY 17, 2021

LONDON–( BUSINESS WIRE )– Ixaka Ltd , an integrated cell and gene therapy company focused on the natural power of the body to cure disease, launches today. The new business will continue to develop Ixaka’s proprietary technologies – concentrated multi-cell therapies (MCTs) and targeted nanoparticle (TNP) therapeutics.

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The Pharma Data

JANUARY 27, 2021

HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG). For more information, please visit: www.harbourbiomed.com. CAMBRIDGE, Mass.

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Drug Target Review

JULY 18, 2024

However, what has really helped the sensitivity is using a tumour-informed approach where mutations found when sequencing the patient’s own tumour are part of the design. How is leveraging liquid biopsy leading to innovative trial designs in oncology and ultimately our ability to develop new drugs in the adjuvant setting?

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PPD

OCTOBER 16, 2023

There has been continuous growth in the variety and volume of available health care data, and newer applications for use of real-world data (RWD) and real-world evidence (RWE) to enhance the speed of patient access to new therapies. Consent development: Informed consent is the most important step in the tokenization process.

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The Pharma Data

DECEMBER 2, 2020

Based on the Phase 2 study findings to date, marstacimab may have the potential to offer improved bleed control via subcutaneous injection and potentially eliminate the need for prophylactic factor replacement, providing an enhanced treatment option compared to factor replacement therapy.”. About Pfizer Rare Disease. Pfizer Inc.:

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Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Read it now. The Altascientist : Issue No.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Why Partnering with Genetic Counselors May Benefit Your Clinical Program The American College of Medical Genetics (ACMG) has issued a statement that geneticists should be involved in the development of genetic therapies. These datasets can help find providers and patients based on genetic information.

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The Pharma Data

MARCH 17, 2022

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies, with research directed at earlier stages of disease and novel combinations. For further information, please visit the ETOP website: www.etop-eu.org. About Lung Cancer. In 2020 alone, there were more than 2.2

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Drug Target Review

OCTOBER 1, 2024

At the beginning of my career, during my scholarship, I worked for two years at a research institute where I set up a research project focused on the study of metronomic oral therapies for patients with metastatic breast cancer (BC). That paper, of which I was in the authorship, remains a current point of reference for that therapy usage.

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Drug Target Review

JUNE 6, 2023

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. For the last several years, the field has worked to unlock the potential of IO therapies for additional tumour types, and has explored options beyond checkpoint inhibitors.

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Drug Target Review

MAY 1, 2024

The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development. T-DM1, for example, is approved in patients with HER2-positive breast cancer and residual invasive cancer following neoadjuvant therapy.

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Cytel

OCTOBER 13, 2023

Written by Alind Gupta, Cytel; Haridarshan Patel, Horizon Therapeutics; and Jason Simeone, Cytel Ophthalmology is well-suited to using artificial intelligence (AI) methods because clinical decisions often rely on complex data-rich information from medical images of the eye and patient health status.

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The Pharma Data

JUNE 25, 2021

Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?) Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. About Eisai Co.,

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The Pharma Data

JUNE 7, 2023

Consider the potential for drug interactions prior to and during PREVYMIS therapy; review concomitant medications during PREVYMIS therapy; and monitor for adverse reactions associated with PREVYMIS and concomitant medications. See additional Selected Safety Information below. Source link: [link]

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Drug Target Review

APRIL 3, 2024

I am currently working as Chief Scientific Officer at CatalYm, where we translate the latest scientific findings into clinical applications. Our company has identified a new role for Growth Differentiation Factor 15 (GDF-15) as a potent local immunosuppressor mediating cancer resistance to therapy.

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PPD

NOVEMBER 14, 2023

In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. Here’s how we do it. Recruitment and talent management are critical to FSP performance.

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Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7 It can also potentially drive up net costs of the research.

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DrugBank

SEPTEMBER 26, 2024

While some clinical trials are necessary to confirm safety and efficacy in humans, these are typically smaller and shorter in duration compared to the extensive trials required for novel biopharmaceuticals. Future Outlook on Biosimilars  The biosimilar landscape is dynamic and continues to evolve.

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Precision for Medicine

APRIL 7, 2023

These labs are an integral part of the transformational infrastructure of capabilities Precision has built to accelerate the development of complex therapies.” This convergence of trials, labs, and data sciences is driving faster clinical development and approval. For more information, visit PrecisionForMedicine.com.

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The Pharma Data

SEPTEMBER 16, 2020

executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept. PDT , David M.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

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The Pharma Data

JANUARY 26, 2021

Short will be responsible for overseeing the clinical development of VarmX’s pipeline, including progression of its lead product, VMX-C001, into clinical proof of concept and registrational studies. During this time, he grew the medical, clinical, and regulatory groups, and established an in-house pharmacovigilance function.

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Precision for Medicine

JUNE 26, 2023

Unraveling the complexity of manufacturing next-gen biologics is critical to the shared mission of accelerating patient access to new therapies,” said Chad Clark, President of Precision for Medicine. This convergence is driving faster clinical development and approval. For more information, visit PrecisionForMedicine.com.

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