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The next phase of the multiomics evolution, powered by AI

Drug Target Review

In 2003, the completion of the Human Genome Project was celebrated as the start of a new era in medicine. The problem is not a lack of genetic insight; instead, biological processes operate on a level that goes far beyond genetic sequences. Understanding health and disease requires more than reading the genomic code.

RNA 71
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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product.

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How AI and LLMs are transforming drug discovery: part 1

Drug Target Review

The challenges lie in regulated industries where governance frameworks for standard quantitative models dont necessarily apply to LLMs. The challenges lie in regulated industries where governance frameworks for standard quantitative models don’t necessarily apply to LLMs. For more: [link] ; [link] ; [link]

Drugs 69
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Navigating Regulatory Hurdles in Drug Development

DrugBank

Drug development is a complex and highly regulated process. While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. This means pharmaceutical companies must remain vigilant and adaptable to comply with evolving regulations. Regulatory agencies, such as the U.S.

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Inavolisib

New Drug Approvals

Members of the PI3K family regulate cellular processes such as cell growth and proliferation, survival, remodelling, and intracellular transport of organelles. [15] Koyasu S (April 2003). Combining inavolisib with palbociclib and fulvestrant might improve treatment of breast cancer. [14] 22 June 2021. Retrieved 21 September 2023.

FDA 57
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Levers for Biological Progress

Codon

A first draft was published in 2003; it was a patchwork of sequenced DNA from multiple people. It demands protocols, regulations, and collaborative efforts between human beings. Department of Energy and National Institutes of Health initiated a 15-year plan to map ‘the sequence of all 3.2

DNA 133
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Gamma delta T cells: a rising star in cancer therapy

Drug Target Review

from 2003 to 2006, covering the biotechnology and life-science tools sectors. Regulation of cutaneous malignancy by gammadelta T cells. J Exp Med 198(5):747-755 (2003). Previously, Mr Ho served as a Senior Equity Research Analyst at Bank of America from 2006 to 2009 and an Equity Research Analyst at Piper Jaffray & Co.

Therapies 105