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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

Understanding the Pharmaceutical Market Dynamics The pharmaceutical industry is a complex ecosystem where branded drugs and generics coexist, each playing a vital role in patient care and market dynamics. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.

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FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)

FDA Law Blog: Biosimilars

Under the heading “Facilitating Competition” are multiple initiatives designed to either hasten development of generic drugs or limit blockades to market. FDA also asks for recall authority over drugs—both human and animal—to remove violative drug products from market “more quickly”.

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Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars

The Pharma Data

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

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FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

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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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. §

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Investment Trends in Pharmaceutical Research

DrugBank

This high attrition rate directly results from the scientific and regulatory hurdles that drug candidates must overcome. The Investment Landscape Despite these challenges, the potential rewards for successful drug development are substantial.

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Innovation Drives Excellence, Innovent Successfully Held 2020 Virtual R&D Day

The Pharma Data

Dr. Liu shared his over 30 years of R&D experience in drug development both in the global pharmaceutical companies and world renowned scientific research institutions. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.