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Dragonfly Therapeutics and Bristol Myers Squibb Announce Exclusive Global License for Dragonfly’s IL-12 Investigational Immunotherapy Program

The Pharma Data

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products and the definitive agreement with Dragonfly (the “Definitive Agreement”).

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OPQ’s State of Pharmaceutical Quality Report Is a Data Bonanza (with Cameos by Eye Drops and Hand Sanitizers)

FDA Law Blog: Biosimilars

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. Last week, OPQ released its 6th Annual Report on the State of Pharmaceutical Quality. By Kalie E. Richardson & John W.M. Measured in raw numbers, the U.S.

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The National Products Association Challenges FDA’s Interpretation of the Dietary Supplement Exclusionary Clause

FDA Law Blog: Biosimilars

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. On August 28 of this year, NPA sued FDA challenging FDA’s determination that NMN is excluded from the dietary supplement definition.

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Available for Preorder: The 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. pharmaceutical distribution industry. If you have any questions before purchasing a license to the report, please email me ( afein@drugchannels.net ). d/b/a Drug Channels Institute.

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Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights

The Premier Consulting Blog

Determining if you have a combination product The high-level definition of combination product seems straightforward: a product with at least two constituent parts, such as: Drug/biologic (e.g., metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e) therapeutic drug/monoclonal antibody) Drug/device (e.g.,

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Building collaborations to fight a pandemic

The Pharma Data

Fortunately, as a member of the Novartis Business Development & Licensing (BD&L) department, she was in a position to try to help. Jennifer Leeds , Head of West Coast Search and Evaluation, NIBR Business Development & Licensing. I guess that’s the true definition of situational leadership.

Virus 52
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Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. Definitions from the existing E.U. Definitions from the existing E.U.