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Regulatory Requirements › Prescription Drugs › Orphan Drugs

Knobbe Martens

Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth

Knobbe Martens on

The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more

Goodwin

Henlius Receives Orphan-Drug Designation for HLX22 (anti-HER2 mAb) for Gastric Cancer

Goodwin on

On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more

Goodwin

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

Goodwin on

On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect...more

Bricker Graydon LLP

340B Drug Pricing Program

Bricker Graydon LLP on

The 340B Drug Pricing Program has been a hot topic in Congress lately. It seems like new legislation and/or Congressional hearings related to the 340B Program pop up almost daily. ...more

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