News & Analysis as of

Competition Food and Drug Administration (FDA) Regulatory Requirements

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

Troutman Pepper Locke on

Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Bradley Arant Boult Cummings LLP

Cannabis Beverages: Fab or Fad?

Are cannabis beverages poised to take over the market for intoxicating beverages from alcoholic beverages, or are they simply the latest fad set to give way to alcoholic beverages’ century of dominance? A decade ago, the...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Biosimilars at the Crossroads: A $234 Billion Opportunity or a Missed Chance for Healthcare Savings?

The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...more

Husch Blackwell LLP

THC Beverage Makers and Distributors: Top 5 Concerns for 2025

Husch Blackwell LLP on

In the past couple of weeks, I have been contacted by a few major news outlets about the legality of “THC beverages“. While it sounds like you can only find these products in a state-licensed cannabis dispensary, reporters...more

Skadden, Arps, Slate, Meagher & Flom LLP

The FTC Challenges Companies’ Allegedly Improper Orange Book Patent Listings

The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more

Fish & Richardson

Biosimilars 2022 Year in Review

Fish & Richardson on

2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

Hogan Lovells

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

Hogan Lovells on

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives...more

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