News & Analysis as of

Food and Drug Administration (FDA) Orphan Drugs Healthcare

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

Hogan Lovells

FDA’s Bendeka decision reverses approvals of Treanda generics

Hogan Lovells on

Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more

Mintz - ML Strategies

Health Care Update - October 2015

Mintz - ML Strategies on

Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

BakerHostetler

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

BakerHostetler on

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

Troutman Pepper

District Court Rules Pharmaceutical Manufacturers Are Not Required to Discount Orphan Drugs - Regardless of the Condition Being...

Troutman Pepper on

HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more

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