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Latest From Legal Issues

Acthar Proposed Giveaway Program Raises Kickback Concerns, OIG Says

High price of Mallinckrodt’s H.P. Acthar Gel is important factor in conclusion, HHS Office of Inspector General advisory opinion notes.

Pricing Debate Medicaid

'Teva Has Earned Nothing,' US FDA Tells Court In Battle Over Generic Restasis 180-Day Exclusivity

Court orders agency to provide 48 hours' notice before issuing decision that would allow any manufacturer other than Teva to launch a generic.

Generic Drugs Legal Issues

AbbVie Inks Sixth Humira Biosimilar Settlement, Battles Boehringer's 'Unclean Hands' Claim

Boehringer stands out in its decision to litigate rather than settle, and the firm has obtained AbbVie's settlement agreements with other biosimilar makers.

Legal Issues Biosimilars

Pharma Slammed Over European Hospital Drug Shortages

A new survey has found that more than 90% of European hospital pharmacies see medicine shortages as an ongoing problem, and that more than a third experience shortages on a weekly basis. In many cases the pharmacists blame manufacturers for failing to notify them of impending shortages. 
Distribution Europe

AbbVie, Genentech Raise New Constitutional Challenge To Inter Partes Review

Firms contend that IPR should not apply to patents filed before America Invents Act was enacted, objecting to IPR decisions invalidating Humira, Avastin and Herceptin patents.

Legal Issues Intellectual Property

Amarin Says REDUCE-IT Results Are Off Limits To Omega-3 Supplement Claims

REDUCE-IT results are limited to Amarin's Vascepa "and cannot be extrapolated to omega-3 products that are materially different based on, for example, composition, dosage, and regulatory status," pharma firm says in complaints against Coromega and Omax. Amarin seeks to stifle the omega-3 supplement firms despite First Amendment argument it made in successful litigation against FDA to make truthful statements about its products even though the information is not approved by the agency.
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