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Latest From Legal Issues

English Court Queries EMA Primacy & Says Avastin Can Be Used In AMD

The English High Court has rejected attempts by Novartis and Roche to stop clinical commissioning groups from offering Avastin to wet AMD patients in a cost-containment move. In a development that has alarmed pharma firms, the court also questioned the exclusive role of the European Medicines Agency in marketing authorizations, saying that CCGs as well as the health technology assessment body, NICE, have competences in that area, and called on the UK regulator to review its guidance on off-label and unlicensed use.

Reimbursement Regulation

Dutch Insurer Seeks €4m from AZ Over ‘High’ Seroquel Price

AstraZeneca is being pursued in court for compensation over what a health insurer calls the “unnecessarily high price” that the company charged for Seroquel.

Pricing Debate Reimbursement

UK Court Opens Way To Generic Versions Of Gilead’s Truvada

The High Court has ruled that Gilead’s supplementary protection certificate on Truvada is invalid, opening the way to generic versions of the combination drug for preventing HIV infection.


Intellectual Property United Kingdom

Will CBO Score CREATE Momentum For Generic Bill's Passage?

Strong savings estimate – and brand pharma's need to have pay-fors for its own legislative priorities – could finally get bill allowing generic companies to sue brand sponsors for access to samples.
Generic Drugs Legislation

AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Advertising, Marketing & Sales Legal Issues

Bayer Fortifies Branding In OTC Naproxen Market With Win In Trademark Litigation

Bayer convinces federal court to affirm USPTO appeal board decision to cancel competitor Belmora’s Flanax US naproxen product trademark because the firm used packaging that resembled a Bayer product with the same name sold in Mexico. The ruling could provide standing for owners of foreign marks to assert priority rights over similar US marks, according to a patent attorney.

International Mexico
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