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Latest From Legal Issues

Generic Industry Hit With Avalanche Of Price Fixing Suits

As state attorneys general and Department of Justice move against generic manufacturers, plaintiffs’ firms have filed more than 90 antitrust suits on behalf of third party payers.

BioPharmaceutical Policy

Patient-Centered Promotion? Marathon's Non-Launch Of Emflaza Illustrates Challenge Of New Era

Can a company explain the situation surrounding a newly approved drug, including the effect of the indication on access, without violating off-label communication regulations?

Advertising, Marketing & Sales Legal Issues

Judge Gorsuch Could Be Pharma Ally In FDA Disputes

Supreme Court nominee's opposition to deference for administrative agencies could help biopharma industry in its battle over off-label communications if the issue ever goes before the court; he also supports securities litigation reform.

BioPharmaceutical Policy

Amgen Can't Stop Avastin Biosimilar 'Patent Dance' After Opting In, Genentech Says

Genentech seeks court order requiring Amgen to provide biosimilar manufacturing info so it can evaluate potential infringement; Supreme Court to hear Zarxio case on April 26.

BioPharmaceutical Policy

‘Intended Use’ Rule: Industry Urges US FDA To Revoke ‘Totality Of Evidence’ Standard

Trade groups say final rule would allow any activity to be considered evidence of a manufacturer’s intended use of a product and increase exposure to potential liability.

BioPharmaceutical Regulation

PSCK9 Battle: Sanofi Not Negotiating Praluent Fate With Amgen; Ruling Possible By June

Sanofi attorneys describe three possible outcomes of fight over injunction and validity of Repatha patents, and contrast litigation to other patent disputes where innovators did not seek removal of innovator product from market.

BioPharmaceutical Policy
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