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Latest From Organon USA Inc.

What Is An Acceptable Drug Discount? DOJ and Industry Disagree

Government contends a price reduction is the only discount exception to the Anti-Kickback Statute; PhRMA says this interpretation puts companies at risk of criminal liability for other discount arrangements.

Legal Issues Reimbursement

Ferring Wins In Combo Exclusivity Case; FDA Lacks 'Legitimate Reason' To Reject

Court finds FDA erred in not giving the fixed-dose combo product Prepopik five years of market exclusivity since it had awarded the exclusivity to similarly situated single-entity drug products.

Regulation Drug Review

Sugammadex Review: Has Merck Finally Put Safety Concerns To Rest?

Adequacy of data on risks of hypersensitivity/anaphylaxis and cardiac dysrhythmia with neuromuscular blockade reversal agent are focus of FDA advisory committee review.

BioPharmaceutical United States

Fertility Market Poised For Growth Spurt After Fallow Decade

Late-stage pipeline is dominated by follicle stimulating hormones, split between “biobetters” and biosimilars. Next-generation oxytocin antagonists are leading candidates for the next novel entities in infertility.

BioPharmaceutical
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