Sens. Elizabeth Warren (D-Mass.) and Shelley Moore Capito (R-W.Va.) urged FDA Commissioner Scott Gottlieb to task the agency’s opioid policy steering committee with promoting “partial fill” policies to limit the…
Facing a drastic loss of revenue and market share to a competing generic drug, Indivior said it will appeal an adverse federal court ruling on its patent for Suboxone (buprenorphine…
Novo Nordisk will pay more than $58 million for failing to comply with FDA regulations on risk disclosures for its diabetes medication Victoza. Source: Drug Industry Daily
If Congress were to require a Medicaid-style rebate structure for Medicare Part B prescription drugs, drugmakers would have to pay at least $1.8 billion in annual rebates — about 9…
The FDA finalized its 2015 guidance on reporting deviations for human cells, tissues and cellular and tissue-based products, also known as HCT/Ps, offering recommendations for complying with federal reporting requirements…
Insys Therapeutics should be prosecuted for efforts to increase use of its fentanyl spray Subsys, according to Sen. Claire McCaskill (D-Mo.), in a report from her investigation into opioid manufacturers…
The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU. Source: Drug Industry Daily
The European Medicines Agency is implementing a new form to submit required postmarket data on safety, efficacy and quality, and it is now a mandatory part of Module 1.0 of…
The FDA directed a Canadian opioid manufacturer to send information to doctors correcting the complete absence of warnings of serious risks associated with the drug in professional promotional materials distributed…
BIO and PhRMA filed a lawsuit challenging Nevada’s new price transparency law for diabetes drugs, arguing it oversteps the state’s authority. Source: Drug Industry Daily