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FTC Wades Into ‘Rebate Walls’ And Biosimilar Access With Remicade Investigation

 
• By Cathy Kelly

Investigation may help define when rebate arrangements seeking to protect a brand against biosimilar competition are anticompetitive.

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FTC Investigating Issues Involved In Pfizer Lawsuit Against J&J, Pfizer Says

The US Federal Trade Commission is likely to consider whether manufacturers can use rebates and exclusive coverage arrangements with payers to block access to biosimilars with an investigation into Johnson & Johnson’s contracting for Remicade (infliximab).

“In June 2019, the United States Federal Trade Commission … issued a civil investigative demand to Johnson & Johnson in connection with its investigation of whether Janssen’s Remicade contracting practices violate federal antitrust laws,” J&J

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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.