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Generic Price Fixing Probe: First Charges Unsealed, More May Come Before Inauguration Day

 
• By Brenda Sandburg

Heritage Pharmaceuticals’ former CEO and former president charged by US DOJ with conspiracy to fix prices and allocate customers for doxycycline and glyburide; Heritage alleges they embezzled intellectual property.

United States Department of Justice headquarter building in Washington D.C.

The Department of Justice has filed the first charges in its two-year antitrust investigation of the generic drug industry, charging two former executives at Heritage Pharmaceuticals Inc. with conspiracy to fix prices and allocate customers for the antibiotic doxycycline and the diabetes drug glyburide.

The felony charges against former CEO Jeffrey Glazer and former president Jason Malek were unsealed Dec. 14 in the US District Court for the Eastern District of Pennsylvania. The charges do not identify their former company but refer to it as Company A

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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

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US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
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Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

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More from Biosimilars & Generics

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.