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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...

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More from Policy & Regulation

Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 
• By Urtė Fultinavičiūtė

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

Fresenius Adds To Denosumab Competitors In Europe

 
• By Dave Wallace

At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.

Regulatory Recap: ICH To Determine The Future Of Biosimilar Comparative Efficacy Studies

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

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Alvotech And Advanz Add Three More In €160m EU Partnership Expansion

 
• By Dean Rudge

Fresh from filing a proposed biosimilar to Xolair (omalizumab) in the UK, Alvotech and Advanz have shaken hands on a further deal to expand their partnership.

After Dasatinib Apotex Debuts US Tasigna Competition

 
• By Dean Rudge

Canada’s Apotex is continuing to spearhead generic competition in the tyrosine kinase inhibitor (TKI) space for chronic myelogenous leukemia, with the launch of the first generic version of Novartis’ Tasigna (nilotinib) blockbuster.

Abiogen And mAbxience Join Forces In Italy

 
• By Dave Wallace

Spanish biosimilars developer mAbxience has struck a deal with Italy’s Abiogen covering an undisclosed biosimilar for the Italian market.