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Mylan NV

www.mylan.com

Latest From Mylan NV

Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline

Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.

Biologics Legislation

Ranitidine Recalls Begin As European Regulators Take Action

OTC ranitidine products are among the first to be recalled in Europe following the discovery of a human carcinogen in ranitidine-based drugs.With investigations underway worldwide, regulators across Europe are split into two camps: immediate action or wait and see.

Product Recalls Drug Safety

Finance Watch: SpringWorks, Satsuma Launch IPOs; BioNTech Filing Shows US-China Trade War Impact

BioNTech has plenty of cash and is gearing up for an IPO, but money from a Hong Kong investor is in limbo. Plus, Satsuma and SpringWorks bring US IPO total to 34 this year, Fate's FOPO raises $150.5m and Pharvaris brings in $66m.

Financing Business Strategies

Apotex Mystery: Why Has Accord BioPharma Taken Its Place In US Biosimilar Pegfilgrastim Litigation?

Court grants request to substitute Accord BioPharma for Apotex in Amgen infringement suit. Apotex says it has no plans to exit the biosimilar business.

Biosimilars Legal Issues
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