Baxter resolves US plant’s GMP whistleblower allegations for just $18m, a bargain compared to the $750m GlaxoSmithKline paid in 2010 and the $500m Ranbaxy paid in 2013. One reason: it was more narrowly focused.
The nearly $18.2m settlement with Baxter Healthcare Corp. that the Justice Department announced Jan. 12 pales in comparison to the only other GMP false claims settlements, the $750m settlement in October 2010 with GlaxoSmithKline PLC and the $500m settlement in May 2013 with Ranbaxy Laboratories Ltd.
As with the first two, the Baxter settlement included payment for both criminal and civil charges, but with relatively more...
While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.
