FDA rescinds Ranbaxy’s esomeprazole and valganciclovir ANDA tentative approvals because of GMP compliance issues; firm loses its 180-day marketing exclusivity for valganciclovir but not for esomeprazole.
Generic firms may soon launch generic versions of Roche’s antiviral Valcyte (valganciclovir) but it remains unclear whether Ranbaxy Laboratories Ltd.’s tie up of the generic market for AstraZeneca PLC’s heartburn drug Nexium (esomeprazole) will continue.
Ranbaxy announced in a Nov. 6 statement to the Indian Stock Exchange that FDA had rescinded the tentative approvals it...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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 AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.
