FDA approves Ranbaxy's ANDA for 125 mg, 250 mg and 500 mg tablets of cefuroxime axetil Feb. 20. The approvals were cleared by FDA's denial of petitions for a stay of cefuroxime approvals filed by GlaxoSmithKline and PDI. "Ranbaxy has met its burden" to show that the partially crystalline cefuroxime axetil in its product is the 'same' as the amorphous cefuroxime axetil in GSK's Ceftin, FDA said. Patent infringement litigation brought in October 2000 continues over the 4,562,181 Ceftin patent (1"The Pink Sheet" Aug. 20, 2001, p. 17)...
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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.’
EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.
The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.
Claims for the dermatological appearing on websites and social media were challenged by Dupixent marketer Sanofi. Galderma said it would comply with the National Advertising Division’s recommendations, a move that underscores the challenging times for DTC advertisers.
