Cipla's Advair Generic US Debut May Be Pushed Out But 'Value Intact'
Cipla to pursue two-site, de-risked filing approach for large respiratory assets even as it awaits an FDA compliance classification for its Indore facility, which will determine the launch timelines for its much-awaited generic Advair in the US.
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Companies Vigilant As China Expands Wide-Ranging Anti-Espionage Legislation
The recent arrest of a local Japanese employee of Astellas triggered alarms for pharma firms operating in China, while a newly-expanded and wide-ranging anti-espionage law means that sponsors must pay careful attention to overseas data transfers, especially related to clinical trials, business intelligence and due diligence, as well as other activities.
The Quality Lowdown: Alvotech, Lupin, Cipla, Lilly, Rentschler Inspection Findings And Akorn Recall
US FDA finds flawed data integrity, investigations, aseptic practices and more at range of foreign and domestic drug product manufacturing facilities, while a bankruptcy leads to a massive drug recall.
'Brands Don’t Die': Cipla Grabs Rights To Novartis’ Galvus In India
Novartis draws up perpetual license agreement with Cipla for its vildagliptin brand in India. Experts weigh in on some deal nuances and whether the DPP-4 inhibitor can deliver long-term value in an ultra-competitive segment.