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Latest From Helsinn Healthcare SA

2020 In Review: Despite Pandemic, The US FDA Issued Just 20% Fewer Drug GMP Warning Letters

The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.

Manufacturing Quality

Dr Reddy’s Wants To Break Into Top Five In India

Dr Reddy’s signals a sharp step up in ambitions at home, propelled by building leadership in 10 therapy segments and an “India-first” approach for specialty products. Uptick in the China business and the potential launch of a Russia-partnered COVID-19 vaccine were other aspects of the business discussed at JPM.

Strategy Biosimilars

With US Respiratory Pipeline Unlocked, Cipla Wants Lung Leadership

Cipla sees an incremental revenue opportunity of up to $500m for its US franchise by fiscal 2025 and expects to propel growth with strong execution of its complex generics pipeline. The company is also beginning to “lay the blueprint” in China and Brazil, it said at the J.P. Morgan Healthcare Conference.

Strategy Respiratory

Dr Reddy’s Wants To Break Into Top Five In India

Dr Reddy’s signals a sharp step up in ambitions at home, propelled by building leadership in 10 therapy segments and an “India-first” approach for specialty products. Uptick in the China business and the potential launch of a Russia-partnered COVID-19 vaccine were other aspects of the business discussed at JPM.

Commercial Biosimilars
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