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Latest From Grace Montgomery
Alvogen can sell in the US generic lenalidomide on a volume-limited basis after March 2022, and without volume limitations in early 2026, after settling patent litigation with Celgene relating to the originator’s Revlimid. Dr Reddy's has also settled in Canada.
Alvogen’s Lotus subsidiary and Cambrex are expanding their manufacturing capabilities in Taiwan and Canada respectively. As several firms reveal the results of FDA inspections, the agency slaps United Exchange Corporation with a warning letter.
A Q&A document has been released by the EMA outlining measures EU authorities are taking to prevent medicine shortages as a result of Brexit. Safety, medicine evaluation, clinical trials and supplies are all topics that are addressed in the text.
In 2018, Shanghai Fosun focused on core therapeutic areas, enhanced its international capabilities and promoted industrial upgrading; a strategy that enabled the Chinese firm to post annual sales that rose by over a third to RMB24.9 billion.
Lupin and YL Biologics have obtained approval from Japanese regulator PMDA to manufacture and sell biosimilar etanercept in the region. The firm has also just received GMP certification in the EU for its Indian Pune facility where the drug will be produced.
Multiple generic versions of Eli Lilly’s Cialis (tadalafil) tablets have been launched in the US, following the expiry of Teva’s 180-day exclusivity. The Israeli company introduced its first-to-file version of its Cialis rival in September 2018; now a number of firms have obtained approval, while others have launched generic alternatives.