Lupin hopes a surge in demand for albuterol sulphate due to increased off-label use in COVID-19 patients will help its generic version, which is likely to be launched in the first half of FY21. But the Indian firm may recall a batch of metformin after the US FDA recently asked a few companies to retract extended-release versions due to NDMA concerns.
Lupin expects a shortage of albuterol sulphate in the US, caused by the drug's off-label use in COVID-19 patients, to aid sales of its generic to Teva’s Proair on launch.
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As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.
The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.
Sandoz has struck a deal worth up to $301m with Henlius giving it rights to a proposed ipilimumab biosimilar to Yervoy in countries across the world.
Reflecting increased regulatory pressure and a wider drive towards the reshoring of pharmaceutical manufacturing to the US, Speranza has launched a new generics business called Lotus Therapeutics.
Sandoz has struck a deal worth up to $301m with Henlius giving it rights to a proposed ipilimumab biosimilar to Yervoy in countries across the world.
Reflecting increased regulatory pressure and a wider drive towards the reshoring of pharmaceutical manufacturing to the US, Speranza has launched a new generics business called Lotus Therapeutics.
As its need for development resources declines, Iconovo is cutting staff to save money as it moves to the commercialization stage for its portfolio of off-patent inhaled products.
