Latest from Dean Rudge
Sandoz is facing a lengthy wait for its proposed generic version of the touted mega blockbuster Caplyta (lumateperone), while the market waits with anticipation to see if the product’s robust IP can hold up to challenges from an additional six ANDA filers.
Boehringer Ingelheim “made it more difficult” for doctors to prescribe generic versions of its Spiriva (tiotropium) inhalers, Romania’s Competition Council has found, as it levied a fine of more than $25m on the German originator.
Hungary’s Gedeon Richter and its Japanese partner Mochida have together unveiled plans to file their proposed Actemra/RoActemra biosimilar with major regulators, after biosimilar competition to the IL-6 receptor inhibitor materialized in the US last year.
Viatris expressed confidence at the J.P. Morgan Healthcare Conference that it will hit its targets for complex injectables in 2025, while providing an update on its GLP-1 ambitions and its delinquent manufacturing facility in Indore, India.
A lot can happen in 24 hours, as Novartis can attest. The Swiss originator has managed to win a court order temporarily putting the brakes on MSN’s Entresto ANDA product – just hours after a lower court refused a similar request.
At the J.P. Morgan Healthcare Conference in San Francisco, Teva has provided a timeline for its much-talked-about long-acting injectable olanzapine candidate, after wrapping up a Phase III clinical trial with data that the firm believes will give it a major advantage over its competitors.