Novartis sues Cipla over generic Onbrez

Novartis has reportedly sued Cipla in the Delhi High Court for infringing patents related to Novartis’s Onbrez Breezhaler indacaterol DPI (Arcapta Neohaler). Cipla began marketing a generic indacaterol DPI called “Unibrez” in October; after losing a trademark infringement case, Cipla changed the product’s name to “Indaflo.” Cipla has claimed that there is a shortage of . . . Read more

Insmed provides update on its pipeline

According to Insmed, the company has filed an MAA for its Arikayce liposomal amikacin for inhalation, and it has been informed by the EMA that the only remaining issue, a review of the Pediatric Investigation Plan (PIP) by the agency’s Pediatric Committee, should be finished by the first quarter of 2015. A trial of Arikayce . . . Read more

Hovione announces results of FDA pre-approval inspection

Hovione has announced that the FDA has found its Loures, Portugal manufacturing site to be GMP compliant, although the agency issued a Form 483 citing three inspectional observations. The inspection took place from December 1 to December 5, 2014. In October 2013, the company announced that it had completed a successful FDA inspection of the . . . Read more