Companies

EPO Appeal Board overturns earlier ruling and invalidates Biogen’s 480mg Tecfidera patent, clearing the way for broader dimethyl fumarate competition in Europe.

FDA clears Accord’s first fully in-house biosimilars, with a US launch planned for its denosumab biosimilars in 2026.

Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.

Aeon’s cash infusion and upcoming FDA session, now rescheduled for early next year, positions firm to push ABP-450 biosimilar closer to market entry.

European Commission approval positions Celltrion to streamline hospital workflows, with modelling suggesting millions in potential annual savings for healthcare systems.

Approval of Gobivaz across the 30-country EEA introduces long-awaited competition to Simponi, though the partners have yet to confirm a commercial launch date.

The Italian specialty pharma says an underdiagnosed patient population will drive multi-year growth for its steroidogenesis inhibitor.

Lupin’s US launch of its long-acting risperidone marks the first commercial use of Nanomi’s PrecisionSphere platform, validating a decade-long bet on complex injectables.

Teva is continuing to decide whether to speed up the FDA review time for its proposed long-acting olanzapine injectable, though the company has numerous options for deploying its priority review voucher across a busy late-stage pipeline.

Korean biopharma firms are bracing for the impending US tariffs on pharmaceuticals and taking different approaches to tackle the situation.

Scrip brings you its quarterly roundup of earnings and other key developments in the Korean pharma sector including the acquisition of Taxotere by Boryung and the progress of Hanmi’s obesity contender.

Spun out of Mallinckrodt following its merger with Endo, Par Health begins operations as a major US producer of generics, sterile injectables and APIs, while Mallinckrodt’s remaining branded arm rebrands as Keenova Therapeutics.