BioPharmaceutical

A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.

The FDA said an ANDA managed to be submitted during a period when no new ANDAs could be accepted.

In the wake of recent FDA guidance setting out a streamlined approach to biosimilar registration, developers have spent the past month responding. While most reactions have been enthusiastic, some firms have sounded a note of caution.

Lupin announced US FDA approval for its Armlupeg (pegfilgrastim-unne) biosimilar and a licensing deal with Valorum in a span of a few days.

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

AstraZeneca, Lilly, Novo Nordisk and Amgen all moved up in the rankings on the Scrip 100 leaderboard powered by impressive double-digit growth.

The pharmaceutical industry continues to experience significant shifts in sales performance, with some companies achieving remarkable growth while others face stagnation or decline.

ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.

Propranolol prices that were almost five times higher in November meant that the beta-blocker topped our table of UK price rises this month, as ciprofloxacin prices also continued to climb.

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.

The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.