Canadian firm received approval from FDA for NDA submitted in May 2023 for Lumify Preservative Free. A month earlier, FDA approved Dr. Reddy's ANDA submitted in July 2021 for an equivalent of Lumify’s formulation, brimonidine tartrate 0.025% ophthalmic solution.

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits. Scrip takes a look at the likely impact.

M&A edition: Mergers by Century/Clade, Eliem/Tenet, Kintara/TuHURA, Aditxt/Appili, Onconova/Traws and Apotex/Searchlight follow other companies joining forces in a tight cash environment.

Lupin and Zydus are targeting a market worth at least $1bn a year – and more than $2.4bn all told – after both in quick succession announcing the launch of generic versions of Astellas Pharma’s Myrbetriq treatment for overactive bladder.