Commercial Strategies

With two late-stage lupus assets finishing recruitment and a newly acquired nephrology franchise running three concurrent Phase III programs, Biogen is making its most significant commitment yet to immunology beyond its legacy MS business.

Collaboration aims to bring two biosimilars for osteoporosis and osteoarthritis to Mexico, with Saya leading commercialization and Enzene overseeing development and manufacturing.

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

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.

With Gilead reporting that both of its approved CAR-Ts saw sales declines as other products saw growth, a mixture of different competitive headwinds seems to be behind the disparities.

The pharmaceutical industry has been pushing back on a deeply unpopular rebate on products deemed to be “free combination” medicines in Germany.

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

The US FDA’s accelerated approval makes sevabertinib the second drug for that patient segment after BI’s Hernexeos, which won accelerated approval in August.

The pharmaceutical industry has been pushing back on a deeply unpopular rebate on products deemed to be “free combination” medicines in Germany.

The US FDA approved the menin inhibitor for NPM1-mutant relapsed/refractory acute myeloid leukemia.