Respiratory

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

Teva will have to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March, as the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

The European Medicines Agency is consulting on new requirements in its guideline on clinical trials for acute respiratory distress syndrome. The updates cover the selection of target population, choice of endpoints, use of biomarkers and pandemic preparedness.

The European Medicines Agency is considering whether apitegromab, brensocatib and diazoxide choline, from Scholar, Insmed and Soleno respectively, are drugs that are of potential major public health interest, particularly from the point of view of therapeutic innovation.

With sales remaining sluggish, on the back of fewer launches, Glenmark’s management nevertheless struck an upbeat tone when discussing the firm’s prospects in the US moving into the company’s 2026 financial year.

The CEO of Korean biotech Bridge Biotherapeutics shares progress and strategy for its lead candidate for IPF, along with thoughts on what Trump and the ongoing Korean political crisis might mean for the industry.

GSK’s depemokimab, if approved, could become the first ultra-long-acting drug for treating asthma and chronic rhinosinusitis with nasal polyps. Meanwhile, Sanofi’s teplizumab, which the US approved as the first disease-modifying therapy for type 1 diabetes in 2022, has now been filed for review by the European Medicines Agency.

Boston-area biotech Apnimed expects Phase III readouts for its obstructive sleep apnea combination drug by May. Patients with OSA are desperate for a pill to treat the condition, and GLP-1 agonists are only part of the solution.

The Teva v. Amneal battle over inhaler patents in the FDA’s Orange Book has become a noteworthy case that will impact both branded and generic drug companies. Yet, the clarity over patent listings might be overshadowed by possible future litigations, discussed law firm Polsinelli’s chair Chad Landmon with Generics Bulletin.

The fight between Teva and Amneal over the ProAir HFA inhaler has reached another milestone, with the appellate court affirming the previous ruling to delist five patents from the FDA’s Orange Book. However, Teva might not be backing down.