Respiratory

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.

Teva vows to make two of its inhalers more accessible in the US through charity Direct Relief, despite still being tangled up in a lawsuit with Amneal over ProAir HFA. Also, another inhaler maker GSK is scrutinized over its pricey authorized generic alternative.

Aurobindo has revealed details of a product development and commercialization deal that it has struck for multiple respiratory products. However, the identity of its “global pharma major” partner remains a mystery for now.

Patients in the ICU continue to die from SARS-CoV-2-induced acute respiratory distress syndrome, says InflaRx, which is one of companies whose product the European Medicines Agency today announced should be approved for marketing in the EU.

The European Medicines Agency’s human medicines committee is meeting this week due to decide whether or not to back pan-EU marketing approval for a number of new drugs.

FDA’s OTC office director details a 2023 guidance as opening doors for NRT innovation at recent public meeting, but researchers and an industry executive note the most recent approval in the US for an innovative NRT was more than 20 years ago and say FDA isn’t allowing sufficient flexibility for approvals of new products or indications other than cessation related to quitting smoking.