Respiratory

A Senate report finds GSK’s withdrawal of Flovent and shift to an authorized generic increased costs, restricted access and disrupted asthma care, while helping the company avoid Medicaid rebates, raising broader concerns over pricing loopholes.

Novartis’s ianalumab, for treating Sjögren’s disease, is also among the new drugs that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.

So far this year, four drug candidates have secured a place on the European Medicines Agency’s priority medicines scheme for promising treatments for unmet medical needs.

Previously known only as AMP-007, the generic Atrovent HFA inhaler is now set for a Q2 launch with six months of exclusivity.

Glenmark says it plans to launch imminently the first US generic fluticasone propionate rival to Flovent, for which it has just received FDA approval – with an added bonus of 180 days of Competitive Generic Therapy exclusivity.

The company announced topline results from its Phase II VALIANT trial, which follow chronic rhinosinusitis data that it announced in September.

SK bioscience jumps into RSV preventive antibody space through new Gates alliance.

Transpire Bio continues to advance its complex generics franchise, with another Paragraph IV filing for GSK’s Ellipta portfolio inhaler.

CEO Ahmed Mousa believes buloxibutid represents a real breakthrough.

The US FDA approved the biologic as a twice-yearly add-on for patients with severe asthma with an eosinophilic phenotype.

Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.

NRTX-1001, taladegib and AZD0292 are the latest investigational products to make it onto PRIME, the European Medicines Agency’s priority medicines scheme for drugs for unmet medical needs.