Respiratory

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.

FDA tobacco programs chief emphasizes moving smokers to lower risk alternatives and NIDA executive encourages proposals for e-cigarettes as nicotine replacement treatments. FDA also seizes $76m in unauthorized e-cigarettes.

Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.

Country Life Vitamins launches healthy aging support line as it announces less than half of US consumers in a recent survey were aware of biological processes that affect aging. Groupe Berken and Arctic Biosciences partner to bring to North America herring caviar oil extract in a supplement designed to support optimal health across all life stages.

The Avillion-partnered treatment has succeeded in the BATURA trial, adding to the body of evidence supporting Airsupra as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of disease severity.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Philips has issued a recall of various Trilogy ventilators due to safety issues that may affect their ability to properly function. The US FDA has designated the recall class I, its most serious.

The Swedish company is well positioned, and well financed with a bit of help from the French major, to push its idiopathic pulmonary fibrosis hopeful buloxibutid closer to the regulatory finishing line.

The IL-4/13 inhibitor was approved in the US for COPD, a blockbuster-sized indication, but the commercial ramp could take time and several competitors are on its heels. 

Philip Morris described a scenario of being essentially blacklisted by the health care sector and its CDMO partners as it threw in the towel on its £1.1bn acquisition of UK inhalation specialist Vectura. It agreed to offload the firm at a fraction of the initial cost.