Aradigm Corp. (NSDQ:ARDM) shares tumbled today after the company reported that the FDA denied its application for an inhaled drug designed to treat non-cystic fibrosis bronchiectasis patients with chronic lung infections. The agency’s complete response letter reportedly highlighted an array of concerns with the initial application, including product quality and the company’s clinical data. Specifically, the […]
Respiratory
Medtech stories we missed this week: Jan. 26, 2018
From Attune Medical receiving FDA 510(k) clearance to Synapse Medical having CE Mark approval, here are some medtech stories we missed this week but thought were still worth mentioning. 1. Attune Medical gets FDA 510(k) clearance Attune Medical announced in a Jan. 8 press releasethat it has received FDA 510(k) clearance for its EnsoETM model […]
EMA committee backs label change for GSK’s Relvar Ellipta asthma therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that a European Medicines Agency committee has backed an updated label for its once-daily asthma therapy, Relvar Ellipta. If granted marketing authorization by the European Commission, the combination drug treatment will be approved for use in patients whose asthma is already controlled on an inhaled corticosteroid and a long-acting beta-2-agonist. […]
Adherium to expand in U.S. market with direct-to-consumer push for smart inhaler tech
Adherium Ltd. (ASK:ADR), which sells a smart inhaler technology in Europe and Australia, is reportedly looking to jump into the direct-to-consumer U.S. market in the first half of this year. The New Zealand-based company has a deal with AstraZeneca (NYSE:AZN) to combine its Smartinhaler monitoring device with the Symbicort inhaler, but CEO Arik Anderson told MobiHealthNews that he is […]
Pulmatrix wins EU nod for inhaled dry-powder anti-fungal trial
The UK Medicines and Healthcare Products Regulatory Agency has given Pulmatrix (NSDQ:PULM) the go-ahead to launch its first-in-human study for an inhaled formulation of the anti-fungal drug, itraconazole. The company is evaluating its drug, Pulmazole, as a treatment for allergic bronchopulmonary aspergillosis in patients with asthma. The 42-patient Phase I/Ib study is slated to assess the drug’s safety […]
EpiPen shortage in Canada to last until March
Pfizer Canada (NYSE:PFE) has warned Health Canada that there is a shortage of 0.3 mg EpiPen auto-injectors due to a manufacturing disruption. The company, which licenses the emergency allergy treatment from Mylan (NSDQ:MYL), reported that the problem should be resolved by March 2. There are no alternative auto-injectors available on the market in Canada for patients at […]
FDA revises label on opioid cold meds to limit pediatric use
The FDA this week announced that it’s mandating labeling changes to cut the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in kids under 18 years of age. The agency wrote in a statement that the risks of these drugs outweigh their potential benefits for children. The medications will also receive […]
Bellerophon brings inhaled nitric oxide into Ph2 pulmonary hypertension trial
Bellerophon Therapeutics (NSDQ:BLPH) has enrolled the first patient in a Phase IIb study assessing its INOpulse device in patients with pulmonary hypertension due to interstitial lung disease. The company’s placebo-controlled study is slated to evaluate the safety and efficacy of pulsed, inhaled nitric oxide in patients with PH-ILD, including those with idiopathic pulmonary fibrosis, Bellerophon reported. […]
AstraZeneca wins FDA nod to remove boxed warning from asthma drug label
After reviewing results from trials involving more than 41,000 asthma patients, the FDA has agreed to remove the boxed warning of serious asthma-related outcomes for AstraZeneca‘s (NYSE:AZN) Symbicort product. Patients using Symbicort, which combines an inhaled corticosteroid and a long-acting beta2-adrenergic agonist in a single inhaler, did not experience a significant increase in the risk […]
Aerogen, Lyomark ink inhaled surfactant deal
Aerogen and Lyomark Pharma said today that they inked a deal to develop an inhaled surfactant treatment for respiratory distress syndrome in pre-term infants. The pact calls for the duo to combine a compound called AP-002, a nasally inhaled surfactant based on a combination of Lyomark’s Alveofact bovine lung surfactant and Aerogen’s PDAP nasal delivery technology. Aerogen […]