Regulatory

On November 1, 2019, Aquestive Therapeutics filed a citizen petition asking the FDA to stay approval of a 505(b)(2) NDA submitted by Neurelis in September 2018 for Valtoco diazepam nasal spray for the treatment of cluster seizures in epilepsy. Aquestive, which is developing a diazepam buccal oral film for the treatment of breakthrough seizures, says the agency … [Read more...] about Aquestive files citizen petition asking FDA to delay approval of Valtoco nasal spray

After having been notified that CHMP was likely to issue a negative opinion regarding its MAA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE), Aradigm has withdrawn the application. The company initially submitted the MAA in March 2018. Aradigm filed for … [Read more...] about Aradigm withdraws Linhaliq MAA

According to Aradigm Corporation, the company has been informed that its MAA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE) is likely to receive a negative opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). CHMP is scheduled to … [Read more...] about Aradigm says Linhaliq likely to receive negative opinion from CHMP

The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Janssen's Spravato esketamine nasal spray for use with either a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) for the treatment of treatment-resistant major depressive disorder, the company said. A final decision by the … [Read more...] about Janssen’s Spravato esketamine nasal spray gets positive opinion from CHMP

Janssen Pharmaceutical said that it has submitted a supplemental new drug application to the FDA requesting to expand the use of Spravato esketamine CIII nasal spray for the treatment of major depressive disorder in patients with active suicidal ideation with intent. The company recently published positive results from the Phase 3 ASPIRE 1 and 2 studies of Spravato … [Read more...] about Janssen submits sNDA for Spravato nasal spray

GlaxoSmithKline and Innoviva announced that GSK has submitted a supplemental new drug application for the use of the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of asthma. The FDA initially approved Trelegy Ellipta for the treatment of COPD in September 2017 and approved an sNDA to expand the indication for wider use of the DPI … [Read more...] about GSK submits sNDA for Trelegy Ellipta for the treatment of asthma

Savara said that the FDA provided a written response after a Type C meeting regarding the company's planned biologics license application (BLA) submission for Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) in which the agency recommended against … [Read more...] about FDA discourages BLA submission for Mogradex for aPAP

AstraZeneca Canada has announced today that Health Canada has approved the use of Symbicort Turbuhaler budesonide/formoterol DPI as an anti-inflammatory reliever for the treatment of mild persistent asthma.  According to the company, the expanded use was based on data from the Phase 3 SYGMA 1 and 2 trials. AstraZeneca Canada VP, Scientific … [Read more...] about Health Canada approves use of Symbicort Turbuhaler as anti-inflammatory reliever for mild persistent asthma

According to AstraZeneca, the FDA has issued a complete response letter to the company's NDA for PT010 budesonide/glycopyrronium/formoterol fumarate MDI for the treatment of COPD. AstraZeneca recently announced positive results from the Phase 3 ETHOS trial of PT010 and said that the MDI had been approved in Japan as Breztri Aerosphere. Results from the ETHOS trial … [Read more...] about AstraZeneca gets CRL for PT010