Regulatory

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

Senzer Pharmaceuticals said that it plans to launch its cannabinoid inhaler in the UK and elsewhere in Europe by the end of 2019 now that the device has received Class IIa Medical Device approval for the "safe and effective delivery of pharmaceutical cannabinoids." The company said that in the UK it planned to supply unlicensed products in the "Specials" … [Read more...] about Senzer cannabinoid inhaler gets CE mark

Russian biopharmaceutical company Generium JSC's dornase alfa biosimilar inhalation solution has received marketing approval from Russian regulators for the treatment of cystic fibrosis, according to its partner Selexis, which developed the cell line. Genentech's Pulmozyme dornase alfa inhalation solution has been approved in the US since 1993 and in Europe since … [Read more...] about Generium’s biosimilar of dornase alfa inhalation solution approved in Russia

The FDA has approved Akorn's ANDA for its azelastine hydrochloride nasal spray, 0.15%, for the treatment of allergic and perennial rhinitis in patients 6 years old and older, the company said.  In May 2019, the FDA approved Akorn's 0.1% azelastine hydrochloride nasal spray. According to Akorn, the nasal spray is manufactured at the company's facility in Amityville, … [Read more...] about FDA approves Akorn azelastine hydrochloride nasal spray