Regulatory

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)… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .